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The study was terminated prior to completing the planned cohorts and analysis because of problems with the infusion set resulting in inadequate insulin delivery
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| Name | Class |
|---|---|
| Boston University | OTHER |
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This study will compare two different models of a wearable bionic pancreas device (the iPhone-based bionic pancreas vs. the iLet bionic pancreas) in adult participant with type 1 diabetes. Both bionic pancreas devices measure glucose levels every five minutes and then give insulin and/or glucagon automatically to regulate the blood glucose (BG).
The iPhone bionic pancreas has been used in earlier studies, during which volunteers used the system for up to 11 days at a time while living their normal lives at home and work. The iLet bionic pancreas has never been tested in humans. In this new study, volunteers will participate in a training visit to learn how both devices work. They will then use the iPhone-based BP for 1 day and the iLet BP for 1 day in random order using Lilly glucagon. They will then use the iLet BP for one additional day using Xeris Xerisol glucagon (a stable formulation of human glucagon).
A custom infusion set is required for this bihormonal system, to prevent future consumers from being able to accidentally swap their insulin and glucagon reservoirs and infusion sets, which could be potentially fatal. Previous experiments have demonstrated flaws in the infusion set design, requiring human experiments to be suspended and modifications to the infusion set be made. We believe the current infusion set has addressed these flaws by incorporating an anti-coring heel and a tri-beveled needle, and the infusion set sub-study is designed to isolate and study the infusion set function before further experiments using the iLet BP are conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iPhone bionic pancreas - Lilly glucagon | Active Comparator | iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits. |
|
| iLet bionic pancreas - Lilly glucagon | Experimental | iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits. |
|
| iLet bionic pancreas - Xerisol glucagon | Experimental | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. |
|
| iLet infusion set | Experimental | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. |
|
| Contact Detach infusion set | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iPhone bionic pancreas | Device | An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps |
| Measure | Description | Time Frame |
|---|---|---|
| Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Aggregate of Both Insulin and Glucagon Doses) | Average percent dose amounts calculated by the bionic pancreas control algorithm that are successfully delivered by the pump (aggregate of both insulin and glucagon doses) - primary outcome for iPhone-based BP using Lilly glucagon vs. iLet BP using Lilly glucagon | 8 hours |
| Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Glucagon Doses). | Average percent dose amounts calculated by the bionic pancreas control algorithm that are successfully delivered by the pump (glucagon doses) - - primary outcome for iLet BP using Lilly glucagon vs. iLet BP using Xeris Xerisol glucagon | 8 hours |
| Insulin Area Under the Curve in the 3.5 Hours Following the Insulin Bolus | This applies only to the infusion set sub-study | 3.5 hours following insulin bolus |
| Measure | Description | Time Frame |
|---|---|---|
| Average Continuous Glucose Monitor (CGM) Glucose | The average glucose according to continuous glucose monitor readings. This only applies to the iPhone vs. iLet BP experiments. | 8 hours |
| Percentage of Time in Each of the Following Ranges: < 50 mg/dl, < 60 mg/dl, <70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, >180 mg/dl, >250 mg/dl |
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Inclusion Criteria:
iPhone and iLet BP experiments
iLet Infusion Set Sub-Study
Exclusion Criteria:
iPhone and iLet BP experiments
iLet Infusion Set Sub-Study
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| Name | Affiliation | Role |
|---|---|---|
| Steven J Russell, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Diabetes Research Center | Boston | Massachusetts | 02114 | United States |
De-identified IPD will be published as online supplemental material to the main paper describing the results, as we have done for all of our previous bionic pancreas studies.
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| ID | Title | Description |
|---|---|---|
| FG000 | iPhone BP First, Then iLet BP (Lilly gLucagon) | iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits. iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2017 |
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The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. |
|
| iLet bionic pancreas | Device | An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. |
|
| Xeris Xerisol glucagon | Drug | A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
|
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| Lilly glucagon | Drug | An aqueous formulation of human glucagon with limited stability that must be changed daily |
|
|
| iLet infusion set | Device | The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
|
| Contact Detach infusion set | Device | The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
|
Percentage of time subjects spent in each of these ranges based on continuous glucose monitor readings. This only applies to the iPhone vs iLet BP visits. |
| 8 hours |
| Number of Subjects With Mean CGM Glucose < 154 mg/dl | The number of subjects who achieved a mean CGM glucose < 154 mg/dl, which correlates to an estimated hemoglobin a1c of 7%, which is the ADA goal for therapy. This applies only to the iPhone vs iLet BP experiments | 8 hours |
| Number of Severe Hypoglycemic Events (Subject Unable to Self-treat, Requiring the Assistance of Another Person) | The number of severe hypoglycemic events subjects experience. This applies only to the iPhone vs iLet BP experiments. | 8 hours |
| Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump. | The average percentage of successfully delivered insulin doses. This applies only to the iPhone vs iLet BP experiments. | 8 hours |
| Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump. | The average percentage of successfully delivered glucagon doses. This applies only to the iPhone vs iLet BP experiments. | 8 hours |
| Average Percent Insulin Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump. | The average percentage of successfully issued insulin doses that are then delivered successfully by the pump. This applies only to the iPhone vs iLet BP experiments. | 8 hours |
| Average Percent Glucagon Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That a Successfully Delivered by the Pump. | The average percentage of successfully issued glucagon doses that are then delivered successfully by the pump. This applies only to the iPhone vs iLet BP experiments. | 8 hours |
| Average Percent of 5 Minute Steps During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time CGM Data (New CGM Glucose Reading Captured, Dose Calculated, Dose Issued to Pumps | The percentage of time (measured in 5 minute "steps") that the bionic pancreas is working, indicated by the presence of a CGM reading, a successful dose calculation and successful issuing of a dose. This applies only to the iPhone vs iLet BP experiments. | 8 hours |
| Average Percent of 5 Minute Steps During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured (Dose Calculated, Dose Issued to Pumps). | The percentage of time (measured in 5 minute "steps") that the bionic pancreas is working even without a CGM reading being present, indicated by a successful dose calculation and successful issuing of a dose. This applies only to the iPhone vs iLet BP experiments. | 8 hours |
| CGM Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM. | A measure of CGM reliability, indicating the percentage of values the CGM displayed out of the total values it should have displayed in that time. This applies only to the iPhone vs iLet BP experiments. | 8 hours |
| Glucagon Total Delivery Per kg of Body Mass. | The average total glucagon delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments. | 8 hours |
| Insulin Total Delivery Per kg of Body Mass. | The average total insulin delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments. | 8 hours |
| Number of Episodes of Symptomatic Hypoglycemia. | Number of time subjects experienced symptoms of hypoglycemia and reported that to study staff. This applies only to the iPhone vs iLet BP experiments. | 8 hours |
| Total Grams of Carbohydrate Taken for Hypoglycemia. | The total grams of carbohydrates given to subjects for treatment of hypoglycemia. This applies only to the iPhone vs iLet BP experiments. | 8 hours |
| Difference in Mean Nausea From VAS During the Study | This applies only the iPhone vs. iLet BP experiments. Subjects were given a visual analog scale measuring 100 mm and asked to draw a line to indicate their level of nausea at timepoints during the study with 100 being the "worst possible nausea" and 0 being "no nausea". | 8 hours |
| Average Insulin Infusion Site Pain From VAS | This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments. Subjects were given a visual analog scale measuring 100 mm and asked to draw a line to indicate their level of pain at timepoints during the study with 100 being the "worst possible pain" and 0 being "no pain". | 8 hours |
| Difference in Local Erythema and Edema According to the Draize Scale | This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments. The draize scale assess erythema, eschar and edema using a score from 0-4, with 4 meaning a worse outcome. | 8 hours |
| Number of Unscheduled Infusion Set Replacements. | This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments. | 8 hours |
| Number of Unscheduled CGM Sensor Changes. | This applies only to the iPhone vs. iLet BP experiments | 8 hours |
| Insulin Area Under the Curve During the Initial 90 Minute Fasted Period | This applies only to the infusion set sub-study | 8 hours |
| Mean Insulin Levels During the Initial 90 Minute Fasted Period | This applies only to the infusion set sub-study | 8 hours |
| Difference Between Insulin Levels at Baseline and at 90 Minutes | This applies only to the infusion set sub-study | 8 hours |
| Tmax After the Insulin Dose | This applies only to the infusion set sub-study | 8 hours |
| T 1/2 Max After the Insulin Dose | This applies only to the infusion set sub-study | 8 hours |
| C Max After the Insulin Dose | This applies only to the infusion set sub-study | 8 hours |
| AUC in the First 30 Minutes After the Insulin Dose | This applies only to the infusion set sub-study | 8 hours |
| AUC in the First 60 Minutes After the Insulin Dose | This applies only to the infusion set sub-study | 8 hours |
| AUC in the First 90 Minutes After the Insulin Dose | This applies only to the infusion set sub-study | 8 hours |
| Terminal Half Life After the Insulin Dose | This applies only to the infusion set sub-study | 8 hours |
| Difference Between the Fasted PG Value and the PG Value at 90 Minutes | This applies only to the infusion set sub-study | Baseline Fasted State and 90 Minutes |
| Difference in the PG Prior to the Meal and Peak Post-prandial Glucose | This applies only to the infusion set sub-study | Pre-meal PG value and peak PG value during the 3.5 hours following the meal. |
| PG AUC in the 3.5 Hours Following the Meal | This applies only to the infusion set sub-study | 3.5 hours following the meal |
| FG001 | iLet BP First, Then iPhone BP (Lilly Glucagon) | iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits. iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. |
| FG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| FG003 | iLet Infusion Set First, Then Contact Detach | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| FG004 | Contact Detach Infusion Set First, Then iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| COMPLETED |
|
| NOT COMPLETED |
|
The study was terminated and the iLet BP arm with Xeris glucagon was never conducted.
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| ID | Title | Description |
|---|---|---|
| BG000 | iPhone Bionic Pancreas - Lilly Glucagon | iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits. iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed dailyy |
| BG001 | iLet Bionic Pancreas - Lilly Glucagon | iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily |
| BG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| BG003 | iLet Infusion Set First, Then Contact Detach | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| BG004 | Contact Detach First, Then iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Hemoglobin A1c | Mean | Standard Deviation | percent |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Aggregate of Both Insulin and Glucagon Doses) | Average percent dose amounts calculated by the bionic pancreas control algorithm that are successfully delivered by the pump (aggregate of both insulin and glucagon doses) - primary outcome for iPhone-based BP using Lilly glucagon vs. iLet BP using Lilly glucagon | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits. | Posted | Mean | Standard Deviation | percentage of doses delivered | 8 hours |
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| Primary | Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Glucagon Doses). | Average percent dose amounts calculated by the bionic pancreas control algorithm that are successfully delivered by the pump (glucagon doses) - - primary outcome for iLet BP using Lilly glucagon vs. iLet BP using Xeris Xerisol glucagon | This analysis only applies to the iLet BP using Lilly glucagon vs the iLet BP using Xerisol glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. Data for this outcome is reported for the iPhone BP and iLet BP arms using Lilly glucagon. This analysis does not apply to the infusion set sub study. | Posted | Mean | Standard Deviation | percentage of doses | 8 hours |
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| Primary | Insulin Area Under the Curve in the 3.5 Hours Following the Insulin Bolus | This applies only to the infusion set sub-study | This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed. | Posted | 3.5 hours following insulin bolus |
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| Secondary | Average Continuous Glucose Monitor (CGM) Glucose | The average glucose according to continuous glucose monitor readings. This only applies to the iPhone vs. iLet BP experiments. | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits. | Posted | Mean | Standard Deviation | mg/dl | 8 hours |
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| Secondary | Percentage of Time in Each of the Following Ranges: < 50 mg/dl, < 60 mg/dl, <70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, >180 mg/dl, >250 mg/dl | Percentage of time subjects spent in each of these ranges based on continuous glucose monitor readings. This only applies to the iPhone vs iLet BP visits. | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits. | Posted | Mean | Standard Deviation | percentage of time | 8 hours |
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| Secondary | Number of Subjects With Mean CGM Glucose < 154 mg/dl | The number of subjects who achieved a mean CGM glucose < 154 mg/dl, which correlates to an estimated hemoglobin a1c of 7%, which is the ADA goal for therapy. This applies only to the iPhone vs iLet BP experiments | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits. | Posted | Count of Participants | Participants | 8 hours |
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| Secondary | Number of Severe Hypoglycemic Events (Subject Unable to Self-treat, Requiring the Assistance of Another Person) | The number of severe hypoglycemic events subjects experience. This applies only to the iPhone vs iLet BP experiments. | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits. | Posted | Number | events | 8 hours |
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| Secondary | Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump. | The average percentage of successfully delivered insulin doses. This applies only to the iPhone vs iLet BP experiments. | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits. | Posted | Mean | Standard Deviation | percentage of doses | 8 hours |
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| Secondary | Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump. | The average percentage of successfully delivered glucagon doses. This applies only to the iPhone vs iLet BP experiments. | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits. | Posted | Mean | Standard Deviation | percentage of doses | 8 hours |
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| Secondary | Average Percent Insulin Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump. | The average percentage of successfully issued insulin doses that are then delivered successfully by the pump. This applies only to the iPhone vs iLet BP experiments. | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits. | Posted | Mean | Standard Deviation | percentage of doses | 8 hours |
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| Secondary | Average Percent Glucagon Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That a Successfully Delivered by the Pump. | The average percentage of successfully issued glucagon doses that are then delivered successfully by the pump. This applies only to the iPhone vs iLet BP experiments. | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits. | Posted | Mean | Standard Deviation | percentage of doses | 8 hours |
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| Secondary | Average Percent of 5 Minute Steps During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time CGM Data (New CGM Glucose Reading Captured, Dose Calculated, Dose Issued to Pumps | The percentage of time (measured in 5 minute "steps") that the bionic pancreas is working, indicated by the presence of a CGM reading, a successful dose calculation and successful issuing of a dose. This applies only to the iPhone vs iLet BP experiments. | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. | Posted | Mean | Standard Deviation | percentage of 5 minute steps | 8 hours |
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| Secondary | Average Percent of 5 Minute Steps During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured (Dose Calculated, Dose Issued to Pumps). | The percentage of time (measured in 5 minute "steps") that the bionic pancreas is working even without a CGM reading being present, indicated by a successful dose calculation and successful issuing of a dose. This applies only to the iPhone vs iLet BP experiments. | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. | Posted | Mean | Standard Deviation | percentage of 5 minutes steps | 8 hours |
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| Secondary | CGM Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM. | A measure of CGM reliability, indicating the percentage of values the CGM displayed out of the total values it should have displayed in that time. This applies only to the iPhone vs iLet BP experiments. | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. | Posted | Mean | Standard Deviation | percentage of CGM values | 8 hours |
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| Secondary | Glucagon Total Delivery Per kg of Body Mass. | The average total glucagon delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments. | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits. | Posted | Mean | Standard Deviation | mcg/kg | 8 hours |
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| Secondary | Insulin Total Delivery Per kg of Body Mass. | The average total insulin delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments. | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits. | Posted | Mean | Standard Deviation | units/kg | 8 hours |
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| Secondary | Number of Episodes of Symptomatic Hypoglycemia. | Number of time subjects experienced symptoms of hypoglycemia and reported that to study staff. This applies only to the iPhone vs iLet BP experiments. | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits. | Posted | Number | number of episodes | 8 hours |
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| Secondary | Total Grams of Carbohydrate Taken for Hypoglycemia. | The total grams of carbohydrates given to subjects for treatment of hypoglycemia. This applies only to the iPhone vs iLet BP experiments. | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits. | Posted | Number | number of grams of carbohydrates | 8 hours |
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| Secondary | Difference in Mean Nausea From VAS During the Study | This applies only the iPhone vs. iLet BP experiments. Subjects were given a visual analog scale measuring 100 mm and asked to draw a line to indicate their level of nausea at timepoints during the study with 100 being the "worst possible nausea" and 0 being "no nausea". | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits. | Posted | Mean | Standard Deviation | score on a scale | 8 hours |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Average Insulin Infusion Site Pain From VAS | This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments. Subjects were given a visual analog scale measuring 100 mm and asked to draw a line to indicate their level of pain at timepoints during the study with 100 being the "worst possible pain" and 0 being "no pain". | The experimental arm with the iLet BP using Xeris glucagon was never conducted. Analysis includes 9 subjects that completed both the BP visits and 4 subjects that completed both infusion set sub study visits. | Posted | Mean | Standard Deviation | score on a scale | 8 hours |
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| Secondary | Difference in Local Erythema and Edema According to the Draize Scale | This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments. The draize scale assess erythema, eschar and edema using a score from 0-4, with 4 meaning a worse outcome. | The experimental arm with the iLet BP using Xeris glucagon was never conducted. Analysis includes 9 subjects that completed both the BP visits and 4 subjects that completed both infusion set sub study visits. | Posted | Mean | Standard Deviation | score on a scale | 8 hours |
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| Secondary | Number of Unscheduled Infusion Set Replacements. | This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments. | The experimental arm with the iLet BP using Xeris glucagon was never conducted. Analysis includes 9 subjects that completed both the BP visits and 4 subjects that completed both infusion set sub study visits. | Posted | Number | number of infusion set changes | 8 hours |
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| Secondary | Number of Unscheduled CGM Sensor Changes. | This applies only to the iPhone vs. iLet BP experiments | This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits. | Posted | Number | number of sensor changes | 8 hours |
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| Secondary | Insulin Area Under the Curve During the Initial 90 Minute Fasted Period | This applies only to the infusion set sub-study | This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed. | Posted | 8 hours |
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| Secondary | Mean Insulin Levels During the Initial 90 Minute Fasted Period | This applies only to the infusion set sub-study | This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed. | Posted | 8 hours |
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| Secondary | Difference Between Insulin Levels at Baseline and at 90 Minutes | This applies only to the infusion set sub-study | This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed. | Posted | 8 hours |
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| Secondary | Tmax After the Insulin Dose | This applies only to the infusion set sub-study | This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed. | Posted | 8 hours |
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| Secondary | T 1/2 Max After the Insulin Dose | This applies only to the infusion set sub-study | This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed. | Posted | 8 hours |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | C Max After the Insulin Dose | This applies only to the infusion set sub-study | This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed. | Posted | 8 hours |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC in the First 30 Minutes After the Insulin Dose | This applies only to the infusion set sub-study | This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed. | Posted | 8 hours |
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| Secondary | AUC in the First 60 Minutes After the Insulin Dose | This applies only to the infusion set sub-study | This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed. | Posted | 8 hours |
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| Secondary | AUC in the First 90 Minutes After the Insulin Dose | This applies only to the infusion set sub-study | This outcome only applies to the infusion set sub study, the other arms were not analyzed.The infusion set sub study was terminated and the insulin assays were not completed. | Posted | 8 hours |
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| Secondary | Terminal Half Life After the Insulin Dose | This applies only to the infusion set sub-study | This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed. | Posted | 8 hours |
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| Secondary | Difference Between the Fasted PG Value and the PG Value at 90 Minutes | This applies only to the infusion set sub-study | This outcome only applies to the infusion set sub study, the other arms were not analyzed. The Overall Number of Participants Analyzed represents all Completed participants that received the intervention | Posted | Mean | Standard Deviation | mg/dl | Baseline Fasted State and 90 Minutes |
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| Secondary | Difference in the PG Prior to the Meal and Peak Post-prandial Glucose | This applies only to the infusion set sub-study | This outcome only applies to the infusion set sub study, the other arms were not analyzed. The Overall Number of Participants Analyzed represents all Completed participants that received the intervention | Posted | Mean | Standard Deviation | mg/dl | Pre-meal PG value and peak PG value during the 3.5 hours following the meal. |
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| Secondary | PG AUC in the 3.5 Hours Following the Meal | This applies only to the infusion set sub-study | This outcome only applies to the infusion set sub study, the other arms were not analyzed. The Overall Number of Participants Analyzed represents all Completed participants that received the intervention | Posted | Mean | Standard Deviation | mg*min/dl | 3.5 hours following the meal |
|
During study visits up to 8 hours long
There were no participants at risk for Serious Adverse Events, All-Cause Mortality and any other adverse events in the arm using the iLet bionic pancreas with Xerisol glucagon, because that arm was not conducted.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | iPhone Bionic Pancreas - Lilly Glucagon | iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits. iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily | 0 | 9 | 0 | 9 | 0 | 9 |
| EG001 | iLet Bionic Pancreas - Lilly Glucagon | iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily | 0 | 12 | 0 | 12 | 7 | 12 |
| EG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | iLet Infusion Set | iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG004 | Contact Detach | Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. | 0 | 7 | 0 | 7 | 0 | 7 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Endocrine disorders | Non-systematic Assessment | Hyperglycemia (may or may not include associated ketosis and vomiting) found to be associated with insulin infusion set failure |
|
The original planned experiments and infusion set sub study were terminated early due to infusion site failures before the planned cohorts were completed. Changes to the infusion set design will be implemented prior to initiating any future studies.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Courtney Balliro | MGH Diabetes Research Center | 617-726-1242 | cballiro@partners.org |
| Aug 5, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
Not provided
Not provided
| ID | Term |
|---|---|
| D005934 | Glucagon |
| ID | Term |
|---|---|
| D052336 | Proglucagon |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
|
| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
|
|
| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
|
|
| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
|
|
| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
|
|
| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
|
|
| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
|
|
| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
|
|
| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
|
|
| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
|
|
| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
|
|
| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
|
|
| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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| OG002 |
| iLet Bionic Pancreas - Xerisol Glucagon |
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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| OG002 |
| iLet Bionic Pancreas - Xerisol Glucagon |
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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| OG002 | iLet Bionic Pancreas - Xerisol Glucagon | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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| iLet Bionic Pancreas - Xerisol Glucagon |
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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| OG002 |
| iLet Bionic Pancreas - Xerisol Glucagon |
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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| iLet Bionic Pancreas - Xerisol Glucagon |
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump |
| OG003 | iLet Infusion Set | iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
| OG004 | Contact Detach Infusion Set | Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. |
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