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The current study is designed to determine the effect on mean glucose, hypoglycemia, glucagon usage, and insulin usage of adjusting upward the glucose target of the bi-hormonal bionic pancreas, and determine whether there is a target at which adequate glycemic control is achieved by an insulin-only bionic pancreas with minimal hypoglycemia.
We have two specific aims:
Aim 1 is to conduct an outpatient study testing multiple configurations of the bionic pancreas in 24 adult subjects with type 1 diabetes in a random cross-over study versus usual care with an insulin pump. These bionic pancreas configurations include the insulin only BP at 145 mg/dl set point, 130 mg/dl set point, 120 mg/dl set point and 110 mg/dl set point and the bihormonal BP at 130 mg/dl set point, 115 mg/dl set point and 110 mg/dl set point. These arms are all compared to usual care.
Aim 2 is to evaluate the incremental utility of glucagon in the context of automated insulin delivery by the bionic pancreas in preventing hypoglycemia during exercise in the fasted state. The 130 mg/dl set points and 110 mg/dl set points also participate in this fasted exercise visit. These two set points are double blinded, so neither the subjects nor the study staff are aware which arm is bihormonal and which arm is insulin only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Comparator week to all closed-loop control, utilizing usual diabetes care and the subject's own insulin pump. |
|
| 145 mg/dl Set Point - insulin only | Experimental | Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 145 mg/dl and using only an insulin pump. |
|
| 130 mg/dl Set Point - insulin only | Experimental | Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal. |
|
| 130 mg/dl Set Point - bihormonal | Experimental | Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal. |
|
| 115 mg/dl Set Point - bihormonal | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bionic Pancreas | Device | Participant wears the bionic pancreas, including an insulin and/or glucagon pump depending on which arm they are in. The 100 mg/dl arm for type 1 diabetes patients will deliver insulin and glucagon. The 100 mg/dl arm for type 2 diabetes patients will deliver just insulin. The 115 mg/dl arm will deliver insulin and glucagon. The 120 mg/dl arm will deliver just insulin. The 145 mg/dl arm will deliver just insulin. The 130 mg/dl and 110 mg/dl arms will deliver insulin and placebo, or insulin and glucagon, and will be double blinded. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Continuous Glucose Monitor (CGM) Glucose Values | Glucose values were collected from the Dexcom G4 CGM device every 5 minutes and an average (calculated mean with associated standard deviation) CGM glucose level (mg/dl) was calculated from days 2 and 3 of the study arm. | Days 2 and 3 |
| Percentage of Time With CGM < 60 mg/dl | For this calculation we analyzed data from every 5 minutes of CGM data for days 2 and 3 of each study arm. We looked specifically at the percentage time of those roughly 48 hours that had any glucose values less than 60 mg/dl. The final value presented is the percent of time per 2 days of the study arm spent in a specific hypoglycemia range of less than 60 mg/dl with an associated standard deviation. | Days 2 and 3 |
| Number of Subjects Discordant for Reaching a BG < 60 mg/dl for > 2 Consecutive Plasma Glucose Measurements During Inpatient Exercise Visit | During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes | Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean CGM Glucose | Average glucose according to continuous glucose monitor readings including the 1 day washout | Days 1 through 3 |
| Nausea Severity | The average severity of nausea, as recorded on a 10 centimeter visual analog scale by the daily e-mail survey they receive. Scores were determined by how many centimeters the subject marked as a surrogate for their nausea level on a daily basis. Any value more than 0 cm indicates some degree of nausea with a score of 10 cm being the worst nausea imaginable. A score less than 3 cm indicates a mild level of nausea. |
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Inclusion Criteria:
Type 1 Diabetes Subjects: Age ≥ 18 years and have had clinical type 1 diabetes for at least one year, and managed using an insulin pump for ≥ 6 months Type 2 Diabetes subjects: Age ≥ 18 years and have type 2 diabetes managed with rapid acting insulin in an insulin pump, or multiple daily injections including both long acting and short acting insulin
Exclusion Criteria:
oEpisodic or treatment refractory (requiring 4 or more medications to achieve normotension) hypertension oParoxysms of tachycardia, pallor, or headache oPersonal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease
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| Name | Affiliation | Role |
|---|---|---|
| Steven J Russell, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masscahusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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There were 24 subjects and a total of 9 study arms.The order of the arms was assigned in a psuedo random cross-over design. The 110 and 120 mg/dl arms were added later and were not included in the original randomization. 11 of the same subjects completed all 9 arms. Each arm had 20 subjects total, but these 20 were not the same cohort in each arm.
27 subjects were recruited and found eligible. Of the 27, only 24 subjects participated in the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | 110B, 110IO | Arms were completed in the following order: 110 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas |
| FG001 | 110B, 110IO, 120IO | Arms were completed in the following order: 110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas |
| FG002 | 110IO, 110B, 120IO | Arms were completed in the following order: 110 mg/dl insulin only bionic pancreas, 110 mg/dl bihormonal bionic pancreas, 120 mg/dl insulin only bionic pancreas |
| FG003 | UC, 115B, 100B, 145IO, 130B, 130IO | Arms were completed in the following order: usual care, 115 mg/dl bihormonal bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 145 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas |
| FG004 | 145IO, 100B, 130B, 130IO, UC, 115 | Arms were completed in the following order: 145 mg/dl insulin only bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 130 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas, usual care, 115 mg/dl bihormonal bionic pancreas |
| FG005 | UC, 115B, 145IO, 100B, 130IO, 130B | Arms were completed in the following order: usual care, 115 mg/dl bihormonal bionic pancreas, 145 mg/dl insulin only bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas |
| FG006 | 130B, 130IO, 115B, UC, 100B, 145IO, 120IO | Arms were completed in the following order: 130 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas, 115 mg/dl bihormonal bionic pancreas, usual care, 100 mg/dl bihormonal bionic pancreas, 145 mg/dl insulin only bionic pancreas, 120 mg/dl insulin only bionic pancreas |
| FG007 | 145IO, 100B, UC, 115B, 130IO, 130B, 110B, 110IO | Arms were completed in the following order: 145 mg/dl insulin only bionic pancreas, 100 mg/dl bihormonal bionic pancreas, usual care, 115 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas, 110 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas |
| FG008 | UC, 115B, 100B, 145IO, 130IO, 130B, 110IO, 110B | Arms were completed int he following order: usual care, 115 mg/dl bihormonal bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 145 mg/dl insulin only bionic pancreas, 130 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas, 110 mg/dl bihormonal bionic pancreas |
| FG009 | 130IO, 130B, UC, 145IO, 115B, 100B, 110B, 110IO | Arms were completed in the following order: 130 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas, usual care, 145 mg/dl insulin only bionic pancreas, 115 mg/dl bihormonal bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 110 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas |
| FG010 | 130B, 130IO, UC, 145IO, 115B, 100B, 110B, 110IO | Arms were completed in the following order: 130 mg/dl bihormonal bionic pancreas,130 mg/dl insulin only bionic pancreas, usual care, 145 mg/dl insulin only bionic pancreas, 115 mg/dl bihormonal bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas, 110 mg/dl bihormonal bionic pancreas |
| FG011 | 100B, 145IO, UC, 115B, 130IO, 130B, 110IO, 110B | Arms were completed in the following order: 100 mg/dl bihormonal bionic pancreas, 145 mg/dl insulin only bionic pancreas, usual care, 115 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas, 110 mg/dl bihormonal bionic pancreas |
| FG012 | 130IO, 130B, 145IO, 100B, 115B, UC, 110B, 110IO, 120IO | Arms were completed in the following order: 130 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 115 mg/dl bihormonal bionic pancreas Usual Care 110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas |
| FG013 | 115B, UC, 130B, 130IO, 145IO, 100B, 110IO, 110B, 120IO | Arms were completed in the following order: 115 mg/dl bihormonal bionic pancreas Usual Care 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas |
| FG014 | UC, 145IO, 130B, 130IO, 100B, 115B, 110IO, 110B, 120IO | Arms were completed in the following order: Usual Care 145 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 115 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas |
| FG015 | UC, 145IO, 130B, 130IO, 100B, 115B, 110B, 110IO, 120IO | Arms were completed in the following order: Usual Care 145 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 115 mg/dl bihormonal bionic pancreas 110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas |
| FG016 | 145IO, 100B, UC, 115B, 130B, 130IO, 110IO, 110B, 120IO | Arms were completed in the following order: 145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas Usual Care 115 mg/dl bihormonal bionic pancreas 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas |
| FG017 | 115B, UC, 130B, 130IO, 145IO, 100B, 110B, 110IO, 120IO | Arms were completed in the following order: 115 mg/dl bihormonal bionic pancreas Usual Care 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas |
| FG018 | 130IO, 130B, 145IO, 100B, 115B, UC, 110IO, 110B, 120IO | Arms were completed in the following order: 130 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 115 mg/dl bihormonal bionic pancreas Usual Care 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas |
| FG019 | 100B, 145IO, UC, 115B, 130IO, 130B, 110IO, 110B, 120IO | Arms were completed in the following order: 100 mg/dl bihormonal bionic pancreas 145 mg/dl insulin only bionic pancreas Usual Care 115 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas |
| FG020 | UC, 115B, 145IO, 100B, 130B, 130IO, 110B, 110IO, 120 | Arms were completed in the following order: Usual Care 115 mg/dl bihormonal bionic pancreas 145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas |
| FG021 | 145IO, 100B, 130B, 130IO, UC, 115B, 110IO, 110B, 120IO | Arms were completed in the following order: 145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas Usual Care 115 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas |
| FG022 | 130IO, 130B, 115B, UC, 100B, 145IO, 110B, 110IO, 120IO | Arms were completed in the following order: 130 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 115 mg/dl bihormonal bionic pancreas Usual Care 100 mg/dl bihormonal bionic pancreas 145 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
27 subjects were recruited and found eligible but 3 subjects chose not to participate in the study after eligibility determination
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Subjects | All subjects enrolled into the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Continuous Glucose Monitor (CGM) Glucose Values | Glucose values were collected from the Dexcom G4 CGM device every 5 minutes and an average (calculated mean with associated standard deviation) CGM glucose level (mg/dl) was calculated from days 2 and 3 of the study arm. | Posted | Mean | Standard Deviation | mg/dl | Days 2 and 3 |
|
Days 1-3 of each study arm
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Enrolled Subjects | All subjects enrolled into the study | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Courtney A Balliro | Massachusetts General Hospital | 617-726-1242 | cballiro@partners.org |
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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 | Jan 18, 2018 | May 5, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Some of the study arms are double blinded: the 110 mg/dl and 130 mg/dl set point configurations of the bionic pancreas are double blinded, so neither the patient nor the study team know if they are using the bihormonal bionic pancreas or insulin only bionic pancreas
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Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump. |
|
| 100 mg/dl Set Point - bihormonal | Experimental | Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump. |
|
| 110 mg/dl Set Point - insulin only | Experimental | Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal. |
|
| 110 mg/dl Set Point - bihormonal | Experimental | Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal. |
|
| 120 mg/dl Set Point - insulin only | Experimental | Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump. |
|
|
| Usual Care | Other | Participant cares for their diabetes according to their usual practice, with blinded CGM monitoring. No medication will be administered by the study in this intervention. |
|
| Days 1-3 |
| Percentage of Time Spent in: < 50 mg/dl, < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, >250 mg/dl | The fraction of time spent in each of these ranges according to continuous glucose monitor readings | Days 2-3 |
| Percentage of Subjects With Mean CGM < 154 mg/dl | The percentage of subjects who's mean CGM glucose level is < 154 mg/dl, which is an estimated hemoglobin a1c < 7%, which is the ADA goal for therapy | Days 2-3 |
| Area Between the Glucose Curve and 60 mg/dl Calculated From BG Measurements | Plasma glucose values to create this curve included time points from time 0 to a maximum of 360 minutes, with a sampling frequency of at least every 10 minutes throughout. | Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only) |
| Area Between the Glucose Curve and 60 mg/dl Calculated From CGM Measurements | CGM glucose values to create this curve included time points from time 0 to a maximum of 360 minutes, with a sampling frequency of every 5 minutes | Day 4 in-clinic Exercise Visit (type 1 diabetes only, 110 and 130 mg/dl arms only) |
| Time From Start of Exercise to First BG Measurement < 60 mg/dl | During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes | Day 4 in-clinic Exercise Visit (type 1 diabetes only, 110 and 130 mg/dl arms only) |
| Time From Start of Exercise to First CGM Measurement < 60 mg/dl | During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes | Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only) |
| Grams of Carbohydrates Given to the Subject to Treat Hypoglycemia | During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes | Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only) |
| Total Glucagon Dosing by the Bihormonal Bionic Pancreas From the Start of Exercise Until the End of the Visit | During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes | Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Hemoglobin A1c | Mean | Standard Deviation | percent |
|
| OG002 | 130 mg/dl Set Point - Insulin Only | Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal. |
| OG003 | 130 mg/dl Set Point - Bihormonal | Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal. |
| OG004 | 115 mg/dl Set Point - Bihormonal | Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump. |
| OG005 | 100 mg/dl Set Point - Bihormonal | Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump. |
| OG006 | 110 mg/dl Set Point - Insulin Only | Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal. |
| OG007 | 110 mg/dl Set Point - Bihormonal | Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal. |
| OG008 | 120 mg/dl Set Point - Insulin Only | Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump. |
|
|
| Primary | Percentage of Time With CGM < 60 mg/dl | For this calculation we analyzed data from every 5 minutes of CGM data for days 2 and 3 of each study arm. We looked specifically at the percentage time of those roughly 48 hours that had any glucose values less than 60 mg/dl. The final value presented is the percent of time per 2 days of the study arm spent in a specific hypoglycemia range of less than 60 mg/dl with an associated standard deviation. | Posted | Mean | Standard Deviation | percentage of time | Days 2 and 3 |
|
|
|
| Primary | Number of Subjects Discordant for Reaching a BG < 60 mg/dl for > 2 Consecutive Plasma Glucose Measurements During Inpatient Exercise Visit | During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes | Posted | Count of Participants | Participants | Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only) |
|
|
|
| Secondary | Mean CGM Glucose | Average glucose according to continuous glucose monitor readings including the 1 day washout | Posted | Mean | Standard Deviation | mg/dl | Days 1 through 3 |
|
|
|
| Secondary | Nausea Severity | The average severity of nausea, as recorded on a 10 centimeter visual analog scale by the daily e-mail survey they receive. Scores were determined by how many centimeters the subject marked as a surrogate for their nausea level on a daily basis. Any value more than 0 cm indicates some degree of nausea with a score of 10 cm being the worst nausea imaginable. A score less than 3 cm indicates a mild level of nausea. | Posted | Mean | Standard Deviation | scores on a scale 0-10 cm | Days 1-3 |
|
|
|
| Secondary | Percentage of Time Spent in: < 50 mg/dl, < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, >250 mg/dl | The fraction of time spent in each of these ranges according to continuous glucose monitor readings | Posted | Mean | Standard Deviation | percentage of time | Days 2-3 |
|
|
|
| Secondary | Percentage of Subjects With Mean CGM < 154 mg/dl | The percentage of subjects who's mean CGM glucose level is < 154 mg/dl, which is an estimated hemoglobin a1c < 7%, which is the ADA goal for therapy | Posted | Count of Participants | Participants | Days 2-3 |
|
|
|
| Secondary | Area Between the Glucose Curve and 60 mg/dl Calculated From BG Measurements | Plasma glucose values to create this curve included time points from time 0 to a maximum of 360 minutes, with a sampling frequency of at least every 10 minutes throughout. | Posted | Mean | Standard Deviation | min*mg/dl | Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only) |
|
|
|
| Secondary | Area Between the Glucose Curve and 60 mg/dl Calculated From CGM Measurements | CGM glucose values to create this curve included time points from time 0 to a maximum of 360 minutes, with a sampling frequency of every 5 minutes | Posted | Mean | Standard Deviation | min*mg/dl | Day 4 in-clinic Exercise Visit (type 1 diabetes only, 110 and 130 mg/dl arms only) |
|
|
|
| Secondary | Time From Start of Exercise to First BG Measurement < 60 mg/dl | During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes | Posted | Mean | Standard Deviation | minutes | Day 4 in-clinic Exercise Visit (type 1 diabetes only, 110 and 130 mg/dl arms only) |
|
|
|
| Secondary | Time From Start of Exercise to First CGM Measurement < 60 mg/dl | During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes | Posted | Mean | Standard Deviation | minutes | Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only) |
|
|
|
| Secondary | Grams of Carbohydrates Given to the Subject to Treat Hypoglycemia | During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes | Posted | Mean | Standard Deviation | grams of carbohydrates | Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only) |
|
|
|
| Secondary | Total Glucagon Dosing by the Bihormonal Bionic Pancreas From the Start of Exercise Until the End of the Visit | During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes | Posted | Mean | Standard Deviation | mcg/kg | Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only) |
|
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| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| < 70 mg/dl |
|
| 70-120 mg/dl |
|
| 70-180 mg/dl |
|
| > 180 mg/dl |
|
| > 250 mg/dl |
|