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| Name | Class |
|---|---|
| Boston University | OTHER |
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Subjects will participate in three weeks of the bionic pancreas in the insulin-only configuration. Each week, subjects will use a different rapid acting insulin analog -- Humalog, Novolog, or BC222 insulin lispro -- in a randomized cross-over order.
The investigators hypothesize that differences in the PK characteristics of insulin analogs will lead to differences in glycemic outcomes when delivered by the insulin-only configuration of the bionic pancreas. Specifically, the investigators predict that insulin analogs that have faster absorption (numerically lower Tmax and/or T½max) and insulin analogs that have faster clearance (numerically lower terminal half-life) will result in lower mean glucose and/or a lower percentage of time in the hypoglycemic range.
Up to 30 subjects will participate in three 7-day study arms using insulin lispro, insulin aspart, and BC222 lispro in the bionic pancreas in random order. The co-primary outcomes will be mean CGMG and fraction of time spent with CGMG <54 mg/dl with comparisons made between arms for individual participants. Secondary analyses will include time in glycemic ranges (<50, <60, <70, 70-120, 70-180, >180, >250 mg/dl), coefficient of variation, mean postprandial excursion (difference in CGMG from the time of meal announcement to the peak CGMG in the first 4 hours after the meal announcement) for both mixed meal challenges, number of symptomatic hypoglycemic events, grams of carbohydrate consumed to treat hypoglycemia, and TDD of insulin, between arms for individual subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bionic Pancreas - Humalog | Experimental | Subjects will participate in one week of wearing the insulin only bionic pancreas using humalog as the rapid acting insulin. |
|
| Bionic Pancreas - Novolog | Experimental | Subjects will participate in one week of wearing the insulin only bionic pancreas using novolog as the rapid acting insulin. |
|
| Bionic Pancreas - BC222 insulin lispro | Experimental | Subjects will participate in one week of wearing the insulin only bionic pancreas using BC222 insulin lispro as the rapid acting insulin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Humalog | Drug | Subjects will participate in one week of wearing the insulin only bionic pancreas using humalog as the rapid acting insulin. |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Continuous Glucose Monitor (CGM) Glucose | The average glucose achieved by the bionic pancreas as measured by the continuous glucose monitor during each arm | 7 days |
| Percentage of Time Spent With CGM Glucose < 54 mg/dl | The amount of time the subject spent in the hypoglycemic range < 54 mg/dl as measured by the continuous glucose monitor during each arm | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time Spent Within Each of the Following Ranges: | The amount of time subject's spent in each of the listed glucose ranges as measured by the continuous glucose monitor during each bionic pancreas arm | 7 days |
| Within Day Coefficient of Variation |
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Inclusion Criteria:
Exclusion Criteria:
Acceptable contraception methods include: Oral contraceptive pill (OCP), Intrauterine Device (IUD, hormonal or copper), Male condoms, Female condoms, Diaphragm or cervical cap with spermicide, Contraceptive patch (such as OrthoEvra), Contraceptive implant (such as Implanon, Nexplanon), Vaginal ring (such as NuvaRing), Progestin shot (such as Depo-Provera), Male partner with a vasectomy proven to be effective by semen analysis
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| Name | Affiliation | Role |
|---|---|---|
| Steven J Russell, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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20 subjects signed the consent form and screened into the study. 2 subjects were found to be ineligible after they were enrolled. 13 pariticpants were randomized. The numbers listed here, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No relevant data was collected from designated contacts.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin-only Bionic Pancreas With BC222 Lispro, Then Insulin Lispro, Then Insulin Aspart | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
| 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 | Jun 17, 2019 |
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Participants will be blinded to the type of insulin used in the iLet bionic pancreas each arm of the study.
|
| Novolog | Drug | Subjects will participate in one week of wearing the insulin only bionic pancreas using novolog as the rapid acting insulin. |
|
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| BC222 insulin lispro | Drug | Subjects will participate in one week of wearing the insulin only bionic pancreas using BC222 insulin lispro as the rapid acting insulin. |
|
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| Bionic Pancreas | Device | The insulin-only bionic pancreas will be used in all three arms of the study |
|
A measure of dispersion of glucose values around the mean |
| 7 days |
| Mean Post Prandial Excursion | Difference in CGMG from the beginning of the meal challenge to the peak CGMG in the 4 hours after the meal, for both mixed meal challenges. | 7 days |
| Number of Symptomatic Hypoglycemic Events Per Day | The number of times subjects report experiencing symptoms of hypoglycemia during each bionic pancreas arm | 7 days |
| Grams of Carbohydrates Consumed to Treat Hypoglycemia Per Day | The total amount of grams of carbohydrates subjects report having to take in for treatment of hypoglycemia | 7 days |
| Total Daily Dose of Insulin | The average total amount of insulin delivered daily by the bionic pancreas during each bionic pancreas arm. | 7 days |
| FG001 | Insulin-only Bionic Pancreas With BC222 Lispro, Then Insulin Aspart, Then Insulin Lispro | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
| FG002 | Insulin-only Bionic Pancreas With Insulin Lispro, Then BC222 Lispro, Then Insulin Aspart | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
| FG003 | Insulin-only Bionic Pancreas With Insulin Lispro, Then Insulin Aspart, Then BC222 Lispro | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
| FG004 | Insulin-only Bionic Pancreas With Insulin Aspart, Then BC222 Lispro, Then Insulin Lispro | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
| FG005 | Insulin-only Bionic Pancreas With Insulin Aspart, Then Insulin Lispro, Then BC222 Lispro | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
| COMPLETED |
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| NOT COMPLETED |
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20 participants consented to participate. 13 participants were randomized to complete three weeks using the insulin-only bionic pancreas. Only 6 completed all three arms.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts that is relevant to this protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin-only Bionic Pancreas With BC222 Lispro, Then Insulin Lispro, Then Insulin Aspart | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
| BG001 | Insulin-only Bionic Pancreas With BC222 Lispro, Then Insulin Aspart, Then Insulin Lispro | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
| BG002 | Insulin-only Bionic Pancreas With Insulin Lispro, Then BC222 Lispro, Then Insulin Aspart | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
| BG003 | Insulin-only Bionic Pancreas With Insulin Lispro, Then Insulin Aspart, Then BC222 Lispro | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
| BG004 | Insulin-only Bionic Pancreas With Insulin Aspart, Then BC222 Lispro, Then Insulin Lispro | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
| BG005 | Insulin-only Bionic Pancreas With Insulin Aspart, Then Insulin Lispro, Then BC222 Lispro | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
| BG006 | 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Hemoglobin A1c | Mean | Standard Deviation | percent of glycated hemoglobin |
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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 Continuous Glucose Monitor (CGM) Glucose | The average glucose achieved by the bionic pancreas as measured by the continuous glucose monitor during each arm | Posted | Mean | Standard Deviation | mg/dl | 7 days |
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| Primary | Percentage of Time Spent With CGM Glucose < 54 mg/dl | The amount of time the subject spent in the hypoglycemic range < 54 mg/dl as measured by the continuous glucose monitor during each arm | Posted | Mean | Standard Deviation | percentage of CGM glucose values | 7 days |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Time Spent Within Each of the Following Ranges: | The amount of time subject's spent in each of the listed glucose ranges as measured by the continuous glucose monitor during each bionic pancreas arm | Posted | Mean | Standard Deviation | percentage of CGM glucose values | 7 days |
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| Secondary | Within Day Coefficient of Variation | A measure of dispersion of glucose values around the mean | Posted | Mean | Standard Deviation | percentage of CGM glucose values | 7 days |
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| Secondary | Mean Post Prandial Excursion | Difference in CGMG from the beginning of the meal challenge to the peak CGMG in the 4 hours after the meal, for both mixed meal challenges. | Posted | Mean | Standard Deviation | mg/dl | 7 days |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Symptomatic Hypoglycemic Events Per Day | The number of times subjects report experiencing symptoms of hypoglycemia during each bionic pancreas arm | Posted | Mean | Standard Deviation | number of events | 7 days |
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| Secondary | Grams of Carbohydrates Consumed to Treat Hypoglycemia Per Day | The total amount of grams of carbohydrates subjects report having to take in for treatment of hypoglycemia | Posted | Mean | Standard Deviation | grams of carbohydrates | 7 days |
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| Secondary | Total Daily Dose of Insulin | The average total amount of insulin delivered daily by the bionic pancreas during each bionic pancreas arm. | Posted | Mean | Standard Deviation | units per kilogram per day | 7 days |
|
1 week of study participation using each insulin, for a total of up to three weeks of study intervention
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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 | Insulin-only Bionic Pancreas With BC222 Lispro | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG001 | Insulin-only Bionic Pancreas With Insulin Lispro | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Insulin-only Bionic Pancreas With Insulin-aspart | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. | 0 | 9 | 0 | 9 | 0 | 9 |
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The study was terminated, so only a limited number of participants completed all three interventions.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Steven J. Russell, MD, PhD | Massachusetts General Hospital | 617.726.1848 | sjrussell@mgh.harvard.edu |
| Feb 24, 2022 |
| Prot_SAP_000.pdf |
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| 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 |
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| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| D007328 | Insulin |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011384 | Proinsulin |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG002 | Insulin-only Bionic Pancreas With Insulin Aspart | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
|
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| OG002 | Insulin-only Bionic Pancreas With Insulin Aspart | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
|
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| OG002 | Insulin-only Bionic Pancreas With Insulin Aspart | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
|
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| OG002 | Insulin-only Bionic Pancreas With Insulin Aspart | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
|
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| OG002 | Insulin-only Bionic Pancreas With Insulin Aspart | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
|
|
| OG002 | Insulin-only Bionic Pancreas With Insulin Aspart | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
|
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| OG002 | Insulin-only Bionic Pancreas With Insulin Aspart | Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions. The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol. The study had be terminated before all participants could complete all interventions. All available data are reported here. |
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