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| Name | Class |
|---|---|
| Boston University | OTHER |
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This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers glucagon only can prevent or treat hypoglycemia vs. usual care for people with type 1 diabetes > 21 years old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucagon-only Bionic Pancreas (active) | Active Comparator | Glucagon-only Bionic Pancreas will deliver glucagon during 7 of the 14 days. The order of the glucagon days will be randomized in blocks of 2, with no more than 2 days in a row of glucagon. |
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| Glucagon-only Bionic Pancreas (placebo) | Placebo Comparator | Glucagon-only Bionic Pancreas will deliver placebo during 7 of the 14 days. The order of the placebo days will be randomized in blocks of 2, with no more than 2 days in a row of placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucagon-only Bionic Pancreas | Device | A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl | From t=0 to study stop after 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime | 2 weeks | |
| Number of Hypoglycemic Episodes With CGMG < 50 mg/dl | From t=0 to study stop after 2 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Label | URL |
|---|---|
| Information about this and related studies | View source |
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31 participants were enrolled in the trial, but only 22 participants actually participated. 4 subjects were not eligible to participate. The remaining 5 subjects that did not participate were considered "back up" or "benched" subjects who were eligible and willing to participate, but were not required to meet our desired total cohort.
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| ID | Title | Description |
|---|---|---|
| FG000 | Glucagon-only Bionic Pancreas | Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day). Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Glucagon-only Bionic Pancreas | Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day). Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl | Posted | Mean | Standard Deviation | mg/dl/min | From t=0 to study stop after 2 weeks |
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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 | Glucagon-only Bionic Pancreas | Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day). Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Steven J Russell | Massachusetts General Hospital | 617-726-1848 | sjrussell@partners.org |
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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 |
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|
| Number of Hypoglycemic Episodes With CGMG < 60 mg/dl |
| from t=0 to study stop after 2 weeks |
| Number of Hypoglycemic Episodes With CGMG < 70 mg/dl | from t=0 to study stop after 2 weeks |
| Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All CGMG Measurements: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl, >180 mg/dl, >250 mg/dl | from t=0 to stud stop after 2 weeks |
| Count of Subjects With Mean CGMG < 154mg/dl | from t=0 to study stop after 2 weeks |
| Mean CGMG During Exercise | Times of exercise were not collected during the study, and therefore this outcome cannot be calculated. | 2 weeks |
| Mean Absolute Relative Deviation (MARD) vs. Subset of BG Measurements Before Meals and at Bedtime | Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome. | 2 weeks |
| Mean Absolute Relative Deviation (MARD) Between Capillary Blood Glucose and CGM Glucose Values | Paired values between the blood glucose measurements and CGM glucose measurements were compared, and the percent difference was recorded. The mean of the absolute value of all the differences is reported here, and reflects the accuracy of the CGM glucose measurements relative to the capillary blood glucose measurements. | from t=0 to study stop after 2 weeks |
| Number of Hypoglycemic Events (< 60 mg/dl) as Determined From BG Measurements | from t=0 to study stop after 2 weeks |
| Average BG as Determined From the Measurements Taken Before Meals and Before Bedtime | Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome. | 2 weeks |
| Percentage of the BG Values Taken Before Meals and Before Bedimte Less Than 70 mg/dl | Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome. | 2 weeks |
| Number of All BG Values Less Than 70 mg/dl | from t=0 to study stop after 2 weeks |
| Number of Study Days With Mean BG < 154 mg/dl | 2 weeks |
| Fraction Measurements Within Each of the Following Glucose Ranges as Determined From HemoCue Measurements Taken Before Meals and Before Bed: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl | Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome. | 2 weeks |
| Mean BG During Exercise | Times of exercise were not collected during the study, and therefore this outcome cannot be calculated. | 2 weeks |
| • Fraction of BG Values < 70 During Exercise Fraction of BG Values < 70 During Exercise | Times of exercise were not collected during the study, and therefore this outcome cannot be calculated. | 2 weeks |
| Number of Carbohydrate Interventions for Hypoglycemia | from t=0 to study stop after 2 weeks |
| Total Number of Grams of Carbohydrate Taken for Hypoglycemia | from t=0 to study stop after 2 weeks |
| Insulin Total Daily Dose | from t=0 to study stop after 2 weeks |
| • Number of Carbohydrate Interventions for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM) | Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated | 2 weeks |
| Total Number of Grams of Carbohydrate Taken for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM) | Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated | 2 weeks |
| Number of Carbohydrate Interventions for Hypoglycemia Overnight (11:00 PM - 7:00 AM) | Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated | 2 weeks |
| Total Number of Grams of Carbohydrate Taken for Hypoglycemia Overnight (11:00 PM - 7:00 AM) | Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated | 2 weeks |
| Total Glucagon Dosing (mcg/kg/24 Hours) | from t=0 to study stop after 2 weeks |
| Episodes of Nausea Per Day on Glucagon vs Placebo | from t=0 to study stop after 2 weeks |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime | Posted | Mean | Standard Deviation | percentage of time | 2 weeks |
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| Secondary | Number of Hypoglycemic Episodes With CGMG < 50 mg/dl | Posted | Mean | Standard Deviation | number of episodes | From t=0 to study stop after 2 weeks |
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| Secondary | Number of Hypoglycemic Episodes With CGMG < 60 mg/dl | Posted | Mean | Standard Deviation | number of episodes | from t=0 to study stop after 2 weeks |
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| Secondary | Number of Hypoglycemic Episodes With CGMG < 70 mg/dl | Posted | Mean | Standard Deviation | number of episodes | from t=0 to study stop after 2 weeks |
|
|
|
| Secondary | Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All CGMG Measurements: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl, >180 mg/dl, >250 mg/dl | Posted | Mean | Standard Deviation | percentage of time | from t=0 to stud stop after 2 weeks |
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| Secondary | Count of Subjects With Mean CGMG < 154mg/dl | Posted | Count of Participants | Participants | from t=0 to study stop after 2 weeks |
|
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| Secondary | Mean CGMG During Exercise | Times of exercise were not collected during the study, and therefore this outcome cannot be calculated. | Times of exercise were not collected during the study, and therefore this outcome cannot be calculated. | Posted | 2 weeks |
|
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| Secondary | Mean Absolute Relative Deviation (MARD) vs. Subset of BG Measurements Before Meals and at Bedtime | Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome. | Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome. | Posted | 2 weeks |
|
|
| Secondary | Mean Absolute Relative Deviation (MARD) Between Capillary Blood Glucose and CGM Glucose Values | Paired values between the blood glucose measurements and CGM glucose measurements were compared, and the percent difference was recorded. The mean of the absolute value of all the differences is reported here, and reflects the accuracy of the CGM glucose measurements relative to the capillary blood glucose measurements. | This analysis is not broken down according to randomization, because it is intended to give context to the other CGM reported outcomes by reflecting the accuracy of the CGM. | Posted | Mean | Standard Deviation | percent difference | from t=0 to study stop after 2 weeks |
|
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| Secondary | Number of Hypoglycemic Events (< 60 mg/dl) as Determined From BG Measurements | Posted | Mean | Standard Deviation | number of events | from t=0 to study stop after 2 weeks |
|
|
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| Secondary | Average BG as Determined From the Measurements Taken Before Meals and Before Bedtime | Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome. | Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome. | Posted | 2 weeks |
|
|
| Secondary | Percentage of the BG Values Taken Before Meals and Before Bedimte Less Than 70 mg/dl | Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome. | Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome. | Posted | 2 weeks |
|
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| Secondary | Number of All BG Values Less Than 70 mg/dl | Posted | Mean | Standard Deviation | number of values | from t=0 to study stop after 2 weeks |
|
|
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| Secondary | Number of Study Days With Mean BG < 154 mg/dl | Posted | Mean | Standard Deviation | number of days | 2 weeks |
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| Secondary | Fraction Measurements Within Each of the Following Glucose Ranges as Determined From HemoCue Measurements Taken Before Meals and Before Bed: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl | Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome. | Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome. | Posted | 2 weeks |
|
|
| Secondary | Mean BG During Exercise | Times of exercise were not collected during the study, and therefore this outcome cannot be calculated. | Times of exercise were not collected during the study, and therefore this outcome cannot be calculated. | Posted | 2 weeks |
|
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| Secondary | • Fraction of BG Values < 70 During Exercise Fraction of BG Values < 70 During Exercise | Times of exercise were not collected during the study, and therefore this outcome cannot be calculated. | Times of exercise were not collected during the study, and therefore this outcome cannot be calculated. | Posted | 2 weeks |
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| Secondary | Number of Carbohydrate Interventions for Hypoglycemia | Posted | Mean | Standard Deviation | number of interventions per day | from t=0 to study stop after 2 weeks |
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| Secondary | Total Number of Grams of Carbohydrate Taken for Hypoglycemia | Posted | Mean | Standard Deviation | grams per day | from t=0 to study stop after 2 weeks |
|
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| Secondary | Insulin Total Daily Dose | Posted | Mean | Standard Deviation | units per day | from t=0 to study stop after 2 weeks |
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| Secondary | • Number of Carbohydrate Interventions for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM) | Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated | Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated | Posted | 2 weeks |
|
|
| Secondary | Total Number of Grams of Carbohydrate Taken for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM) | Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated | Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated | Posted | 2 weeks |
|
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| Secondary | Number of Carbohydrate Interventions for Hypoglycemia Overnight (11:00 PM - 7:00 AM) | Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated | Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated | Posted | 2 weeks |
|
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| Secondary | Total Number of Grams of Carbohydrate Taken for Hypoglycemia Overnight (11:00 PM - 7:00 AM) | Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated | Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated | Posted | 2 weeks |
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| Secondary | Total Glucagon Dosing (mcg/kg/24 Hours) | Posted | Mean | Standard Deviation | mcg/kg/day | from t=0 to study stop after 2 weeks |
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| Secondary | Episodes of Nausea Per Day on Glucagon vs Placebo | Posted | Mean | Standard Deviation | episodes of nausea per day | from t=0 to study stop after 2 weeks |
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| 0 |
| 22 |
| 0 |
| 22 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| Title | Measurements |
|---|
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| Placebo - overnight |
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| CGMG 70-180 mg/dl |
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| CGMG > 180 mg/dl |
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| CGMG > 250 mg/dl |
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