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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK085633-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Juvenile Diabetes Research Foundation | OTHER |
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The investigators hypothesize that our closed-loop glucose-control system can provide BG control in subjects with type 1 diabetes using the estimated BG signal from a CGM as the input signal to the controller.
To test the safety and efficacy of our control system in the bi-hormonal configuration in regulating BG in adults (18 years of age or older) and in children (12-17 years of age) with type 1 diabetes based on interstitial-fluid (ISF) glucose data from a CGM. Experiments will be 51 hours in length incorporating 6 meals and two (night) sleep periods. In order to evaluate the effect of exercise on BG control, the last 48 hours of the experiment will be divided into two 24 hour blocks, the second of which will contain a period of structured exercise near the beginning of the block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bi-hormonal with meal-priming bolus | Experimental | The first meal-priming bolus was solely based on weight (0.05 U/kg), after which meal-priming boluses were automatically adapted by the control system online targeting 75% of the anticipated insulin needed in the first four hours after the start of the meal |
|
| Bi-hormonal without meal-priming bolus | Experimental | The insulin controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bi-hormonal (insulin and glucagon) artificial pancreas | Device | Subjects wore a bionic pancreas consisting of a continuous glucose monitor, an insulin pump and a glucagon pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl) | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time Spent With Blood Glucose < 60 mg/dl | 48 hours | |
| Percentage of Time Spent With Blood Glucose <70 mg/dl | 48 hours | |
| Percentage of Time Spent With Blood Glucose 70-180 mg/dl |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23275350 | Derived | Damiano ER, El-Khatib FH, Zheng H, Nathan DM, Russell SJ. A comparative effectiveness analysis of three continuous glucose monitors. Diabetes Care. 2013 Feb;36(2):251-9. doi: 10.2337/dc12-0070. Epub 2012 Dec 28. | |
| 22923666 | Derived | Russell SJ, El-Khatib FH, Nathan DM, Magyar KL, Jiang J, Damiano ER. Blood glucose control in type 1 diabetes with a bihormonal bionic endocrine pancreas. Diabetes Care. 2012 Nov;35(11):2148-55. doi: 10.2337/dc12-0071. Epub 2012 Aug 24. |
| Label | URL |
|---|---|
| Related Info | View source |
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Twelve adult and twelve pediatric subjects with type 1 diabetes and no endogenous insulin secretion participated in two 51-h experiments. The protocol was approved by the Massachusetts General Hospital (MGH) and Boston University Human Research Committees
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| ID | Title | Description |
|---|---|---|
| FG000 | Bi-hormonal Bionic Pancreas With Meal-priming Bolus | The first meal-priming bolus was solely based on weight (0.05 U/kg), after which meal-priming boluses were automatically adapted by the control system online targeting 75% of the anticipated insulin needed in the first four hours after the start of the meal. |
| FG001 | Bi-hormonal Bionic Pancreas With no Meal-priming Bolus | Bi-hormonal bionic pancreas with no meal-priming bolus. The controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bi-hormonal Pancreas With Meal-priming Bolus | An automatically adapting meal priming bolus was given by the controller at the time each meal was presented |
| BG001 | Bi-hormonal Pancreas Without Meal-priming Bolus |
| 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 | Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl) | Overall number of participants was 24, 12 in each arm | Posted | Mean | Standard Deviation | mg/dl | 48 hours |
|
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51 hours per experiment
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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 | Bi-hormonal With Meal Priming Bolus | Bi-hormonal with adaptive meal priming bolus |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | Systematic Assessment | The subject with the slowest insulin absorption and who received the most glucagon reported nausea on several occasions. However, the timing of these symptoms did not correspond to periods of high plasma glucagon levels |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward R. Damiano | Department of Biomedical Engineering, Boston University, Boston, Massachusetts. | (617) 353-9493 | edamiano@bu.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019397 | Pancreas, Artificial |
| ID | Term |
|---|---|
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| The Leona M. and Harry B. Helmsley Charitable Trust |
| OTHER |
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| 48 hours |
| Insulin Total Daily Dose | 48 hours |
| Number of Carbohydrate Interventions for Hypoglycemia | 48 hours |
| Number of Blood Glucose Events < 70 mg/dl | 48 hours |
| Nadir Blood Glucose in Each Arm | 48 hours |
The insulin controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Percentage of Time Spent With Blood Glucose < 60 mg/dl | Overall number of participants=24 (12 in each arm) | Posted | Mean | Standard Deviation | percentage of total time | 48 hours |
|
|
|
| Secondary | Percentage of Time Spent With Blood Glucose <70 mg/dl | Overall number of participants=24 (12 in each arm) | Posted | Mean | Standard Deviation | percentage of total time | 48 hours |
|
|
|
| Secondary | Percentage of Time Spent With Blood Glucose 70-180 mg/dl | Overall number of participants=24 (12 in each arm) | Posted | Mean | Standard Deviation | percentage of total time | 48 hours |
|
|
|
| Secondary | Insulin Total Daily Dose | Overall number of participants=24 (12 in each arm) | Posted | Mean | Standard Deviation | u/kg/day | 48 hours |
|
|
|
| Secondary | Number of Carbohydrate Interventions for Hypoglycemia | Overall number of participants=24 (12 in each arm) | Posted | Number | Carbohydrate Interventions | 48 hours |
|
|
|
| Secondary | Number of Blood Glucose Events < 70 mg/dl | Posted | Number | Number of events | 48 hours |
|
|
|
| Secondary | Nadir Blood Glucose in Each Arm | Posted | Mean | Standard Deviation | mg/dl | 48 hours |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Bi-hormonal Without Meal Priming Bolus | Bi-hormonal with no meal announcements or meal priming boluses | 0 | 12 | 0 | 12 | 1 | 12 |
|
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| D006946 | Hyperinsulinism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Adolescents |
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| Adolescents |
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|
| Adolescents |
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| Adolescents |
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|