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| ID | Type | Description | Link |
|---|---|---|---|
| H-27207 | |||
| SPID#0813 |
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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Juvenile Diabetes Research Foundation | OTHER |
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We hypothesize that our integrated closed-loop glucose-control system can provide effective, tight, and safe blood glucose (BG) control in type 1 diabetes, thereby establishing the feasibility of closed-loop BG control.
This study investigates the utility of an integrated closed-loop glucose-control system for regulating BG in type 1 diabetic subjects. The closed-loop system utilizes sub-cutaneous infusion or insulin and glucagon under the control of a computer algorithm. The only inputs to the algorithm are the subject weight and BG values measured every five minutes. Subjects will undergo up to three 27 hour GCRC admissions during which they will consume three standardized meals. Subject may participate in up to two closed-loop visits (with different insulin lispro pharmacokinetic parameter settings in the control algorithm) and some subjects will participate in open-loop visits. During the closed-loop admission BG will be controlled by the closed-loop system. During the open-loop visit subjects will regulate their own BG in the usual function using their insulin pumps. A small group of non-diabetic subjects will undergo a single 27 hour GCRC admission during which they will eat the same standardized meals. During all admission BG will be measured every 5 minutes and blood will be collected for measurement of insulin and glucagon levels every 10 minutes. During the closed-loop admission of diabetic subjects and the single admission of non-diabetic subjects, three commercially available continuous glucose monitoring devices will be worn. The data from these devices will later be compared to reference BG data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed-loop | Experimental | Type 1 diabetic subjects under closed-loop blood glucose control |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed-loop | Device | Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target |
| Measure | Description | Time Frame |
|---|---|---|
| Average Blood Glucose Over the Closed-loop Control Period | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time Spent Within 70-180 mg/dl | 24 hours | |
| Peak Hyperglycemia Following Each Meal | After each of 3 meals | |
| Percentage of Time Spent in Hyperglycemia (BG> 180 mg/dl) After Meals |
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Inclusion Criteria (type 1 diabetic subjects):
Inclusion Criteria (non-diabetic subjects):
Exclusion Criteria (all subjects):
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| Name | Affiliation | Role |
|---|---|---|
| Steven J Russell, M.D., Ph.D. | Massachusetts General Hospital | Study Director |
| Edward Damiano, Ph.D. | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17425438 | Background | El-Khatib FH, Jiang J, Gerrity RG, Damiano ER. Pharmacodynamics and stability of subcutaneously infused glucagon in a type 1 diabetic Swine model in vivo. Diabetes Technol Ther. 2007 Apr;9(2):135-44. doi: 10.1089/dia.2006.0006. | |
| 19888405 | Background | El-Khatib FH, Jiang J, Damiano ER. Adaptive closed-loop control provides blood-glucose regulation using dual subcutaneous insulin and glucagon infusion in diabetic Swine. J Diabetes Sci Technol. 2007 Mar;1(2):181-92. doi: 10.1177/193229680700100208. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Closed-loop | Type 1 diabetic subjects under closed-loop blood glucose control Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Closed-loop | Type 1 diabetic subjects under closed-loop blood glucose control Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target |
| 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 |
| 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 Blood Glucose Over the Closed-loop Control Period | Posted | Mean | Standard Deviation | mg/dl | 24 hours |
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24 hours
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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 | Closed-loop | Type 1 diabetic subjects under closed-loop blood glucose control Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Russell | Massachusetts General Hospital | 6177261848 | sjrussell@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| D006943 | Hyperglycemia |
| D007003 | Hypoglycemia |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| After each of 3 meals |
| Percentage of Peak Post-prandial Hyperglycemias < 180 mg/dl (ADA Target) | 24 hours |
| Percentage of Time Spent With BG < 70 mg/dl | 24 hours |
| Number of Hypoglycemic Events | This outcome captures the number of hypoglycemic events that occurred throughout the entire study | 24 hours |
| Nadir Blood Glucose Level for Each Hypoglycemic Event | 24 hours |
| Percentage of Time Spent With BG > 180 mg/dl | 24 hours |
| Total Insulin Dose | 24 hours |
| Glucagon T-max | Time to maximum peak glucagon concentration | 24 hours |
| Total Glucagon Dose | 24 hours |
| Blood Glucagon Levels | 24 hours |
| Average Glucose and Glycemic Variability (MAGE) During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24-hour Period the Day Prior to Admission as Measured by Navigator CGM Data | 24 hours |
| Number of Carbohydrate Interventions | 24 hours |
| Number of Participants Achieving a Stable Glucose Response to Insulin Dosing | 24 hours |
| Number of Participants Achieving a Stable Glucose Response to Insulin Dosing Around Idle Times Prior to Meals | 24 hours |
| Accuracy of the Continuous Glucose Monitor (CGM) Using Blood Glucose Measurement as the Standard | Measuring the mean absolute relative difference (MARD) between the blood glucose measurement and CGM glucose readings, on three different CGM devices: Dexcom, Guardian and Navigator | 24 hours |
| Average Glucose and Glycemic Variability During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24 Hour Period in Non-diabetic Subjects | 24 hours |
| Insulin and Glucagon Levels During the Closed-loop Admission as Compared to the Comparable 24 Hour Period During the Open Loop Admission of Diabetic Subjects | 24 hours |
| Sensitivity for Hypo- and Hyperglycemia of the CGM Devices Using the BG Measurement as the Standard | Mean absolute relative difference (MARD) of CGM and BG glucose readings in hypoglycemia (< 70 mg/dl) and hyperglycemia (>180 mg/dl) in three different CGM devices: Dexcom, Navigator and Guardian | 24 hours |
| Set Point Using CGM Data as the Input to the Controller for Future Studies | The algorithm in the Bionic Pancreas must have a pre-specified target glucose it is trying to achieve in order to make dosing decisions. Using data from this study, investigators planned to determine what an appropriate glucose target should be for future studies. | 24 hours |
| Insulin and Glucagon Levels During Closed Loop and Open Loop Admissions of Diabetic Subjects Compared to the Comparable 24 Hour Period During the Admission of Non-diabetic Subject | 24 hours |
| 20144330 | Background | El-Khatib FH, Jiang J, Damiano ER. A feasibility study of bihormonal closed-loop blood glucose control using dual subcutaneous infusion of insulin and glucagon in ambulatory diabetic swine. J Diabetes Sci Technol. 2009 Jul 1;3(4):789-803. doi: 10.1177/193229680900300428. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Percentage of Time Spent Within 70-180 mg/dl | Posted | Mean | Standard Deviation | percentage of time | 24 hours |
|
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| Secondary | Peak Hyperglycemia Following Each Meal | Posted | Mean | Standard Deviation | mg/dl | After each of 3 meals |
|
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| Secondary | Percentage of Time Spent in Hyperglycemia (BG> 180 mg/dl) After Meals | Posted | Mean | Standard Deviation | percentage of time | After each of 3 meals |
|
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| Secondary | Percentage of Peak Post-prandial Hyperglycemias < 180 mg/dl (ADA Target) | Posted | Number | percentage of blood glucose measurements | 24 hours |
|
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| Secondary | Percentage of Time Spent With BG < 70 mg/dl | Posted | Mean | Standard Deviation | percentage of time | 24 hours |
|
|
|
| Secondary | Number of Hypoglycemic Events | This outcome captures the number of hypoglycemic events that occurred throughout the entire study | Posted | Number | Number of events | 24 hours |
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| Secondary | Nadir Blood Glucose Level for Each Hypoglycemic Event | Posted | Number | mg/dl | 24 hours |
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| Secondary | Percentage of Time Spent With BG > 180 mg/dl | Posted | Mean | Standard Deviation | percentage of time | 24 hours |
|
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| Secondary | Total Insulin Dose | Posted | Mean | Standard Deviation | u/kg | 24 hours |
|
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| Secondary | Glucagon T-max | Time to maximum peak glucagon concentration | Posted | Mean | Standard Deviation | minutes | 24 hours |
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| Secondary | Total Glucagon Dose | Posted | Mean | Standard Deviation | mcg/kg | 24 hours |
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| Secondary | Blood Glucagon Levels | Posted | Mean | Standard Deviation | microgram/kg | 24 hours |
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| Secondary | Average Glucose and Glycemic Variability (MAGE) During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24-hour Period the Day Prior to Admission as Measured by Navigator CGM Data | Navigator CGM data from the day prior to admission was not obtained | Posted | 24 hours |
|
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| Secondary | Number of Carbohydrate Interventions | Posted | Number | number of interventions | 24 hours |
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| Secondary | Number of Participants Achieving a Stable Glucose Response to Insulin Dosing | Posted | Number | participants | 24 hours |
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| Secondary | Number of Participants Achieving a Stable Glucose Response to Insulin Dosing Around Idle Times Prior to Meals | Posted | Number | participants | 24 hours |
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| Secondary | Accuracy of the Continuous Glucose Monitor (CGM) Using Blood Glucose Measurement as the Standard | Measuring the mean absolute relative difference (MARD) between the blood glucose measurement and CGM glucose readings, on three different CGM devices: Dexcom, Guardian and Navigator | Posted | Mean | Standard Deviation | percent absolute difference | 24 hours |
|
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| Secondary | Average Glucose and Glycemic Variability During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24 Hour Period in Non-diabetic Subjects | This outcome was not analyzed. There were no experiments in non-diabetic subjects that we were able to make a comparison with | Posted | 24 hours |
|
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| Secondary | Insulin and Glucagon Levels During the Closed-loop Admission as Compared to the Comparable 24 Hour Period During the Open Loop Admission of Diabetic Subjects | This outcome was not analyzed. There were no open loop experiments in diabetic subjects that we were able to make a comparison with | Posted | 24 hours |
|
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| Secondary | Sensitivity for Hypo- and Hyperglycemia of the CGM Devices Using the BG Measurement as the Standard | Mean absolute relative difference (MARD) of CGM and BG glucose readings in hypoglycemia (< 70 mg/dl) and hyperglycemia (>180 mg/dl) in three different CGM devices: Dexcom, Navigator and Guardian | Posted | Mean | Standard Deviation | percent absolute difference | 24 hours |
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| Secondary | Set Point Using CGM Data as the Input to the Controller for Future Studies | The algorithm in the Bionic Pancreas must have a pre-specified target glucose it is trying to achieve in order to make dosing decisions. Using data from this study, investigators planned to determine what an appropriate glucose target should be for future studies. | Posted | Number | mg/dl | 24 hours |
|
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| Secondary | Insulin and Glucagon Levels During Closed Loop and Open Loop Admissions of Diabetic Subjects Compared to the Comparable 24 Hour Period During the Admission of Non-diabetic Subject | This outcome was not analyzed. There were no experiments in non-diabetic subjects that we were able to make a comparison with | Posted | 24 hours |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
|
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Dexcom > 180 |
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| Navigator > 180 |
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| Guardian > 180 |
|