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| Name | Class |
|---|---|
| Boston University | OTHER |
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The purpose of this study is to test an experimental medical device designed to automatically control blood sugar. This device was designed for use by patients with diabetes while they are in the hospital, and others who may develop high blood sugar as a result of their medical problems.
The goal of this first-in-man trial is to test the safety and efficacy of the automated, closed-loop control system in insulin sensitive subjects with type 1 diabetes, insulin sensitive subjects with type 2 diabetes (TTD > 1u/kg/day), and subjects with type 2 diabetes and substantial insulin resistance (<2 u/kg/day). The results of this study will help to design future studies, exploring the use of the closed-loop system for BG control in hospitalized patients, including those with diabetes or hyperglycemia of critical illness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed-loop blood glucose control | Experimental | Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed-loop blood glucose control | Device | The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg). |
| Measure | Description | Time Frame |
|---|---|---|
| Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements. | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol | 12 hours | |
| Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements | 12 hours |
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Inclusion Criteria
Subjects with type 1 diabetes
Subjects with type 2 diabetes
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 |
|---|---|---|---|---|---|---|
| MGH Diabetes Research Center | Boston | Massachusetts | 02114 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Closed-loop Blood Glucose Control | Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg. Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Closed-loop Blood Glucose Control |
| 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, 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 | Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements. | Posted | Mean | Standard Deviation | mg/dl | 12 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 Blood Glucose Control |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven J. Russell | Massachusetts General Hospital | 617-726-8722 | sjrussell@partners.org |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl | 12 hours |
| Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm | 12 hours |
| Number of BG Events < 70 mg/dl as Determined by the CGM | 12 hours |
| Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl | 12 hours |
| Insulin Dosing (u/kg) | 12 hours |
| Dextrose Dosing (g/kg) | 12 hours |
| Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard. | The Mean Absolute Relative Difference (MARD) between CGM and Glucoscout | 12 hours |
| 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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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol | Posted | Number | number of carbohydrate interventions | 12 hours |
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| Secondary | Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements | Posted | Number | Blood glucose values < 70 mg/dl | 12 hours |
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| Secondary | Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl | Posted | Mean | Standard Deviation | percentage of time | 12 hours |
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| Secondary | Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm | Posted | Mean | Standard Deviation | mg/dl | 12 hours |
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| Secondary | Number of BG Events < 70 mg/dl as Determined by the CGM | Posted | Number | events | 12 hours |
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| Secondary | Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl | Posted | Mean | Standard Deviation | percentage of time | 12 hours |
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| Secondary | Insulin Dosing (u/kg) | Posted | Mean | Standard Deviation | units/kilogram | 12 hours |
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| Secondary | Dextrose Dosing (g/kg) | Posted | Mean | Standard Deviation | grams/kilogram | 12 hours |
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| Secondary | Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard. | The Mean Absolute Relative Difference (MARD) between CGM and Glucoscout | Posted | Mean | Standard Deviation | percent absolute relative difference | 12 hours |
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| 0 |
| 12 |
| 0 |
| 12 |
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| Title | Measurements |
|---|---|
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| > 180 mg/dl |
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