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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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).
MGH Diabetes Research Center
Boston, Massachusetts, United States
Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements.
Time frame: 12 hours
Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol
Time frame: 12 hours
Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements
Time frame: 12 hours
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
Time frame: 12 hours
Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm
Time frame: 12 hours
Number of BG Events < 70 mg/dl as Determined by the CGM
Time frame: 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
Time frame: 12 hours
Insulin Dosing (u/kg)
Time frame: 12 hours
Dextrose Dosing (g/kg)
Time frame: 12 hours
Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard.
The Mean Absolute Relative Difference (MARD) between CGM and Glucoscout
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Time frame: 12 hours