The goal of this study is to perform a first-in-humans trial of a fully integrated, automated, closed-loop blood glucose control system designed for inpatient use. The GlucoSTAT 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.
Our envisioned end product is an in-patient automated closed-loop control system for PG regulation in the ICU as well as on the general hospital wards. In order to qualify the system for the broad spectrum of challenges it will face in the inpatient setting, this study will test the ability of the new integrated configuration of the system (the GlucoSTAT) to control PG in subjects with extremes of insulin sensitivity. The first goal of this study is to test the safety and efficacy of the control system in insulin sensitive subjects with type 1 diabetes. The second goal of this study is to test the safety and efficacy of the control system in subjects with type 2 diabetes and substantial insulin resistance (TDD \> 0.75 u/kg/day, with up to 3 subjects with a TDD \> 2 u/kg/day).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Closed-loop blood glucose control using intravenous insulin and dextrose
Massachusetts General Hospital
Boston, Massachusetts, United States
Average plasma glucose over the closed-loop control period
Average plasma glucose
Time frame: every 15 minutes for 8.5 hours
Number of carbohydrate interventions needed to treat hypoglycemia
The number of times that carbohydrates were consumed in response to hypoglycemia throughout the 8.5 hour experiment
Time frame: 8.5 hour experiment duration
Grams of carbohydrates needed to treat hypoglycemia
The amount of carbohydrates consumed in response to hypoglycemia throughout the 8.5 hour experiment
Time frame: 8.5 hour experiment duration
Carbohydrate content and total calories of consumed lunch meal
The amount of carbohydrates and total calories the subject consumed during their provided lunch
Time frame: during 30 minute meal
Insulin dosing (u/kg)
Total amount of insulin delivered by the GlucoSTAT during the experiment
Time frame: 8.5 hour experiment duration
Dextrose dosing (g/kg)
Total amount of dextrose delivered by the GlucoSTAT during the experiment
Time frame: 8.5 hour experiment duration
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