Type 2 Diabetes Mellitus Clinical Trial
Official title:
The Set-Point Study for Type 2 Diabetes: Evaluating the Safety and Efficacy of an Insulin Only Bionic Pancreas System in Patients With Type 2 Diabetes
Our goal is to conduct an outpatient study testing the bionic pancreas in the insulin-only configuration at a set-point of 100 mg/dl in 10 adult (≥ 18 years of age) subjects with type 2 diabetes in a random-order crossover study versus usual care with daily injections or an insulin pump.
The study will consist of two 7 day study arms: one usual care, and one insulin-only bionic pancreas at a set point of 100 mg/dl. The co-primary outcomes will be the mean Dexcom CGM glucose level and time <54 mg/dl, both in the last five days of each arm because these will be predictive of outcomes in long term use. The first two days will be excluded to allow for the extended washout of long acting insulins. ;
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