At a glance
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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
In Brief
A clinical study evaluating Bionic Pancreas and Usual Care for Type 2 Diabetes Mellitus. Completed, enrolled 16 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
During this arm the subject will ONLY use our bionic pancreas device with an insulin only configuration using a rapid-acting insulin analog. Subjects will wear a continuous glucose monitoring device (the Dexcom G5) as part of the bionic pancreas, and use the study provided glucose meter.
Subject will wear a continuous glucose monitoring device (the Dexcom G5) and use the study provided glucose meter.. Subject will not change their prescribed home insulin therapy regimen during this arm whether that be an insulin pump or multiple daily injections.