Insulin Pump Therapy clinical trials

MD Logic Pump Advisor- Adults Study

Prospective, randomized, controlled, 30-78 days trial comparing MD-Logic pump algorithm to the standard of care of patients with type 1 diabetes. The objective of this feasibility study is to evaluate the efficacy and safety of automated determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1 diabetes.The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment, the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for dropouts. The randomized controled study segment will be initiated after the pilot segment.Each segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will wear continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin pump settings will not be changed during the study period (patient's usual standard of care).