Type 1 Diabetes Clinical Trial
Official title:
An Open-label, Two-center, Randomized, Cross-over Study to Evaluate the Safety and Efficacy of Night Closed-loop Control Using the MD-Logic Automated Insulin Delivery System Compared to Sensor Augmented Pump Therapy in Poorly Controlled Patients With Type 1 Diabetes at Home
The MD-Logic Automated Insulin Delivery System is intended for patients with type 1 diabetes
mellitus for subcutaneous infusion of insulin and the continuous measurement of interstitial
glucose to aid in the management of their diabetes. The product automatically adjusts basal
insulin delivery and delivers correction boluses in response to real-time glucose
measurements by CGM to maintain blood glucose within the desired range, to improve metabolic
control without increasing the risk of hypoglycemia.
The proposed study is an open-label, two-center, randomized, cross-over study to evaluate the
safety and efficacy of night closed-loop control using the MD-Logic automated insulin
delivery system compared to sensor augmented pump therapy in poorly controlled patients with
type 1 diabetes at home The objective of this pilot study is to evaluate the safety and
efficacy of 4 weeks glucose control using the MD-Logic System in individuals with poorly
controlled type 1 diabetes at patient's home
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