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The "Glucositter" overnight automated closed loop system for type 1 diabetes: a randomized crossover trial
Revital Nimri1, Thomas Danne, Olga Kordonouri
1The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.
Pediatric Diabetes
|March 2, 2013
Summary
The MD-Logic Artificial Pancreas (MDLAP) safely improved overnight glucose control in type 1 diabetes patients, significantly reducing glucose variability and time below range without increasing hypoglycemia risk.
Area of Science:
- Endocrinology
- Biomedical Engineering
- Diabetes Technology
Background:
- Tight glucose control is crucial for preventing long-term diabetes complications.
- Hypoglycemia, particularly nocturnal hypoglycemia, presents a significant barrier to achieving optimal glucose control in type 1 diabetes mellitus (T1DM).
Purpose of the Study:
- To evaluate the safety and efficacy of the closed-loop MD-Logic Artificial Pancreas (MDLAP) system for managing nocturnal glucose levels in individuals with T1DM.
Main Methods:
- A randomized, multicenter, multinational, crossover trial involving 12 T1DM patients.
- Participants underwent two overnight sessions: one with continuous subcutaneous insulin infusion (CSII) and another with closed-loop MDLAP control.
- Primary outcome was the incidence of hypoglycemia (glucose < 63 mg/dL), with analyses based on sensor glucose readings.
Main Results:
- No nocturnal hypoglycemic events occurred during MDLAP closed-loop control, compared to three events during CSII (p=0.18).
- Time spent in the target glucose range (63-140 mg/dL) was significantly higher with MDLAP (76%) versus CSII (29%) (p=0.02).
- MDLAP reduced mean overnight glucose by 36 mg/dL and significantly decreased glucose variability compared to CSII (p<0.001).
Conclusions:
- The MDLAP system effectively and safely enhances nocturnal glucose control in T1DM patients.
- This closed-loop system demonstrates potential for improving glycemic management without elevating hypoglycemia risk across diverse clinical settings.
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