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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Closed Loop System
Sensor augmented pump therapy
Diabetes -Zentrum fuer kinder und jugendliche
Hanover, Germany
Schneider Children's Medical Center
Petah Tikva, Israel
Percentage of glucose sensor readings within 70 to 180 mg/dl (3.9 to 10 mmol/l) during the night (23:00-7:00 h)
Time frame: At the final visit- Day 115
Percentage of glucose sensor readings within 70 to 180 mg/dl (3.9 to 10 mmol/l) per 24 hours
Time frame: At the final visit- Day 115
Percentage of glucose sensor readings below 70 mg/dl (3.9 mmol/l) during the night (23:00-7:00 h) and per 24 hours
Time frame: At the final visit- Day 115
Percentage of glucose sensor readings above 180 mg/dl (10 mmol/l) during the night (23:00-7:00 h) and per 24 hours
Time frame: At the final visit- Day 115
Average and standard deviation of glucose sensor readings per 24 hours
Time frame: At the final visit- Day 115
Fasting blood glucose levels
Time frame: At the final visit- Day 115
HbA1c change from baseline to the end of the intervention period
Time frame: At the final visit- Day 115
Acceptance and use intention of an Artificial Pancreas
Questionnaire assessing the acceptance and use intention of an Artificial Pancreas
Time frame: At the final visit- Day 115
Well-Being
Questionnaire assessing the well-being of participants
Time frame: At the final visit- Day 115
Diabetes-specific family conflicts
Questionnaire assessing the diabetes-specific family conflicts of participants
Time frame: At the final visit- Day 115
Area under the curve of glucose readings <50
Time frame: At the final visit- Day 115
Area under the curve of glucose readings <70
Time frame: At the final visit- Day 115
Area under the curve of glucose readings <60
Time frame: At the final visit- Day 115
Percentage of glucose readings <70 mg/dl
Time frame: At the final visit- Day 115
Percentage of glucose readings <60 mg/dl
Time frame: At the final visit- Day 115
Number of sensor based hypoglycemic events <70mg/dl
Time frame: At the final visit- Day 115
Number of sensor based hypoglycemic events <60mg/d
Time frame: At the final visit- Day 115
Number of sensor based hypoglycemic events <50mg/d
Time frame: At the final visit- Day 115
Area Under the Curve of sensor glucose readings >240 mg/dl
Time frame: At the final visit- Day 115
Area Under the Curve of sensor glucose readings >300 mg/dl
Time frame: At the final visit- Day 115
Percentage of sensor glucose readings >240 mg/dl
Time frame: At the final visit- Day 115
Percentage of sensor glucose readings >300 mg/dl
Time frame: At the final visit- Day 115
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