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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: MD- Logic Closed Loop System
* Device: sensor augmented pump therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with type 1 diabetes >1year since diagnosis Insulin infusion pump (CSII) therapy for at least 3 months Patients able to use sensor after training based on researcher's estimation Age between 10 and 18 years (both included) HbA1c at inclusion between 7.5 and 11.0 % (both included) Patients willing to follow study instructions Patients live with at least one other adult person Body Mass Index Standard Deviation Score - below the 95th percentile for age Patients with caregivers who are capable of operating a computer based system Exclusion Criteria: Concomitant diseases that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, history of adrenal insufficiency) or other medical condition, which in the Investigator's opinion, may compromise patient safety Participation in any other interventional study Known or suspected allergy to trial products such as adhesives, tapes, needles. An allergy to contrast medium, use of other active medical devices and planned imaging Any significant diseases or conditions including psychiatric disorders and substance abuse that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study, or compromise patient safety Diabetic ketoacidosis in the past 1 month Severe hypoglycemia six month prior to enrollment Current use of the following medications: medications that are used to lower blood glucose , Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study Subject is participating in another drug or device study that could affect glucose measurements or glucose management Female subject who is pregnant or breast-feeding or is planning to become pregnant within the planned study duration Not sufficient vision or hearing to recognize pump/sensor alarms or to perform Blood Glucose-self measurements 4-times daily. Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus -Subject has unstable or rapidly progressive renal disease or is receiving dialysis- Subject has active proliferating retinopathy Active gastroparesis Patient suffers from an eating disorder

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Closed Loop System<br>MD-Logic automated insulin delivery system - all subjects wearing the study system during nights over 4 weeks | Device: MD- Logic Closed Loop System<br>* Closed Loop System<br>|
| Active Comparator: Sensor augmented pump therapy<br>Sensor augmented pump therapy - all subjects are using sensor augmented pump therapy over 4 weeks | Device: sensor augmented pump therapy<br>* Sensor augmented pump therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | At the final visit- Day 115 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of glucose sensor readings within 70 to 180 mg/dl (3.9 to 10 mmol/l) per 24 hours |  | 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 |  | 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 |  | At the final visit- Day 115 | 
| Average and standard deviation of glucose sensor readings per 24 hours |  | At the final visit- Day 115 | 
| Fasting blood glucose levels |  | At the final visit- Day 115 | 
| HbA1c change from baseline to the end of the intervention period |  | 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 | At the final visit- Day 115 | 
| Well-Being | Questionnaire assessing the well-being of participants | At the final visit- Day 115 | 
| Diabetes-specific family conflicts | Questionnaire assessing the diabetes-specific family conflicts of participants | At the final visit- Day 115 | 
| Area under the curve of glucose readings <50 |  | At the final visit- Day 115 | 
| Area under the curve of glucose readings <70 |  | At the final visit- Day 115 | 
| Area under the curve of glucose readings <60 |  | At the final visit- Day 115 | 
| Percentage of glucose readings <70 mg/dl |  | At the final visit- Day 115 | 
| Percentage of glucose readings <60 mg/dl |  | At the final visit- Day 115 | 
| Number of sensor based hypoglycemic events <70mg/dl |  | At the final visit- Day 115 | 
| Number of sensor based hypoglycemic events <60mg/d |  | At the final visit- Day 115 | 
| Number of sensor based hypoglycemic events <50mg/d |  | At the final visit- Day 115 | 
| Area Under the Curve of sensor glucose readings >240 mg/dl |  | At the final visit- Day 115 | 
| Area Under the Curve of sensor glucose readings >300 mg/dl |  | At the final visit- Day 115 | 
| Percentage of sensor glucose readings >240 mg/dl |  | At the final visit- Day 115 | 
| Percentage of sensor glucose readings >300 mg/dl |  | At the final visit- Day 115 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Closed Loop