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

Clalit Health Services

Status

Withdrawn

Conditions

Type 1 Diabetes

Treatments

Device: sensor augmented pump therapy

Device: MD- Logic Closed Loop System

Study type

Interventional

Funder types

Other

Identifiers

NCT02733211

RMC010016Ctil

Details and patient eligibility

About

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

Sex

All

Ages

10 to 18 years old

Volunteers

No Healthy Volunteers

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