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

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

Study Overview

• Status: Withdrawn
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: MD- Logic Closed Loop System; Device: sensor augmented pump therapy

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany, 30173
    • Diabetes -Zentrum fuer kinder und jugendliche
• Israel
  • Petach-Tikva, Israel, 49202
    • Schneider Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: GIF

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: April 5, 2016
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (Estimate): April 11, 2016

Study Record Updates

• Last Update Posted (Actual): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 26, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Closed Loop
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: RMC010016Ctil

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No