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

NCT02733211 | Withdrawn

• 1 other identifier: RMC010016Ctil
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Type 1 Diabetes

Keywords

Closed Loop

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• 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

Study Arms (2)

Closed Loop System

EXPERIMENTAL

MD-Logic automated insulin delivery system - all subjects wearing the study system during nights over 4 weeks

Device: MD- Logic Closed Loop System

Sensor augmented pump therapy

ACTIVE COMPARATOR

Sensor augmented pump therapy - all subjects are using sensor augmented pump therapy over 4 weeks

Device: sensor augmented pump therapy

Interventions

MD- Logic Closed Loop System DEVICE

Closed Loop System

Closed Loop System

sensor augmented pump therapy DEVICE

Sensor augmented pump therapy

Sensor augmented pump therapy

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead
• GIF: collaborator

Study Sites (2)

Diabetes -Zentrum fuer kinder und jugendliche

Hanover, 30173, Germany

Location

Schneider Children's Medical Center

Petah Tikva, 49202, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 11, 2016
• Study Start: March 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 30, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); IL (1)