Overnight Type 1 Diabetes Control Under MD-Logic Closed Loop System at the Patient's Home

NCT ID: NCT01726829

Last Updated: 2016-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-12-31

Brief Summary

This is a randomized prospective single blind trial to evaluate blood glucose control overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system in patients with type 1 diabetes, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia and Hannover, Germany; In this study,75 eligible patients will be enrolled.Each subject will participate in four consecutive over nights under closed-loop with MDLAP, and four additional over nights under regular sensor augmented pump therapy at home with a washout period of 10 ± 3 days between arms.

Detailed Description

In the last two decades, remarkable technological progress has been made with the development of continuous glucose sensors, miniature devices, implantable pumps and sensors and wireless communications, interest in the closed-loop insulin delivery was revived.

Control trails that evaluate the clinical benefits of continuous glucose sensor have shown improved HbA1c with no significant increase in sever hypoglycemia, trend towards lower hypoglycemic episodes although not significant and no significant change in sever hypoglycemia. One of the main drawbacks of continuous glucose sensor is noncompliant of the patient, the flow of information and the need to act accordingly makes this devise a burden for some patients. Theoretically subcutaneous insulin pumps and glucose sensors attached to an artificial pancreas in a closed-loop system can mimic the activity of functioning pancreatic beta cells, with strict control of blood glucose levels. Such a system may also offer an opportunity to free the patients from the daily burden of dealing with their diabetes.

Study Objectives are to determine the safety and efficacy of using the MDLAP system to automatically control overnight blood glucose in type 1 diabetic patients. Overnight glucose control time defined as the time range between bedtime (21:00-23:00 PM) and awaking time (7:00 AM).

This is a randomized prospective single blind trial to evaluate blood glucose control overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system in patients with type 1 diabetes, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia and Hannover, Germany; 75 eligible patients will be enrolled.Each subject will participate in four consecutive over nights under closed-loop with MDLAP, and four additional over nights under regular sensor augmented pump therapy at home with a washout period of 10 ± 3 days between arms.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MD-Logic Artificial Pancreas (MDLAP) system

four consecutive outpatients overnight sessions at home under closed loop MD-Logic Artificial Pancreas (MDLAP) system

Group Type: EXPERIMENTAL

MD-Logic Artificial Pancreas (MDLAP) system

Intervention Type: DEVICE

Standard treatment with sensor augmented pump therapy

four consecutive outpatients overnight sessions at home under standard treatment with sensor augmented pump therapy

Group Type: ACTIVE_COMPARATOR

sensor augmented pump therapy

Intervention Type: PROCEDURE

Interventions

MD-Logic Artificial Pancreas (MDLAP) system

Intervention Type: DEVICE

sensor augmented pump therapy

Intervention Type: PROCEDURE

Other Intervention Names

four consecutive outpatients overnight sessions at home under closed loop MD-Logic Artificial Pancreas (MDLAP) system; four consecutive outpatients overnight sessions at home under standard treatment with sensor augmented pump therapy

Eligibility Criteria

Inclusion Criteria

• Subject with Type 1 diabetes (>1yr since diagnosis)
• Insulin infusion pump therapy for at least 3 months
• Patients whom used continuous glucose sensor previously
• Age at inclusion ≥ 10 years and ≤ 65 years
• HbA1c at inclusion ≥ 7 and <10
• Patients willing to follow study instructions
• Patients live with at least one other adult person
• BMI SDS(Standard Deviation Score) - below the 97th percentile for age
• An internet connection at patient's home
• Patients with care givers who are capable of operating a computer based system

Exclusion Criteria

• Concomitant diseases that influence metabolic control
• Participation in any other interventional study
• Known or suspected allergy to trial products
• Any significant diseases (such as preexisting seizures or epilepsy) or conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subjects ability to complete the study or compromise patients safety
• Diabetic ketoacidosis in the past 1 month
• Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment.
• Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
• Female subject who is pregnant or planning to become pregnant within the planned study duration

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moshe Phillip, MD

Role: PRINCIPAL_INVESTIGATOR

Schneider Children's Medical Center

Locations

Diabetes -Zentrum fuer kinder und jugendliche

Hanover, , Germany

Schneider Children's Medical Center

Petah Tikva, , Israel

University Children's Hospital

Slovenia, , Slovenia

Countries

Germany; Israel; Slovenia

References

Nimri R, Muller I, Atlas E, Miller S, Kordonouri O, Bratina N, Tsioli C, Stefanija MA, Danne T, Battelino T, Phillip M. Night glucose control with MD-Logic artificial pancreas in home setting: a single blind, randomized crossover trial-interim analysis. Pediatr Diabetes. 2014 Mar;15(2):91-9. doi: 10.1111/pedi.12071. Epub 2013 Aug 15.

Reference Type: DERIVED

PMID: 23944875 (View on PubMed)

Other Identifiers

rmc007053ctil

Identifier Type: -

Identifier Source: org_study_id