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

NCT01726829 | Completed

• 1 other identifier: rmc007053ctil
• Study Type: interventional
• Target: 75
• Locations: 3 countries
• Sites: 3

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.

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; Artificial Pancreas; Closed Loop

Outcome Measures

Primary Outcomes (2)

• time sensor glucose level spent below 70mg/dl

  final visit (day 44)

• The percentage of nights mean overnight sensor glucose levels was within90-140 mg/dl

  At final visit (day 44)

Secondary Outcomes (12)

• The time sensor glucose level spent within 70-140 mg/dl

  At final visit (day 44)

• The number and frequency of hypoglycemic events below 63, 79 mg/dl

  At final visit (day 44)

• The time sensor glucose level spent above 140, 180 mg/dl

  At final visit (day 44)

• The area under the curve <63, <70, >140, >180 mg/dl

  At final visit (day 44)

• Glucose variability

  At final visit (day 44)

Study Arms (2)

MD-Logic Artificial Pancreas (MDLAP) system

EXPERIMENTAL

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

Device: MD-Logic Artificial Pancreas (MDLAP) system

Standard treatment with sensor augmented pump therapy

ACTIVE COMPARATOR

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

Procedure: sensor augmented pump therapy

Interventions

MD-Logic Artificial Pancreas (MDLAP) system DEVICE

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

MD-Logic Artificial Pancreas (MDLAP) system

sensor augmented pump therapy PROCEDURE

Also known as: four consecutive outpatients overnight sessions at home under standard treatment with sensor augmented pump therapy

Standard treatment with sensor augmented pump therapy

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with Type 1 diabetes (\>1yr since diagnosis)
• Insulin infusion pump therapy for at least 3 months
• Patients whom used continuous glucose sensor previously
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (3)

Diabetes -Zentrum fuer kinder und jugendliche

Hanover, Germany

Location

Schneider Children's Medical Center

Petah Tikva, 49202, Israel

Location

University Children's Hospital

Slovenia, Slovenia

Location

Related Publications (1)

• 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.

  PMID: 23944875 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Moshe Phillip, MD

  Schneider Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 15, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 8, 2016

Record last verified: 2016-04

Locations

SL (1); DE (1); IL (1)