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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: MD-Logic Artificial Pancreas (MDLAP) system; Procedure: sensor augmented pump therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany
    • Diabetes -Zentrum fuer kinder und jugendliche
• Israel
  • Petah-Tikva, Israel, 49202
    • Schneider Children's Medical Center
• Slovenia
  • Slovenia, Slovenia
    • University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MD-Logic Artificial Pancreas (MDLAP) system; four consecutive outpatients overnight sessions at home under closed loop MD-Logic Artificial Pancreas (MDLAP) system	Device: MD-Logic Artificial Pancreas (MDLAP) system; Other Names: four consecutive outpatients overnight sessions at home under closed loop MD-Logic Artificial Pancreas (MDLAP) system
Active Comparator: Standard treatment with sensor augmented pump therapy; four consecutive outpatients overnight sessions at home under standard treatment with sensor augmented pump therapy	Procedure: sensor augmented pump therapy; Other Names: four consecutive outpatients overnight sessions at home under standard treatment with sensor augmented pump therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	glucose variability measured as the standard deviation from the mean glucose	At final visit (day 44)
The total insulin dose during the overnight period		At the final visit (day 44)
Artificial pancreas technical performance defined as total frequency of technical failures		at final visit (day 44)
Artificial pancreas technical performance defined as total frequency of lost or inaccurate sensor records		At final vist (day 44)
Percentage of time of active closed loop control	percentage of time that the MDLAP system worked without any technical problem	At final visit (day 44)
Fear of Hypoglycemia questionnaire		At final visit (day 44)
Acceptance questionnaire		At final visit (day 44)
Artificial Pancreas Satisfaction Questionnaire		At final visit (day 44)

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Moshe Phillip, MD, Schneider Children's Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 8, 2012
• First Submitted That Met QC Criteria: November 11, 2012
• First Posted (Estimate): November 15, 2012

Study Record Updates

• Last Update Posted (Estimate): April 8, 2016
• Last Update Submitted That Met QC Criteria: April 7, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Type 1 Diabetes; Artificial Pancreas; 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; Gastrointestinal Agents; Pancrelipase; Pancreatin
• Other Study ID Numbers: rmc007053ctil