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

This study is currently recruiting participants.
Verified October 2013 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01726829
First received: November 8, 2012
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Device: MD-Logic Artificial Pancreas (MDLAP) system
Procedure: sensor augmented pump therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Overnight Type 1 Diabetes Control Under MD-Logic Closed Loop System at the Patient's Home, Pilot Study.

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • time sensor glucose level spent below 70mg/dl [ Time Frame: final visit (day 44) ] [ Designated as safety issue: Yes ]
  • The percentage of nights mean overnight sensor glucose levels was within90-140 mg/dl [ Time Frame: At final visit (day 44) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The time sensor glucose level spent within 70-140 mg/dl [ Time Frame: At final visit (day 44) ] [ Designated as safety issue: No ]
  • The number and frequency of hypoglycemic events below 63, 79 mg/dl [ Time Frame: At final visit (day 44) ] [ Designated as safety issue: Yes ]
  • The time sensor glucose level spent above 140, 180 mg/dl [ Time Frame: At final visit (day 44) ] [ Designated as safety issue: No ]
  • The area under the curve <63, <70, >140, >180 mg/dl [ Time Frame: At final visit (day 44) ] [ Designated as safety issue: No ]
  • Glucose variability [ Time Frame: At final visit (day 44) ] [ Designated as safety issue: No ]
    glucose variability measured as the standard deviation from the mean glucose

  • The total insulin dose during the overnight period [ Time Frame: At the final visit (day 44) ] [ Designated as safety issue: No ]
  • Artificial pancreas technical performance defined as total frequency of technical failures [ Time Frame: at final visit (day 44) ] [ Designated as safety issue: No ]
  • Artificial pancreas technical performance defined as total frequency of lost or inaccurate sensor records [ Time Frame: At final vist (day 44) ] [ Designated as safety issue: No ]
  • Percentage of time of active closed loop control [ Time Frame: At final visit (day 44) ] [ Designated as safety issue: No ]
    percentage of time that the MDLAP system worked without any technical problem

  • Fear of Hypoglycemia questionnaire [ Time Frame: At final visit (day 44) ] [ Designated as safety issue: No ]
  • Acceptance questionnaire [ Time Frame: At final visit (day 44) ] [ Designated as safety issue: No ]
  • Artificial Pancreas Satisfaction Questionnaire [ Time Frame: At final visit (day 44) ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: November 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: four consecutive outpatients overnight sessions at home under standard treatment with 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.

  Eligibility

Ages Eligible for Study:   10 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726829

Contacts
Contact: Moshe Phillip, MD 972-3-9253747 mosheph@clalit.org.il
Contact: Alona Hamou, Msc 972-3-9253778 alonah@clalit.org.il

Locations
Germany
Diabetes -Zentrum fuer kinder und jugendliche Recruiting
Hannover, Germany
Contact: Thomas Danne, MD    +49 511 8115 3330      
Principal Investigator: Thomas Danne, MD         
Israel
Schneider Children's Medical Center Completed
Petah-Tikva, Israel, 49202
Slovenia
University Children's Hospital Recruiting
Slovenia, Slovenia
Contact: Tadej Battelino, MD    +386 1 5232 8353    tadej.battelino@mf.uni-lj.si   
Principal Investigator: Tadej Battelino, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Moshe Phillip, MD Schneider Children's Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01726829     History of Changes
Other Study ID Numbers: rmc007053ctil
Study First Received: November 8, 2012
Last Updated: October 9, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Type 1 Diabetes
Artificial Pancreas
Closed Loop

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014