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

Information source: Rabin Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes

Intervention: MD-Logic Artificial Pancreas (MDLAP) system (Device); sensor augmented pump therapy (Procedure)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Rabin Medical Center

Official(s) and/or principal investigator(s):
Moshe Phillip, MD, Principal Investigator, Affiliation: Schneider Children's Medical Center

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome:

time sensor glucose level spent below 70mg/dl

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

Secondary outcome:

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

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

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

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

Glucose variability

The total insulin dose during the overnight period

Artificial pancreas technical performance defined as total frequency of technical failures

Artificial pancreas technical performance defined as total frequency of lost or inaccurate sensor records

Percentage of time of active closed loop control

Fear of Hypoglycemia questionnaire

Acceptance questionnaire

Artificial Pancreas Satisfaction Questionnaire

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

Minimum age: 10 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Diabetes -Zentrum fuer kinder und jugendliche, Hannover, Germany

Schneider Children's Medical Center, Petah-Tikva 49202, Israel

University Children's Hospital, Slovenia, Slovenia

Additional Information

Starting date: November 2012
Last updated: March 18, 2015

Page last updated: August 23, 2015

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