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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726829
• Other study ID #: rmc007053ctil
• Status: Completed
• Phase: N/A
• First received: November 8, 2012
• Last updated: April 7, 2016
• Start date: November 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• MD-Logic Artificial Pancreas (MDLAP) system

Procedure:
• sensor augmented pump therapy

Locations

Country	Name	City	State
Germany	Diabetes -Zentrum fuer kinder und jugendliche	Hannover
Israel	Schneider Children's Medical Center	Petah-Tikva
Slovenia	University Children's Hospital	Slovenia

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Countries where clinical trial is conducted

Germany,  Israel,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time sensor glucose level spent below 70mg/dl		final visit (day 44)	Yes
Primary	The percentage of nights mean overnight sensor glucose levels was within90-140 mg/dl		At final visit (day 44)	No
Secondary	The time sensor glucose level spent within 70-140 mg/dl		At final visit (day 44)	No
Secondary	The number and frequency of hypoglycemic events below 63, 79 mg/dl		At final visit (day 44)	Yes
Secondary	The time sensor glucose level spent above 140, 180 mg/dl		At final visit (day 44)	No
Secondary	The area under the curve <63, <70, >140, >180 mg/dl		At final visit (day 44)	No
Secondary	Glucose variability	glucose variability measured as the standard deviation from the mean glucose	At final visit (day 44)	No
Secondary	The total insulin dose during the overnight period		At the final visit (day 44)	No
Secondary	Artificial pancreas technical performance defined as total frequency of technical failures		at final visit (day 44)	No
Secondary	Artificial pancreas technical performance defined as total frequency of lost or inaccurate sensor records		At final vist (day 44)	No
Secondary	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)	No
Secondary	Fear of Hypoglycemia questionnaire		At final visit (day 44)	No
Secondary	Acceptance questionnaire		At final visit (day 44)	No
Secondary	Artificial Pancreas Satisfaction Questionnaire		At final visit (day 44)	No