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/dlThe 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/dlThe 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
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