Overview

This trial is active, not recruiting.

Condition diabetes, type i
Treatment continuous glucose sensors and insulin pump
Sponsor Rabin Medical Center
Start date October 2007
End date December 2015
Trial size 80 participants
Trial identifier NCT00541515, rmc004706ctil

Summary

An open interventional data collection study in order to build a database to close the loop between glucose sensor and insulin pump.

background: The ultimate goal in diabetes treatment is to develop an autonomous insulin delivery system (artificial pancreas) capable of continuous glucose sensing, thereby mimicking the physiologic function of the islet beta cells and freeing the patient from the need for constant calculations of daily insulin and carbohydrates. Several prototypes of closed-loop system have been developed in recent years, based on different types of control algorithms, to establish the connection between the sensor and the insulin pump. Current research in the formulation of this type of subcutaneous closed-loop system still faces major challenges, therefore, there is a need for further study and evaluation.

Objectives:

1. To evaluate the lag time of the effect of subcutaneous insulin infusion on blood glucose levels by using continuous glucose sensor

2. To measure the insulin sensitivity as expressed by changes in blood glucose levels after s.c insulin infusion .

3. To evaluate real time sensor calibration algorithms based on the measured lag times

4. Collecting clinical data in order to develop and evaluate mathematical models which will serve a base to simulators.

5. Developing and accessing advanced learning and control algorithms as a step towards developing an artificial pancreas

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Device: continuous glucose sensors and insulin pump
continuous glucose sensors and insulin pump
continuous glucose sensors and insulin pump

Primary Outcomes

Measure
Blood glucose levels
time frame: countinuasly

Eligibility Criteria

Male or female participants from 10 years up to 65 years old.

Inclusion Criteria: 1. Diabetes type 1 for at least one year. 2. ages >10 years. 3. signed informed consent form. 4. willing to cooperate with all study requirements. Exclusion Criteria: 1. Sensor allergy. 2. Psychiatrist diseases. 3. other chronic diseases. 4. Participation in another study that involves a medicine or a medical device.Subjects have to finish participating in other studies at least 30 days before joining this study. Each subject can participate in this study only once.

Additional Information

Official title Closing the Loop Between Glucose Sensor and Insulin Pump-developing an Algorithm
Principal investigator Moshe Phillip, Professor
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Rabin Medical Center.