Closing the Loop Between Glucose Sensor and Insulin Pump-developing an Algorithm

Diabetes, Type I Clinical Trial

Official title:

Closing the Loop Between Glucose Sensor and Insulin Pump-developing an Algorithm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00541515
• Other study ID #: rmc004706ctil
• Status: Completed
• Phase: N/A
• First received: October 8, 2007
• Last updated: April 7, 2016
• Start date: October 2007
• Est. completion date: September 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes, Type I

Intervention

Device:
• continuous glucose sensors and insulin pump
continuous glucose sensors and insulin pump

Locations

Country	Name	City	State
Israel	schneider children medical center of Israel	Petach-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose levels		countinuasly	Yes