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

This study is currently recruiting participants.
Verified July 2013 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00541515
First received: October 8, 2007
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

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

Condition Intervention
Diabetes, Type I
Device: continuous glucose sensors and insulin pump

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Closing the Loop Between Glucose Sensor and Insulin Pump-developing an Algorithm

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Blood glucose levels [ Time Frame: countinuasly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: October 2007
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: closed loop system
Device: continuous glucose sensors and insulin pump
Device: continuous glucose sensors and insulin pump
continuous glucose sensors and insulin pump

  Eligibility

Ages Eligible for Study:   10 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541515

Contacts
Contact: Moshe Phillip, Prof. 03-9253778 mosheph@clalit.org.il

Locations
Israel
schneider children medical center of Israel Recruiting
Petach-Tikva, Israel
Principal Investigator: Moshe Phillip, Prof         
Sub-Investigator: Ravital Nimri, Dr.         
Sub-Investigator: Shlomit Shalitin, Dr.         
Sub-Investigator: Liat de Vries, Dr.         
Sub-Investigator: Sharon Demol, Dr.         
Sub-Investigator: Ariel Tenenbaum, Dr.         
Sub-Investigator: Tal Oron, Dr.         
Sub-Investigator: Liora Lazar, Dr.         
Sub-Investigator: Yael Levental, Dr.         
Sub-Investigator: Eran Atlas         
Sub-Investigator: Rachel Frumkin         
Sub-Investigator: Eli Grunberg, BSc         
Sub-Investigator: Shachar Miler, Bsc         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Moshe Phillip, Professor Schneider Children Medical Center
  More Information

No publications provided by Rabin Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00541515     History of Changes
Other Study ID Numbers: rmc004706ctil
Study First Received: October 8, 2007
Last Updated: July 15, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Type 1 diabetes
Artificial pancreas
Insulin Pump

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014