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

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ClinicalTrials.gov Identifier: NCT00541515
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Brief 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

Condition or disease Intervention/treatment Phase
Diabetes, Type I Device: continuous glucose sensors and insulin pump Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Closing the Loop Between Glucose Sensor and Insulin Pump-developing an Algorithm
Study Start Date : October 2007
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: closed loop system
Device: continuous glucose sensors and insulin pump
Device: continuous glucose sensors and insulin pump
continuous glucose sensors and insulin pump



Primary Outcome Measures :
  1. Blood glucose levels [ Time Frame: countinuasly ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00541515


Locations
Israel
schneider children medical center of Israel
Petach-Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Moshe Phillip, Professor Schneider Children Medical Center

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
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016

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

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs