Closing the Loop Between Glucose Sensor and Insulin Pump-developing an Algorithm
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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:
- To evaluate the lag time of the effect of subcutaneous insulin infusion on blood glucose levels by using continuous glucose sensor
- To measure the insulin sensitivity as expressed by changes in blood glucose levels after s.c insulin infusion .
- To evaluate real time sensor calibration algorithms based on the measured lag times
- Collecting clinical data in order to develop and evaluate mathematical models which will serve a base to simulators.
- 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 |
- 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 |
Inclusion Criteria:
- Diabetes type 1 for at least one year.
- ages >10 years.
- signed informed consent form.
- willing to cooperate with all study requirements.
Exclusion Criteria:
- Sensor allergy.
- Psychiatrist diseases.
- other chronic diseases.
- 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| Contact: Moshe Phillip, Prof. | 03-9253778 | mosheph@clalit.org.il |
| 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 | |
| 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: | January 1, 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 Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013