Clinical trial NCT00541515: Closing the Loop Between Glucose Sensor and Insulin Pump-developing an Algorithm
Official title: Closing the Loop Between Glucose Sensor and Insulin Pump-developing an Algorithm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes, Type I
Keywords: Type 1 diabetes
Artificial pancreas
Insulin Pump
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2007-10-10
Enrollment: 38
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Blood glucose levels
timeFrame: countinuasly
Secondary outcomes:
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: schneider children medical center of Israel
Study officials:
affiliation: Schneider Children Medical Center
name: Moshe Phillip, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nimri R, Atlas E, Ajzensztejn M, Miller S, Oron T, Phillip M. Feasibility study of automated overnight closed-loop glucose control under MD-logic artificial pancreas in patients with type 1 diabetes: the DREAM Project. Diabetes Technol Ther. 2012 Aug;14(8):728-35. doi: 10.1089/dia.2012.0004.
citation: Atlas E, Nimri R, Miller S, Grunberg EA, Phillip M. MD-logic artificial pancreas system: a pilot study in adults with type 1 diabetes. Diabetes Care. 2010 May;33(5):1072-6. doi: 10.2337/dc09-1830. Epub 2010 Feb 11.