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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2015-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Diabetes, Type I

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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closed loop system

Device: continuous glucose sensors and insulin pump

Group Type EXPERIMENTAL

continuous glucose sensors and insulin pump

Intervention Type DEVICE

continuous glucose sensors and insulin pump

Interventions

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continuous glucose sensors and insulin pump

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No