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OpenTrials
Completed

NCT Number: NCT00541515

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

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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Key information

Age range

10 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

schneider children medical center of Israel

Petah Tikva, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

continuous glucose sensors and insulin pump

Device

continuous glucose sensors and insulin pump

Primary outcomes

  1. Blood glucose levels

    Time frame: countinuasly

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Oct 10, 2007
Registry last updated
Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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