NCT00541515

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. 1.To evaluate the lag time of the effect of subcutaneous insulin infusion on blood glucose levels by using continuous glucose sensor
  2. 2.To measure the insulin sensitivity as expressed by changes in blood glucose levels after s.c insulin infusion .
  3. 3.To evaluate real time sensor calibration algorithms based on the measured lag times
  4. 4.Collecting clinical data in order to develop and evaluate mathematical models which will serve a base to simulators.
  5. 5.Developing and accessing advanced learning and control algorithms as a step towards developing an artificial pancreas

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

April 8, 2016

Status Verified

April 1, 2016

Enrollment Period

7.8 years

First QC Date

October 8, 2007

Last Update Submit

April 7, 2016

Conditions

Diabetes, Type I

Keywords

Type 1 diabetesArtificial pancreasInsulin Pump

Outcome Measures

Primary Outcomes (1)

  • Blood glucose levels

    countinuasly

Study Arms (1)

closed loop system

EXPERIMENTAL

Device: continuous glucose sensors and insulin pump

Device: continuous glucose sensors and insulin pump

Interventions

continuous glucose sensors and insulin pumpDEVICE

continuous glucose sensors and insulin pump

closed loop system

Eligibility Criteria

Age10 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes type 1 for at least one year.
  • ages \>10 years.
  • signed informed consent form.
  • willing to cooperate with all study requirements.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

schneider children medical center of Israel

Petah Tikva, Israel

Location

Related Publications (2)

  • 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.

    PMID: 22853723DERIVED

  • 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.

    PMID: 20150292DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Moshe Phillip, Professor

    Schneider Children Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2007

First Posted

October 10, 2007

Study Start

October 1, 2007

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

April 8, 2016

Record last verified: 2016-04

Locations

IL(1)