NCT00324584

Brief Summary

The purpose of this study is to determine if telecare using modern telecommunication devices can improve the metabolic control and the quality of life of type 1 diabetic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

2 active sites

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

April 1, 2003

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
Last Updated

July 7, 2006

Status Verified

July 1, 2006

First QC Date

May 10, 2006

Last Update Submit

July 4, 2006

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes mellitustelecaretelemedicineinsulin pump therapy

Outcome Measures

Primary Outcomes (5)

  • Glycated hemoglobin HbA1c

  • monthly mean capillary blood glucose value

  • blood glucose variability index (MAGE Index and LBGI index)

  • quality of life score (DQOL score)

  • frequency of hypoglycemic episodes (<70 mg/dl)

Interventions

Telemonitoring of glucose values using GlucoNet deviceDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes mellitus
  • Age ≥ 18
  • HbA1c between 7.5 and 10%
  • Treated with continuous subcutaneous insulin infusion for a minimum of 3 months

You may not qualify if:

  • Unstabilized diabetic microangiopathy
  • Ongoing pregnancy or planned pregnancy
  • Unwilling to perform a minimum of 4 capillary blood tests per day
  • Unable to use the GlucoNet device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital, Department of Endocrinology

Grenoble, 38043, France

Location

University Hospital, Department of Endocrinology

Toulouse, 31000, France

Location

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

  • Pierre Y Benhamou, MD, PhD

    Universty Hospital, Grenoble, France

    PRINCIPAL INVESTIGATOR

  • Helene Hanaire, MD, PhD

    University Hospital, Toulouse, France

    STUDY DIRECTOR

  • Serge Halimi, MD

    University Hospital, Grenoble, France

    STUDY DIRECTOR

  • Jean L Bosson, MD, PhD

    CIC-INSERM

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 11, 2006

Study Start

April 1, 2003

Study Completion

September 1, 2004

Last Updated

July 7, 2006

Record last verified: 2006-07

Locations

FR(2)