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Web-Based Follow-Up Using Cellular Phone in Type 1 Diabetic Patients Under Insulin Pump Therapy : The PumpNet Study

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Telemonitoring of glucose values using GlucoNet device
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring type 1 diabetes mellitus, telecare, telemedicine, insulin pump therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, Department of Endocrinology
  • University Hospital, Department of Endocrinology

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
May 10, 2006
Last Updated
July 4, 2006
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT00324584
Brief Title
Web-Based Follow-Up Using Cellular Phone in Type 1 Diabetic Patients Under Insulin Pump Therapy : The PumpNet Study
Official Title
Surveillance Des données De l'Autosurveillance glycémique Via Internet Et Le réseau téléphonique GSM Chez Le diabétique De Type 1 Sous Traitement Insulinique Par Pompe Externe : Etude Prospective randomisée PumpNet.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Grenoble

4. Oversight

5. Study Description

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.
Detailed Description
We aim at comparing conventional follow-up of type 1 diabetic patients treated with continuous subcutaneous insulin infusion (CSII) (face-to-face visits) with an intensive coaching using the Web and the cellular phone network for data transmission and Short Message Service (SMS). This telecommunication device is called GlucoNet. The specific objectives are to measure the efficiency of GlucoNet in improving metabolic control, reducing health care costs and improving the quality of life of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
type 1 diabetes mellitus, telecare, telemedicine, insulin pump therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Telemonitoring of glucose values using GlucoNet device
Primary Outcome Measure Information:
Title
Glycated hemoglobin HbA1c
Title
monthly mean capillary blood glucose value
Title
blood glucose variability index (MAGE Index and LBGI index)
Title
quality of life score (DQOL score)
Title
frequency of hypoglycemic episodes (<70 mg/dl)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 diabetes mellitus Age ≥ 18 HbA1c between 7.5 and 10% Treated with continuous subcutaneous insulin infusion for a minimum of 3 months Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Y Benhamou, MD, PhD
Organizational Affiliation
Universty Hospital, Grenoble, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helene Hanaire, MD, PhD
Organizational Affiliation
University Hospital, Toulouse, France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Serge Halimi, MD
Organizational Affiliation
University Hospital, Grenoble, France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jean L Bosson, MD, PhD
Organizational Affiliation
CIC-INSERM
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital, Department of Endocrinology
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
University Hospital, Department of Endocrinology
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

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Web-Based Follow-Up Using Cellular Phone in Type 1 Diabetic Patients Under Insulin Pump Therapy : The PumpNet Study

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