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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00324584
First received: May 10, 2006
Last updated: July 4, 2006
Last verified: July 2006
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Device: Telemonitoring of glucose values using GlucoNet device
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

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)

Estimated Enrollment: 40
Study Start Date: April 2003
Estimated Study Completion Date: September 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324584

Locations
France
University Hospital, Department of Endocrinology
Grenoble, France, 38043
University Hospital, Department of Endocrinology
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Pierre Y Benhamou, MD, PhD Universty Hospital, Grenoble, France
Study Director: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00324584     History of Changes
Other Study ID Numbers: DCIC 03 01
Study First Received: May 10, 2006
Last Updated: July 4, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
type 1 diabetes mellitus
telecare
telemedicine
insulin pump therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014