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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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ClinicalTrials.gov Identifier: NCT00324584
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : July 7, 2006
Sponsor:
Information provided by:

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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : April 2003
Estimated Study Completion Date : September 2004

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Glycated hemoglobin HbA1c
  2. monthly mean capillary blood glucose value
  3. blood glucose variability index (MAGE Index and LBGI index)
  4. quality of life score (DQOL score)
  5. frequency of hypoglycemic episodes (<70 mg/dl)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00324584     History of Changes
Other Study ID Numbers: DCIC 03 01
First Posted: May 11, 2006    Key Record Dates
Last Update Posted: July 7, 2006
Last Verified: July 2006

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