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

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Completed

CT.gov ID

NCT00324584

Collaborator

(none)

Enrollment

Locations

17.1

Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

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

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 :

Apr 1, 2003

Study Completion Date :

Sep 1, 2004

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital, Department of Endocrinology	Grenoble		France	38043
2	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