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

Type 1 Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324584
• Other study ID #: DCIC 03 01
• Status: Completed
• Phase: Phase 3
• First received: May 10, 2006
• Last updated: July 4, 2006
• Start date: April 2003
• Est. completion date: September 2004

Study information

• Verified date: July 2006
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• Telemonitoring of glucose values using GlucoNet device

Locations

Country	Name	City	State
France	University Hospital, Department of Endocrinology	Grenoble
France	University Hospital, Department of Endocrinology	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin HbA1c
Primary	monthly mean capillary blood glucose value
Primary	blood glucose variability index (MAGE Index and LBGI index)
Primary	quality of life score (DQOL score)
Primary	frequency of hypoglycemic episodes (<70 mg/dl)