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

NCT ID: NCT00324584

Last Updated: 2006-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-09-30

Brief Summary

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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

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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.

Conditions

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Type 1 Diabetes Mellitus

Keywords

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type 1 diabetes mellitus telecare telemedicine insulin pump therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Telemonitoring of glucose values using GlucoNet device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Principal Investigators

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Pierre Y Benhamou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universty Hospital, Grenoble, France

Helene Hanaire, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Toulouse, France

Serge Halimi, MD

Role: STUDY_DIRECTOR

University Hospital, Grenoble, France

Jean L Bosson, MD, PhD

Role: STUDY_DIRECTOR

CIC-INSERM

Locations

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University Hospital, Department of Endocrinology

Grenoble, , France

Site Status

University Hospital, Department of Endocrinology

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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DCIC 03 01

Identifier Type: -

Identifier Source: org_study_id