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Completed

NCT Number: NCT00324584

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital, Department of Endocrinology, Grenoble, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemonitoring of glucose values using GlucoNet device

Device

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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.

Important dates

Study start
2003
Study completion
2004
First posted
May 11, 2006
Registry last updated
Jul 7, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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