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NCT Number: NCT00758082

Reinforcement of the Impact of a Functional Insulin Therapy Training Course by Telemonotoring With a PDA-phone in Type 1 Diabetic Patients. The TELFIT Study Patients

TELFIT is a monocenter, controlled, randomised trial. It focuses on type 1 diabetes patients that have attended a functional insulin therapy training course. The Primary objective of the TELFIT study is to evaluate whether a PDA with telemonitoring by phone reinforces the effects of the functional insulin therapy training course as compared with conventional care.

Main judgment criteria: comparison of HbA1c means between M0 (start) and M3(3 months)

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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 Grenoble

Grenoble, 38043, France

About this study

All patients will attend a functional insulin therapy training course and be randomized into 2 groups. One group will receive a PDA-phone and one month of phone consultations with a nurse and a physician. The other group will only have the usual paper support. This study compares the evolution of HbA1c in the 2 groups over a period of 3 months. It also assesses time spent by nurses and physicians, changes in quality of life, hypoglycaemia frequency and weight changes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 diabetes mellitus for ≥ 6 months or more
  • Age > 18 year old
  • The patient has attended a functional insulin therapy class or workshop
  • Insulin basal-bolus therapy for at least 6 months. At inclusion, patients should be treated either with a long-acting insulin and insulin rapid analog before each meal, or with rapid insulin analog delivered with a pump
  • Ability to understand how the PDA-phone works and ability to use it
  • Social Security membership or benefit from Social Security
  • Patients equipped with a memory blood glucose monitor
  • Informed consent, with a signed and approved form

Exclusion criteria

  • Underage patient, major patient under guardianship or protected by the Law
  • Patient with any unstable associated evolutive pathology that could cause a diabetes imbalance within the coming year
  • Change in diabetes treatment within the 3 months before inclusion or planned during the study
  • Patient who needs a more frequent diabetic follow-up than in the protocol (especially severe or evolving complication due to diabetes)
  • Patient attending another education program within the 3 months before inclusion or planning to attend one during the study
  • Patient with toxicomania, alcoholism or psychological troubles that could impact the study
  • Type-2-diabetic patient
  • Patient who doesn't need strict metabolic objectives
  • Pregnant or possibly pregnant woman
  • Person with no freedom (prisoner)

Treatment and study plan

paper support

Device

Patients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support.

PDA-phone + telemonitoring

Device

Patients will received PDA-phone + a telephone follow up + standard visit at 3 months

Primary outcomes

  1. Comparison of HbA1c means

    Time frame: M0 (start) and M3 (3 months)

Secondary outcomes

  1. Difference between theoretical insulin dose and actual dose, one week before the 3-month reevaluation session

    Time frame: M0 (start) and M3 (3 months)

  2. DHP scale of quality of life and satisfaction dimension of the DQOL questionnaire

    Time frame: M0 (start) and M3 (3 months)

  3. Time spent by physicians and nurses in the different groups

    Time frame: M0 (start) and M3 (3 months)

  4. Weight changes during the 3-month period

    Time frame: M0 (start) and M3 (3 months)

  5. Number of hypoglycemias (moderate and severe) during the 3-month period

    Time frame: M0 (start) and M3 (3 months)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • AGIR à Dom

Registry information

Official study title

Reinforcement of the Impact of a Functional Insulin Therapy Training Course by Telemonotoring With a PDA-phone in Type 1 Diabetic Patients. The TELFIT Study

Acronym: TELFIT

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 23, 2008
Registry last updated
Mar 11, 2010

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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