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

This study has been completed.
Sponsor:
Collaborator:
AGIR à Dom
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00758082
First received: September 19, 2008
Last updated: March 10, 2010
Last verified: March 2010
  Purpose

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)


Condition Intervention Phase
Type 1 Diabetes Mellitus
Device: paper support
Device: PDA-phone + telemonitoring
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Comparison of HbA1c means [ Time Frame: M0 (start) and M3 (3 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference between theoretical insulin dose and actual dose, one week before the 3-month reevaluation session [ Time Frame: M0 (start) and M3 (3 months) ] [ Designated as safety issue: No ]
  • DHP scale of quality of life and satisfaction dimension of the DQOL questionnaire [ Time Frame: M0 (start) and M3 (3 months) ] [ Designated as safety issue: No ]
  • Time spent by physicians and nurses in the different groups [ Time Frame: M0 (start) and M3 (3 months) ] [ Designated as safety issue: No ]
  • Weight changes during the 3-month period [ Time Frame: M0 (start) and M3 (3 months) ] [ Designated as safety issue: No ]
  • Number of hypoglycemias (moderate and severe) during the 3-month period [ Time Frame: M0 (start) and M3 (3 months) ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: July 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support
Device: paper support
Patients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support.
Experimental: 2
PDA-phone + phone consultations + standard visit at 3 months
Device: PDA-phone + telemonitoring
Patients will received PDA-phone + a telephone follow up + standard visit at 3 months

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758082

Locations
France
University Hospital Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
AGIR à Dom
Investigators
Principal Investigator: Pierre Y Benhamou, PhD University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: Pr Pierre-Yves Benhamou, University Hospital Grenoble
ClinicalTrials.gov Identifier: NCT00758082     History of Changes
Other Study ID Numbers: 2008-A00389-46
Study First Received: September 19, 2008
Last Updated: March 10, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
type 1 diabetes
PDA phone (Personal Digital Assistant)
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014