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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 23, 2014