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)

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

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)

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: paper support; Device: PDA-phone + telemonitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • University Hospital Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of HbA1c means	M0 (start) and M3 (3 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference between theoretical insulin dose and actual dose, one week before the 3-month reevaluation session	M0 (start) and M3 (3 months)
DHP scale of quality of life and satisfaction dimension of the DQOL questionnaire	M0 (start) and M3 (3 months)
Time spent by physicians and nurses in the different groups	M0 (start) and M3 (3 months)
Weight changes during the 3-month period	M0 (start) and M3 (3 months)
Number of hypoglycemias (moderate and severe) during the 3-month period	M0 (start) and M3 (3 months)

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: AGIR à Dom
• Investigators: Principal Investigator: Pierre Y Benhamou, PhD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: September 19, 2008
• First Submitted That Met QC Criteria: September 22, 2008
• First Posted (Estimate): September 23, 2008

Study Record Updates

• Last Update Posted (Estimate): March 11, 2010
• Last Update Submitted That Met QC Criteria: March 10, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: HbA1c; type 1 diabetes; PDA phone (Personal Digital Assistant)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2008-A00389-46