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

NCT ID: NCT00758082

Last Updated: 2010-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-03-31

Brief Summary

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)

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

paper support

Intervention Type: DEVICE

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

2

PDA-phone + phone consultations + standard visit at 3 months

Group Type: EXPERIMENTAL

PDA-phone + telemonitoring

Intervention Type: DEVICE

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

Interventions

paper support

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

Intervention Type: DEVICE

PDA-phone + telemonitoring

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

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AGIR à Dom

OTHER

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

University Hospital Grenoble

Principal Investigators

Pierre Y Benhamou, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

University Hospital Grenoble

Grenoble, , France

Countries

France

Other Identifiers

2008-A00389-46

Identifier Type: -

Identifier Source: org_study_id