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

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Completed

Phase 3

Conditions

Type 1 Diabetes Mellitus

Treatments

Device: paper support

Device: PDA-phone + telemonitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT00758082

2008-A00389-46

Details and patient eligibility

About

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)

Full 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.

Enrollment

62 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)