Clinical trial NCT00758082: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Keywords: type 1 diabetes
PDA phone (Personal Digital Assistant)
HbA1c
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: AGIR à Dom
First posted: 2008-09-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Comparison of HbA1c means
timeFrame: M0 (start) and M3 (3 months)
Secondary outcomes:
measure: Difference between theoretical insulin dose and actual dose, one week before the 3-month reevaluation session
timeFrame: M0 (start) and M3 (3 months)
measure: DHP scale of quality of life and satisfaction dimension of the DQOL questionnaire
timeFrame: M0 (start) and M3 (3 months)
measure: Time spent by physicians and nurses in the different groups
timeFrame: M0 (start) and M3 (3 months)
measure: Weight changes during the 3-month period
timeFrame: M0 (start) and M3 (3 months)
measure: Number of hypoglycemias (moderate and severe) during the 3-month period
timeFrame: M0 (start) and M3 (3 months)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Pierre Y Benhamou, PhD
role: PRINCIPAL_INVESTIGATOR
References: