Type 1 Diabetes Mellitus
Conditions
Keywords
type 1 diabetes, PDA phone (Personal Digital Assistant), HbA1c
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.
Interventions
DEVICEpaper support
Patients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support.
DEVICEPDA-phone + telemonitoring
Patients will received PDA-phone + a telephone follow up + standard visit at 3 months
Sponsors
AGIR à Dom
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of HbA1c means | M0 (start) and M3 (3 months) |
Secondary
| 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) |
Countries
France
Outcome results
None listed