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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: paper support
* Device: PDA-phone + telemonitoring


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support | Device: paper support<br>* Patients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support.<br>|
| Experimental: 2<br>PDA-phone + phone consultations + standard visit at 3 months | Device: PDA-phone + telemonitoring<br>* Patients will received PDA-phone + a telephone follow up + standard visit at 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, PDA phone (Personal Digital Assistant), HbA1c