Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients

Study Overview
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Brief Summary
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TELEDIAB-1 is a national, multicenter, controlled, randomised trial. The Primary objective of the TELEDIAB-1 study is to demonstrate that the PDA-FIT system (PDA-Phone and/or telemonitoring) is able to improve metabolic control of chronically uncontrolled type 1 diabetic patients, despite intensive insulin therapy (multiple daily injections with basal-bolus insulin or insulin pump), as compared with conventional care. Main judgment criteria: comparison of HbA1c means between the 3 groups at 6 months

Detailed Description
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Secondary Objectives : To assess the improvement of blood glucose control and quality of life in patients using the PDA-FIT system To assess the improvement in diabetes care provided by the use of the PDA-FIT system Satisfaction of patients and physicians towards the PDA-FIT system

Official Title
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Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients With Chronic Failure of Intensive Insulin Therapy and Conventional Care. The TELEDIAB-1 STUDY

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: placebo
* Device: VISITS + PDA-FIT system
* Device: PDA-FIT System + telephone follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 1 diabetes mellitus for ≥ 12 months or more (including C-peptide negative secondary diabetes) age > 18 y.o. intensive insulin basal-bolus therapy for ≥ 6 months. At inclusion, patients should be treated, either with a combination of a basal, long-acting insulin and insulin rapid analog before each meal, or with rapid insulin analog delivered with a pump chronically uncontrolled diabetes with HbA1c ≥ 8 % during the past 12 months and at inclusion Exclusion Criteria: patient with unstable associated evolutive pathology patient who need a more frequent diabetic follow up (than in the protocol) patient with a education teaching within the 3 months before inclusion patient with a hemoglobinopathy patient with toxicomania, alcoholism or psychological troubles type 2 diabetes patients patient who don't need strict metabolic objectives pregnant or parturient women 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>standard visit at 3 and 6 months | Device: placebo<br>* Patients will have face to face visits at 3 and 6 months and no PDA-FIT system. Patients will record glycemia on paper support.<br>* Other names: without PDA-FIT system;|
| Active Comparator: 2<br>PDA-FIT system + standard visit at 3 and 6 months | Device: VISITS + PDA-FIT system<br>* patients will have face to face visits at 3 and 6 months + PDA-FIT system<br>* Other names: PDA-FIT system;|
| Active Comparator: 3<br>PDA-FIT system + 12 telephone visits + standard visit at 6 months | Device: PDA-FIT System + telephone follow-up<br>* patients will received PDA-FIT system + a telephone follow up (12 phone calls) and a face to face visit at 6 months<br>* Other names: PDA-FIT system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of HbA1c mean between the 3 groups |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute HbA1c differences (M0-M6) |  | inclusion and M6 | 
| HbA1c changes at M0, M3 and M6 |  | inclusion, M3 and M6 | 
| Percentage of patients reaching HbA1c <7.5% at 6 months |  | 6 months | 
| Mean of blood glucose values as provided by glucose meters during the 14 days prior to inclusion and prior to the 6 months-visit |  | 14 days prior to inclusion and prior to M6 | 
| Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period |  | study period | 
| Frequency of symptomatic benign hypoglycaemic episodes during the week prior to inclusion and prior to the 6 months-visit |  | week before inclusion and prior to M6 | 
| 8-point blood glucose profiles at inclusion and 6 months |  | inclusion and M6 | 
| Quality of life at inclusion and 6 months, using the DHP scale and the Satisfaction item of the DQOL questionnaire |  | inclusion and M6 | 
| Improvement in diabetes care, as assessed by the change in blood glucose testing frequency, reflected by the glucose meter memory |  | study period | 
| Time spent by physicians with patients during visits (either face to face visits or phone call visits) and time spent by patients during transport, waiting time and lost working time |  | study period | 
| Satisfaction of patients and physicians with the system and willingness to carry on the use of the system in routine care |  | 6 months | 
| Effective number of patients carrying on the use of the system in routine care, at their own expense and in agreement with their physician |  | 6 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