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

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète180 enrolled

Overview

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

Secondary Objectives : 1. To assess the improvement of blood glucose control and quality of life in patients using the PDA-FIT system 2. To assess the improvement in diabetes care provided by the use of the PDA-FIT system 3. Satisfaction of patients and physicians towards the PDA-FIT system

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

180

Conditions

Type 1 Diabetes

Interventions

placeboDEVICE

Patients will have face to face visits at 3 and 6 months and no PDA-FIT system. Patients will record glycemia on paper support.

VISITS + PDA-FIT systemDEVICE

patients will have face to face visits at 3 and 6 months + PDA-FIT system

PDA-FIT System + telephone follow-upDEVICE

patients will received PDA-FIT system + a telephone follow up (12 phone calls) and a face to face visit at 6 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (18)

Centre Hospitalier de Belfort Montbéliard

Belfort, Belfort, France

CHU Jean Minjoz

Besançon, Besancon, France

Outcomes

Primary Outcomes

Comparison of HbA1c mean between the 3 groups

Time frame: at 6 months

Secondary Outcomes

Absolute HbA1c differences (M0-M6)

Time frame: inclusion and M6

HbA1c changes at M0, M3 and M6

Time frame: inclusion, M3 and M6

Percentage of patients reaching HbA1c <7.5% at 6 months

Time frame: 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

Time frame: 14 days prior to inclusion and prior to M6

Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period

Time frame: study period

Frequency of symptomatic benign hypoglycaemic episodes during the week prior to inclusion and prior to the 6 months-visit

Time frame: week before inclusion and prior to M6

8-point blood glucose profiles at inclusion and 6 months

Time frame: inclusion and M6

Quality of life at inclusion and 6 months, using the DHP scale and the Satisfaction item of the DQOL questionnaire

Time frame: inclusion and M6

Improvement in diabetes care, as assessed by the change in blood glucose testing frequency, reflected by the glucose meter memory

Time frame: study period

Data from ClinicalTrials.gov

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