Clinical trial NCT00629304: Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
PDA phone (Personal Digital Assistant)
HbA1c
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
Collaborators: name: University Hospital, Grenoble
First posted: 2008-03-05
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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

Eligibility criteria: 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)

Primary outcomes:
measure: Comparison of HbA1c mean between the 3 groups
timeFrame: at 6 months
Secondary outcomes:
measure: Absolute HbA1c differences (M0-M6)
timeFrame: inclusion and M6
measure: HbA1c changes at M0, M3 and M6
timeFrame: inclusion, M3 and M6
measure: Percentage of patients reaching HbA1c <7.5% at 6 months
timeFrame: 6 months
measure: Mean of blood glucose values as provided by glucose meters during the 14 days prior to inclusion and prior to the 6 months-visit
timeFrame: 14 days prior to inclusion and prior to M6
measure: Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period
timeFrame: study period
measure: Frequency of symptomatic benign hypoglycaemic episodes during the week prior to inclusion and prior to the 6 months-visit
timeFrame: week before inclusion and prior to M6
measure: 8-point blood glucose profiles at inclusion and 6 months
timeFrame: inclusion and M6
measure: Quality of life at inclusion and 6 months, using the DHP scale and the Satisfaction item of the DQOL questionnaire
timeFrame: inclusion and M6
measure: Improvement in diabetes care, as assessed by the change in blood glucose testing frequency, reflected by the glucose meter memory
timeFrame: study period
measure: 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
timeFrame: study period
measure: Satisfaction of patients and physicians with the system and willingness to carry on the use of the system in routine care
timeFrame: 6 months
measure: Effective number of patients carrying on the use of the system in routine care, at their own expense and in agreement with their physician
timeFrame: 6 months
Other outcomes:
Locations:
city: Belfort
country: France
facility: Centre Hospitalier de Belfort Montbéliard
city: Besancon
country: France
facility: CHU Jean Minjoz
city: Corbeil Essonnes
country: France
facility: CH SUD Francilien
city: Grenoble
country: France
facility: University Hospital Grenoble
city: Lille
country: France
facility: CHRU Lille
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Marseille
country: France
facility: CHU Marseille Hôpitaux Sud
city: Montpellier
country: France
facility: Chu Montpellier
city: Nancy
country: France
facility: CHU Hôpital Jeanne d'Arc
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Hopital Hotel Dieu
city: Paris
country: France
facility: Hopital COCHIN
city: Paris
country: France
facility: HOPITAL Saint Louis
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Rennes
country: France
facility: CHU Rennes
city: Saint Etienne
country: France
facility: Hopital Bellevue
city: Strasbourg
country: France
facility: Centre Hospitalier Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: University Hospital, Grenoble
name: Pierre Yves BENHAMOU, MD PHD
role: STUDY_CHAIR
References:
citation: Charpentier G, Benhamou PY, Dardari D, Clergeot A, Franc S, Schaepelynck-Belicar P, Catargi B, Melki V, Chaillous L, Farret A, Bosson JL, Penfornis A; TeleDiab Study Group. The Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support improves HbA1c in poorly controlled type 1 diabetic patients: a 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study). Diabetes Care. 2011 Mar;34(3):533-9. doi: 10.2337/dc10-1259. Epub 2011 Jan 25.