Status:
COMPLETED
Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients
Lead Sponsor:
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Collaborating Sponsors:
University Hospital, Grenoble
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 t...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00629304
Start Date
September 1 2007
End Date
August 1 2009
Last Update
February 9 2012
Active Locations (18)
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1
Centre Hospitalier de Belfort Montbéliard
Belfort, Belfort, France, 90016
2
CHU Jean Minjoz
Besançon, Besancon, France, 25030
3
CH SUD Francilien
Corbeil-Essonnes, Corbeil Essonnes, France, 91100
4
University Hospital Grenoble
Grenoble, Grenoble, France, 38043