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

Launched by CENTRE D'ETUDES ET DE RECHERCHE POUR L'INTENSIFICATION DU TRAITEMENT DU DIABÈTE · Mar 4, 2008

Keywords

ClinConnect Summary

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

Gender

ALL

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)