Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, PDA phone (Personal Digital Assistant), HbA1c
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
Interventions
DEVICEplacebo
Patients will have face to face visits at 3 and 6 months and no PDA-FIT system. Patients will record glycemia on paper support.
DEVICEVISITS + PDA-FIT system
patients will have face to face visits at 3 and 6 months + PDA-FIT system
DEVICEPDA-FIT System + telephone follow-up
patients will received PDA-FIT system + a telephone follow up (12 phone calls) and a face to face visit at 6 months
Sponsors
University Hospital, Grenoble
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of HbA1c mean between the 3 groups | at 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Absolute HbA1c differences (M0-M6) | 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 |
| 8-point blood glucose profiles at inclusion and 6 months | inclusion and M6 |
Countries
France
Outcome results
None listed