TELEDIAB-2 is a national, multicenter, controlled, randomised trial. The primary objective of the study is to show that during the initiation of a basal insulin treatment , a computerized decision-making system of adaptation of the insulin, coupled to a distance follow-up (thanks to PDAphone or an interactive vocal server (IVS)), is able to improve metabolic control at the end of 4 mouths as compared with conventional care. Main judgment criteria: comparison of HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group at 4 months.
Secondary objectives : 1. \- To compare the 2 methods of telemonitoring employed. 2. \- To evaluate the speed of the glycemic attack of the objective to the rising, according to the method of follow-up employed. 3. \- To evaluate the satisfaction of the patients and the doctors with respect to systems of telemonitoring, and improvement of the quality of life (DQOL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
180
paper support for glycaemia face to face visit at T4mounths
patients transmit their glycaemia to the IVS, which advises them the insulin amount recommended by their physician in this situation. Face to face visit at T4mounths plus telephone visits each 2 weeks.
Patients will receive PDA phone system. They will hace face to face visit at T4mounths and telephone visits each 2 weeks
CH Aix en Provence
Aix-en-Provence, France
Centre Hospitalier Intercommunal Alençon-Mamers
Alençon, France
CH Avignon
Avignon, France
Centre Hospitalier de Belfort Montbéliard
Belfort, France
CHU Jean Minjoz
Besançon, France
CHU de Caen
Caen, France
Hôpital Gabriel Montpied
Clermont-Ferrand, France
CH sud francilien
Corbeil-Essonnes, France
CH de Dreux
Dreux, France
CHU Pierre Zobda-Quitman
Fort de France, France
...and 18 more locations
Comparison HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group.
Time frame: To T4 months
Comparison of absolute HbA1c difference
Time frame: T0-T4 months
Comparison of evolution of HbA1c
Time frame: T0 and T4 months
Comparison of percentage of patients reaching HbA1c < 7.0% in 4 months
Time frame: T0 and T4 months
Comparison of percentage of patients within the objective glycemic (the last 3 days Jeun Glycemia average with between 0.73 and 1.08 g/l) at the end of the study, and the average time allowing to achieve this goal
Time frame: T0 and T4 months
Comparison of the average jeun glycemia the 14 days previous the visit in 4 months
Time frame: T4 months
Comparison of the frequency of benign hypoglycemias, symptomatic or not, night and severe throughout study
Time frame: study period
Comparison of the evolution of the weight
Time frame: T0 and T4 months
Comparison of evolution of the quality of life at the beginning and at the end of the study (the scale of quality of life DHP as well as the items of dimension Satisfaction of the DQOL)
Time frame: T0 and T4 months
Comparison of the time spent by physicians with patients during visit (either face to face visits or phone call visit);
Time frame: study period
Comparison of the satisfaction of the patients and physicians with the system and willingness to carry on the use of the system in routine care
Time frame: 4 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
Time frame: 4 months
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