3-week thermal cure:
Spa treatment harmonized in the different stations
Therapeutic education workshops and conferences common to all stations in the form of practical workshops during supervised lunches
Adapted physical activity, workshops are common to all spas and use an electric bike suitable for health (VELIS) with briefing and debriefing. An APA (Adapted Physical Activity) coaching consultation at the end of the cure for personalized post-cure programs and objectives is planned as well as a telephone or internet coaching during the 5 months post-cure (objectives and adaptation, motivation)
Maintenance of the usual treatment within 6 months post randomization with optimization of the therapeutic target in HbA1c and therapeutic strategies by the software Diascope and / or HAS
Information booklet for inclusion (French Association of Diabetics)

Maintenance of usual treatment within 6 months post-randomization with optimization of the therapeutic target in HbA1c and therapeutic strategies by Diascope and HAS software In addition, a "discovery" access to the baths of 2-3 days will be offered to patients. Finally, the information booklet on diabetes will be given at the inclusion (French Federation of Diabetics).

Diabetes Mellitus

Physical Activity

Dietetic Rules

Therapeutic Education

3 weeks SPA Treatment plus therapeutic education plus physical activity

SPA Treatment with therapeutic education and physical activity

access to the station for a week end after maintenance of usual treatment during 6 months

Week end

ROUSSEL Ludivine

SOUDET Simon

ODDOU Christel

CLERGEOT Annie

WATERLOT

DAOUDI

PENFORNIS Alfred

BETRY Cécile

PARADIS Sabrina

Evaluation of the Benefit at 6 Months of a 3 Weeks Spa Treatment in the Type 2 Diabetic Patient.

Evaluation of the Benefit at 6 Months of a 3 Weeks Spa Treatment in the Type 2 Diabetic Patient. Multicenter Randomized Therapeutic Trial

Difference in mean HbA1c between the intervention group (spa treatment) at 6 months post start of treatment and the reference group (usual care) at 6 months post randomization taking into account (Ancova) the last value of d HbA1c available (at baseline or at baseline).

Success defined by three criteria for the evolution of HbA1c: percentage of patients with HbA1c less than or equal to 7% (HAS Criterion) or percentage of patients with at least 1% reduction in HbA1c or percentage of patients who achieved the target HbA1c defined at inclusion

HbA1C at 12 months in quantitative value adjusted to the value at inclusion

The ADDQOL (Audit of Diabetes-Dependent Quality of Life Scale) contain 19 domains.
These 19 domains ask the respondents to evaluate how their life would be if they did not have diabetes. The scales range from −3 to +1 for 19 life domains (impact rating) and from 0 to +3 in attributed importance (importance rating). A weighted score for each domain is calculated as a multiplier of impact rating and importance rating (ranging from −9 to +3). Lower scores reflect poorer QoL. Finally, a mean weighted impact score (ADDQOL score) is calculated for the entire scale across all applicable domains.

Euroquol 5D (EQ5D- 3L) quality of life scale. Euroquol 5D (EQ5D- 3L) quality of life scale. EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ5D-3L contains 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).
Each dimension has 3 levels (no problem, some problem, extreme problem).

evaluation of the medical care of patients (treatments, paramedical procedures, hospitalizations ...), comparison between the 2 groups of treatment modifications.

Evolution of overweight (abdominal perimeter)

Evolution at 6 months and 12 months of the clinical repercussions of diabetes (collection of declarative SAEs with validation by a committee). Analysis of hospitalizations related to diabetes (macro and microvascular repercussions, metabolic complications, severe hypoglycaemia).

Measurement of physical activity at 6 and 12 months with Global Physical Activity Questionnaire (GPAQ score).The Global Questionnaire on Physical Exercise (GPAQ), has 16 questions.
The score obtained makes it possible to establish three profiles: insufficient level of physical activity, level according to the recommendations, high level

Pre and post cure measurement of physical performance. Evolution of performances during bike rides (VELIS). Profile of the parameters recorded on the VELIS (cardio, speed, electric power supplied by the engine, pressure on the pedals) at the beginning and end of treatment on the same reference course.

Assessment of self-esteem building with the Rosenberg score.The Rosenberg score is between 10 and 40.
The interpretation of the results is identical for a man or a woman. score below 25, self-esteem is very low. score between 25 and 31, self-esteem is low. score between 31 and 34, self-esteem is average. score between 34 and 39, self-esteem is strong. score above 39, self-esteem is very strong

Evaluate the participation in thermal treatment, education and physical activity

Evaluation of the achievement of educational objectives of health behaviors by intermediate telephone follow-up.

Evaluation of the side effects of the thermal treatment (SAE reporting). Evaluation of all adverse events attributable to treatment, or not, according to the usual criteria of pharmacovigilance in clinical trials

Sub group analysis on the primary outcome measure (stratification on primo spa therapy and age (median 62 years)).

Association Francaise pour la Recherche Thermale

TIMC-IMAG

Floralis

Multicenter, Controlled, Randomized, Open Group Therapeutic Trial

We wil use the zelen randomisation to minimize patient disappointment. The patient will be advice of only one group (3 weeks SPA treatment or only a week end access to the SPA)

A pilot study will be done on 20 patients with abnormal glucose tolerance which will include:
A-Continuous glucose monitoring system (CGMS) : A glucometer will be given to each patient and will be asked to measure blood glucose before meals and snacks and record the valus in the CGMS for better calibration (Khammar A et al., 2009).
B-Therapeutic intervention:
Thalassemia patients who proved to have diabetes according to the ADA criteria will be put on sc insulin

A pilot study will be done on 20 patients with abnormal glucose tolerance which will include:
A-Continuous glucose monitoring system (CGMS) : A glucometer will be given to each patient and will be asked to measure blood glucose before meals and snacks and record the valus in the CGMS for better calibration (Khammar A et
B-Therapeutic intervention:
Thalassemia patients who proved to have diabetes according to the ADA criteria will be put on insulin pump

Diabetes

Prediabetes

B-Thalassemia

A-Continuous glucose monitoring system (CGMS) : A glucometer will be given to each patient and will be asked to measure blood glucose before meals and snacks and record the valus in the CGMS for better calibration (Khammar A et al., 2009).
B-Therapeutic intervention:
Thalassemia patients who proved to have diabetes according to the ADA criteria will be subjected to
• Insulin pump will be tried in each diabetic thalassemic patient versus conventional insulin therapy(Bruttomesso D et al., 2009).

insulin pump/CGMS

The Use of CGMS to Detect Alterations of Blood Glucose in Thalassemic Patients

Evaluation of Continuous Blood Glucose Monitoring Method for Detection of Alterations in Glucose Homeostasis in Beta Thalassemia Patients

to find out the number of patients with thalassemia major having impaired glucose tolerance

to find out the number of patients with thalassemia major having diabetes mellitus

to compare the use of conventional insulin therapy to insulin pump in diabetic thalassemic patients

polyuria/obesity

Evaluation of the Benefit at 6 Months of a 3 Weeks Spa Treatment in the Type 2 Diabetic Patient.

The Use of CGMS to Detect Alterations of Blood Glucose in Thalassemic Patients

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