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Change in methodology too important - end of randomization
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Therapeutic education of patients is a mandatory component of intensive insulin therapy of type 1 diabetes in order to reach optimal safety and efficacy. Used educational methods aim at facilitating patients' autonomy in their own management of diabetes. Therefore, self-management of patient with type 1 diabetes must be systematically assessed in order to evaluate the effectiveness of education programs .The main objective of this prospective controlled randomized monocentric study is to assess the impact of functional insulin therapy on the level of self-management of patients with type 1 diabetes via Confidence In Diabetes Self-care scale (CIDS) test.
170 patients with type 1 diabetes, volunteering for education to functional insulin therapy, will be recruited by the Department od Endocrinology, Diabetes, Nutrition of Montpellier University Hospital.
After inclusion, the patients will be randomized in 2 groups: group 1 will be immediately trained to functional insulin therapy and group 2 will be trained at the end of the study. The patients will be met as outpatients 3 months after inclusion. The primary endpoint will be the global score for CIDS questionnaire.
Secondary endpoints will include: HbA1c level at month 3, frequency of hypoglycemia from inclusion to month 3, scores for each of the 20 items of CIDS questionnaire.
An ancillary study will assess: the acceptability of the new EAD questionnaire which specifically evaluates the self-management of diabetes, the concordance validity of EAD and CDIS questionnaires, the reproducibility test-retest, the internal consistency and the sensitivity to change of EAD questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education to functional insulin therapy immediately | Experimental | Immediately after inclusion, patients will follow a functional insulin therapy training course during 2.5 days. |
|
| No education to functional insulin therapy immediately | Other | After inclusion in the study, patients go on usual diabetes management. At the end of study, they will receive education to functional insulin therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training course to functional insulin therapy | Other | Carbohydrate counting, carbohydrate/insulin ratio, sensitivity to insulin factor |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the impact of therapeutic education by functional insulin therapy in patients with type 1 diabetes on their ability to disease self-management. | CIDS questionnaire | three months (from inclusion until end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of education to functional insulin therapy on HbA1c level | HbA1c | three months (from inclusion until end of study) |
| To assess the effect of education to functional insulin therapy on hypoglycemia frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elise DUTERTRE, MD | CHU Montpellier, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lapeyronie Hospital - CHU de Montpellier | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Usual diabetes management. | Other |
|
Hypoglycemia occurrence
| three months (from inclusion until end of study) |
| To assess the effect of education to functional insulinotherapy on the score of each of the 20 items of CIDS questioonaire | CIDS questionnaire sub scores | three months (from inclusion until end of study) |
| To assess the validity, the concordance and the sensitivity to change of EAD questionnaire (specific for self-management of diabetes) in comparison with CIDS test | EAD questionnaire score | three months (from inclusion until end of study) |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |