Self-management of Type 1 Diabetes Under Functional Insulin Therapy (EVAUTODIAB)
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|ClinicalTrials.gov Identifier: NCT02272348|
Recruitment Status : Unknown
Verified October 2014 by University Hospital, Montpellier.
Recruitment status was: Not yet recruiting
First Posted : October 22, 2014
Last Update Posted : October 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Basal-bolus Multiple-dily Insulin Injections Insulin Pump (CSII)||Other: Training course to functional insulin therapy Other: Usual diabetes management.||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Self-management of Patients With Type 1 Diabetes After Education to Functional Insulin Therapy|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||October 2015|
Experimental: Education to functional insulin therapy immediately
Immediately after inclusion, patients will follow a functional insulin therapy training course during 2.5 days.
Other: Training course to functional insulin therapy
Carbohydrate counting, carbohydrate/insulin ratio, sensitivity to insulin factor
No education to functional insulin therapy immediately
After inclusion in the study, patients go on usual diabetes management. At the end of study, they will receive education to functional insulin therapy.
Other: Usual diabetes management.
- To assess the impact of therapeutic education by functional insulin therapy in patients with type 1 diabetes on their ability to disease self-management. [ Time Frame: three months (from inclusion until end of study) ]CIDS questionnaire
- To assess the effect of education to functional insulin therapy on HbA1c level [ Time Frame: three months (from inclusion until end of study) ]HbA1c
- To assess the effect of education to functional insulin therapy on hypoglycemia frequency [ Time Frame: three months (from inclusion until end of study) ]Hypoglycemia occurrence
- To assess the effect of education to functional insulinotherapy on the score of each of the 20 items of CIDS questioonaire [ Time Frame: three months (from inclusion until end of study) ]CIDS questionnaire sub scores
- 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 [ Time Frame: three months (from inclusion until end of study) ]EAD questionnaire score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272348
|Contact: Elise DUTERTRE, MD||+33 4 67 33 83 email@example.com|
|Contact: Eric RENARD, PU-PH||+33 4 67 33 83 firstname.lastname@example.org|
|Lapeyronie Hospital - CHU de Montpellier|
|Montpellier, France, 34295|
|Principal Investigator:||Elise DUTERTRE, MD||CHU Montpellier, France|