Self-management of Type 1 Diabetes Under Functional Insulin Therapy

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Evaluation of Self-management of Patients With Type 1 Diabetes After Education to Functional Insulin Therapy

Conditions
-----------------
Type 1 Diabetes, Basal-bolus Multiple-dily Insulin Injections, Insulin Pump (CSII)

Intervention / Treatment
-----------------
* Other: Training course to functional insulin therapy
* Other: Usual diabetes management.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes from at least 1 year Age from 18 to 70 (70 not included) Basal-bolus multiple-dily insulin injections or insulin pump (CSII) Informed consent Affiliated or benefit from an insurance regimen Exclusion Criteria: Type 2 diabetes Unable to make mathematic calculation Pregnancy, breast-feeding or absence of effective contraception Psychiatric and/or cognitive status uncompatible with study Eating disorders Law protected person, vulnerable person

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education to functional insulin therapy immediately<br>Immediately after inclusion, patients will follow a functional insulin therapy training course during 2.5 days. | Other: Training course to functional insulin therapy<br>* Carbohydrate counting, carbohydrate/insulin ratio, sensitivity to insulin factor<br>|
| Other: No education to functional insulin therapy immediately<br>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.<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Therapeutic education, Functional insulin therapy