Basal-bolus Multiple-dily Insulin Injections, Insulin Pump (CSII), Type 1 Diabetes
Conditions
Keywords
Therapeutic education, Functional insulin therapy
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.
Interventions
OTHERTraining course to functional insulin therapy
Carbohydrate counting, carbohydrate/insulin ratio, sensitivity to insulin factor
OTHERUsual diabetes management.
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the impact of therapeutic education by functional insulin therapy in patients with type 1 diabetes on their ability to disease self-management. | three months (from inclusion until end of study) | CIDS questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the effect of education to functional insulin therapy on HbA1c level | three months (from inclusion until end of study) | HbA1c |
| To assess the effect of education to functional insulin therapy on hypoglycemia frequency | 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 | 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 | three months (from inclusion until end of study) | EAD questionnaire score |
Countries
France
Outcome results
None listed