Clinical trial NCT02272348: Self-management of Type 1 Diabetes Under Functional Insulin Therapy
Official title: Evaluation of Self-management of Patients With Type 1 Diabetes After Education to Functional Insulin Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 1 Diabetes
Basal-bolus Multiple-dily Insulin Injections
Insulin Pump (CSII)
Keywords: Therapeutic education
Functional insulin therapy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: To assess the impact of therapeutic education by functional insulin therapy in patients with type 1 diabetes on their ability to disease self-management.
timeFrame: three months (from inclusion until end of study)
Secondary outcomes:
measure: To assess the effect of education to functional insulin therapy on HbA1c level
timeFrame: three months (from inclusion until end of study)
measure: To assess the effect of education to functional insulin therapy on hypoglycemia frequency
timeFrame: three months (from inclusion until end of study)
measure: To assess the effect of education to functional insulinotherapy on the score of each of the 20 items of CIDS questioonaire
timeFrame: three months (from inclusion until end of study)
measure: 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
timeFrame: three months (from inclusion until end of study)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Lapeyronie Hospital - CHU de Montpellier
Study officials:
affiliation: CHU Montpellier, France
name: Elise DUTERTRE, MD
role: PRINCIPAL_INVESTIGATOR
References: