Self-management of Type 1 Diabetes Under Functional Insulin Therapy (EVAUTODIAB)

University Hospital Center (CHU)

Status: Terminated

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

Treatments: Other: Training course to functional insulin therapy; Other: Usual diabetes management.

Study type: Interventional

Funder types: Other

Identifiers

NCT02272348

9372

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Education to functional insulin therapy immediately

Experimental group

Description:

Immediately after inclusion, patients will follow a functional insulin therapy training course during 2.5 days.

Treatment:

Other: Training course to functional insulin therapy

No education to functional insulin therapy immediately

Other group

Description:

After inclusion in the study, patients go on usual diabetes management. At the end of study, they will receive education to functional insulin therapy.

Treatment:

Other: Usual diabetes management.