Self-management of Type 1 Diabetes Under Functional Insulin Therapy

Type 1 Diabetes Clinical Trial

— EVAUTODIAB  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02272348
• Other study ID #: 9372
• Status: Terminated
• Phase: N/A
• Start date: February 10, 2015
• Est. completion date: September 10, 2020

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: September 10, 2020
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Training course to functional insulin therapy
Carbohydrate counting, carbohydrate/insulin ratio, sensitivity to insulin factor
• Usual diabetes management.

Locations

Country	Name	City	State
France	Lapeyronie Hospital - CHU de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess the effect of education to functional insulin therapy on HbA1c level	HbA1c	three months (from inclusion until end of study)
Secondary	To assess the effect of education to functional insulin therapy on hypoglycemia frequency	Hypoglycemia occurrence	three months (from inclusion until end of study)
Secondary	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)
Secondary	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)