Self-management of Type 1 Diabetes Under Functional Insulin Therapy
Information source: University Hospital, Montpellier
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes; Basal-bolus Multiple-dily Insulin Injections; Insulin Pump (CSII)
Intervention: Training course to functional insulin therapy (Other); Usual diabetes management. (Other)
Phase: N/A
Status: Not yet recruiting
Sponsored by: University Hospital, Montpellier Official(s) and/or principal investigator(s): Elise DUTERTRE, MD, Principal Investigator, Affiliation: CHU Montpellier, France
Overall contact: Elise DUTERTRE, MD, Phone: +33 4 67 33 83 82, Email: e-dutertre@chu-montpellier.fr
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.
Clinical Details
Official title: Evaluation of Self-management of Patients With Type 1 Diabetes After Education to Functional Insulin Therapy
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: To assess the impact of therapeutic education by functional insulin therapy in patients with type 1 diabetes on their ability to disease self-management.
Secondary outcome: To assess the effect of education to functional insulin therapy on HbA1c levelTo assess the effect of education to functional insulin therapy on hypoglycemia frequency To assess the effect of education to functional insulinotherapy on the score of each of the 20 items of CIDS questioonaire 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
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Elise DUTERTRE, MD, Phone: +33 4 67 33 83 82, Email: e-dutertre@chu-montpellier.fr
Lapeyronie Hospital - CHU de Montpellier, Montpellier 34295, France; Active, not recruiting
Additional Information
Starting date: December 2014
Last updated: October 20, 2014
|