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

December 9, 2021 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Lapeyronie Hospital - CHU de Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education to functional insulin therapy immediately
Immediately after inclusion, patients will follow a functional insulin therapy training course during 2.5 days.
Other: Training course to functional insulin therapy
Carbohydrate counting, carbohydrate/insulin ratio, sensitivity to insulin factor
Other: No education to functional insulin therapy immediately
After inclusion in the study, patients go on usual diabetes management. At the end of study, they will receive education to functional insulin therapy.
Other: Usual diabetes management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the impact of therapeutic education by functional insulin therapy in patients with type 1 diabetes on their ability to disease self-management.
Time Frame: three months (from inclusion until end of study)
CIDS questionnaire
three months (from inclusion until end of study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the effect of education to functional insulin therapy on HbA1c level
Time Frame: three months (from inclusion until end of study)
HbA1c
three months (from inclusion until end of study)
To assess the effect of education to functional insulin therapy on hypoglycemia frequency
Time Frame: three months (from inclusion until end of study)
Hypoglycemia occurrence
three months (from inclusion until end of study)
To assess the effect of education to functional insulinotherapy on the score of each of the 20 items of CIDS questioonaire
Time Frame: three months (from inclusion until end of study)
CIDS questionnaire sub scores
three months (from inclusion until end of study)
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
Time Frame: three months (from inclusion until end of study)
EAD questionnaire score
three months (from inclusion until end of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Elise DUTERTRE, MD, CHU Montpellier, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2015

Primary Completion (Actual)

September 10, 2020

Study Completion (Actual)

September 10, 2020

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Actual)

December 10, 2021

Last Update Submitted That Met QC Criteria

December 9, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9372

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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