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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272348
Recruitment Status : Unknown
Verified October 2014 by University Hospital, Montpellier.
Recruitment status was:  Not yet recruiting
First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Basal-bolus Multiple-dily Insulin Injections Insulin Pump (CSII) Other: Training course to functional insulin therapy Other: Usual diabetes management. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Evaluation of Self-management of Patients With Type 1 Diabetes After Education to Functional Insulin Therapy
Study Start Date : December 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. To assess the effect of education to functional insulin therapy on HbA1c level [ Time Frame: three months (from inclusion until end of study) ]
    HbA1c

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272348


Contacts
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Contact: Elise DUTERTRE, MD +33 4 67 33 83 82 e-dutertre@chu-montpellier.fr
Contact: Eric RENARD, PU-PH +33 4 67 33 83 82 e-renard@chu-montpellier.fr

Locations
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France
Lapeyronie Hospital - CHU de Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Elise DUTERTRE, MD CHU Montpellier, France

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02272348    
Other Study ID Numbers: UF9372
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014
Keywords provided by University Hospital, Montpellier:
Therapeutic education
Functional insulin therapy
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs