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Self-management of Type 1 Diabetes Under Functional Insulin Therapy

NCT ID: NCT02272348

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-10

Study Completion Date

2020-09-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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Therapeutic education Functional insulin therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Education to functional insulin therapy immediately

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

Group Type EXPERIMENTAL

Training course to functional insulin therapy

Intervention Type OTHER

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.

Group Type OTHER

Usual diabetes management.

Intervention Type OTHER

Interventions

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Training course to functional insulin therapy

Carbohydrate counting, carbohydrate/insulin ratio, sensitivity to insulin factor

Intervention Type OTHER

Usual diabetes management.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elise DUTERTRE, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Montpellier, France

Locations

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Lapeyronie Hospital - CHU de Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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9372

Identifier Type: -

Identifier Source: org_study_id