Online Education Programme for People With Type 1 Diabetes and Suboptimal Metabolic Control

NCT ID: NCT05708820

Last Updated: 2023-02-01

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-14

Study Completion Date

2024-07-31

Brief Summary

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The aim of this study is to evaluate the effectiveness of an online intervention for people with type 1 diabetes who present not optimal control of the disease.

Detailed Description

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Study area: adults with type 1 diabetes, HbA1c \>7.5%, \>3 years diagnosed. Methods: randomized clinical trial. It will include 60 participants . The improvement of Glycated Haemoglobin in both groups before and after intervention will be compared; adherence to the treatment, quality of life, time in the glycaemic range, perception of hypoglycaemia and knowledge about diabetes.

Conditions

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Diabetes Mellitus, Type I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Standard care

Group in face-to-face session

Group Type ACTIVE_COMPARATOR

Standard education programme

Intervention Type BEHAVIORAL

Face-to-face educacion programme in a group session

Online education programme

Group in online sessions

Group Type EXPERIMENTAL

Online education programme

Intervention Type BEHAVIORAL

Online group will follow the education programme through videos that they can view at any time and a live session to answer questions.

Interventions

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Online education programme

Online group will follow the education programme through videos that they can view at any time and a live session to answer questions.

Intervention Type BEHAVIORAL

Standard education programme

Face-to-face educacion programme in a group session

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* HbA1c ≥7,5%
* More than 3 years of diagnosis
* Ability to follow online sessions
* Having a device to follow up the education programme

Exclusion Criteria

* Pregnants
* People on corticosteroid treatment
* People with severe disease
* People with continuous subcutaneous insulin infusion (CSII)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Mutua de Terrassa

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Núria Alonso, RN

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Mútua Terrassa

Locations

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Hospital Mutua de Terrassa

Terrassa, Barcelona, Spain

Site Status RECRUITING

Hospital Universitari Mútua de Terrassa

Terrassa, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Núria Alonso-Carril, RN

Role: CONTACT

+34 937365050 ext. 11330

Facility Contacts

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Endocrinology Unit

Role: primary

Núria Alonso-Carril, RN

Role: primary

Núria Alonso

Role: backup

Other Identifiers

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EO2014

Identifier Type: -

Identifier Source: org_study_id

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