Online Education Programme for People With Type 1 Diabetes and Suboptimal Metabolic Control (OPTIM@TE)

January 24, 2023 updated by: Hospital Mutua de Terrassa
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

Study Locations

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
        • Recruiting
        • Hospital Universitari Mutua de Terrassa
        • Contact:
          • Núria Alonso-Carril, RN
        • Contact:
          • Núria Alonso
      • Terrassa, Barcelona, Spain, 08221
        • Recruiting
        • Hospital Mútua de Terrassa
        • Contact:
          • Endocrinology Unit
        • Principal Investigator:
          • Núria Alonso, RN

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard care
Group in face-to-face session
Behavioral: Standard education programme
Face-to-face educacion programme in a group session
EXPERIMENTAL: Online education programme
Group in online sessions
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Change from Baseline at 12 months
glycosylated hemoglobin
Change from Baseline at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in Range (TIR)
Time Frame: Change from Baseline at 12 months
Time spent between 70-180 mg/dl measured by glucose sensor
Change from Baseline at 12 months
Knowledge related to diabetes management
Time Frame: Change from Baseline at 12 months
Diabetes Knowledge Questionnaire (DKQ2)- 15 questions with 4 options, high score indicates maximum level of knowledge
Change from Baseline at 12 months
Awareness of hypoglycemia
Time Frame: Change from Baseline at 12 months
Clarke Test- 8 questions, ≥ 4 answers with R= reduced awareness
Change from Baseline at 12 months

Collaborators and Investigators

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

Sponsor

Hospital Mutua de Terrassa

Investigators

  • Principal Investigator: Núria Alonso, RN, Hospital Universitari Mutua Terrassa

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)

December 14, 2022

Primary Completion (ANTICIPATED)

July 31, 2023

Study Completion (ANTICIPATED)

July 31, 2024

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

January 24, 2023

First Posted (ACTUAL)

February 1, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EO2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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