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

Diabetes Mellitus, Type I Clinical Trial

— OPTIM@TE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05708820
• Other study ID #: EO2014
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2023
• Source: Hospital Mutua de Terrassa
• Contact: Núria Alonso-Carril, RN
• Phone: +34 937365050
• Email: nuriaalonso[@]mutuaterrassa.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type I

Intervention

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.
• Standard education programme
Face-to-face educacion programme in a group session

Locations

Country	Name	City	State
Spain	Hospital Mutua de Terrassa	Terrassa	Barcelona
Spain	Hospital Universitari Mútua de Terrassa	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Mutua de Terrassa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	glycosylated hemoglobin	Change from Baseline at 12 months
Secondary	Time in Range (TIR)	Time spent between 70-180 mg/dl measured by glucose sensor	Change from Baseline at 12 months
Secondary	Knowledge related to diabetes management	Diabetes Knowledge Questionnaire (DKQ2)- 15 questions with 4 options, high score indicates maximum level of knowledge	Change from Baseline at 12 months
Secondary	Awareness of hypoglycemia	Clarke Test- 8 questions, = 4 answers with R= reduced awareness	Change from Baseline at 12 months