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

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type I
• Interventions: Behavioral: Standard education programme; Behavioral: Online education programme

• Registration Number: NCT05708820
• Lead Sponsor: Hospital Mutua de Terrassa

Brief 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.

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 Timeline

• Study First Submitted: 2022-03-29
• Study Start: 2022-12-14
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-24
• Last Update Submitted: 2023-01-24
• Study First Posted: 2023-02-01
• Last Update Posted: 2023-02-01
• Primary Completion: 2023-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard education programme	Group in face-to-face session
Online education programme	Online education programme	Group in online sessions

Primary Outcome Measures

Name	Time	Method
HbA1c	Change from Baseline at 12 months	glycosylated hemoglobin

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hospital Mutua de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital Universitari Mútua de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain