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

Study Overview
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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.

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

Conditions
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Diabetes Mellitus, Type I

Intervention / Treatment
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* Behavioral: Online education programme
* Behavioral: Standard education programme


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care<br>Group in face-to-face session | Behavioral: Standard education programme<br>* Face-to-face educacion programme in a group session<br>|
| Experimental: Online education programme<br>Group in online sessions | Behavioral: Online education programme<br>* Online group will follow the education programme through videos that they can view at any time and a live session to answer questions.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in Range (TIR) | Time spent between 70-180 mg/dl measured by glucose sensor | Change from Baseline at 12 months | 
| 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 | 
| Awareness of hypoglycemia | Clarke Test- 8 questions, ≥ 4 answers with R= reduced awareness | Change from Baseline at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type I, education programme, online