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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | Active Comparator | Group in face-to-face session |
|
| Online education programme | Experimental | Group in online sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online education programme | Behavioral | Online group will follow the education programme through videos that they can view at any time and a live session to answer questions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | glycosylated hemoglobin | Change from Baseline at 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Núria Alonso-Carril, RN | Contact | +34 937365050 | 11330 | nuriaalonso@mutuaterrassa.com |
| Name | Affiliation | Role |
|---|---|---|
| Núria Alonso, RN | Hospital Universitari Mútua Terrassa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Mutua de Terrassa | Recruiting | Terrassa | Barcelona | 08221 | Spain |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Standard education programme | Behavioral | Face-to-face educacion programme in a group session |
|
| 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 |
| Hospital Universitari Mútua de Terrassa | Recruiting | Terrassa | Barcelona | 08221 | Spain |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |