Digital Diabetes Self Management Education and Support for Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to test the effect of using a digital diabetes self management education and support system compared with standard care for patients with type 2 diabetes in primary health care.

Detailed Description
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After being informed verbally and in text participants will sign a consent to participate. The participant will then be randomized to either use a digital diabetes self management education and support system for 10 weeks together with a diabetes nurse, or to continue with the regular care. The effects will be evaluated after 6, 12 and 36 months from randomization with emphasis on cardiovascular risk factors, life-style, diabetes knowledge and health economics.

Official Title
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Randomized Controlled Trial of a Digital Diabetes Self Management Education and Support System for Patients With Type 2 Diabetes in Primary Health Care

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Digital diabetes self management education and support system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus diagnosed according to WHO criteria < 5 years from randomization: Fasting plasma glucose > 7 mmol/L at two timepoints. OR HbA1c ≥ 48 mmol/mol twice or in combination with fasting plasma glucose > 7 mmo/L once. OR Non-fasting plasma glucose ≥ 11.1 mmol/L at one timepoint in combination with symptoms of hyperglycemia. Access to a digital ID-card to access the digital system Access to a computer, tablet or smart phone Sufficient knowledge of written and spoken Swedish to understand the information given in the digital system. Exclusion Criteria: Treatment with Insulin Other co-morbidities limiting the use of the digital system according to the diabetes nurse judgement. E.g. dementia or severe psychiatric disease. Other forms of diabetes mellitus than type 2 diabetes.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital DSME/S<br>Ten-week intervention during which the participant uses a digital diabetes self management education and support system together with the diabetes nurse. | Other: Digital diabetes self management education and support system<br>* Digital diabetes self management and support system<br>* Other names: Live well with type 2 diabetes;|
| No Intervention: Standard care<br>Control group continuing with regular standardized care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | The level of glycated hemoglobin A1 in blood measured in mmol/mol. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, Primary health care, Type 2 diabetes