Randomized Controlled Trial of a Digital Diabetes Self Management Education and Support System for Patients With Type 2 Diabetes in Primary Health Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 138
- Locations
- 15
- Primary Endpoint
- HbA1c
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
The outcomes assessor will be blinded to group allocation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
HbA1c
Time Frame: 6 months
The level of glycated hemoglobin A1 in blood measured in mmol/mol.
Secondary Outcomes
No secondary outcomes reported