Digital support for managing type 2 diabetes
Randomized Controlled Trial of a Digital Diabetes Self Management Education and Support System for Patients With Type 2 Diabetes in Primary Health Care
NA · Region Jönköping County · NCT05026528
This study tests whether a digital support program for managing type 2 diabetes can help people do better than just regular care from their doctor.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Jönköping County (other gov) |
| Locations | 2 sites (Jönköping and 1 other locations) |
| Trial ID | NCT05026528 on ClinicalTrials.gov |
What this trial studies
This study tests the effectiveness of a digital diabetes self-management education and support system compared to standard care for patients with type 2 diabetes in primary health care. Participants will be randomly assigned to either use the digital system for 10 weeks alongside a diabetes nurse or continue with regular care. The study will evaluate outcomes related to cardiovascular risk factors, lifestyle changes, diabetes knowledge, and health economics at 6, 12, and 36 months post-randomization.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with type 2 diabetes for less than 5 years who have access to digital technology and can understand Swedish.
Not a fit: Patients who are on insulin treatment or have other significant co-morbidities that limit their ability to use the digital system may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance diabetes management and improve health outcomes for patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promising results with digital health interventions for diabetes management, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Jönköping and 1 other locations
- Wetterhälsan — Jönköping, Sweden (RECRUITING)
- Aroma Vårdcentral — Vetlanda, Sweden (RECRUITING)
Study contacts
- Principal investigator: Andreas Stomby, MD/PhD — Region Jönköping County and Linköping University
- Study coordinator: Andreas Stomby, MD/PhD
- Email: andreas.stomby@rjl.se
- Phone: 0046739595129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes, mHealth, Primary health care, Type 2 diabetes