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

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Other: Digital diabetes self management education and support system

• Registration Number: NCT05026528
• Lead Sponsor: Region Jönköping County

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 Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-30
• Study Start: 2021-11-30
• Last Update Submitted: 2021-11-30
• Last Update Posted: 2021-12-15
• Primary Completion: 2023-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital DSME/S	Digital diabetes self management education and support system	Ten-week intervention during which the participant uses a digital diabetes self management education and support system together with the diabetes nurse.

Primary Outcome Measures

Name	Time	Method
HbA1c	6 months	The level of glycated hemoglobin A1 in blood measured in mmol/mol.

Trial Locations

Locations (2)

Wetterhälsan; 🇸🇪 Jönköping, Sweden

Aroma Vårdcentral; 🇸🇪 Vetlanda, Sweden