Clinical trial NCT05026528: Digital Diabetes Self Management Education and Support for Patients With Type 2 Diabetes
Official title: Randomized Controlled Trial of a Digital Diabetes Self Management Education and Support System for Patients With Type 2 Diabetes in Primary Health Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: mHealth
Primary health care
Type 2 diabetes
Lead sponsor: Region Jönköping County
Sponsor class: OTHER_GOV
Collaborators: name: Linkoeping University
name: Region Östergötland
name: Uppsala County Council, Sweden
name: The Swedish Diabetes Foundation
name: Medical Research Council of Southeast Sweden
First posted: 2021-08-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: HbA1c
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Plasma cholesterol
timeFrame: 6, 12 and 36 months
measure: Plasma LDL-cholesterol
timeFrame: 6, 12 and 36 months
measure: Plasma HDL-cholesterol
timeFrame: 6, 12 and 36 months
measure: Fasting plasma triglycerides
timeFrame: 6, 12 and 36 months
measure: Fasting plasma glucose
timeFrame: 6, 12 and 36 months
measure: Urinary albumin/creatinine ratio
timeFrame: 6, 12 and 36 months
measure: Waist circumference
timeFrame: 6 and 12 months
measure: Body mass index
timeFrame: 6, 12 and 36 months
measure: Self reported physical activity level
timeFrame: 6 and 12 months
measure: Objectively measured physical activity level
timeFrame: 6 and 12 months
measure: Self reported dietary intake
timeFrame: 6 and 12 months
measure: Health literacy
timeFrame: 6 and 12 months
measure: Patient-reported outcome and experience measures
timeFrame: 6 and 12 months
Locations:
city: Jönköping
country: Sweden
facility: Wetterhälsan
city: Vetlanda
country: Sweden
facility: Aroma Vårdcentral
Study officials:
affiliation: Region Jönköping County and Linköping University
name: Andreas Stomby, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: