Type 2 Diabetes
Conditions
Keywords
mHealth, Primary health care, Type 2 diabetes
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.
Interventions
OTHERDigital diabetes self management education and support system
Digital diabetes self management and support system
Sponsors
Linkoeping University
Region Östergötland
Uppsala County Council, Sweden
The Swedish Diabetes Foundation
Medical Research Council of Southeast Sweden
Region Jönköping County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The outcomes assessor will be blinded to group allocation.
Intervention model description
An interim analysis comparing the change in HbA1c from baseline to six months between the two intervention groups was performed in march 2024 including 80 participants. The analysis was done according to intention-to-treat.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 6 months | The level of glycated hemoglobin A1 in blood measured in mmol/mol. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma cholesterol | 6, 12 and 36 months | mmol/L |
| Plasma LDL-cholesterol | 6, 12 and 36 months | mmol/L |
| Self reported dietary intake | 6 and 12 months | Indicator questions from the Swedish National Board of Health and Welfare |
| Plasma HDL-cholesterol | 6, 12 and 36 months | mmol/L |
| Fasting plasma triglycerides | 6, 12 and 36 months | mmol/L |
| Fasting plasma glucose | 6, 12 and 36 months | mmol/L |
| Health literacy | 6 and 12 months | HLS-EU-Q16 questionnaire. 0-12 points. Higher score is better. |
| Waist circumference | 6 and 12 months | cm |
| Body mass index | 6, 12 and 36 months | kg/m2 |
| Self reported physical activity level | 6 and 12 months | International Physical Activity Questionnaire (IPAQ) |
| Objectively measured physical activity level | 6 and 12 months | Accelerometer Axivity AX3 will be used on a subgroup of 100 participants. |
| Patient-reported outcome and experience measures | 6 and 12 months | Questionnaire developed and validated by the National Swedish Diabetes Registry. 0-100 points for each of 8 PROM scales and 4 PREM scales. Higher score is better. |
| Urinary albumin/creatinine ratio | 6, 12 and 36 months | mg/mmol |
Countries
Sweden
Outcome results
None listed