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Interim analysis of primary outcome (HbA1c at 6 months) revealed no numerical differences after 80 included participants. Further inclusion of participants to reach prespecified N to evaluate primary outcome deemed futile. 138 participants included.
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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
| Region Östergötland | OTHER |
| Uppsala County Council, Sweden | OTHER_GOV |
| The Swedish Diabetes Foundation |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital DSME/S | Experimental | Ten-week intervention during which the participant uses a digital diabetes self management education and support system together with the diabetes nurse. |
|
| Standard care | No Intervention | Control group continuing with regular standardized care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital diabetes self management education and support system | Other | Digital diabetes self management and support system |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | The level of glycated hemoglobin A1 in blood measured in mmol/mol. | 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma cholesterol | mmol/L | 6, 12 and 36 months |
| Plasma LDL-cholesterol | mmol/L | 6, 12 and 36 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Stomby, MD/PhD | Region Jönköping County and Linköping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boxholms vårdcentral | Boxholm | Sweden | ||||
| Eksjö vårdcentral |
Individual participant data will be available upon request to the principal investigator (Andreas Stomby) if it is in accordance with Swedish and international law. Thus, all requests will be judged before IPD is eventually shared.
Data will be available after the research group has conducted the planned analyses. Preliminary in year 2027.
See above
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| UNKNOWN |
| Medical Research Council of Southeast Sweden | OTHER_GOV |
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.
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The outcomes assessor will be blinded to group allocation.
| Plasma HDL-cholesterol | mmol/L | 6, 12 and 36 months |
| Fasting plasma triglycerides | mmol/L | 6, 12 and 36 months |
| Fasting plasma glucose | mmol/L | 6, 12 and 36 months |
| Urinary albumin/creatinine ratio | mg/mmol | 6, 12 and 36 months |
| Waist circumference | cm | 6 and 12 months |
| Body mass index | kg/m2 | 6, 12 and 36 months |
| Self reported physical activity level | International Physical Activity Questionnaire (IPAQ) | 6 and 12 months |
| Objectively measured physical activity level | Accelerometer Axivity AX3 will be used on a subgroup of 100 participants. | 6 and 12 months |
| Self reported dietary intake | Indicator questions from the Swedish National Board of Health and Welfare | 6 and 12 months |
| Health literacy | HLS-EU-Q16 questionnaire. 0-12 points. Higher score is better. | 6 and 12 months |
| Patient-reported outcome and experience measures | 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. | 6 and 12 months |
| Eksjö |
| Sweden |
| Gislaved vårdcentral | Gislaved | Sweden |
| Rosenhälsans vårdcentral | Huskvarna | Sweden |
| Gränna vårdcentral | Jönköping | Sweden |
| Lokstallarna vårdcentral | Jönköping | Sweden |
| Norrahammars vårdcentral | Jönköping | Sweden |
| Råslätts vårdcentral | Jönköping | Sweden |
| Wetterhälsan | Jönköping | Sweden |
| Kvarnholmens hälsocentral | Kalmar | Sweden |
| Kärna vårdcentral | Linköping | Sweden |
| Linghems vårdcentral | Linköping | Sweden |
| Tannefors vårdcentral | Linköping | Sweden |
| Stora Trädgårdsgatans hälsocentral | Västervik | Sweden |
| Aroma Vårdcentral | Vetlanda | Sweden |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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