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TerminatedNo phase

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

Reason given: 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.

Key facts

Where
Boxholm, Eksjö, Gislaved, Huskvarna, Jönköping, Kalmar, Linköping, Västervik, and Vetlanda, SwedenSee the 15 sites

Where in Sweden

  • Boxholms vårdcentralBoxholm, SwedenNo longer taking part
  • Eksjö vårdcentralEksjö, SwedenNo longer taking part
  • Gislaved vårdcentralGislaved, SwedenNo longer taking part
  • Rosenhälsans vårdcentralHuskvarna, SwedenNo longer taking part
  • Gränna vårdcentralJönköping, SwedenNo longer taking part
  • Lokstallarna vårdcentralJönköping, SwedenNo longer taking part
  • Norrahammars vårdcentralJönköping, SwedenNo longer taking part
  • Råslätts vårdcentralJönköping, SwedenNo longer taking part
  • WetterhälsanJönköping, SwedenNo longer taking part
  • Kvarnholmens hälsocentralKalmar, SwedenNo longer taking part
  • Kärna VårdcentralLinköping, SwedenNo longer taking part
  • Linghems vårdcentralLinköping, SwedenNo longer taking part
  • Tannefors vårdcentralLinköping, SwedenNo longer taking part
  • Stora Trädgårdsgatans hälsocentralVästervik, SwedenNo longer taking part
  • Aroma VårdcentralVetlanda, SwedenNo longer taking part

Trial details

Who runs it
Region Jönköping County
Trial code
NCT05026528
Record updated
18 December 2025
Original description
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.Read full original descriptionShow less

Randomized Controlled Trial of a Digital Diabetes Self Management Education and Support System for Patients With Type 2 Diabetes in Primary Health Care

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.

Inclusion: 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: 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.

ClinicalTrials.gov NCT05026528