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

  • STATUS
    Recruiting
  • End date
    Dec 16, 2026
  • participants needed
    300
  • sponsor
    Region Jönköping County
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Updated on 16 September 2022
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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.

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.

Details
Condition Type 2 Diabetes
Age 18years or above
Treatment Digital diabetes self management education and support system
Clinical Study IdentifierNCT05026528
SponsorRegion Jönköping County
Last Modified on16 September 2022

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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