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

NCT ID: NCT05026528

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes

Keywords

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mHealth Primary health care Type 2 diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The outcomes assessor will be blinded to group allocation.

Study Groups

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Digital DSME/S

Ten-week intervention during which the participant uses a digital diabetes self management education and support system together with the diabetes nurse.

Group Type EXPERIMENTAL

Digital diabetes self management education and support system

Intervention Type OTHER

Digital diabetes self management and support system

Standard care

Control group continuing with regular standardized care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Digital diabetes self management education and support system

Digital diabetes self management and support system

Intervention Type OTHER

Other Intervention Names

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Live well with type 2 diabetes

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role collaborator

Region Östergötland

OTHER

Sponsor Role collaborator

Uppsala County Council, Sweden

OTHER_GOV

Sponsor Role collaborator

The Swedish Diabetes Foundation

UNKNOWN

Sponsor Role collaborator

Medical Research Council of Southeast Sweden

OTHER_GOV

Sponsor Role collaborator

Region Jönköping County

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Stomby, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Region Jönköping County and Linköping University

Locations

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Boxholms vårdcentral

Boxholm, , Sweden

Site Status

Eksjö vårdcentral

Eksjö, , Sweden

Site Status

Gislaved vårdcentral

Gislaved, , Sweden

Site Status

Rosenhälsans vårdcentral

Huskvarna, , Sweden

Site Status

Gränna vårdcentral

Jönköping, , Sweden

Site Status

Lokstallarna vårdcentral

Jönköping, , Sweden

Site Status

Norrahammars vårdcentral

Jönköping, , Sweden

Site Status

Råslätts vårdcentral

Jönköping, , Sweden

Site Status

Wetterhälsan

Jönköping, , Sweden

Site Status

Kvarnholmens hälsocentral

Kalmar, , Sweden

Site Status

Kärna vårdcentral

Linköping, , Sweden

Site Status

Linghems vårdcentral

Linköping, , Sweden

Site Status

Tannefors vårdcentral

Linköping, , Sweden

Site Status

Stora Trädgårdsgatans hälsocentral

Västervik, , Sweden

Site Status

Aroma Vårdcentral

Vetlanda, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Bra liv med diabetes typ 2

Identifier Type: -

Identifier Source: org_study_id