NCT05026528

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

15 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

3.4 years

First QC Date

August 24, 2021

Last Update Submit

December 11, 2025

Conditions

Type 2 Diabetes

Keywords

mHealthPrimary health careType 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    The level of glycated hemoglobin A1 in blood measured in mmol/mol.

    6 months

Other Outcomes (13)

  • Plasma cholesterol

    6, 12 and 36 months

  • Plasma LDL-cholesterol

    6, 12 and 36 months

  • Plasma HDL-cholesterol

    6, 12 and 36 months

  • +10 more other outcomes

Study Arms (2)

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.

Other: Digital diabetes self management education and support system

Standard care

NO INTERVENTION

Control group continuing with regular standardized care.

Interventions

Digital diabetes self management education and support systemOTHER

Digital diabetes self management and support system

Also known as: Live well with type 2 diabetes
Digital DSME/S

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Boxholms vårdcentral

Boxholm, Sweden

Location

Eksjö vårdcentral

Eksjö, Sweden

Location

Gislaved vårdcentral

Gislaved, Sweden

Location

Rosenhälsans vårdcentral

Huskvarna, Sweden

Location

Gränna vårdcentral

Jönköping, Sweden

Location

Lokstallarna vårdcentral

Jönköping, Sweden

Location

Norrahammars vårdcentral

Jönköping, Sweden

Location

Råslätts vårdcentral

Jönköping, Sweden

Location

Wetterhälsan

Jönköping, Sweden

Location

Kvarnholmens hälsocentral

Kalmar, Sweden

Location

Kärna vårdcentral

Linköping, Sweden

Location

Linghems vårdcentral

Linköping, Sweden

Location

Tannefors vårdcentral

Linköping, Sweden

Location

Stora Trädgårdsgatans hälsocentral

Västervik, Sweden

Location

Aroma Vårdcentral

Vetlanda, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Andreas Stomby, MD/PhD

    Region Jönköping County and Linköping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The outcomes assessor will be blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2021

First Posted

August 30, 2021

Study Start

November 30, 2021

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will be available after the research group has conducted the planned analyses. Preliminary in year 2027.
Access Criteria
See above

Locations

SE(15)