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

December 11, 2025 updated by: Region Jönköping County

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
      • Boxholm, Sweden
        • Boxholms vårdcentral
      • Eksjö, Sweden
        • Eksjö vårdcentral
      • Gislaved, Sweden
        • Gislaved vårdcentral
      • Huskvarna, Sweden
        • Rosenhälsans vårdcentral
      • Jönköping, Sweden
        • Wetterhälsan
      • Jönköping, Sweden
        • Gränna vårdcentral
      • Jönköping, Sweden
        • Lokstallarna vårdcentral
      • Jönköping, Sweden
        • Norrahammars vårdcentral
      • Jönköping, Sweden
        • Råslätts vårdcentral
      • Kalmar, Sweden
        • Kvarnholmens hälsocentral
      • Linköping, Sweden
        • Kärna Vårdcentral
      • Linköping, Sweden
        • Linghems vårdcentral
      • Linköping, Sweden
        • Tannefors vårdcentral
      • Vetlanda, Sweden
        • Aroma Vårdcentral
      • Västervik, Sweden
        • Stora Trädgårdsgatans hälsocentral

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: Digital diabetes self management education and support system
Digital diabetes self management and support system
Other Names:
  • Live well with type 2 diabetes
No Intervention: Standard care
Control group continuing with regular standardized care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 6 months
The level of glycated hemoglobin A1 in blood measured in mmol/mol.
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma cholesterol
Time Frame: 6, 12 and 36 months
mmol/L
6, 12 and 36 months
Plasma LDL-cholesterol
Time Frame: 6, 12 and 36 months
mmol/L
6, 12 and 36 months
Plasma HDL-cholesterol
Time Frame: 6, 12 and 36 months
mmol/L
6, 12 and 36 months
Fasting plasma triglycerides
Time Frame: 6, 12 and 36 months
mmol/L
6, 12 and 36 months
Fasting plasma glucose
Time Frame: 6, 12 and 36 months
mmol/L
6, 12 and 36 months
Urinary albumin/creatinine ratio
Time Frame: 6, 12 and 36 months
mg/mmol
6, 12 and 36 months
Waist circumference
Time Frame: 6 and 12 months
cm
6 and 12 months
Body mass index
Time Frame: 6, 12 and 36 months
kg/m2
6, 12 and 36 months
Self reported physical activity level
Time Frame: 6 and 12 months
International Physical Activity Questionnaire (IPAQ)
6 and 12 months
Objectively measured physical activity level
Time Frame: 6 and 12 months
Accelerometer Axivity AX3 will be used on a subgroup of 100 participants.
6 and 12 months
Self reported dietary intake
Time Frame: 6 and 12 months
Indicator questions from the Swedish National Board of Health and Welfare
6 and 12 months
Health literacy
Time Frame: 6 and 12 months
HLS-EU-Q16 questionnaire. 0-12 points. Higher score is better.
6 and 12 months
Patient-reported outcome and experience measures
Time Frame: 6 and 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Jönköping County

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Linkoeping University
Region Östergötland
Uppsala County Council, Sweden
Medical Research Council of Southeast Sweden
The Swedish Diabetes Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andreas Stomby, MD/PhD, Region Jönköping County and Linköping University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Bra liv med diabetes typ 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be available after the research group has conducted the planned analyses. Preliminary in year 2027.

IPD Sharing Access Criteria

See above

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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