Type 2 DiabetesNCT05026528
Digital Diabetes Self Management Education and Support for Patients With Type 2 Diabetes
A study testing Digital diabetes self management education and support system in people with Type 2 Diabetes, run by Region Jönköping County at 15 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Digital diabetes self management education and support system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 15 sitesSweden
- Study dates
- 30 Nov 2021to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Sweden15 sites
Boxholms vårdcentral
Boxholm
Eksjö vårdcentral
Eksjö
Gislaved vårdcentral
Gislaved
Rosenhälsans vårdcentral
Huskvarna
Gränna vårdcentral
Jönköping
Lokstallarna vårdcentral
Jönköping
Norrahammars vårdcentral
Jönköping
Råslätts vårdcentral
Jönköping
Wetterhälsan
Jönköping
Kvarnholmens hälsocentral
Kalmar
Kärna vårdcentral
Linköping
Linghems vårdcentral
Linköping
Tannefors vårdcentral
Linköping
Stora Trädgårdsgatans hälsocentral
Västervik
Aroma Vårdcentral
Vetlanda
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Digital diabetes self management education and support system
- Keywords
- mHealth, Primary health care, Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital diabetes self management education and support systemOther
Also called Live well with type 2 diabetes
Digital diabetes self management and support system
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Digital diabetes self management education and support system |
| Standard care | No intervention | Control group continuing with regular standardized care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
The level of glycated hemoglobin A1 in blood measured in mmol/mol.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start30 Nov 2021
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Jönköping County
- Sponsor type
- Other government
- Collaborators
- Linkoeping University, Region Östergötland, Uppsala County Council, Sweden, The Swedish Diabetes Foundation, Medical Research Council of Southeast Sweden
- Responsible party
- Sponsor
- Investigators
- Andreas Stomby, MD/PhD, Principal investigator, Region Jönköping County and Linköping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026528
- Sponsor's protocol ID
- Bra liv med diabetes typ 2
- Status last verified
- Dec 2025
- First submitted
- 24 Aug 2021
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Digital Diabetes Self Management Education and Support System for Patients With Type 2 Diabetes in Primary Health Care
- ClinicalTrials.gov ID
- NCT05026528
- Acronym / sponsor ID
- Bra liv med diabetes typ 2
- Conditions
- Type 2 Diabetes
- Keywords
- mHealth, Primary health care, Type 2 diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Region Jönköping CountyOther government
- Collaborators
- Linkoeping University, Region Östergötland, Uppsala County Council, Sweden, The Swedish Diabetes Foundation, Medical Research Council of Southeast Sweden
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Digital DSME/S | Experimental | Other: Digital diabetes self management education and support systemTen-week intervention during which the participant uses a digital diabetes self management education and support system together with the diabetes nurse. |
| Standard care | No intervention | –Control group continuing with regular standardized care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital diabetes self management education and support systemAlso: Live well with type 2 diabetesDigital diabetes self management and support system | Other | Digital DSME/S |
Primary outcome
HbA1c
Time frame: 6 months
The level of glycated hemoglobin A1 in blood measured in mmol/mol.
Results and safety
The study was stopped early (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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Stomby, MD/PhD principal investigator
Region Jönköping County and Linköping University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital diabetes self management education and support system in people with Type 2 Diabetes, run by Region Jönköping County at 15 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.