Type 2 Diabetes MellitusNCT03053336
App-technology to Increase Physical Activity Among Patients With Type 2 Diabetes
A study testing App-technology to increase physical activity in people with Type 2 Diabetes Mellitus and Exercise, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of this study is to investigate the effect of using new app-based technology to improve self-care, compared to usual care in patients with type 2 diabetes. The hypothesis is that the intervention, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Exercise
- What is being tested?
- App-technology to increase physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteSweden
- Study dates
- 21 Feb 2017to 30 Jun 2019
- 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
- Have a diagnosis of type 2 diabetes
- 18 years of age or older
- Ability to communicate in Swedish
- Have and be able to use a smartphone
Who cannot join
- Not being able to walk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: App-technology to Enhance Self-care for Patients With Diabetes Type 2 - A Randomized Controlled Trial
The aim of this study is to investigate the effect of using new app-based technology to improve self-care, compared to usual care in patients with type 2 diabetes. The hypothesis is that the intervention, i.e. using the new technology, will have a greater positive effect on physical activity levels and outcomes of HbA1c than usual care.
- Conditions
- Type 2 Diabetes Mellitus, Exercise
- Being tested
- App-technology to increase physical activity
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-technology to increase physical activityBehavioural
Access to the smartphone-app during 12 weeks. A personal step goal is set for each individual in the app.
| Study group | Role | What they receive |
|---|---|---|
| App-technology group | Experimental | Participants in the intervention group (App-technology) will use a newly developed smartphone application ("app") in which steps are automatically measured and laboratory values from blood sampling within primary care will be shown.
Intervention: App-technology to increase physical activity Receives: Behavioral: App-technology to increase physical activity |
| Control group | No intervention | The control group will receive standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity level (counts/min from accelerometers)
Measured: baseline and month 3, 6 and 12
Secondary outcomes (12)
HbA1c (mmol/mol)
Measured: Baseline and month 3, 6 and 12
Steps/day
Measured: Baseline and month 3, 6 and 12
Total cholesterol (mmol/L)
Measured: Baseline and month 3, 6 and 12
HDL-cholesterol (mmol/L)
Measured: Baseline and month 3, 6 and 12
Triglycerides (mmol/L)
Measured: Baseline and month 3, 6 and 12
Apolipoprotein A1 (g/l)
Measured: Baseline and month 3, 6 and 12
Apolipoprotein B (g/l)
Measured: Baseline and month 3, 6 and 12
Body weight (kg)
Measured: Baseline and month 3, 6 and 12
Body Mass Index (BMI, kg/m2)
Measured: Baseline and month 3, 6 and 12
Body composition
Including: %Body Fat, Fat free mass (kg), Muscle mass (kg), Total body water (kg, %)
Measured: Baseline and month 3, 6 and 12
Waist circumference (cm)
Measured: Baseline and month 3, 6 and 12
Blood pressure (mmHg)
Measured: Baseline and month 3, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start21 Feb 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Ylva Trolle Lagerros, Karolinska Institutet
- Investigators
- Ylva Trolle Lagerros, MD, PhD, Principal investigator, Karolinska Institutet and Stockholm County Councill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053336
- Sponsor's protocol ID
- Dnr: 2016/2041-31/2
- Status last verified
- Sep 2020
- First submitted
- 7 Feb 2017
- Last updated
- 29 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bonn SE, Hummel M, Peveri G, Eke H, Alexandrou C, Bellocco R, Lof M, Trolle Lagerros Y. Effectiveness of a Smartphone App to Promote Physical Activity Among Persons With Type 2 Diabetes: Randomized Controlled Trial. Interact J Med Res. 2024 Mar 21;13:e53054. doi: 10.2196/53054.
PubMed 38512333Sjoblom L, Bonn SE, Alexandrou C, Dahlgren A, Eke H, Trolle Lagerros Y. Dietary habits after a physical activity mHealth intervention: a randomized controlled trial. BMC Nutr. 2023 Feb 2;9(1):23. doi: 10.1186/s40795-023-00682-4.
PubMed 36732788Hummel M, Bonn SE, Trolle Lagerros Y. The effect of the smartphone app DiaCert on health related quality of life in patients with type 2 diabetes: results from a randomized controlled trial. Diabetol Metab Syndr. 2022 Dec 17;14(1):192. doi: 10.1186/s13098-022-00965-z.
PubMed 36528609Bonn SE, Alexandrou C, Hjorleifsdottir Steiner K, Wiklander K, Ostenson CG, Lof M, Trolle Lagerros Y. App-technology to increase physical activity among patients with diabetes type 2 - the DiaCert-study, a randomized controlled trial. BMC Public Health. 2018 Jan 10;18(1):119. doi: 10.1186/s12889-018-5026-4.
PubMed 29316905
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- App-technology to Enhance Self-care for Patients With Diabetes Type 2 - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03053336
- Acronym / sponsor ID
- Dnr: 2016/2041-31/2
- Conditions
- Type 2 Diabetes Mellitus, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 15 Feb 2017 (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 aim of this study is to investigate the effect of using new app-based technology to improve self-care, compared to usual care in patients with type 2 diabetes. The hypothesis is that the intervention, i.e. using the new technology, will have a greater positive effect on physical activity levels and outcomes of HbA1c than usual care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App-technology group | Experimental | Behavioral: App-technology to increase physical activityParticipants in the intervention group (App-technology) will use a newly developed smartphone application ("app") in which steps are automatically measured and laboratory values from blood sampling within primary care will be shown. Intervention: App-technology to increase physical activity |
| Control group | No intervention | –The control group will receive standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a diagnosis of type 2 diabetes
- 18 years of age or older
- Ability to communicate in Swedish
- Have and be able to use a smartphone
Key exclusion criteria (1 listed)
- Not being able to walk
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 |
|---|---|---|
| App-technology to increase physical activityAccess to the smartphone-app during 12 weeks. A personal step goal is set for each individual in the app. | Behavioural | App-technology group |
Primary outcome
Change in physical activity level (counts/min from accelerometers)
Time frame: baseline and month 3, 6 and 12
12 secondary outcomes
HbA1c (mmol/mol)
Time frame: Baseline and month 3, 6 and 12
Steps/day
Time frame: Baseline and month 3, 6 and 12
Total cholesterol (mmol/L)
Time frame: Baseline and month 3, 6 and 12
HDL-cholesterol (mmol/L)
Time frame: Baseline and month 3, 6 and 12
Triglycerides (mmol/L)
Time frame: Baseline and month 3, 6 and 12
Apolipoprotein A1 (g/l)
Time frame: Baseline and month 3, 6 and 12
Apolipoprotein B (g/l)
Time frame: Baseline and month 3, 6 and 12
Body weight (kg)
Time frame: Baseline and month 3, 6 and 12
Body Mass Index (BMI, kg/m2)
Time frame: Baseline and month 3, 6 and 12
Body composition
Time frame: Baseline and month 3, 6 and 12
Waist circumference (cm)
Time frame: Baseline and month 3, 6 and 12
Blood pressure (mmHg)
Time frame: Baseline and month 3, 6 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Derived from this study: PubMed 38512333Bonn SE, Hummel M, Peveri G, Eke H, Alexandrou C, Bellocco R, Lof M, Trolle Lagerros Y. Effectiveness of a Smartphone App to Promote Physical Activity Among Persons With Type 2 Diabetes: Randomized Controlled Trial. Interact J Med Res. 2024 Mar 21;13:e53054. doi: 10.2196/53054.
- Derived from this study: PubMed 36732788Sjoblom L, Bonn SE, Alexandrou C, Dahlgren A, Eke H, Trolle Lagerros Y. Dietary habits after a physical activity mHealth intervention: a randomized controlled trial. BMC Nutr. 2023 Feb 2;9(1):23. doi: 10.1186/s40795-023-00682-4.
- Derived from this study: PubMed 36528609Hummel M, Bonn SE, Trolle Lagerros Y. The effect of the smartphone app DiaCert on health related quality of life in patients with type 2 diabetes: results from a randomized controlled trial. Diabetol Metab Syndr. 2022 Dec 17;14(1):192. doi: 10.1186/s13098-022-00965-z.
- Derived from this study: PubMed 29316905Bonn SE, Alexandrou C, Hjorleifsdottir Steiner K, Wiklander K, Ostenson CG, Lof M, Trolle Lagerros Y. App-technology to increase physical activity among patients with diabetes type 2 - the DiaCert-study, a randomized controlled trial. BMC Public Health. 2018 Jan 10;18(1):119. doi: 10.1186/s12889-018-5026-4.
- Individual participant dataSharing planned: No
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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.
Ylva Trolle Lagerros, MD, PhD principal investigator
Karolinska Institutet and Stockholm County Councill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-technology to increase physical activity in people with Type 2 Diabetes Mellitus and Exercise, run by Karolinska Institutet at 1 site 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in physical activity level (counts/min from accelerometers) (time frame: baseline and month 3, 6 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03053336, which also lists 4 linked publications.
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 29 Sep 2020.