NCT03053336

Brief 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. using the new technology, will have a greater positive effect on physical activity levels and outcomes of HbA1c than usual care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
181

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

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

February 7, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

February 21, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

2.4 years

First QC Date

February 7, 2017

Last Update Submit

September 28, 2020

Conditions

Type 2 Diabetes MellitusExercise

Outcome Measures

Primary Outcomes (1)

  • Change in physical activity level (counts/min from accelerometers)

    baseline and month 3, 6 and 12

Secondary Outcomes (12)

  • HbA1c (mmol/mol)

    Baseline and month 3, 6 and 12

  • Steps/day

    Baseline and month 3, 6 and 12

  • Total cholesterol (mmol/L)

    Baseline and month 3, 6 and 12

  • HDL-cholesterol (mmol/L)

    Baseline and month 3, 6 and 12

  • Triglycerides (mmol/L)

    Baseline and month 3, 6 and 12

  • +7 more secondary outcomes

Other Outcomes (10)

  • Change in dietary habits assessed using a food frequency questionnaire

    Baseline and month 3, 6 and 12

  • Change in tobacco use habits (smoking and Swedish snuff use)

    Baseline and month 3, 6 and 12

  • Change in sleeping habits assessed using a 13 item questionnaire

    Baseline and month 3, 6 and 12

  • +7 more other outcomes

Study Arms (2)

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

Behavioral: App-technology to increase physical activity

Control group

NO INTERVENTION

The control group will receive standard care

Interventions

App-technology to increase physical activityBEHAVIORAL

Access to the smartphone-app during 12 weeks. A personal step goal is set for each individual in the app.

App-technology group

Eligibility Criteria

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

You may qualify if:

  • Have a diagnosis of type 2 diabetes
  • years of age or older
  • Ability to communicate in Swedish
  • Have and be able to use a smartphone

You may not qualify if:

  • Not being able to walk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 38512333DERIVED

  • Sjoblom 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.

    PMID: 36732788DERIVED

  • Hummel 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.

    PMID: 36528609DERIVED

  • Bonn 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.

    PMID: 29316905DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Ylva Trolle Lagerros, MD, PhD

    Karolinska Institutet and Stockholm County Councill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associate professor

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 15, 2017

Study Start

February 21, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

September 29, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)