NCT05977218

Brief Summary

This randomized controlled trial will assess the impact of the FoodSwitch mobile app, which provides interpretive front-of-pack labelling via barcode scanning, in 900 Swedish adults with type 2 diabetes. Participants will be randomized to app + standard advice or standard advice alone. The primary outcome is change in HbA1c at 6 months; secondary outcomes include anthropometrics, quality of life, medication use, hospitalizations, and mortality.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
68mo left

Started Aug 2025

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress11%
Aug 2025Dec 2031

First Submitted

Initial submission to the registry

July 6, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
2.1 years until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

July 6, 2023

Last Update Submit

September 19, 2025

Conditions

Type 2 Diabetes

Keywords

DietMobile healthHbA1c

Outcome Measures

Primary Outcomes (1)

  • Mean HbA1c

    Mean glycated haemoglobin

    Change from baseline at week 26

Secondary Outcomes (6)

  • Self-measured waist circumference (cm)

    Change from baseline at week 26

  • Self-reported quality of life

    Change from baseline at week 26

  • Self-measured body weight (kg)

    Change from baseline at week 26

  • Registry-based data on medication use, hospitalizations, outpatient visits, and diabetes complications

    Change from baseline at week 26

  • Self-reported dietary self-efficacy

    Change from baseline at week 26

  • +1 more secondary outcomes

Other Outcomes (1)

  • Dietary effects on proteomics and metabolomics

    Change from baseline at week 26

Study Arms (2)

Intervention

EXPERIMENTAL

Access to the 'DiabetesSwitch' filter of the FoodSwitch app when grocery shopping during 26 weeks, in addition to standard written dietary advice

Other: FoodSwitch

Control

NO INTERVENTION

Access to standard written dietary advice

Interventions

FoodSwitchOTHER

Access to the 'DiabetesSwitch' filter of the FoodSwitch app when grocery shopping. When a packaged food item bar code is scanned, the FoodSwitch app will show an interpretive nutritional information score for the scanned product and recommend alternate healthier food options in the same category.

Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75 years
  • Self-reported type 2 diabetes with a duration of ≥2 years
  • Regularly grocery shopping

You may not qualify if:

  • No access to BankID (a digital identification system commonly used in Sweden)
  • Failure to complete eligibility screening and run-in periods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping University

Linköping, Sweden

RECRUITING

Related Publications (1)

  • Af Geijerstam P, Johansson E, Fagerstam S, Wu JH, Ghafouri B, Karlsson K, Hebib L, Kastbom L, Wennberg P, Gustafson Hedov E, Storgards M, Sundstrom J, Radholm K. Effect of the FoodSwitch application on type 2 diabetes in Sweden: a study protocol for the randomised controlled DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients trial (DIATEST-HELP). BMJ Open. 2025 Nov 16;15(11):e110141. doi: 10.1136/bmjopen-2025-110141.

    PMID: 41248424DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Karin Rådholm, MD, PhD

    Linkoeping University

    STUDY DIRECTOR

Central Study Contacts

Lana Hebib, MD

CONTACT

013-28 10 00lana.hebib@liu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 6, 2023

First Posted

August 4, 2023

Study Start

August 25, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2031

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
After publication in a peer-reviewed journal and for the period of time for which local archive regulations stipulate.
Access Criteria
To be determined on a case by case basis.

Locations

SE(1)