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NCT Number: NCT05977218

DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients Trial

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.

Recruiting

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

A healthy diet improves glycaemic control and reduces cardiovascular risk in type 2 diabetes (T2D), but access to dietitians is limited. Unlike several countries, Sweden has not implemented interpretive front-of-pack labelling. Smartphone applications may offer an alternative. This trial evaluates the dietary and clinical impact of FoodSwitch, a mobile app providing interpretive labelling to Swedish adults with T2D. Nine hundred individuals with T2D for ≥2 years who regularly shop for groceries will be recruited via general practices and community advertisements and randomized to receive access to FoodSwitch plus standard written dietary advice, or standard written dietary advice only. The primary outcome is change in self-measured glycated haemoglobin (HbA1c) after 6 months. Secondary outcomes include waist circumference, body weight, quality of life, dietary self-efficacy, medication use, hospitalizations, and all-cause mortality. Exploratory outcomes include omics analyses.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

FoodSwitch

Other

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.

Primary outcomes

  1. Mean HbA1c

    Time frame: Change from baseline at week 26

    Mean glycated haemoglobin

Secondary outcomes

  1. Self-measured waist circumference (cm)

    Time frame: Change from baseline at week 26

    Self-measured waist circumference (cm)

  2. Self-reported quality of life

    Time frame: Change from baseline at week 26

    Self-reported quality of life - questionnaire

  3. Self-measured body weight (kg)

    Time frame: Change from baseline at week 26

    Self-measured body weight (kg)

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

    Time frame: Change from baseline at week 26

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

  5. Self-reported dietary self-efficacy

    Time frame: Change from baseline at week 26

    Self-reported dietary self-efficacy

  6. Difference in all-cause mortality

    Time frame: Change from baseline at week 26

    Difference in all-cause mortality

Other outcomes

  1. Dietary effects on proteomics and metabolomics

    Time frame: Change from baseline at week 26

    Dietary effects on proteomics and metabolomics

Study contacts

Contact information is provided by the study sponsor or research team.

Lana Hebib, MD

CONTACT

[email protected]

013-28 10 00

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Acronym: DIATEST-HELP

Important dates

Study start
2025
Primary completion
2026
Study completion
2031
First posted
Aug 4, 2023
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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