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Recruiting NCT05977218

DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients Trial

No phase Interventional Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FoodSwitch.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

  • Other FoodSwitch
    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 outcome measures

  • Mean HbA1c [Time frame: Change from baseline at week 26]
Secondary outcome measures (6)
  • Self-measured waist circumference (cm) [Time frame: Change from baseline at week 26]
  • Self-reported quality of life [Time frame: Change from baseline at week 26]
  • Self-measured body weight (kg) [Time frame: Change from baseline at week 26]
  • Registry-based data on medication use, hospitalizations, outpatient visits, and diabetes complications [Time frame: Change from baseline at week 26]
  • Self-reported dietary self-efficacy [Time frame: Change from baseline at week 26]
  • Difference in all-cause mortality [Time frame: Change from baseline at week 26]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Sweden · 1 center
  • Linköping University — Linköping

Publications

  • 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 PMID 41248424

Identifiers

NCT: NCT05977218 · DIATEST-HELP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗