DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients Trial (DIATEST-HELP)

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: FoodSwitch

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.

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lana Hebib, MD; Phone Number: 013-28 10 00; Email: lana.hebib@liu.se

Study Locations

• Sweden
  • Linköping, Sweden
    • Recruiting
    • Linköping University
    • Contact: Siri Fägerstam; Phone Number: +46-(0)13-281661; Email: diatest-help@liu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Access to the 'DiabetesSwitch' filter of the FoodSwitch app when grocery shopping during 26 weeks, in addition to standard written dietary advice	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.
No Intervention: Control; Access to standard written dietary advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean HbA1c	Mean glycated haemoglobin	Change from baseline at week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-measured waist circumference (cm)	Self-measured waist circumference (cm)	Change from baseline at week 26
Self-reported quality of life	Self-reported quality of life - questionnaire	Change from baseline at week 26
Self-measured body weight (kg)	Self-measured body weight (kg)	Change from baseline at week 26
Registry-based data on medication use, hospitalizations, outpatient visits, and diabetes complications	Registry-based data on medication use, hospitalizations, outpatient visits, and diabetes complications	Change from baseline at week 26
Self-reported dietary self-efficacy	Self-reported dietary self-efficacy	Change from baseline at week 26
Difference in all-cause mortality	Difference in all-cause mortality	Change from baseline at week 26

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary effects on proteomics and metabolomics	Dietary effects on proteomics and metabolomics	Change from baseline at week 26

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Study Director: Karin Rådholm, MD, PhD, Linkoeping University

Publications and helpful links

General Publications

• Dunford E, Trevena H, Goodsell C, Ng KH, Webster J, Millis A, Goldstein S, Hugueniot O, Neal B. FoodSwitch: A Mobile Phone App to Enable Consumers to Make Healthier Food Choices and Crowdsourcing of National Food Composition Data. JMIR Mhealth Uhealth. 2014 Aug 21;2(3):e37. doi: 10.2196/mhealth.3230.
• Coughlin SS, Whitehead M, Sheats JQ, Mastromonico J, Hardy D, Smith SA. Smartphone Applications for Promoting Healthy Diet and Nutrition: A Literature Review. Jacobs J Food Nutr. 2015;2(3):021.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: HbA1c; Diet; Mobile health
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DIATEST-HELP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: After publication in a peer-reviewed journal and for the period of time for which local archive regulations stipulate.
• IPD Sharing Access Criteria: To be determined on a case by case basis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No