DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients Trial

NCT ID: NCT05977218

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-25
• Study Completion Date: 2031-12-31

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.

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

FoodSwitch

Intervention Type: 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.

Control

Access to standard written dietary advice

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Lana Hebib

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karin Rådholm, MD, PhD

Role: STUDY_DIRECTOR

Linkoeping University

Locations

Linköping University

Linköping, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Lana Hebib, MD

Role: CONTACT

lana.hebib@liu.se

013-28 10 00

Facility Contacts

Siri Fägerstam

Role: primary

diatest-help@liu.se

+46-(0)13-281661

Other Identifiers

DIATEST-HELP

Identifier Type: -

Identifier Source: org_study_id