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

Linköping University (LiU)

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Other: FoodSwitch

Study type: Interventional

Funder types: Other

Identifiers

NCT05977218

DIATEST-HELP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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900 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Other: FoodSwitch

Control

No Intervention group

Description:

Access to standard written dietary advice