DIATEST-HELP: A pragmatic randomized controlled trial in Type 2 Diabetes

A picture showing a stetoscope and a plate with fruits and vegetables

DIATEST-HELP is a national, fully remote trial assessing whether the FoodSwitch app helps people with type 2 diabetes make healthier food choices and improve glycaemic control and cardiovascular risk.

Type 2 Diabetes

Approximately 5% of the Swedish population lives with T2D, a metabolic disease associated with an increased risk of cardiovascular complications. Although dietary management is one of four pillars of T2D treatment, access to dietetic services remains limited for many patients in primary care, where most individuals with T2D receive their treatment.

The DIATEST-HELP RCT

DIATEST-HELP (DIgitAl diabeTES Treatment – the Healthy Eating, heaLthy Patients trial) evaluates the effectiveness of the FoodSwitch/DiabetesSwitch smartphone application developed by our collaborator The George Institute for Global Health, designed to assist individuals with T2D in making healthier food purchasing decisions in grocery stores.

The study is conducted nationwide and is open to Swedish-speaking adults who have been diagnosed with T2D for at least two years and regularly purchase food in grocery stores. Participants are randomized either to receive access to the intervention, described as a “digital dietitian in the pocket”, or to continue receiving standard diabetes care and dietary advice through primary healthcare services.

A small red object sitting on top of a finger.

All participants use a digital platform to report symptoms, functioning, and quality of life. At baseline and after 3 and 6 months, participants collect capillary blood samples at home using a finger-prick dried blood spot (DBS) sampling and return the samples by regular postal services. At the end of the study, participants receive feedback on their HbA1c levels.

Remote Participation and Outcomes

The study combines questionnaire data and blood samples with information from Swedish healthcare registers. The primary outcome is change in HbA1c, a key marker of long-term glycemic control. Secondary outcomes include dietary habits, symptoms, health-related quality of life, and cardiometabolic biomarkers such as blood lipids and markers of low-grade inflammation.

Scientific and Societal Relevance

DIATEST-HELP aims to establish an accessible and scalable infrastructure for remote data collection in clinical research. By integrating digital health technologies with home-based sampling, the study seeks to facilitate nationwide participation, reduce geographical barriers to research involvement, and strengthen the role of Swedish primary care in patient-centered clinical research. This approach has the potential to improve both research accessibility and the implementation of evidence-based lifestyle interventions for individuals with T2D.

Collaborators and Funding

DIATEST-HELP is conducted in collaboration with Region Östergötland, Uppsala University, Umeå University, and the George Institute for Global Health (Sydney, Australia), as well as the companies Minforskning AB, Symptoms Europe AB, and Vitas AB. The study is primarily funded by the Swedish Research Council (Vetenskapsrådet), the Swedish Diabetes Foundation (Diabetesfonden), ALF funding, and the Swedish Society of Medicine (Svenska Läkarsällskapet).

Publications

Dried blood spot sample extraction for metabolomics and proteomics profiling for clinical trials: a descriptive exploratory study

Siri Fägerstam, Emir Johansson, Peder af Geijerstam, Karin Rådholm & Bijar Ghafouri

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)

Peder af Geijerstam1,2, Emir Johansson1,3, Siri Fägerstam1, Jason HY Wu4, Bijar Ghafouri1, Karin Karlsson5, Lana Hebib1,6, Lisa Kastbom1,7, Patrik Wennberg8, Emelie Gustafson Hedov5, Maria Storgärds9, Johan Sundström4,5, Karin Rådholm1,3,4