“Healthy eating - healthy patients”, an mHealth intervention trial to improve clinical management of type 2 diabetes mellitus

Diet is a key component in treatment of type 2 diabetes mellitus (T2DM), a metabolic disorder associated with increased risk of cardiovascular disease.

Few patients have access to dieticians in clinical care and there are currently no mHealth tools that are effective in improving diet and clinical management of patients with T2DM in Sweden.We will use a randomized controlled trial to study the effects of the FoodSwitch app in 900 patients with T2DM on the primary outcome, change in mean HbA1c between baseline and 6 months for the FoodSwitch intervention vs standard dietary advice.

Secondary outcomes are key surrogate measures of cardiovascular disease risk including blood lipids, estimated glomerular filtration rate, microalbuminuria, self-measured waist circumference and low-grade inflammation.

Blood- and urine samples will be self- administered on filter papers and sent via mail, to facilitate study participation regardless of living area.

We will assess primary and major secondary outcomes via a series of analysis of covariance (ANCOVAs).The time plan includes development of the full technical platform and app release in 2024, inclusion from 2024 and follow-up through 2026.

In 2026, statistical analysis will be done and manuscript writing of the key publication.This is a novel technical approach to aid individuals with T2DM in healthier food choices, a cornerstone treatment of T2DM, which can benefit individual patients as well as the wider community.