Diabetes Mellitus, Type 2 Clinical Trial
Official title:
DIATEST - a mHealth Intervention to Improve Clinical Management of Type 2 Diabetes Mellitus
Dietary modification is effective in the prevention and treatment of type 2 diabetes mellitus (T2DM). However, the access to dieticians in primary care is limited. While mHealth tools have been shown to improve diet and clinical management of patients with T2DM, there are currently no mobile health (mHealth) tools that are effective in improving diet and clinical management of T2DM in Sweden. The aim of this project is to study the effect of the FoodSwitch app, an mHealth intervention for patients with T2DM.
This randomized controlled trial will determine the effect of the FoodSwitch app for healthier food choices on HbA1c, blood lipids, renal function and low-grade inflammation in individuals with T2DM. The effect of the mHealth tool on HbA1c and cardiovascular risk factors, will be compared to standard dietary advice for patients with T2DM. Randomization will be performed in a 1:1 ratio to receive the FoodSwitch app intervention or control and stratified by age (<50 years/≥50 years), sex, and baseline insulin use (Yes/No). The intervention group will scan all their purchased packaged food with the FoodSwitch app for one week at 6 and 12, 18 and 26 weeks. The control group will photograph and upload images of their receipts or share digital shopping receipts for one week at 6 and 12, 18 and 26 weeks. All participants in both the intervention and control group will report symptoms, functions, and quality of life, as often as they like as well as at 6 and 12, 18 and 26 weeks. All participants will be mailed a blood and urine collection kit and instructed to use it and to self-measure waist circumference at the start of the study and at 26 weeks. The primary outcome (HbA1c) and secondary outcomes (blood measurements of total cholesterol, LDL and HDL cholesterol, eGFR, TNF-α, IL-1β, IL-6, CRP, proteomics, and metabolomics; microalbuminuria; self-measured waist circumference; self-reported quality of life, 24-hour dietary recall, as well as other present symptoms; smartphone-obtained physical activity levels and patterns) will be evaluated at 26 weeks. National registry-obtained data on medication use, hospitalizations and deaths will also be evaluated. ;
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