DIATEST - mHealth and Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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DIATEST - a mHealth Intervention to Improve Clinical Management of Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: FoodSwitch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-75 years regularly participate in grocery shopping self-report of having T2DM, with or without diabetes medication Exclusion Criteria: no access to BankID (a digital identification system commonly used in Sweden), thus unable to consent to the study fail to complete the run-in procedures HbA1c <48 mmol/mol in combination with no ongoing diabetes treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Access to the 'DiabetesSwitch' filter of the FoodSwitch app when food shopping during 26 weeks. | Other: FoodSwitch<br>* Access to the 'DiabetesSwitch' filter of the FoodSwitch app when food 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.<br>|
| No Intervention: Control<br>Access to written dietary advice during 26 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (mmol/mol) | Hemoglobin A1C (mmol/mol) | Change from baseline at week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol (mmol/l) | Total cholesterol (mmol/l) | Change from baseline at week 26 | 
| LDL (mmol/l) | Low-density lipoprotein (mmol/l) | Change from baseline at week 26 | 
| HDL (mmol/l) | High-density lipoprotein (mmol/l) | Change from baseline at week 26 | 
| eGFR (ml/min) | Estimated glomerular filtration rate (ml/min) | Change from baseline at week 26 | 
| TNF-α (ng/L) | Tumor necrosis factor - alpha (ng/L) | Change from baseline at week 26 | 
| IL-1β (ng/L) | Interleukin 1β (ng/L) | Change from baseline at week 26 | 
| IL-6 (ng/L) | Interleukin 6 (ng/L) | Change from baseline at week 26 | 
| hsCRP (mg/L) | High sensitive c-reactive protein (mg/L) | Change from baseline at week 26 | 
| Proteomics, and metabolomics | The analysis of proteomics and metabolomics is explorative, and therefore the selection of proteins and metabolites is not pre-determined but will rather include those that are available and deemed appropriate at the time of analysis | Change from baseline at week 26 | 
| Albuminuria (mg/l) | Albuminuria (mg/l) | Change from baseline at week 26 | 
| Self-measured waist circumference (cm) | Self-measured waist circumference (cm) | Change from baseline at week 26 | 
| Self-reported quality of life | Self-reported quality of life - questionnaire | Change from baseline at week 26 |