DIATEST - mHealth and Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

— DIATEST  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05977218
• Other study ID #: diatest2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: July 2023
• Source: Linkoeping University
• Contact: Lana Hebib, MD
• Phone: 013-28 10 00
• Email: lana.hebib[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• FoodSwitch
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

References & Publications (2)

Coughlin SS, Whitehead M, Sheats JQ, Mastromonico J, Hardy D, Smith SA. Smartphone Applications for Promoting Healthy Diet and Nutrition: A Literature Review. Jacobs J Food Nutr. 2015;2(3):021. — View Citation

Dunford E, Trevena H, Goodsell C, Ng KH, Webster J, Millis A, Goldstein S, Hugueniot O, Neal B. FoodSwitch: A Mobile Phone App to Enable Consumers to Make Healthier Food Choices and Crowdsourcing of National Food Composition Data. JMIR Mhealth Uhealth. 2014 Aug 21;2(3):e37. doi: 10.2196/mhealth.3230. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	24-hour dietary recall	24-hour dietary recall	Change from baseline at week 26
Primary	HbA1c (mmol/mol)	Hemoglobin A1C (mmol/mol)	Change from baseline at week 26
Secondary	Total cholesterol (mmol/l)	Total cholesterol (mmol/l)	Change from baseline at week 26
Secondary	LDL (mmol/l)	Low-density lipoprotein (mmol/l)	Change from baseline at week 26
Secondary	HDL (mmol/l)	High-density lipoprotein (mmol/l)	Change from baseline at week 26
Secondary	eGFR (ml/min)	Estimated glomerular filtration rate (ml/min)	Change from baseline at week 26
Secondary	TNF-a (ng/L)	Tumor necrosis factor - alpha (ng/L)	Change from baseline at week 26
Secondary	IL-1ß (ng/L)	Interleukin 1ß (ng/L)	Change from baseline at week 26
Secondary	IL-6 (ng/L)	Interleukin 6 (ng/L)	Change from baseline at week 26
Secondary	hsCRP (mg/L)	High sensitive c-reactive protein (mg/L)	Change from baseline at week 26
Secondary	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
Secondary	Albuminuria (mg/l)	Albuminuria (mg/l)	Change from baseline at week 26
Secondary	Self-measured waist circumference (cm)	Self-measured waist circumference (cm)	Change from baseline at week 26
Secondary	Self-reported quality of life	Self-reported quality of life - questionnaire	Change from baseline at week 26