Identification of Patients With Elevated Urine Albumin–to-Creatinine Ratio Levels in a Type 2 Diabetes Mellitus Cohort Based on Data Submitted by Patients via a Smartphone App (SMART-Finder): Protocol for an Observational Study (Preprint)

Abstract

BACKGROUND Despite effective treatment options, chronic kidney disease (CKD) has become a major cause of mortality worldwide due to the ever-increasing number of patients with type 2 diabetes mellitus (T2DM). Guideline-compliant, at least annual screening of T2DM patients is crucial to prevent renal disease progression. However, data on the prevalence of CKD in patients with T2DM and on screening frequency are limited. SMART-Finder is the first study to exclusively use data provided directly by patients via an adherence app to collect information on the prevalence of CKD, risk factors, disease management, and quality of life of patients with T2DM in Germany. OBJECTIVE The primary objective of this study is to determine the proportion of patients with T2DM and an elevated urine-albumine-creatinine-ratio (UACR) (ACR stage A2 and A3) at baseline and after 12 (+/- 3) months. Secondary objectives include the proportion of patients who remain in or switch to another ACR classification category after 12 months, information on quality of life, disease awareness, and adherence rates, as well as the proportion of patients without any UACR-Screening data. Recruitment occurs via push notification among MyTherapy app users with T2DM. METHODS This is a retrospective/prospective, observational, digital, patient-centered cohort study, with recruitment and data documentation via a health app. Required routine laboratory data are provided by treating physicians to their patients for data entry. The study population includes adult patients with T2DM documenting their data in the MyTherapy app using their own smart phone or tablet. Study participants are provided with a specifically developed electronic case report form on demographic and general data, quality of life, disease awareness, and lab values eGFR (estimated glomerula filtration rate), UACR, HbA1c (hemoglobin 1Ac), and blood pressure. Apart from demographic and general data, all data are collected at baseline and 12 months after the last UACR assessment. An automatically generated push notification reminds participants of the second data entry. The extracted and pseudonymized data are analyzed descriptively. RESULTS Enrolment period for this study will start on February 2023 and end after 12 months or after enrolment of 5000 patients. An interim analysis is planned 3 months after inclusion of the first patient, and the final analysis after 12 months of follow-up. CONCLUSIONS Overall, the study will contribute to minimizing the existing data gap on the prevalence of CKD in T2DM patients in Germany, provide important insights into the current disease management of T2DM patients in everyday clinical practice in Germany and support guideline-based care for the participating patients.