RecruitingNCT05552339

A Study Called SMART-Finder to Look for People With Increased Amounts of Albumin in the Urine (UACR Level) in a Group of Type 2 Diabetes Mellitus Patients

SMART-Finder - Identification of Patients With Elevated UACR Levels in a T2DM Cohort


Sponsor

Bayer

Enrollment

5,000 participants

Start Date

Aug 18, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

This is an observational study in which data from people with type 2 diabetes mellitus (T2DM) in Germany who use the medical app "myTherapy" are studied. In observational studies, only observations are made without specified advice or interventions. In people with T2DM, the body does not make enough of a hormone called insulin or does not use insulin well enough. The resulting high blood sugar level can cause damage to the kidneys over time. As a result, chronic kidney disease (CKD) can occur as a complication of T2DM. Kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive decrease in the kidneys' ability to properly filter the blood. Abnormal amounts of proteins such as albumin in the urine are a sign of kidney damage, as proteins are normally kept in the blood. The amount of albumin in the urine is measured as so-called urine-albumin-creatinine-ratio (UACR) in this study. Studies in people with T2DM and CKD in a real-world care setting are limited, particularly those that look at the number of people concerned over time. The main purpose of this study is to learn how many people with T2DM have also increased amounts of albumin in the urine (UACR level) in users of the medical app "myTherapy" in Germany. In addition, researchers want to learn how these albumin levels change over time. To answer this, the researchers will collect the participant's UACR level at start of the study and about 12 months later. The UACR is measured by the participant's physician during routine care using urine dip-sticks. All participants of this study are already receiving or will receive one of the available T2DM treatments prescribed by their doctors according to the approved use or are regularly using devices to check their blood sugar levels. And they use the "myTherapy" app to support and track their T2DM therapy. The data collected includes both participant-reported data and physician-provided lab values. All data are entered into the "myTherapy" app by the participant. They will be collected from October 2022 to December 2024 and cover a period of up to 15 months per participant. Besides this data collection, no further tests or examinations are planned in this study.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a smartphone app (myTherapy) to screen people with type 2 diabetes for early kidney damage by checking for a protein called albumin in the urine (a sign of kidney stress). The goal is to identify at-risk patients earlier and connect them to care. **You may be eligible if...** - You have type 2 diabetes (self-reported) - You are 18 or older - You are using the myTherapy app to track your medications for diabetes or related conditions - You are participating in a kidney awareness program within the app **You may NOT be eligible if...** - You have type 1 diabetes - You are already being treated with specific kidney-protective medications that would affect the test results (such as certain drugs already in this category) - You are currently pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFinerenone (Kerendia, BAY94-8862)

Following the physicians' decision.

DRUGType 2 DM drugs

Following the physicians' decision


Locations(1)

Many locations

Multiple Locations, Germany

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NCT05552339


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