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

Type 2 Diabetes Mellitus Clinical Trial

— SMART-Finder  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552339
• Other study ID #: 22280
• Status: Recruiting
• Start date: August 18, 2023
• Est. completion date: November 18, 2025

Study information

• Verified date: May 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: November 18, 2025
• Est. primary completion date: November 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients participating in the Chronic Kidney Disease (CKD) awareness program within myTherapy App

• Patient self-reported diagnosis of Type 2 Diabetes Mellitus

• Patients tracking their adherence for at least one of the following drug containing medical products/devices within myTherapy App: Metformin, Acarbose, Dipeptidyl peptidase (DDP)-4 inhibitors, Glucagon-like peptide (GLP) inhibitors, RAS inhibitors, Sodium-dependent glucose transporters 2 (SGLT2) inhibitors, Basal insulin, Finerenone (once available in Germany), Sulfonylurea, Glucose test strips

• Adult (= 18 years) female, male or diverse patient

• Signed informed consent

Exclusion Criteria:

• Patient self-reported diagnosis of Type 1 Diabetes Mellitus

• Patients tracking their adherence for at least one of the following medical products:

Insulin pump

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Finerenone (Kerendia, BAY94-8862)
Following the physicians' decision.
• Type 2 DM drugs
Following the physicians' decision

Locations

Country	Name	City	State
Germany	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Urine albumin-creatinine ratio (UACR) values between 30 and 299 mg/g and above 300 mg/g	The urine albumin-creatinine ratio (UACR) measured by a healthcare professional and provided to the patient	Up to 15 months after the date the initial UACR test took place
Secondary	Number of patients changing their UACR values regarding their baseline Albumin-Creatinine-Ratio (ACR) classification.		Up to 15 months after the date the initial UACR test took place
Secondary	Number of patients with hypertension and nephrotoxic co-medication		12 month previous informed consent date until end of observation
Secondary	Mean EuroQol-5 Dimensions (EQ-5D)		Up to 15 months after the date the initial UACR test took place
Secondary	Diabetes Treatment Satisfaction Questionnaire (DTSQ)		Up to 15 months after the date the initial UACR test took place
Secondary	Number of patients with CKD, Hypertension, Type 2 Diabetes Mellitus and tobacco use		Up to 15 months after the date the initial UACR test took place
Secondary	Adherence - number of patients compliant and persistent in the observation period	Patients included: documenting at least 80% of the expected medication tracked in myTherapy App (compliance), and; not stopping using their medication (persistence).	12 month previous informed consent date until end of observation
Secondary	Number of Health Care Professionals (HCPs) providing UACR to patients		Up to 15 months after the date the initial UACR test took place
Secondary	Location of HCP		Up to 15 months after the date the initial UACR test took place

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