Type 2 Diabetes MellitusSMART-FinderNCT05552339
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
An observational study of Type 2 Diabetes Mellitus and Chronic Kidney Disease, run by Bayer at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Chronic Kidney Disease
- What is being tested?
- Finerenone (Kerendia, BAY94-8862) and Type 2 DM drugs
- How many people
- 348 participants
- Where
- 1 siteGermany
- Study dates
- 18 Aug 2023to 18 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MyTherapy App users in Germany with the Self-reported Type 2 Diabetes Mellitus patients who have been prescribed the drugs defined according inclusion criteria will be eligible to be enrolled.
Who may be able to join
- 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
Who cannot join
- Patient self-reported diagnosis of Type 1 Diabetes Mellitus
- Patients tracking their adherence for at least one of the following medical products: Insulin pump
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SMART-Finder - Identification of Patients With Elevated UACR Levels in a T2DM Cohort
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.
Read more
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.
- Conditions
- Type 2 Diabetes Mellitus, Chronic Kidney Disease
- Being tested
- Finerenone (Kerendia, BAY94-8862), Type 2 DM drugs
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finerenone (Kerendia, BAY94-8862)Drug
Following the physicians' decision.
Type 2 DM drugsDrug
Following the physicians' decision
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes Mellitus patients | MyTherapy App users with Self-reported Type 2 Diabetes Mellitus who had been prescribed drugs for their T2DM. Receives: Drug: Finerenone (Kerendia, BAY94-8862); Drug: Type 2 DM drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 15 months after the date the initial UACR test took place
Secondary outcomes (8)
Number of patients changing their UACR values regarding their baseline Albumin-Creatinine-Ratio (ACR) classification.
Measured: Up to 15 months after the date the initial UACR test took place
Number of patients with hypertension and nephrotoxic co-medication
Measured: 12 month previous informed consent date until end of observation
Mean EuroQol-5 Dimensions (EQ-5D)
Measured: Up to 15 months after the date the initial UACR test took place
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Measured: Up to 15 months after the date the initial UACR test took place
Number of patients with CKD, Hypertension, Type 2 Diabetes Mellitus and tobacco use
Measured: Up to 15 months after the date the initial UACR test took place
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).
Measured: 12 month previous informed consent date until end of observation
Number of Health Care Professionals (HCPs) providing UACR to patients
Measured: Up to 15 months after the date the initial UACR test took place
Location of HCP
Measured: Up to 15 months after the date the initial UACR test took place
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start18 Aug 2023
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552339
- Sponsor's protocol ID
- 22280
- Acronym
- SMART-Finder
- Status last verified
- Apr 2026
- First submitted
- 21 Sep 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART-Finder - Identification of Patients With Elevated UACR Levels in a T2DM Cohort
- ClinicalTrials.gov ID
- NCT05552339
- Acronym / sponsor ID
- SMART-Finder / 22280
- Conditions
- Type 2 Diabetes Mellitus, Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes Mellitus patients | – | Drug: Finerenone (Kerendia, BAY94-8862), Drug: Type 2 DM drugsMyTherapy App users with Self-reported Type 2 Diabetes Mellitus who had been prescribed drugs for their T2DM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MyTherapy App users in Germany with the Self-reported Type 2 Diabetes Mellitus patients who have been prescribed the drugs defined according inclusion criteria will be eligible to be enrolled.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patient self-reported diagnosis of Type 1 Diabetes Mellitus
- Patients tracking their adherence for at least one of the following medical products: Insulin pump
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finerenone (Kerendia, BAY94-8862)Following the physicians' decision. | Drug | Type 2 Diabetes Mellitus patients |
| Type 2 DM drugsFollowing the physicians' decision | Drug | Type 2 Diabetes Mellitus patients |
Primary outcome
Number of patients with Urine albumin-creatinine ratio (UACR) values between 30 and 299 mg/g and above 300 mg/g
Time frame: Up to 15 months after the date the initial UACR test took place
The urine albumin-creatinine ratio (UACR) measured by a healthcare professional and provided to the patient
8 secondary outcomes
Number of patients changing their UACR values regarding their baseline Albumin-Creatinine-Ratio (ACR) classification.
Time frame: Up to 15 months after the date the initial UACR test took place
Number of patients with hypertension and nephrotoxic co-medication
Time frame: 12 month previous informed consent date until end of observation
Mean EuroQol-5 Dimensions (EQ-5D)
Time frame: Up to 15 months after the date the initial UACR test took place
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: Up to 15 months after the date the initial UACR test took place
Number of patients with CKD, Hypertension, Type 2 Diabetes Mellitus and tobacco use
Time frame: Up to 15 months after the date the initial UACR test took place
Adherence - number of patients compliant and persistent in the observation period
Time frame: 12 month previous informed consent date until end of observation
Number of Health Care Professionals (HCPs) providing UACR to patients
Time frame: Up to 15 months after the date the initial UACR test took place
Location of HCP
Time frame: Up to 15 months after the date the initial UACR test took place
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Chronic Kidney Disease, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Urine albumin-creatinine ratio (UACR) values between 30 and 299 mg/g and above 300 mg/g (time frame: Up to 15 months after the date the initial UACR test took place). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 2 Nov 2026.