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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 Diabetes Mellitus patients | MyTherapy App users with Self-reported Type 2 Diabetes Mellitus who had been prescribed drugs for their T2DM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finerenone (Kerendia, BAY94-8862) | Drug | Following the physicians' decision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Number of patients with hypertension and nephrotoxic co-medication |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Multiple Locations | Germany |
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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| Type 2 DM drugs | Drug | Following the physicians' decision |
|
| 12 month previous informed consent date until end of observation |
| Mean EuroQol-5 Dimensions (EQ-5D) | Up to 15 months after the date the initial UACR test took place |
| Diabetes Treatment Satisfaction Questionnaire (DTSQ) | 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 | 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:
| 12 month previous informed consent date until end of observation |
| Number of Health Care Professionals (HCPs) providing UACR to patients | Up to 15 months after the date the initial UACR test took place |
| Location of HCP | Up to 15 months after the date the initial UACR test took place |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C576501 | finerenone |
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