Clinical trial NCT05552339: 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
Official title: SMART-Finder - Identification of Patients With Elevated UACR Levels in a T2DM Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes Mellitus
Chronic Kidney Disease
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 criteria: 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

Primary outcomes:
measure: Number of patients with Urine albumin-creatinine ratio (UACR) values between 30 and 299 mg/g and above 300 mg/g
timeFrame: Up to 15 months after the date the initial UACR test took place
Secondary outcomes:
measure: Number of patients changing their UACR values regarding their baseline Albumin-Creatinine-Ratio (ACR) classification.
timeFrame: Up to 15 months after the date the initial UACR test took place
measure: Number of patients with hypertension and nephrotoxic co-medication
timeFrame: 12 month previous informed consent date until end of observation
measure: Mean EuroQol-5 Dimensions (EQ-5D)
timeFrame: Up to 15 months after the date the initial UACR test took place
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: Up to 15 months after the date the initial UACR test took place
measure: Number of patients with CKD, Hypertension, Type 2 Diabetes Mellitus and tobacco use
timeFrame: Up to 15 months after the date the initial UACR test took place
measure: Adherence - number of patients compliant and persistent in the observation period
timeFrame: 12 month previous informed consent date until end of observation
measure: Number of Health Care Professionals (HCPs) providing UACR to patients
timeFrame: Up to 15 months after the date the initial UACR test took place
measure: Location of HCP
timeFrame: Up to 15 months after the date the initial UACR test took place
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many locations
Study officials:
References: