account_circleRecruiting

Type 2 diabetes mellitus, Chronic kidney disease

Bayer Identifier:

22280

ClinicalTrials.gov Identifier:

NCT05552339

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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
  • - 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 summary

Enrollment Goal
5000
Trial Dates
August 2023 - November 2025
Phase
Phase 4
Could I Receive a placebo
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many locationsMany locations, Germany

Primary Outcome

  • 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
    date_rangeTime Frame:
    Up to 15 months after the date the initial UACR test took place

Secondary Outcome

  • Number of patients changing their UACR values regarding their baseline Albumin-Creatinine-Ratio (ACR) classification.
    date_rangeTime Frame:
    Up to 15 months after the date the initial UACR test took place
  • Number of patients with hypertension and nephrotoxic co-medication
    date_rangeTime Frame:
    12 month previous informed consent date until end of observation
  • Mean EuroQol-5 Dimensions (EQ-5D)
    date_rangeTime Frame:
    Up to 15 months after the date the initial UACR test took place
  • Diabetes Treatment Satisfaction Questionnaire (DTSQ)
    date_rangeTime 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
    date_rangeTime 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
    Patients included: a. documenting at least 80% of the expected medication tracked in myTherapy App (compliance), and b. not stopping using their medication (persistence).
    date_rangeTime Frame:
    12 month previous informed consent date until end of observation
  • Number of Health Care Professionals (HCPs) providing UACR to patients
    date_rangeTime Frame:
    Up to 15 months after the date the initial UACR test took place
  • Location of HCP
    date_rangeTime Frame:
    Up to 15 months after the date the initial UACR test took place

Trial design

SMART-Finder - Identification of patients with elevated UACR levels in a T2DM cohort
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

​Click here for access to information about Bayer’s transparency standards and Bayer studies