Observational study on albumin levels in urine among type 2 diabetes patients
SMART-Finder - Identification of Patients With Elevated UACR Levels in a T2DM Cohort
This study looks at urine albumin levels in people with type 2 diabetes to see how it relates to kidney damage and how well they stick to their medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT05552339 on ClinicalTrials.gov |
What this trial studies
This observational study examines data from individuals with type 2 diabetes mellitus (T2DM) in Germany who utilize the myTherapy medical app. The focus is on measuring the urine-albumin-creatinine ratio (UACR) to assess kidney damage, as abnormal albumin levels can indicate chronic kidney disease (CKD) in T2DM patients. Participants are required to track their medication adherence through the app, which includes various diabetes medications. The study aims to gather real-world data on the relationship between T2DM and CKD.
Who should consider this trial
Good fit: Ideal candidates include adults with a self-reported diagnosis of type 2 diabetes who are using the myTherapy app to track their medication adherence.
Not a fit: Patients with type 1 diabetes mellitus or those using insulin pumps may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of kidney health in type 2 diabetes patients and improve early detection of chronic kidney disease.
How similar studies have performed: Other studies have shown success in using real-world data to understand the impact of diabetes on kidney health, making this approach both relevant and tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Multiple Locations
- Many locations — Multiple Locations, Germany (Recruiting)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.