Feasibility of Decentralised Response-Guided Albuminuria Monitoring to Optimise Empagliflozin and Finerenone Therapy in Type 2 Diabetes and Chronic Kidney Disease
Abstract
Aims: To assess the feasibility of a decentralised response-guided trial and to characterise urinary albumin-to-creatinine ratio (UACR) responses to empagliflozin and finerenone in type 2 diabetes and chronic kidney disease (CKD).
Materials and methods: Adults with type 2 diabetes, estimated glomerular filtration rate (eGFR) ≥ 25 mL/min/1.73 m2, and UACR > 4.5 mg/mmol (> 40 mg/g) were enrolled in a decentralised response-guided trial. Participants completed study procedures remotely and received empagliflozin 10 mg once daily for 3 weeks. Based on predefined UACR response thresholds during empagliflozin treatment, participants entered a 4-week second treatment phase with continuation of empagliflozin, add-on finerenone or substitution with finerenone. Primary outcomes were feasibility measures, including participant-reported acceptability, sample delivery and completion of home measurements. Exploratory outcomes included changes in UACR.
Results: Eleven participants completed the study (mean [SD] age 69.6 [6.1] years; mean eGFR 61.1 [24.8] mL/min/1.73 m2; median [IQR] UACR 246.9 mg/g [102.8-457.7]). All predefined feasibility criteria were met: urine and capillary blood sample delivery rates were 100% and 98.8%, respectively; home blood pressure and body weight completion rates were 91.3% and 98.6%. During empagliflozin monotherapy, UACR changed by -18.7% overall, after which nine participants (81.8%) initiated empagliflozin-finerenone combination therapy and 2 (18.2%)…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
Read the paper
Related studies
- Strategy for Mitigating DKA Risk in Patients with Type 1 Diabetes on Adjunctive Treatment with SGLT Inhibitors: A STICH Protocol
- Glucoraphanin: a broccoli sprout extract that ameliorates obesity-induced inflammation and insulin resistance
- SGLT2 Inhibitors in Heart Failure: Targeted Metabolomics and Energetic Metabolism
- Mechanisms of blood pressure reduction with sodium-glucose co-transporter 2 (SGLT2) inhibitors
- Sodium-glucose cotransporter inhibitors: beyond glycaemic control
- Decoding the effects of SGLT2 inhibitors on cardiac arrhythmias in heart failure
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.