drugset / Trial / NCT07436585
CGM-Guided Acarbose for Painful Diabetic Neuropathy
RandomizedParallel-groupTriple-blindTreatment
Summary
This Phase II pragmatic hybrid effectiveness-implementation trial tests whether acarbose, titrated using continuous glucose monitoring (CGM) to blunt post-prandial excursions, reduces 4-week pain area-under-the-curve (AUC) versus placebo in adults with painful diabetic peripheral neuropathy (DPN) and high glycemic variability. Secondary objectives assess CGM variability metrics, microvascular reactivity, inflammatory markers, safety, and feasibility of a pharmacist-led titration workflow using loaner CGMs across multi-region community clinics.
Timeline
- Start
- 2025-09-01
- Primary completion
- 2025-12-01
- Completion
- 2025-12-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acarbose | Unknown | 100 mg | — |