drugset / Trial / NCT07436585

CGM-Guided Acarbose for Painful Diabetic Neuropathy

NCT07436585

Phase 1 Completed 170 enrolled Shifa International Hospital
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

EvaluationDrugModalityDoseRoute
Subject Acarbose Unknown 100 mg