CGM-Guided Acarbose for Painful Diabetic Neuropathy

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.

NCT Number	NCT07436585
Lead Sponsor	Shifa International Hospital
Conditions	Diabetes, Diabetes Complications, Diabetic Neuropathy
Enrollment	170 participants
Start Date	2025-09-01
Primary Completion	2025-12-01 (estimated)
Study Completion	2025-12-10 (estimated)
Updated on ClinicalTrials.gov	2026-03-03