NCT07436585

CGM-Guided Acarbose for Painful Diabetic Neuropathy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Shifa International Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Adults with T2D, painful DPN, and high CGM variability (e.g., MAGE \>50 mg/dL on run-in) are randomized 1:1 to acarbose vs matching placebo for 4 weeks, on stable background analgesics. A standardized pharmacist-led algorithm escalates acarbose to target post-prandial spikes, guided by blinded CGM trend review. The primary endpoint is 4-week daily pain AUC captured via ePRO. Key secondary endpoints include changes in MAGE and time-in-range (TIR), skin microvascular reactivity (laser speckle), serum IL-6, patient global impression of change, rescue-analgesic use, and adverse events. Implementation outcomes (acceptability, feasibility, adoption, cost) are collected to inform scale-up in HIC and LMIC community settings.

Conditions

• Diabetes
• Diabetes Complications
• Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	Acarbose 50 mg	Acarbose with meals; pharmacist-led titration (e.g., 50 mg TID → up to 100 mg TID as tolerated)
DRUG	Placebo	Matching placebo; identical titration schedule

Timeline

• Start date: 2025-09-01
• Primary completion: 2025-12-01
• Completion: 2025-12-10
• First posted: 2026-02-27
• Last updated: 2026-03-03

Locations

1 site across 1 country: Pakistan