CGM-Guided Acarbose for Painful Diabetic Neuropathy
Pakistan170 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion:
* Age 18-75 years.
* Type 2 diabetes ≥1 year; HbA1c 7.0-10.0% within 8 weeks of randomization.
* Painful DPN meeting clinical criteria; average daily pain NRS ≥4 during run-in.
* High CGM variability on 7-10 day run-in (e.g., MAGE \>50 mg/dL).
* Stable analgesic regimen ≥4 weeks pre-baseline.
* Able to use CGM and ePRO; provides informed consent.
Exclusion:
* Type 1 diabetes; non-diabetic neuropathies.
* Contraindications to acarbose (e.g., chronic intestinal malabsorption, inflammatory bowel disease).
* eGFR \<45 mL/min/1.73 m²; significant hepatic disease (ALT/AST \>3× ULN).
* Use of α-glucosidase inhibitors within 3 months.
* Recent change (\<3 months) in GLP-1/GIP agonists, SGLT2i, or basal/bolus insulin strategy.
* Pregnancy/lactation; other conditions compromising safety/assessments.