CGM-Guided Acarbose for Painful Diabetic Neuropathy

February 27, 2026 updated by: Saima Abass Tahammal, Shifa International Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Lahore, Pakistan
        • Shifa International Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A

Acarbose with meals; pharmacist-led titration (e.g., 50 mg TID → up to 100 mg TID as tolerated) to curb post-prandial excursions based on CGM review.

Background analgesics held stable.
Drug: Acarbose 50 mg
Acarbose with meals; pharmacist-led titration (e.g., 50 mg TID → up to 100 mg TID as tolerated)
Placebo Comparator: Arm B
Matching placebo; identical titration schedule. Background analgesics held stable.
Drug: Placebo
Matching placebo; identical titration schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGM MAGE (mg/dL)
Time Frame: baseline→Week 4
CGM MAGE (mg/dL)
baseline→Week 4
Daily pain AUC
Time Frame: baseline→Week 4
Daily pain AUC (ePRO; 0-10 NRS). Method: trapezoidal AUC of daily NRS scores; higher AUC = worse pain. Daily pain area under the curve derived from the Numeric Rating Scale for Pain (NRS). The NRS ranges from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. AUC is calculated using the trapezoidal method from daily NRS scores over the assessment period. Higher AUC values indicate greater overall pain burden.
baseline→Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGM Time-in-Range (70-180 mg/dL, %)
Time Frame: baseline→Week 4
CGM Time-in-Range (70-180 mg/dL, %)
baseline→Week 4
Skin microvascular reactivity
Time Frame: baseline→Week 4
Skin microvascular reactivity by laser speckle contrast imaging
baseline→Week 4
Serum IL-6
Time Frame: baseline→Week 4
Serum IL-6 (pg/mL)
baseline→Week 4
Patient Global Impression of Change (PGIC)
Time Frame: Week 4
Patient Global Impression of Change (PGIC). Patient Global Impression of Change (PGIC) assessed on a 7 point Likert scale ranging from 1 = very much improved to 7 = very much worse. Lower scores indicate improvement; higher scores indicate worsening.
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shifa International Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 10, 2025

Study Registration Dates

First Submitted

February 22, 2026

First Submitted That Met QC Criteria

February 22, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH-34988983

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in this study, including the analyzable dataset and data dictionary, will be made available.

IPD Sharing Time Frame

Data will be available beginning 6 months after publication and for up to 5 years.

IPD Sharing Access Criteria

Data will be made available to qualified researchers upon reasonable request following publication of the primary results. Requests must include a scientifically sound proposal and statistical analysis plan. Access will require approval by the sponsor and execution of a data use agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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