Earlier Diagnosis of Peripheral Neuropathy Using A Simple sCreening Tool (ACT)

This study is looking at people with diabetes (type 1 and type 2 diabetes) to see how well a short questionnaire, called the ACT, can identify nerve damage in the feet and legs (also known as peripheral neuropathy). The investigators will compare the ACT questionnaire to other commonly used tools (the DN4 and Michigan Neuropathy Screening Instrument) and to an eye-test that detects small nerve fibers in the eye (called corneal confocal microscopy, or CCM).

The main goal is to find out if the ACT questionnaire is accurate in detecting nerve damage and painful nerve damage caused by diabetes.

The investigators will also look at whether changes in blood sugar levels, measured with a continuous glucose monitor (Freestyle Libre 3 and iCan), are linked to nerve pain and small nerve fiber damage.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Peripheral Neuropathy Diabetes (DM) Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Neuropathy, Painful Nutritional and Metabolic Diseases Painful Neuropathy Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Weill Cornell Medicine-Qatar

Doha, 24144, Qatar

About this study

This a cross-sectional cohort study in patients with diabetes with the aim of assessing the validity and diagnostic accuracy of the ACT questionnaire in identifying peripheral neuropathy (PN) in patients with diabetes and explore underlying mechanisms for nerve damage. The primary endpoint is to validate the ACT tool in identifying diabetic painful neuropathy against the DN4 questionnaire, Michigan Neuropathy Screening Instrument (MNSI) and in relation to underlying small nerve fibre damage (CCM). And the secondary endpoints include the investigation of the association between glycemic indices using continuous glucose monitoring (CGM- Freestyle Libre 3 and iCan) with neuropathic pain (ACT/DN4/MNSI) and small nerve fibre damage (CCM).

Participants will attend 3 visits and the following will be assessed:

Visit 1(baseline): Consent, screening, CCM, ACT, MNSI, DN4, CGM (Freestyle Libre 3).
Visit 2 (14-days follow-up): CGM (freestyle Libre 3), ACT, MNSI, DN4
Visit 3 (between 1-6 months): CGM (iCan)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with diabetes (T1DM and T2DM)
Age ≥18
Able to provide consent.
Able to sit still for corneal confocal microscopy

Exclusion criteria

Failure to provide informed consent
Participants with a history of ocular trauma or previous ocular surgery in the preceding 6 months, are allergic to oxybuprocaine or local anesthetics or unable to cooperate by holding still or placing their chin on an optical device
Other causes of peripheral neuropathy: vitamin B12 deficiency; hypothyroidism; myeloma.
Cognitively impaired participants
Pregnant women
Nursing women

Treatment and study plan

Primary outcomes

Validation of the ACT tool

Time frame: Baseline (Day 1) and then 14 days after visit 1

Identification of number of participants with diabetic peripheral neuropathy as assessed by the ACT tool.

Sponsors and collaborators

Lead sponsor

Weill Cornell Medical College in Qatar

Other

Collaborators

Hamad Medical Corporation
Procter and Gamble

Registry information

Acronym: ACT

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Sep 9, 2025
Registry last updated: Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting