High Diagnostic Performance of the Indicator Plaster Neuropad for the Detection of Diabetic Autonomic Neuropathy

Aristotle University Of Thessaloniki

Status: Completed

Conditions: Diabetic Neuropathy; Diabetic Autonomic Neuropathy

Treatments: Diagnostic Test: Neuropad

Study type: Observational

Funder types: Other

Identifiers

NCT06734143

16162/24.3.2022

Details and patient eligibility

About

Diabetic autonomic neuropathy (DAN) is a prevalent and severe complication of Diabetes Mellitus (DM). When the autonomic regulation of the cardiovascular system is affected, it is referred to as cardiovascular autonomic neuropathy (CAN), the most critical subtype of DAN. Early diagnosis of CAN is crucial, as it can identify patients at elevated risk for cardiovascular complications. This study aimed to assess the Neuropad test's effectiveness, specificity, sensitivity, and accuracy as a diagnostic tool for detecting DAN.

Full description

Diabetic autonomic neuropathy (DAN) is a prevalent and severe complication of Diabetes Mellitus (DM). When the autonomic regulation of the cardiovascular system is affected, it is referred to as cardiovascular autonomic neuropathy (CAN), the most critical subtype of DAN. Early diagnosis of CAN is crucial, as it can identify patients at elevated risk for cardiovascular complications. This study aimed to assess the Neuropad test's effectiveness, specificity, sensitivity, and accuracy as a diagnostic tool for detecting DAN.

Enrollment: 174 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diabetes mellitus

Exclusion criteria

• age>75 years,
• estimated creatinine clearance rate (using the Cockcroft-Gault formula) <30 ml/ min,
• history of limp amputation,
• causes of neuropathy other than diabetes,
• drugs that can affect perspiration, and
• skin disorders that could affect the result.

Trial design

174 participants in 1 patient group

Group

Description:

patients with diabetes mellitus

Treatment:

Diagnostic Test: Neuropad