NIR- and Multifrequent Impedance Spectroscopy on the Skin in Type 1 Diabetes

Completed

• Conditions: Diabetic Neuropathy

• Registration Number: NCT01707979
• Lead Sponsor: Lise Tarnow

Brief Summary

The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR and impedance.

Detailed Description

The aim of the study is to examine how suitable a hand-held measuring probe (DDD-probe) using NIR (near infrared light) as well as impedance (conductivity), is to detect early signs of diabetic neuropathy.

The DDD-probe is put directly on the skin and is measuring by the use of light and impedance.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-25
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted QC: 2012-10-15
• Last Update Submitted: 2012-10-15
• Study First Posted: 2012-10-16
• Last Update Posted: 2012-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• men with type 1 diabetes (WHO criteria)
• age 35-50 years
• duration of diabetes > 10 years

Exclusion Criteria

• P-creatinine> 120 micromol/l
• other acute or chronic disease, or type of treatment that makes the patient unsuitable to participate, valuated by the investigator
• non intact skin on the measuring spots
• the patient is unable to understand the informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
near infrared spectroscopy	one time	Near infrared (NIR) is measured by spectroscopy on the skin using the DDD probe

Trial Locations

Locations (1)

Steno Diabetes Center; 🇩🇰 Gentofte, Denmark