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

This study has been completed.
Information provided by (Responsible Party):
Lise Tarnow, Steno Diabetes Center Identifier:
First received: September 25, 2012
Last updated: October 15, 2012
Last verified: October 2012
The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR and impedance.

Diabetic Neuropathy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: NIR (Near Infrared)- Spectroscopy and Multifrequent Impedance Spectroscopy on the Skin to Detection of Sensory and Autonomic Neuropathy Among Patients With Type 1 Diabetes

Resource links provided by NLM:

Further study details as provided by Lise Tarnow, Steno Diabetes Center:

Primary Outcome Measures:
  • near infrared spectroscopy [ Time Frame: one time ]
    Near infrared (NIR) is measured by spectroscopy on the skin using the DDD probe

Enrollment: 30
Study Start Date: September 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Diabetic neuropathy
Male participants, type1 diabetic with diabetic neuropathy
Diabetes without neuropathy
Male participants, type1 diabetic without diabetic neuropathy
Non diabetic control
Male participants, control group non diabetic

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.


Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Control group men without diabetes Type1 diabetic men without neuropathy complications Type 1 diabetic men with neuropathy complications

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01707979

Steno Diabetes Center
Gentofte, Denmark, 2820
Sponsors and Collaborators
Lise Tarnow
Principal Investigator: Lise Tarnow, Professor Steno Diabetes Center
  More Information

Responsible Party: Lise Tarnow, Professor, Chief Physician, Steno Diabetes Center Identifier: NCT01707979     History of Changes
Other Study ID Numbers: NIR
Study First Received: September 25, 2012
Last Updated: October 15, 2012

Keywords provided by Lise Tarnow, Steno Diabetes Center:
Near infrared light
Diabetic neuropathy
Sensory neuropathy
Autonomic neuropathy
Sudomotor function

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases processed this record on May 25, 2017