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OpenTrials
Completed

NCT Number: NCT03352518

Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device

This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology M, Odense University Hospital

Odense, 5000, Denmark

About this study

Subjects will collect spectral raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributes with in a timeframe of ten days. A Flash Glucose Monitor will be used as a comparator. In addition to this, four daily capillary Blood Glucose readings will be collected.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female subjects 18 years of age or older
  • Diabetic patients (all types)

Exclusion criteria

  • Pregnant women
  • Subjects not able to understand and read Danish
  • In investigator's opinion, subject is not able to follow instructions as specified in the protocol
  • Subjects not able to hold hand/arm steadily
  • Extensive skin changes, tattoos or diseases on probe application site
  • Known allergy to medical grade alcohol used to disinfect skin

Treatment and study plan

WM3.4NR

Device

The investigational medical device will collect spectral raman data from tissue.

Primary outcomes

  1. Generation and validation of predictive calibration models

    Time frame: 3 months

    The collected data will generate individual calibration models capable of predicting tissue glucose concentrations. An evaluation of the models by the consensus error grid will be performed.

Secondary outcomes

  1. Safety assessment of the intervention by the paucity of adverse events

    Time frame: 3 months

    The number of subjects experiencing device-related adverse events will be recorded.

Sponsors and collaborators

Lead sponsor

RSP Systems A/S

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 24, 2017
Registry last updated
Oct 15, 2018

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.

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