Database and Calibration 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.

Completed

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Key information

Conditions

Diabetes 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, 5000, Denmark

About this study

Subjects will collect 2-4 daily optical raman readings paired with capillary Blood Glucose comparator in own home with maintaining usual routines. Subjects will either collect data for 30 days during a 60 days period or collect data for 90 days during 6 months.

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 (all types) patients

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
Rejection by prescreening optical measurements
Known allergy to medical grade alcohol used to disinfect skin

Treatment and study plan

WM3.4NR

Device

Investigational Medical Device collecting spectral raman data from tissue.

Primary outcomes

Generation and validation of predictive algorithms for determining blood glucose levels

Time frame: 7 months

Collected spectral raman data will found the development of predictive algorithms for glucose determination. Performance of predictive models will be evaluated using the consensus error grid

Sponsors and collaborators

Lead sponsor

RSP Systems A/S

Industry

Registry information

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Dec 5, 2017
Registry last updated: Dec 4, 2019

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.

Completed