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OpenTrials
Completed

NCT Number: NCT03530644

Comparative Study Between Two Models of a Non-invasive Glucose Monitoring Device

This clinical study has been launched to compare the performances of two models of a non-invasive glucose monitoring device.

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Key information

Conditions

Type1diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Odense

Odense, 5000, Denmark

About this study

Subjects will be optical screened at baseline visit. Study comprises two in-clinic visits. Subjects will arrive in a fasting state and and oral glucose bolus will be administered.

Subjects will during each of two study days be subjected to optical readings on two different device prototypes. During each of the study days, FGM readings, capillary blood samples and arterialized venous blood samples 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 type 1 patients
  • Insulin pump users
  • Skin phototype 1-4

Exclusion criteria

  • For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
  • For female participants: Breastfeeding
  • Subjects not able to understand and read Danish
  • In Investigator's opinion, subject is not able to follow instructions as specified in the protocol
  • Rejection by optical screenings
  • Subjects not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
  • Diagnosed with reduced circulation
  • Extensive skin changes, tattoos or diseases on probe application site
  • Known allergy to medical grade alcohol
  • Known allergy to adhesives
  • Systemic or topical administration of glucocorticoids for the past 7 days
  • Subjects undergoing dialysis treatment
  • Medical history or any condition that may, in the opinion of the Investigator, compromise the subject's ability to participate
  • Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff
  • Subjects currently enrolled in another study

Treatment and study plan

WM3.4NR

Device

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

P0.1

Device

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

Primary outcomes

  1. Generation and validation of prediction models

    Time frame: 4 months

    Two in-clinic visits each of a duration of 7-8 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM readings. In parallel, optical glucose data from two different prototypes of the investigational medical device will be collected.

    Optical glucose readings will be masked to the subjects.

    Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models from the two devices will be validated on independent data sets using MARD, ISUP and Consensus Error Grid endpoint measures.

  2. Performance evaluation

    Time frame: 4 months

    Validated calibration models will be compared with MARD, ISUP and Consensus Error Grid endpoint measures.

Secondary outcomes

  1. Safety by paucity of adverse events

    Time frame: 4 months

    To evaluate safety of devices in a descriptive manner by the paucity of adverse events. Adverse events will be recorded during study.

Sponsors and collaborators

Lead sponsor

RSP Systems A/S

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 21, 2018
Registry last updated
Dec 19, 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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