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

NCT ID: NCT03530644

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-28

Study Completion Date

2018-12-14

Brief Summary

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

Detailed Description

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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.

Conditions

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Type1diabetes

Keywords

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Non-invasive glucose monitoring

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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RSP-14

Comparative study of two Investigational Medical Devices (WM3.4NR and P0.1)

Optical data will be obtained from T1D over a dynamic glycemic range. Data will be paired with references.

Group Type EXPERIMENTAL

WM3.4NR

Intervention Type DEVICE

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

P0.1

Intervention Type DEVICE

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

Interventions

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WM3.4NR

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

Intervention Type DEVICE

P0.1

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RSP Systems A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Erik Henriksen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Odense, Denmark

Vibe Vestergaard, Nurse

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Odense, Denmark

Locations

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Steno Diabetes Center Odense

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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RSP-14

Identifier Type: -

Identifier Source: org_study_id