Study of a Novel Non-invasive Glucose Monitoring Device | NCT03782441

Studies
Study of a Novel Non-invasive Glucose Monitoring Device

NCT03782441

Sponsor

RSP Systems A/S

Status

Completed

Last Update Posted

Dec 3, 2020Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

Prototype 0.5

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2019Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Dec 1, 2020Actual

First Submitted Date

Dec 18, 2018

First Submission Date that Met QC Criteria

Dec 19, 2018

First Posted Date

Dec 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2020

Last Update Posted Date

Dec 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This explorative clinical study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.

Detailed Description

The Investigational Medical Device (IMD) for this investigation is the Prototype 0.5 (P0.5) developed and manufactured by RSP Systems (RSP). The device is intended for non-invasive interstitial intermittent glucose monitoring in persons (age 18 and older) with diabetes. The technology relies on the well-established capacities of Raman spectroscopy for directly detecting glucose subcutaneously. The Raman spectroscopy physical principle relies on the fact that when laser light of a given wavelength interferes with a molecule, a small fraction of the incident light will interact with the vibrational states of the molecule, causing the photons to lose a portion of their energy which will change the wavelength of the light. The scattered light will be collected by the optical probe head and analyzed with advanced algorithms to correlate the signal to glucose concentrations. Data collected from the IMD will be paired with validated glucose reference values collected by the finger sticking method.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RSP-19	Experimental	Subjects will perform daily measurements on the IMD (Prototype 0.5) for 42 days.	Device: Prototype 0.5

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prototype 0.5	Device	Investigational Medical Device collecting spectral Raman data from tissue	RSP-19

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement accuracy of IMD	Accuracy of measurements performed on the IMD will be evaluated by data from subjects. Data will be analyzed by Mean Absolute Relative Difference (MARD) and Inter Subject Unified Performance (ISUP)	4 months
Safety evaluation: paucity of adverse events	Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical study	4 months

Secondary Outcomes

Measure	Description	Time Frame
Device deficiency	Description of device deficiencies will be listed. Deficiencies will be reported during the clinical study.	4 months
Device usability	The use of the device by the subjects will be evaluated by means of questionnaires

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female subjects ≥18 years of age
Diagnosed with diabetes, all types except gestational diabetes
HbA1c distribution > 60 mmol/mol at baseline visit
Skin phototype 1-4
Willing to perform a minimum of 8 finger sticks during each day of home-based measurements and 30 finger sticks at the two in-clinic study days
Subject has a wireless internet connection at home to be used in the study

Exclusion Criteria:

For female subjects: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
For female subjects: Breastfeeding
Subject currently participating in another study
Subject not able to understand and read Danish
In investigator's opinion, subject is not able to follow instructions provided and as specified in the protocol
Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease)
Reduced circulation in right hand evaluated by Allen's test
Extensive skin changes, tattoos or diseases on right hand thenar (probe application site)
Known allergy to medical grade alcohol used to clean the skin
Medical history or any condition that may, in the opinion of the investigator compromise the subject's ability to participate
Comorbidity or concomitant medical condition which, in the opinion of the Investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases