Study of a Novel Non-invasive Glucose Monitoring Device

A Pilot Study of a Novel Non-invasive Glucose Monitoring Device

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Prototype 0.5

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Steno Diabetes Center Aarhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RSP-19; Subjects will perform daily measurements on the IMD (Prototype 0.5) for 42 days.	Device: Prototype 0.5; Investigational Medical Device collecting spectral Raman data from tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	4 months

Collaborators and Investigators

• Sponsor: RSP Systems A/S
• Investigators: Principal Investigator: Sanne Fisker, Steno Diabetes Center, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Non-invasive glucose monitoring; Raman spectroscopy
• Other Study ID Numbers: RSP-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No