Study of a Novel Non-invasive Glucose Monitoring Device

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782441
• Other study ID #: RSP-19
• Status: Completed
• Phase: N/A
• Start date: November 5, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2019
• Source: RSP Systems A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Prototype 0.5
Investigational Medical Device collecting spectral Raman data from tissue

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Aarhus	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
RSP Systems A/S

Country where clinical trial is conducted

Denmark, 

Outcome

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