Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device

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

Study Overview

• Status: Withdrawn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

Detailed Description

Participants will be enrolled at six different sites in four different countries. All participants will undergo identical procedures, which include four steps: Baseline visit (1 day), calibration period (25 days), validation period (23 days) and a close-out visit (1 day) with a total duration of 50 days.

The calibration period consists of 23 home-based days and two in-clinic days. At the two in-clinic days, measurement sessions are performed every 30 minutes. A measurement session consists of two reference measurements (Contour Next One) and three measurements on the Investigational Medical Device. The glucose level of the participants is manipulated by administration of a glucose rich drink. At home-based days, the subject must perform four measurement sessions a day. During the validation period, participants perform up to four home-based measurement sessions a day.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Gentofte, Denmark, 2820
    • Steno Diabetes Center Copenhagen (SDCC)
  • Odense C, Denmark, 5000
    • Steno Diabetes Center Odense (SDCO)
• Germany
  • Ulm, Germany, 89081
    • Institut für Diabetes-Technologie Forschungs- und Entwicklungs-gesellschaft mbH an der Universität Ulm (IDT)
• Sweden
  • Gothenburg, Sweden, 413 45
    • Sahlgrenske University Hospital (SUH)
  • Uddevalla, Sweden, 451 53
    • Department of Medicine, Uddevalla Hospital (UVH)
• United Kingdom
  • Birmingham, United Kingdom
    • University Hospitals Birmingham (UHB)

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Male and female subjects ≥18 years of age
• Diagnosed with diabetes, all types except gestational diabetes
• 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 the local language
• 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)
• Subject diagnosed with cardiovascular diseases
• Reduced circulation in right hand evaluated by Allen's test
• Subjects receiving anticoagulants, active cancer treatment, tetracyclines and other medication/topical agents increasing photosensitivity
• Radiotherapy for the past six months
• 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: Diagnostic
• 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-20; Subjects will perform daily measurements on the IMD (Prototype 0.5) in addition to capillary reference measurements for 48 days.	Device: Prototype 0.5; Investigational Medical Device collecting spectral Raman data non-invasively from tissue; Other Names: P0.5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement accuracy	Accuracy of measurements performed on the IMD will be evaluated by data from subjects. Data will be analyzed by Mean Absolute Relative Difference (MARD).	6 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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device deficiencies	Description of device deficiencies will be listed. Deficiencies will be reported during the clinical study.	Up to 6 months
Device usability	The use of the device will be evaluated by means of questionnaires. The subjects are asked if they encountered any problems during measurements, and if so, to elaborate the problems encountered.	6 months

Collaborators and Investigators

• Sponsor: RSP Systems A/S
• Investigators: Principal Investigator: Kirsten Nørgaard, MD, Steno Diabetes Center Copenhagen

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2019
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Non-invasive glucose monitoring; Raman spectroscopy
• Other Study ID Numbers: RSP-20

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