A Study of a Non-invasive Glucose Measuring Device in Out-patient Settings

An Explorative Study of a Novel Non-invasive Glucose Measuring Device in Out-patient Settings

This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Ulm, Germany, 89081
    • Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

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 minimum 18 years of age
• Individuals diagnosed with any type of insulin-dependent diabetes mellitus ≥ 1 year
• Willing to perform up to 12 finger-pricks during each day of out-patient measurements
• Signed informed consent
• For women of childbearing potential: Willing and able to practice FDA approved birth control during the duration of the investigation
• Subject has a 2.4 GHz wireless internet connection at home (standard in normal routers) to be used in the study

Exclusion Criteria:

• For female subjects: Pregnancy or breastfeeding
• Skin phototype VI categorized by Fitzpatrick scale measured on thenar
• Subjects not able to understand and read local language
• Cognitive impairment, or 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)
• Extensive skin changes, tattoos or diseases on right thenar (measurement site)
• Reduced circulation in right hand evaluated by Allen's test
• Known allergy to medical grade alcohol
• Hemodialysis
• Systemic or topical administration of glucocorticoids at the right hand for the past 7 days or during the study period expected
• Any disorder, which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol
• Severe diabetes-related complications such as advanced autonomic neuropathy, kidney disease, foot ulcers, legal blindness, or symptomatic cardiovascular disease as evidenced by a history of cardiovascular episode(s)
• Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor, the study site, and/ or their families)
• Subjects currently participating in another study
• Subjects who have participated in the study IDT-1904-RO/RSP-21 or RSP-19.
• Incapacity for consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• 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-24; Subjects will perform calibrations on the IMD (Prototype 0.5) for 41 days over a 60 day period.	Device: Prototype 0.5; Investigational Medical Device collecting Raman data from tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of number of calibration days	The number of calibration days needed for reaching a well-performing glucose predictive calibration model will be determined. The clinical performance of the reduced calibration model will be based on the data from the validation part by studying linear regression, Inter Subject Unified Performance value and Consensus Error Grid.	2 years
Safety evaluation of the Investigational Medical Device by reporting of adverse events	Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical investigation	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device function	Device function will be evaluated in regard to durability and reliability. This is evaluated by reported device deficiencies during the study in the terms of subject diaries	2 years

Collaborators and Investigators

• Sponsor: RSP Systems A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2020
• Primary Completion (Actual): April 23, 2022
• Study Completion (Actual): April 23, 2022

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 18, 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-24

Drug and device information, study documents

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