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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04518813
• Other study ID #: RSP-24
• Status: Completed
• Phase: N/A
• Start date: September 24, 2020
• Est. completion date: April 23, 2022

Study information

• Verified date: November 2023
• Source: RSP Systems A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: April 23, 2022
• Est. primary completion date: April 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Germany	Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
RSP Systems A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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