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

NCT ID: NCT04518813

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-24
• Study Completion Date: 2022-04-23

Brief Summary

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

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

RSP-24

Subjects will perform calibrations on the IMD (Prototype 0.5) for 41 days over a 60 day period.

Group Type: EXPERIMENTAL

Prototype 0.5

Intervention Type: DEVICE

Investigational Medical Device collecting Raman data from tissue

Interventions

Prototype 0.5

Investigational Medical Device collecting Raman data from tissue

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RSP Systems A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Ulm, , Germany

Countries

Germany

Other Identifiers

RSP-24

Identifier Type: -

Identifier Source: org_study_id