Status:
COMPLETED
A Study of a Non-invasive Glucose Measuring Device in Out-patient Settings
Lead Sponsor:
RSP Systems A/S
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2022
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT04518813
Start Date
September 24 2020
End Date
April 23 2022
Last Update
November 18 2023
Active Locations (1)
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1
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Germany, 89081