Status:
COMPLETED
Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device and Evaluation of the Instructions for Use
Lead Sponsor:
RSP Systems A/S
Collaborating Sponsors:
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the study is to demonstrate the safety and performance of a novel non-invasive glucose monitoring device, to collect data and reference measurements for establishment of calibration models ...
Detailed Description
The Investigational Medical Device (IMD) for this investigation is the Prototype 0.5 (P0.5) developed and manufactured by RSP Systems (RSP). The device is intended for non-invasive interstitial interm...
Eligibility Criteria
Inclusion
- Male and female subjects ≥18 years of age
- Individuals diagnosed with type 1 diabetes. Gestational diabetes excluded
- Skin phototype 1-4
- Willing to perform up to 12 finger sticks during each day of out-patient measurements and up to 40 finger sticks at the two in-clinic study days
- Wireless internet connection at home to be used in the study
Exclusion
- For female subjects: Pregnancy or subject is attempting to conceive or not willing and able to practice NCA approved birth control during the study duration
- For female subjects: breastfeeding
- Subjects currently participating in another study
- Subjects not able to understand and read German
- 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 hand thenar (sensor application site)
- 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
- 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
- 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)
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
- Hypoglycemia unawareness
- Subjects who have participated in the study IDT-1639-RO
Key Trial Info
Start Date :
September 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04033042
Start Date
September 18 2019
End Date
October 31 2019
Last Update
October 8 2020
Active Locations (1)
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1
Institut für Diabetes-Technologie Forschungs- und Entwicklungs-gesellschaft mbH an der Universität Ulm (IDT)
Ulm, Germany, 89081