Clinical trial NCT04031300: Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device
Official title: Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Non-invasive glucose monitoring
Raman spectroscopy
Lead sponsor: RSP Systems A/S
Sponsor class: INDUSTRY
First posted: 2019-07-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pivotal multicenter study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.

Detailed description: Participants will be enrolled at six different sites in four different countries. All participants will undergo identical procedures, which include four steps: Baseline visit (1 day), calibration period (25 days), validation period (23 days) and a close-out visit (1 day) with a total duration of 50 days.

The calibration period consists of 23 home-based days and two in-clinic days. At the two in-clinic days, measurement sessions are performed every 30 minutes. A measurement session consists of two reference measurements (Contour Next One) and three measurements on the Investigational Medical Device. The glucose level of the participants is manipulated by administration of a glucose rich drink. At home-based days, the subject must perform four measurement sessions a day. During the validation period, participants perform up to four home-based measurement sessions a day.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects ≥18 years of age
* Diagnosed with diabetes, all types except gestational diabetes
* Skin phototype 1-4
* Willing to perform a minimum of 8 finger sticks during each day of home-based measurements and 30 finger sticks at the two in-clinic study days
* Subject has a wireless internet connection at home to be used in the study

Exclusion Criteria:

* For female subjects: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
* For female subjects: Breastfeeding
* Subject currently participating in another study
* Subject not able to understand and read the local language
* 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)
* Subject diagnosed with cardiovascular diseases
* Reduced circulation in right hand evaluated by Allen's test
* Subjects receiving anticoagulants, active cancer treatment, tetracyclines and other medication/topical agents increasing photosensitivity
* Radiotherapy for the past six months
* Extensive skin changes, tattoos or diseases on right hand thenar (probe application site)
* Known allergy to medical grade alcohol used to clean the skin
* 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

Primary outcomes:
measure: Measurement accuracy
timeFrame: 6 months
measure: Safety evaluation: paucity of adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Device deficiencies
timeFrame: Up to 6 months
measure: Device usability
timeFrame: 6 months
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center Copenhagen (SDCC)
city: Odense C
country: Denmark
facility: Steno Diabetes Center Odense (SDCO)
city: Ulm
country: Germany
facility: Institut für Diabetes-Technologie Forschungs- und Entwicklungs-gesellschaft mbH an der Universität Ulm (IDT)
city: Gothenburg
country: Sweden
facility: Sahlgrenske University Hospital (SUH)
city: Uddevalla
country: Sweden
facility: Department of Medicine, Uddevalla Hospital (UVH)
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham (UHB)
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Kirsten Nørgaard, MD
role: PRINCIPAL_INVESTIGATOR
References: