Clinical trial NCT03782649: Performance Evaluation of a Novel Non-invasive Glucometer, Calibrated Against Validated Interstitial Glucose References
Official title: Performance Evaluation of a Novel Non-invasive Glucometer, Calibrated Against Validated Interstitial Glucose References
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Non-invasive glucose monitoring
Raman spectroscopy
Lead sponsor: RSP Systems A/S
Sponsor class: INDUSTRY
First posted: 2018-12-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This clinical study has been launched to collect spectral Raman data on the Investigational Medical Device (IMD) compared with reference methods in terms of interstitial fluid samples and capillary and venous references.

Detailed description: Subjects will visit the clinic for a baseline visit and two in-clinic visits. On in-clinic days, subjects will attend the clinic in a fasting state. They will have inserted a Dexcom and Freestyle Libre and a microdialysis catheter. At time = 0, subjects will be administered a glucose rich drink and every 6. minut measurements will be performed. These include a measurement on the IMD, microdialysate, FreeStyle Libre and Dexcom readings. Every 18. minut a venous blood sample will be included and every 36. minut a capillary blood sample will be collected. This continues until time = 180 minutes.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects 18-70 years old
* Patients diagnosed with type 1 or type 2 diabetes (T1D or T2D) (insulin requiring T2D patients)
* Diabetes management strategy: lifestyle regimen + insulin ± oral hypoglycemic agents
* Skin phototype 1-4

Exclusion Criteria:

* For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
* \> 10 cigarettes pr. day
* Participants not able to understand and read Swedish
* In investigator's opinion, participant is not able to follow instructions as specified in the protocol
* Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
* Diagnosed with reduced circulation
* Extensive skin changes, tattoos or diseases on probe application site
* Rejection by screening optical measurements
* Known allergy to medical grade alcohol
* Known allergy to adhesives
* Systemic or topical administration of glucocorticoids for the past 7 days
* Participants undergoing dialysis treatment
* Anti-coagulation or anti-platelet therapy
* Use of beta-blockers
* Medical conditions causing bleeding tendency
* Medical history or any condition that may, in the opinion of the investigator, compromise the subject's ability to participate
* Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff. Such conditions include but are not limited to HIV and Hepatitis B or C.
* Participants currently enrolled in another study

Primary outcomes:
measure: Generation and validation of prediction models - MARD
timeFrame: One year
measure: Generation and validation of prediction models - ISUP
timeFrame: One year
measure: Generation and validation of prediction models - Consensus Error Grid
timeFrame: One year
Secondary outcomes:
measure: Evaluation of dynamics between arterial and venous glucose profiles in relation to interstitial glucose levels
timeFrame: One year
measure: Safety evaluation: paucity of adverse events
timeFrame: One year
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Gothia Forum för Klinisk Forskning, Sahlgrenska Universitetssjukhuset
Study officials:
affiliation: Sahlgrenska Universitetssjukhuset, Gothenburg
name: Per-Anders Jansson, MD
role: PRINCIPAL_INVESTIGATOR
References: