Clinical trial NCT04126759: Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes
Official title: Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes
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
Collaborators: name: Steno Diabetes Center Copenhagen
First posted: 2019-10-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: 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 and reference measurements to establish and validate a calibration model for the device during daily glycemic fluctuations and evaluate analytical performance of device in the hypoglycemic range. The study is a combined home-based and in-clinic study where subjects will attend the clinic two times.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects between 18 and 40 years of age.
* Diagnosed with type 1 diabetes mellitus.
* Uses an insulin pen or pump.
* Hb1Ac \> 55 mmol/mol at baseline visit.
* Skin phototype 1-4 according to Fitzpatrick skin tone scale.
* Willing to perform a minimum of 8 finger sticks per day during the study for the home-based study and approximately 16 finger sticks for the in-clinic study days.
* Willing to have a peripheral venous catheter inserted.
* Willing to provide written signed and dated informed consent.

Exclusion Criteria:

* Breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control according to approved contraceptives from NCA during the study execution (applicable to female subjects only).
* Subjects not able to understand and read Danish.
* Inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator.
* Subject is not able to hold hand/arm steadily (including tremors and Parkinson's Disease).
* Reduced circulation in hand. "Allen's test" is used for assessing hand circulation to evaluate occurrence of reduced blood.
* Extensive skin changes, tattoos or diseases on probe application site (thenar) that could interfere with the accuracy of the interstitial glucose measurements.
* Known allergy to medical grade alcohol.
* Having active cancer treatment and/or use tetracyclines and other medication / topical agents known to increase photosensitivity in skin.
* 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.
* Diagnosed with cardiovascular diseases.
* Subjects currently enrolled in another study.
* Radiotherapy for the past six months.

Primary outcomes:
measure: Generation of predictive algorithms for determining blood glucose levels
timeFrame: 12 months
measure: Validation of predictive algorithms for determining blood glucose levels
timeFrame: 12 months
Secondary outcomes:
measure: Risk/benefit analysis
timeFrame: 12 months
measure: Number of encountered Device Deficiencies
timeFrame: 12 months
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center Copenhagen (SDCC)
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Kirsten Nørgaard
role: PRINCIPAL_INVESTIGATOR
References: