Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes

RSP Systems

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: P0.3

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04126759

RSP-17

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Protocol 1

Experimental group

Description:

The subjects enrolled in this protocol will dedicate 33 days of home-based measurement and two days for in-clinic measurements. For reference measurements, subjects will be equipped with a BG-meter (Contour Next One, Ascenia). Optical measurements are collected with the IMD. Each day of measurements consists of four sessions each comprising two capillary blood glucose measurement with a BG-meter and two IMD measurements. IMD measurements will be performed using the thenar of the right hand of the subject.

Treatment:

Device: P0.3