Clinical trial NCT04060693: Device Accuracy of Non-invasive Glucose Measurements in Ethnic Skin
Official title: Device Accuracy of Non-invasive Glucose Measurements in Ethnic Skin
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Non-invasive glucose monitoring
Lead sponsor: RSP Systems A/S
Sponsor class: INDUSTRY
First posted: 2019-08-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open, non-randomized comparison study between device and blood references with diabetic patients.
Primary purpose: DIAGNOSTIC

Brief summary: This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.

Detailed description: The subjects enrolled in this protocol will dedicate 30 days of home-based measurement, scheduled within a 40 days' time frame. For reference measurements, subjects will be equipped with a blood glucose meter (Contour Next One, Ascenia). Optical measurements are collected with the investigational medical device. Each day of measurements consists of four sessions each comprising two capillary blood glucose measurement with a blood glucose meter and two investigational medical device measurements.

Eligibility criteria: Inclusion Criteria:

* Between 18 and 40 years of age.
* Have a diagnosis of diabetes mellitus.
* Distribution of skin phototype: 50-70 % of enrolled subjects phototype IV, 20-40 % of enrolled subjects phototype III, 5-15 % of enrolled subjects phototype II, 5-15 % of enrolled subjects phototype I.
* Be willing to perform a minimum of 8 finger sticks per day during the study.
* Be willing to perform a minimum of 8 optical measurements per day during the study.
* Be 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 during the study execution (applicable to female subjects only).
* Subjects not able to understand and read English.
* 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).
* 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 probe application site (thenar) that could interfere with the accuracy of the interstitial glucose measurements.
* Known allergy to medical grade alcohol used to clean the skin.
* Systemic or topical administration of glucocorticoids for the past 7 days and under investigation.
* Subjects undergoing dialysis treatment.
* Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff.
* Medical history or any condition that may, in the opinion of the investigator, compromise subject's ability to participate.
* Subjects currently enrolled in another study.

Primary outcomes:
measure: Measurement accuracy of IMD
timeFrame: 8 months
Secondary outcomes:
measure: Safety evaluation: paucity of adverse events
timeFrame: 8 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Centre for Rare Disease ITM, Heritage Building (Queen Elizabeth Hospital Birmingham)
state: Edgbaston
Study officials:
References: