Status:
COMPLETED
Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes
Lead Sponsor:
RSP Systems A/S
Collaborating Sponsors:
Steno Diabetes Center Copenhagen
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-40 years
Phase:
NA
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 eval...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04126759
Start Date
July 1 2019
End Date
January 31 2020
Last Update
October 8 2020
Active Locations (1)
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1
Steno Diabetes Center Copenhagen (SDCC)
Gentofte Municipality, Denmark, 2820