Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT04126759
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04126759
Study Brief:
Protocol Section:
NCT04126759