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 @ 9:47 PM
Ignite Modification Date:
2025-12-24 @ 9:47 PM
NCT ID:
NCT03781232
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age
* Have a diagnosis of type 1 or type 2 diabetes mellitus (for RSP-09-02, only patients with type 1 diabetes)
* Skin phototype 1-4
* Be willing to perform a minimum of 6 / 12 (31 during excursion days) finger sticks per day during the study
* Be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol
* Be willing to provide written signed and dated informed consent
Exclusion Criteria:
* Inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator, due to e.g. known psychiatric diagnoses, lack of cognitive ability, alcohol dependency, drug use, psychosocial overload
* Have known severe allergy to medical grade adhesive or isopropyl alcohol used to clean the skin
* Be breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control during the study execution (applicable to female subjects only)
* Unable to hold hand/arm steadily (including tremors and Parkinson's Disease)
* Severe diabetes related complications such as advanced autonomic neuropathy, kidney disease, foot ulcers, legal blindness, or symptomatic cardiovascular disease as evidenced by a history of cardiovascular episode(s)
* Systemic or topical administration of glucocorticoids for the past 7 days
* Undergoing dialysis treatment
* Have extensive skin changes/diseases at the proposed measurement site (thenar) that could interfere with the accuracy of interstitial glucose measurements
* Have a concomitant medical condition which could interfere with the study devices (study arm 1: intake of acetaminophen study arm 2: intake of salicylic acid or higher doses of ascorbic acid)
* Unsuitable for participation due to any other cause as determined by the Investigator. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation e.g. with required documentation
* Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor, the study site, and/ or their families)
Additional exclusion criteria for study arm 2:
* Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
* Hypoglycemia unawareness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03781232
Study Brief:
Protocol Section:
NCT03781232