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:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT05460260
Eligibility Criteria:
Inclusion Criteria:
* • Diagnosis of type 1 or type 2 (on insulin therapy) diabetes mellitus for at least 6 months
* 18 years of age or older
* Currently self-monitoring capillary blood glucose (on average at least three times per day or more) or on a CGM for at least three months
* Be willing to have blood glucose levels manipulated into high and low glucose levels during in clinic days if deemed appropriate per the protocol based on insulin use.
* Willing to follow all study procedures, including attending all clinic visits during which a venous line will be inserted for blood sampling, wearing CGM sensors for entire study, performing fingertip glucose tests for self-monitoring and calibration, and keeping a diary of activities.
* Be willing to wear two investigational CGM devices.
* Sign informed consent form
Exclusion Criteria:
* • Known allergy to medical grade adhesives
* Magnetic Resonance Imaging (MRI) scheduled during CGM sensor wear period
* Persons with type 2 diabetes using diet and exercise only for diabetes management
* Used an investigational drug within 30 days prior to study entry
* Hematocrit \< 32% (obtained during screening)
* Inadequate veins (in the opinion of the investigator) or known contraindication to placement of a dedicated peripheral line for venous blood withdrawal
* Symptomatic coronary artery disease with a history of angina, or history of a myocardial infarction or coronary intervention (e.g., percutaneous transluminal coronary angioplasty \[PTCA\], stent placement), or coronary artery bypass graft (CABG) within the past six months
* Diagnosis of the following diabetic autonomic neuropathies: orthostatic hypotension, heart rate anomalies, gastroparesis
* Cerebrovascular incident within the past six months
* History or presence of eczema, psoriasis, atopic or contact dermatitis
* Pregnancy at the start of the study.
* Current use or within one-week exposure to topical medications at the proposed insertion sites
* Seizure disorder (epilepsy)
* Malignancy within the past five years, except basal cell or squamous cell skin cancers
* Major surgical operation within 30 days prior to screening
* Other medical conditions that would pose safety concerns, interfere with study conduct or seriously compromise study integrity (reason for exclusion will be clearly documented by investigator or designee)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05460260
Study Brief:
Protocol Section:
NCT05460260