Glucomen Day Cascade CGM System 21-Day Wear Study

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)