Cascade CGM 15-day Performance Assessment

• • Signed informed consent form

    • 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
    • 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.

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 month
    • History or presence of eczema, psoriasis, atopic or contact dermatitis
    • Subject is pregnant 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)