Glucomen Day Cascade CGM System 21-Day Wear Study

GlucoMen Day Cascade CGM 21-Day Study

Assessment of 21-day CGM wear period

This single-site study will include 10 subjects who will wear two CGMs for 21 days. On day 1, 5, 10, 15, and 21 subjects will be in-clinic for 12 hrs of testing with YSI blood glucose measurements taken every 15 minutes.

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)