Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor

Korábbi kezelés

• Currently taking Acetaminophen and unable to switch to another anti-inflammatory or pain reliever
• Currently being treated with an anticoagulation agent
• Currently undergoing treatment with:
  • Systemic oral or intravenous corticosteroids (current or within the last 8 weeks from screening),
  • Thyroid hormones, unless use has been stable during the past 3 months
• Current participation in another clinical drug or device study

Más betegség

• History of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), or blood clotting disorder that in the opinion of the Investigator would compromise safety of the study subject.
• Known cardiovascular disease considered to be clinically relevant by the investigator
• Significant history of any of the following, that in the opinion of the investigator would compromise safety or successful study participation:
  • Alcoholism
  • Drug abuse
• Significant acute or chronic illness, that in the opinion of the investigator might interfere with safety or integrity of study results

Laborértékek

• Currently using one of the following non-insulin glucose-lowering agent, SGLT2 and Insulin Secretagogues

Egyéb

• Female study subject of childbearing potential and has a positive pregnancy screening test
• Female study subject of childbearing potential who is planning to become pregnant or not using adequate method of contraception deemed reliable by Investigator
• 1 of more episodes of hypoglycemia or diabetic ketoacidosis (DKA) in the last 6 months requiring care in a medical facility or assistance from another individual to treat.
• Study subject has a hematocrit (Hct) lower than the normal reference range
• Study subject may not be on the research staff of those performing this study.

• Age 21 to 75 years old inclusive
• Generally, in good health, as determined by the investigator
• Clinical diagnosis or type 1 or type 2 diabetes as determined via medical records or source documentation by an individual qualified to make a medical diagnosis
• Intensive Insulin Therapy - 3 plus injections/day (MDI) or Continuous Subcutaneous Insulin Infusion (CSII)
• HbA1c \<9.0 % in the last 3 months.
• Study subject has adequate venous access as assessed by investigator or appropriate staff.
• Willing to comply with study procedures and be admitted to hospital for up to 5 days.
• Willing to perform up to 7 blood glucose (fingerstick) measurements a day using provided blood glucose meters and strips
• Willing to wear subcutaneous continuous wear glucose sensor for the duration of the study
• Willing to always carry study provided Android Phone during study
• Access to internet for required periodic uploads of study device data
• BMI in the range 18-35 kg/m2
• Has the ability to understand and comply with protocol procedures and to provide informed consent (i.e., proficient in both verbal and written communication in English or from a translator (Portuguese to English).