Bigfoot Biomedical Clinical Research Center (CRC) Trial

Exclusion Criteria

• •1. Females who are sexually active and able to conceive will be excluded if they are not currently using or agree to continue use for the duration of the study an effective method of contraception as determined by investigator
• •2. Females who are pregnant or intending to become pregnant during participation in the trial
• •• Females who are capable of childbearing must have a negative pregnancy test at the time of the screening visit and the pregnancy test must be repeated at enrollment if it was done \> 14 days prior
• •3. Presence of any condition that in the opinion of the investigator impairs the participant's ability to use the system (e.g.,visual impairment that interferes with ability to read the display)
• •4. Unable or unwilling to use study devices and follow study procedures including the meal and exercise/ activity challenges in the CRC.
• •5. A current condition that would prevent the use of a study devices, including blood glucose meter (BGM), continuous glucose monitoring (CGM) or insulin pump (CSII)
• •6. Current participation within the last 60 days in another clinical research study that involves an intervention
• •• Participation in research studies involving data collection only is not an exclusion (e.g.,T1D Exchange Registry)
• •7. Anticoagulant therapy other than aspirin
• •8. Severe hypoglycemia resulting in seizure OR loss of consciousness within 30 days prior to enrollment
• •9. Diabetic ketoacidosis (DKA) requiring treatment in a healthcare facility within 30 days prior to enrollment
• •10. Current use (defined as within the last 3 months) of any medication intended to lower glucose other than insulin (e.g., use of Metformin, Liraglutide, would be exclusions)
• •11. Current use (defined as within the last 3 months) of any medication that according to the dose, frequency, and route of administration may result in hyperglycemia in the investigator's judgment (e.g., current use of oral steroids)
• •• Regular use of inhaled or intranasal steroids is permitted
• •12. Presence of significant renal disease as evidenced by the presence of any of the following:
• •* Current dialysis therapy
• •* Serum creatinine of ≥ 2.0 mg/dL within 30 days of enrollment
• •For screening purposes, serum creatinine levels will be tested in participants who meet any of the following criteria:
• •* A≥10 year history of T1D
• •* Are ≥ 45 years of age
• •13. Presence or history of clinically significant cardiovascular disease (e.g., myocardial infarction, pacemaker, acute coronary syndrome, therapeutic coronary intervention, coronary bypass or stenting procedure, atrial or ventricular fibrillation, treatment for arrhythmia, stable or unstable angina, episode of chest pain of cardiac etiology with associated ECG changes or positive stress test/ cardiac catheterization, congestive heart failure, or cerebrovascular event)
• •14. ECG findings that indicate participation in the planned exercise/ activity session would be contraindicated as determined by trained personnel at the respective clinical center(s)
• •• For screening purposes, ECGs must be completed within 30 days of enrollment in participants who meet any of the following criteria:
• •* A ≥ 10 year history of T1D and ≥ 20 years of age
• •* Are ≥ 45 years of age
• •15. History of adrenal insufficiency
• •16. A diagnosis of gastroparesis or impaired gastric motility that required pharmacological or surgical treatment
• •17. Celiac Disease (CD) diagnosed \< 12 months ago or CD that is currently inadequately treated as determined by the investigator
• •18. Current alcohol abuse or eating disorder as determined by the investigator
• •19. Use or abuse of controlled substances without a prescription in the 6 months prior to enrollment
• •20. History of hemoglobinopathy, sickle cell disease, or blood dyscrasia; blood transfusion within 3 months of enrollment
• •21. Hematocrit that is above or below the normal reference range of the lab used within 14 days of enrollment
• •22. Presence or history of any medical or psychiatric condition, or the use of any medication or therapy, that in the opinion of the investigator may be a contraindication to participation in the study
• •23. Unstable hypertension, thyroid disease, or depression as evidenced by an adjustment in therapy for the condition within the last 2 months, or as determined by investigator