Exercise-Induced Hypoglycemia Prevention in Adults With Type 1 Diabetes Using an Artificial Pancreas

Exclusion Criteria

• •History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment.
• •Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment.
• •Pregnancy or intent to become pregnant during the trial.
• •Currently being treated for a seizure disorder
• •Coronary artery disease or heart failure, unless written clearance is received from a cardiologist or primary care provider and documentation of a negative stress test within the year
• •History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
• •Clinically significant electrocardiogram (ECG) at time of Screening, as interpreted by the study medical physician.
• •Use of non-insulin glucose-lowering agent (including GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals) with the exception of participants who have been on a stable dose of Metformin for at least 3 months.
• •A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
• •Inpatient psychiatric treatment in the past 6 months
• •Presence of a known adrenal disorder
• •Abnormal liver function test results (Transaminase \>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
• •Uncontrolled thyroid disease
• •Use of an automated insulin delivery mechanism that is not FDA approved during the data collection phase
• •Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team
• •Inability to be physically active for at least 30 minutes per day for at least 4 times per week
• •Current enrollment in another clinical trial, unless approved by the investigators of both studies or if clinical trial is a non-interventional registry trial.