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

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Artificial Pancreas, Continuous Glucose Monitor, Exercise, Exercise-Induced Hypoglycemia Read More

Inclusion Criteria:

• Age ≥18 and ≤65 years
• Clinical diagnosis of Type 1 Diabetes for at least one year
• Currently using an insulin pump for at least 6 months
• Uses insulin parameters such as carbohydrate ratio and correction factors consistently on their insulin pump in order to dose insulin for meals or corrections
• Access to internet and willingness to upload data during the study
• Willingness to be physically active for at least 30 minutes per day at least 4 times per week
• Willingness to perform the required exercise regimen during Data Collection Period
• Willingness to not perform regular exercise outside of the study-regimented exercise window
• For females, not currently pregnant or breastfeeding. If a female is of child-bearing potential and sexually active, she must agree to use a form of contraception to prevent pregnancy while participating in the study.
• An understanding and willingness to follow the protocol and sign informed consent.

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.