Using Closed-Loop Artificial Pancreas Technology to Reduce Glycemic Variability and Subsequently Improve Cardiovascular Health in Type 1 Diabetes
This study will examine the potential cardiovascular effect(s) of artificial pancreas (AP) technology in patients with type 1 diabetes. AP technology is a system of devices that closely mimics the glucose-regulating function of a healthy human pancreas. It includes an insulin pump and a continuous glucose monitor (CGM). In this study, the investigators will research whether improvements in blood glucose levels and blood glucose variability will in turn decrease biomarkers of inflammation and endothelial dysfunction while improving cardiovascular function.
• Clinical diagnosis, based on World Health Organization criteria, of type 1 diabetes for at least one year
• Currently using insulin for at least six months
• Ages 18-≤40 years
• Hemoglobin A1c \<10.5%
• Body mass index 18-30 kg/m2
• Blood pressure \<140/90 mmHg
• For females, not currently known to be pregnant or breastfeeding
• If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued
• Both pump and MDI users will use insulin parameters such as carbohydrate ratio and correction factors consistently in order to dose insulin for meals or corrections; pump users will have history of entering this information into their pump
⁃ Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
⁃ Access to internet and willingness to upload data during the study as needed, including data generated prior to the start of the study
⁃ Current use of a glucometer that is downloadable; or willingness to use a study glucometer
⁃ Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
⁃ Willingness to use personal lispro (Humalog) or aspart (Novolog) and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
⁃ Total daily insulin dose (TDD) at least 10 U/day.
⁃ Willingness not to start any new non-insulin glucose-lowering agent during the trial