Using Closed-Loop Artificial Pancreas Technology to Reduce Glycemic Variability and Subsequently Improve Cardiovascular Health in Type 1 Diabetes
University of Virginia
Summary
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.
Description
Cardiovascular disease is a type of disease that affects the heart and blood vessels. The current care for cardiovascular disease prevention in people with type 1 diabetes is to manage blood pressure, cholesterol blood levels, or manage blood glucose levels. 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, we…
Eligibility
- Age range
- 18–40 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Clinical diagnosis, based on World Health Organization criteria, of type 1 diabetes for at least one year 2. Currently using insulin for at least six months 3. Ages 18-≤40 years 4. Hemoglobin A1c \<10.5% 5. Body mass index 18-30 kg/m2 6. Blood pressure \<140/90 mmHg 7. For females, not currently known to be pregnant or breastfeeding 8. 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. Participa…
Interventions
- DeviceTandem t:slim X2 with Control-IQ Technology
FDA approved Tandem t:slim insulin pump with Control-IQ Technology and the Dexcom G6 CGM
- DeviceSensor augmented pump (SAP) therapy
Sensor augmented pump (SAP) therapy that includes the use of a study CGM and the participant's personal insulin pump
Location
- University of Virginia Health SystemCharlottesville, Virginia