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.
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 will use the Food and Drug Administration (FDA)-approved Tandem t:slim insulin pump with Control-IQ Technology and the FDA approved Dexcom G6 CGM. This study will research whether improvements in blood glucose metrics lead to reductions in some of the cardiovascular biomarkers that represent harmful effects in people with type 1 diabetes. Subjects will be randomly assigned to one of two study groups for 12 weeks---Group 1 will be treated with AP Technology and Group 2 will wear the study CGM and continue to use their current diabetes management strategy (i.e., standard care).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
FDA approved Tandem t:slim insulin pump with Control-IQ Technology and the Dexcom G6 CGM
Sensor augmented pump (SAP) therapy that includes the use of a study CGM and the participant's personal insulin pump
University of Virginia Health System
Charlottesville, Virginia, United States
RECRUITINGGlucose Time-in-Range
Time-in-range will measured by continuous glucose monitor device
Time frame: 12 weeks
High-sensitivity C-reactive protein (hs-CRP)
Inflammatory Biomarker
Time frame: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
TNF-alpha
Inflammatory Biomarker
Time frame: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Interleukin-6 (IL-6)
Inflammatory Biomarker
Time frame: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
E-selectin
Biomarker of endothelial dysfunction
Time frame: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Intracellular adhesion molecule 1 (ICAM-1)
Biomarker of endothelial dysfunction
Time frame: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Myocardial Perfusion (measured by contrast-enhanced ultrasound [CEU])
CEU will be assessed before and during a euglycemic-hyperinsulinemic clamp
Time frame: At baseline and 12 weeks of treatment
Carotid Femoral Pulse Wave Velocity (cfPWV)
Measurement of change in central aortic stiffness
Time frame: At baseline and 12 weeks of treatment
Brachial artery flow-mediated dilation (FMD)
Measure of conduit artery endothelial function
Time frame: At baseline and 12 weeks of treatment
Insulin sensitivity
insulin sensitivity will be assessed by M value during a euglycemic-hyperinsulinemic clamp
Time frame: At baseline and 12 weeks of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.