Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
NCT05653518 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-02-25
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.
Conditions
Interventions
- DEVICE
-
Tandem t:slim X2 with Control-IQ Technology
FDA approved Tandem t:slim insulin pump with Control-IQ Technology and the Dexcom G6 CGM
- DEVICE
-
Sensor augmented pump (SAP) therapy
Sensor augmented pump (SAP) therapy that includes the use of a study CGM and the participant's personal insulin pump
Sponsors & Collaborators
-
University of Virginia
lead OTHER
Principal Investigators
-
William B Horton, MD · University of Virginia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-09
- Primary Completion
- 2027-03-30
- Completion
- 2027-03-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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