Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT05653518
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Tandem t:slim X2 with Control-IQ Technology — DEVICE
    FDA approved Tandem t:slim insulin pump with Control-IQ Technology and the Dexcom G6 CGM
  • Sensor augmented pump (SAP) therapy — DEVICE
    Sensor augmented pump (SAP) therapy that includes the use of a study CGM and the participant's personal insulin pump

Study Details

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.

Key Dates

Start date
Sep 9, 2023
Status verified
Feb 2026
Primary completion
Mar 30, 2027
Completion
Mar 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Closed-loop artificial pancreas (AP)
    FDA approved Tandem t:slim insulin pump with Control-IQ Technology and the Dexcom G6 CGM
  • Experimental: Sensor Augmented Pump (SAP) therapy
    Sensor augmented pump (SAP) therapy that includes the use of a study CGM and the participant's current insulin therapy (i.e., either insulin pump or multiple daily injections)

Primary Outcome Measure

Glucose Time-in-Range [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia Health SystemCharlottesvilleVirginia22903
Lee M Hartline
[email protected]
William B Horton, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlottesville, VA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Virginia Health System· Charlottesville, VA

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