Actively Recruiting
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
Led by University of Virginia · Updated on 2026-02-25
40
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of type 1 diabetes for at least one year based on World Health Organization criteria
- Current insulin use for at least six months
- Age between 18 and 40 years
- Hemoglobin A1c less than 10.5%
- Body mass index between 18 and 30 kg/m2
- Blood pressure less than 140/90 mmHg
- For females, not pregnant or breastfeeding
- Sexually active females must use contraception and have negative pregnancy tests; pregnant participants will be discontinued
- Consistent use of insulin dosing parameters; pump users must have history of entering this data
- Willing to suspend personal CGM use during study CGM use
- Access to internet and willingness to upload data as needed
- Current use of a downloadable glucometer or willingness to use study glucometer
- Ability to operate all study devices and adhere to protocol
- Willingness to use only lispro (Humalog) or aspart (Novolog) insulin during study
- Total daily insulin dose of at least 10 units per day
- Willingness not to start new non-insulin glucose-lowering agents during trial
You will not qualify if you...
- Severe hypoglycemia with seizure or loss of consciousness in past 12 months
- Diabetic ketoacidosis diagnosis in past 12 months
- Prior diagnosis of cardiac disease such as myocardial infarction or heart failure
- Stroke within past 12 months
- Uncontrolled resting arterial hypertension
- Conditions making CGM use difficult, such as blindness, severe arthritis, or immobility
- Current use of oral or inhaled glucocorticoids or other contraindicated medications
- Concurrent use of any non-insulin glucose-lowering agents
- Hemophilia or other bleeding disorders
- Currently treated for seizure disorder
- Medical conditions or medications posing risk per investigator judgment
- Current smokers or quit smoking less than 2 years ago
- ECG findings indicating arrhythmia, sinus node disease, or ischemic heart disease
- Low hemoglobin on screening labs (women <11 g/dL, men <12 g/dL)
- History of allergic reaction to intravenous insulin infusion
- Diagnosis of peripheral neuropathy, macroalbuminuria, or advanced retinopathy
- Unstable vasoactive medication doses within 4 weeks prior to enrollment
- History of allergic reaction to Definity microbubble infusion
- Current enrollment in other clinical trials unless approved by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
W
William B Horton, MD
CONTACT
L
Lee Hartline, MEd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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