NCT05653518 · University of Virginia
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
(WBH002)
What this study 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).
View original scientific description
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.
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
Primary outcome measures
Glucose Time-in-Range
Time frame: 12 weeks
Time-in-range will measured by continuous glucose monitor device
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Clinical diagnosis, based on World Health Organization criteria, of type 1 diabetes for at least one year
- Currently using insulin for at least six months
- Ages 18-≤40 years
- Hemoglobin A1c \<10.5%
- Body mass index 18-30 kg/m2
- Blood pressure \<140/90 mmHg
- For females, not currently known to be pregnant or breastfeeding
- 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. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued
- Both pump and MDI users will use insulin parameters such as carbohydrate ratio and correction factors consistently in order to dose insulin for meals or corrections; pump users will have history of entering this information into their pump
- Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
- Access to internet and willingness to upload data during the study as needed, including data generated prior to the start of the study
- Current use of a glucometer that is downloadable; or willingness to use a study glucometer
- Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
- Willingness to use personal lispro (Humalog) or aspart (Novolog) and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
- Total daily insulin dose (TDD) at least 10 U/day.
- Willingness not to start any new non-insulin glucose-lowering agent during the trial
Exclusion criteria
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Diagnosis of diabetic ketoacidosis in the 12 months prior to enrollment
- Prior diagnosis of cardiac disease (e.g., myocardial infarction, congestive heart failure)
- Cerebrovascular accident in the 12 months prior to enrollment
- Uncontrolled resting arterial hypertension
- Conditions that would make use of a CGM difficult (e.g., blindness, severe arthritis, immobility)
- Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- Concurrent use of any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, and/or sulfonylureas)
- Hemophilia or any other bleeding disorder
- Currently being treated for a seizure disorder
- A medical condition or medication, which in the opinion of the investigator or designee, would put the participant or study at risk
- Current smokers or those who have quit smoking \<2 years ago
- Screening Electrocardiogram (ECG) findings indicative of arrhythmia, sinus node disease, or ischemic heart disease
- Any woman with hemoglobin (Hgb) \<11 g/dL or any man with Hgb \<12 g/dL on screening laboratory evaluation (i.e., complete blood count)
- History of hypersensitivity or prior adverse reaction (e.g., anaphylaxis or angioedema) to IV regular insulin infusion
- Diagnosis of peripheral neuropathy (assessed by monofilament examination), macroalbuminuria (urine albumin:creatinine \>300 mg per g), or retinopathy beyond mild, nonproliferative retinopathy
- Unstable (i.e., dose adjustment less than 4 weeks prior to study enrollment) doses of vasoactive medications (e.g., calcium channel blockers, statins, nitrates, alpha-blockers, beta-blockers, ACE inhibitors, etc.)
- History of hypersensitivity or prior adverse reaction to Definity microbubble infusion
- Current enrollment in another clinical trial, unless approved by the investigator of both studies or if clinical trial is a non-interventional registry trial
Where
- Charlottesville, Virginia
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 25, 2026 · Source of record for eligibility and locations