Is NCT05653518 recruiting in Charlottesville, VA?

Yes, NCT05653518 is currently recruiting participants at its Charlottesville, VA location. This type 1 diabetes clinical trial is actively enrolling qualified participants.

How do I join the type 1 diabetes clinical trial in Charlottesville?

To join this clinical trial in Charlottesville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Charlottesville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Type 1 Diabetes Clinical Trial in Charlottesville, VA

About This Type 1 Diabetes Study in Charlottesville

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.

Sponsor: University of Virginia

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Charlottesville?

Yes, this clinical trial (NCT05653518) has an active research site in Charlottesville, VA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Type 1 Diabetes Treatment Options in Charlottesville, VA

If you're searching for type 1 diabetes treatment options in Charlottesville, VA, this clinical trial (NCT05653518) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Charlottesville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced type 1 diabetes specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all type 1 diabetes clinical trials near you to find additional studies recruiting in your area.

Type 1 Diabetes Clinical Trial in Charlottesville, VA

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