Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes (WBH002)

February 23, 2026 updated by: William Horton, MD, University of Virginia

Using Closed-Loop Artificial Pancreas Technology to Reduce Glycemic Variability and Subsequently Improve Cardiovascular Health in Type 1 Diabetes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular disease is a type of disease that affects the heart and blood vessels. The current care for cardiovascular disease prevention in people with type 1 diabetes is to manage blood pressure, cholesterol blood levels, or manage blood glucose levels.

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, we will use the Food and Drug Administration (FDA)-approved Tandem t:slim insulin pump with Control-IQ Technology and the FDA approved Dexcom G6 CGM. This study will research whether improvements in blood glucose metrics lead to reductions in some of the cardiovascular biomarkers that represent harmful effects in people with type 1 diabetes. Subjects will be randomly assigned to one of two study groups for 12 weeks---Group 1 will be treated with AP Technology and Group 2 will wear the study CGM and continue to use their current diabetes management strategy (i.e., standard care).

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Health System
        • Contact:
        • Principal Investigator:
          • William B Horton, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Clinical diagnosis, based on World Health Organization criteria, of type 1 diabetes for at least one year
  2. Currently using insulin for at least six months
  3. Ages 18-≤40 years
  4. Hemoglobin A1c <10.5%
  5. Body mass index 18-30 kg/m2
  6. Blood pressure <140/90 mmHg
  7. For females, not currently known to be pregnant or breastfeeding
  8. 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
  9. 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
  10. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
  11. Access to internet and willingness to upload data during the study as needed, including data generated prior to the start of the study
  12. Current use of a glucometer that is downloadable; or willingness to use a study glucometer
  13. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
  14. Willingness to use personal lispro (Humalog) or aspart (Novolog) and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
  15. Total daily insulin dose (TDD) at least 10 U/day.
  16. Willingness not to start any new non-insulin glucose-lowering agent during the trial

Exclusion Criteria:

  1. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
  2. Diagnosis of diabetic ketoacidosis in the 12 months prior to enrollment
  3. Prior diagnosis of cardiac disease (e.g., myocardial infarction, congestive heart failure)
  4. Cerebrovascular accident in the 12 months prior to enrollment
  5. Uncontrolled resting arterial hypertension
  6. Conditions that would make use of a CGM difficult (e.g., blindness, severe arthritis, immobility)
  7. 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
  8. Concurrent use of any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, and/or sulfonylureas)
  9. Hemophilia or any other bleeding disorder
  10. Currently being treated for a seizure disorder
  11. A medical condition or medication, which in the opinion of the investigator or designee, would put the participant or study at risk
  12. Current smokers or those who have quit smoking <2 years ago
  13. Screening Electrocardiogram (ECG) findings indicative of arrhythmia, sinus node disease, or ischemic heart disease
  14. 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)
  15. History of hypersensitivity or prior adverse reaction (e.g., anaphylaxis or angioedema) to IV regular insulin infusion
  16. Diagnosis of peripheral neuropathy (assessed by monofilament examination), macroalbuminuria (urine albumin:creatinine >300 mg per g), or retinopathy beyond mild, nonproliferative retinopathy
  17. 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.)
  18. History of hypersensitivity or prior adverse reaction to Definity microbubble infusion
  19. Current enrollment in another clinical trial, unless approved by the investigator of both studies or if clinical trial is a non-interventional registry trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Closed-loop artificial pancreas (AP)
FDA approved Tandem t:slim insulin pump with Control-IQ Technology and the Dexcom G6 CGM
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
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose Time-in-Range
Time Frame: 12 weeks
Time-in-range will measured by continuous glucose monitor device
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High-sensitivity C-reactive protein (hs-CRP)
Time Frame: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Inflammatory Biomarker
At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
TNF-alpha
Time Frame: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Inflammatory Biomarker
At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Interleukin-6 (IL-6)
Time Frame: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Inflammatory Biomarker
At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
E-selectin
Time Frame: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Biomarker of endothelial dysfunction
At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Intracellular adhesion molecule 1 (ICAM-1)
Time Frame: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Biomarker of endothelial dysfunction
At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Myocardial Perfusion (measured by contrast-enhanced ultrasound [CEU])
Time Frame: At baseline and 12 weeks of treatment
CEU will be assessed before and during a euglycemic-hyperinsulinemic clamp
At baseline and 12 weeks of treatment
Carotid Femoral Pulse Wave Velocity (cfPWV)
Time Frame: At baseline and 12 weeks of treatment
Measurement of change in central aortic stiffness
At baseline and 12 weeks of treatment
Brachial artery flow-mediated dilation (FMD)
Time Frame: At baseline and 12 weeks of treatment
Measure of conduit artery endothelial function
At baseline and 12 weeks of treatment
Insulin sensitivity
Time Frame: At baseline and 12 weeks of treatment
insulin sensitivity will be assessed by M value during a euglycemic-hyperinsulinemic clamp
At baseline and 12 weeks of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Human CD14+CD16- monocytes
Time Frame: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Proinflammatory immune cells associated with atherosclerosis
At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: William B Horton, MD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2023

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 7, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 220180
  • 941481 (Other Grant/Funding Number: American Heart Association)
  • 3-SRA-2023-1236-M-B (Other Grant/Funding Number: Juvenile Diabetes Research Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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