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

NCT05653518 | Recruiting FDA Device

• 3 other identifiers: 2201809414813-SRA-2023-1236-M-B
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Type 1 Diabetes

Keywords

Glycemic Variability; Inflammation; Oxidative Stress; Endothelial Function; Myocardial Perfusion; Aortic Stiffness; Flow-Mediated Dilation

Outcome Measures

Primary Outcomes (1)

• Glucose Time-in-Range

  Time-in-range will measured by continuous glucose monitor device

  12 weeks

Secondary Outcomes (9)

• High-sensitivity C-reactive protein (hs-CRP)

  At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks

• TNF-alpha

  At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks

• Interleukin-6 (IL-6)

  At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks

• E-selectin

  At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks

• Intracellular adhesion molecule 1 (ICAM-1)

  At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks

Other Outcomes (1)

• Human CD14+CD16- monocytes

  At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks

Study Arms (2)

Closed-loop artificial pancreas (AP)

EXPERIMENTAL

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

Sensor Augmented Pump (SAP) therapy

EXPERIMENTAL

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

Interventions

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

Sensor Augmented Pump (SAP) therapy

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

Closed-loop artificial pancreas (AP)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

RECRUITING

Related Publications (20)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Inflammation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William B Horton, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William B Horton, MD

CONTACT

434-924-1828; WBH2N@uvahealth.org

Lee Hartline, MEd

CONTACT

434-924-5247; lmh9d@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 16, 2022
• Study Start: September 9, 2023
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)