RecruitingNot ApplicableNCT05653518

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

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

Sponsor

University of Virginia

Enrollment

40 participants

Start Date

Sep 9, 2023

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes

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.

Eligibility

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using an artificial pancreas system (a device that automatically monitors blood sugar and delivers insulin) can reduce blood sugar swings and improve heart health in young adults with type 1 diabetes. **You may be eligible if...** - You are between 18 and 40 years old - You have had type 1 diabetes for at least one year and have been using insulin for at least 6 months - Your most recent HbA1c (a 3-month blood sugar average) is below 10.5% - Your BMI is between 18 and 30 - Your blood pressure is below 140/90 mmHg - You are not currently pregnant or breastfeeding **You may NOT be eligible if...** - You are outside the age range of 18–40 - Your blood sugar control is very poor (HbA1c ≥ 10.5%) - You are pregnant, planning to become pregnant during the study, or breastfeeding - You have significant health problems that would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETandem t:slim X2 with Control-IQ Technology

FDA approved Tandem t:slim insulin pump with Control-IQ Technology and the Dexcom G6 CGM

DEVICESensor augmented pump (SAP) therapy

Sensor augmented pump (SAP) therapy that includes the use of a study CGM and the participant's personal insulin pump

Locations(1)

University of Virginia Health System

Charlottesville, Virginia, United States

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NCT05653518

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