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Artificial Pancreas Technology

Artificial Pancreas for Type 1 Diabetes (WBH002 Trial)

N/A

Recruiting

Led By William B Horton, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Total daily insulin dose (TDD) at least 10 U/day

Ages 18-≤40 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks

Awards & highlights

WBH002 Trial Summary

This trial will study if artificial pancreas tech can help reduce inflammation and improve cardiovascular health in people with type 1 diabetes.

Who is the study for?

This trial is for adults aged 18-40 with type 1 diabetes, using insulin for at least six months, and not currently pregnant or planning to become pregnant. Participants must have a BMI of 18-30 kg/m2, controlled blood pressure, and agree to use specific glucose monitors and insulins during the study. Exclusions include severe hypoglycemia history, smoking within two years, certain heart conditions, uncontrolled hypertension, bleeding disorders or hypersensitivity to insulin.Check my eligibility

What is being tested?

The study tests if an artificial pancreas system (Tandem t:slim X2 with Control-IQ Technology) can better regulate blood sugar levels in type 1 diabetics compared to standard sensor-augmented pump therapy. It will assess whether this technology reduces inflammation markers and improves cardiovascular health by mimicking a healthy pancreas's functions.See study design

What are the potential side effects?

Potential side effects may include skin irritation from device wearables like CGM sensors or insulin pumps. There could also be risks associated with incorrect insulin dosing leading to low (hypoglycemia) or high (hyperglycemia) blood sugar levels.

WBH002 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I take at least 10 units of insulin daily.

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I am between 18 and 40 years old.

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I am not pregnant or breastfeeding.

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I am willing to only use Humalog or Novolog insulin during the study.

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I regularly use insulin ratios for meals and corrections, and if I use a pump, I enter this info into it.

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I have been using insulin for at least 6 months.

WBH002 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glucose Time-in-Range

Secondary outcome measures

Asymmetric Dimethylarginine (ADMA)

Brachial artery flow-mediated dilation (FMD)

Carotid Femoral Pulse Wave Velocity (cfPWV)

+8 more

Other outcome measures

Human CD14+CD16- monocytes

WBH002 Trial Design

2Treatment groups

Experimental Treatment

Group I: Sensor Augmented Pump (SAP) therapyExperimental Treatment1 Intervention

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)

Group II: Closed-loop artificial pancreas (AP)Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tandem t:slim X2 with Control-IQ Technology

2017

N/A

~10

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

754 Previous Clinical Trials

1,245,033 Total Patients Enrolled

William B Horton, MDPrincipal InvestigatorUniversity of Virginia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can those less than half a century of age participate in this research project?

"Those that are eligible for this research project must be between 18 and 40 years of age."

Answered by AI

Are there any vacancies left to participate in this experiment?

"Clinicaltrials.gov displays that this research is in search of participants. The trial was initially advertised on September 9th, 2023 and the latest update was made on September 11th, 2023."

Answered by AI

How many volunteers are participating in this experiment?

"Affirmative. According to the clinicaltrials.gov database, this research experiment is still in search of participants following its original posting on September 9th 2023 and last revision on September 11th 2023. 40 patients are being recruited from a single location for participation."

Answered by AI

To whom is recruitment for this study open?

"Recruitment for this clinical trial seeks 40 participants between 18 and 40 years old, who have been clinically diagnosed with type 1 diabetes. Additionally, they must report a Hemoglobin A1c level of less than 10.5%, Body Mass Index within the range of 18-30 kg/m2 , blood pressure below 140/90 mmHg as well as not being pregnant or intending to become pregnant during the study period . Furthermore, all female participants will be required to use contraception while completing the trial and a negative pregnancy test is necessary prior to starting. Lastly, both MDI users and pump wearers are eligible but personal CGM"

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes

Marso, Steven P., Gilbert H. Daniels, Kirstine Brown-Frandsen, Peter Kristensen, Johannes F.E. Mann, Michael A. Nauck, Steven E. Nissen, et al.. 2016. “Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1603827.

PLoS MedicineJournal

Risk of Cardiovascular Disease and Total Mortality in Adults with Type 1 Diabetes: Scottish Registry Linkage Study

Livingstone, Shona J., Helen C. Looker, Eleanor J. Hothersall, Sarah H. Wild, Robert S. Lindsay, John Chalmers, Stephen Cleland, et al.. 2012. “Risk of Cardiovascular Disease and Total Mortality in Adults with Type 1 Diabetes: Scottish Registry Linkage Study”. Edited by Richard Lehman. Plos Medicine. Public Library of Science (PLoS). doi:10.1371/journal.pmed.1001321.

DiabetesJournal

Cause-specific Mortality Trends in a Large Population-based Cohort with Long-standing Childhood-onset Type 1 Diabetes

Secrest, Aaron M., Dorothy J. Becker, Sheryl F. Kelsey, Ronald E. LaPorte, and Trevor J. Orchard. 2010. “Cause-specific Mortality Trends in a Large Population-based Cohort with Long-standing Childhood-onset Type 1 Diabetes”. Diabetes. American Diabetes Association. doi:10.2337/db10-0862.

Journal of Diabetes and its ComplicationsJournal