Current Studies

Trial Title: Patient Centered Multi-Agent Decision Support System (PCM-DSS) for Healthcare Providers (TREAT2D).
IRB-HSR#302621
NCT07063420
PI/MD: Daniel Chernavvsky, MD
CRC: Carlene Alix

The Center for Diabetes Technology is seeking adults, ages 18 and older with type 2 diabetes for a research study. The purpose of the study is to see if a new computer formula can safely help improve blood sugar levels in people with type 2 diabetes. We want to find out if using this tool works well and is safe to use.

You may be eligible for this study if: you have type 2 diabetes, are 18 years old or older, and take insulin as well as other diabetes medications.

If you agree to participate, this study will involve you using your personal insulin pen and wearing a study-provided continuous glucose monitor (CGM) for about 5 months. The study will cover the cost of the CGMs during participation. There are about 14 study visits over the course of the study. All visits may be completed remotely or in-person. Study-related exams may include a hemoglobin A1c test and lab work. The study-related exams and the study supplies are provided at no cost.

Compensation: $200

For more information, please email: Carlene Alix

Trial Title: Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification (GEM).
IRB-HSR#220259
NCT05766735
University of Virginia PI: Chiara Fabris, PhD
Colorado University PI: Tamara Oser, MD
CRC: Jacqueline Rodriguez

The University of Virginia, Center for Diabetes Technology, seeks adults between the ages of 30-80 who have Type 2 Diabetes to participate in a clinical study. The purpose of this study is to find out if people who are newly diagnosed with Type 2 Diabetes respond better to regular routine care or routine care paired with a lifestyle intervention that focuses on reducing how much blood glucose goes up after eating, by avoiding certain foods and increasing routine physical activity.

You may be eligible for this study if:

• You were diagnosed with Type 2 Diabetes within the past 12 months
• You are not currently using a diet program or medication to manage your Type 2 Diabetes

The study involves:

• The study duration is 13 ½ months
• There are up to 7 visits in this study
• There are 3 visits will be in person at the University of Virginia – at the start of the study, after 4 ½ months and after 13 ½ months. These visits will be about 3 ½ hours in length.
• At these visits,
  • You will have a physical examination
  • Your blood will be drawn to check liver function and your hemoglobin A1c
  • You will be asked to electronically complete questionnaires will take less than an hour to complete

Study-related exams or tests include (provided free of charge):

• Blood test
• Physical examination
• Interviews with study team
• Questionnaires to complete
• Dexcom G7 Continuous Glucose Monitoring supplies will be provided at different times in the study

Compensation: Up to $300 to complete the study

For more information, please email: Jacqueline Rodriguez

Trial Title: A Randomized Parallel Clinical Trial of AIDANET, an Automated Insulin Delivery Algorithm, in Fully Closed-Loop Vs Hybrid Closed-Loop Mode In Adults With Type 1 Diabetes (AIDANET at Home).
IRB-HSR#302656
NCT07039617
PI/MD: Sue Brown, MD
CRC: Lianna Smith

The Center for Diabetes Technology seeks adults ages 18 and older with Type 1 Diabetes for a research study. The purpose of this study is to find out if a system called AIDANET (Automated Insulin Delivery Adaptive NETwork) is safe and can help control blood sugar better for people with Type 1 Diabetes. The study involves you to wear the study equipment to manage your diabetes for 4 months. There will be 17 study visits with most of the visits completed by telephone or virtually from home. You may need to attend an in-person training visit to learn how to use the Tandem Mobi insulin pump, a Dexcom continuous glucose monitor (CGM), and the investigational AIDANET system. Study-related equipment and supplies are provided at no cost to you. You will need to use your own insulin.

Compensation: $500 to complete the study and reimbursement of $100 for clinic visits at UVA (maximum of 3 trips = $300)

For more information, please contact the study coordinator, Lianna Smith at lhs7px@uvahealth.org or 434-248-0893.

Trial Title: A Randomized Trial of the Insulin-only Bionic Pancreas in Cystic Fibrosis Related Diabetes (CFRD).
IRB-HSR#231641
NCT06449677
PI/MD: Dr. Sue Brown
CRC: Sara Prince

Click the NCT number for more information.

For more information, please email: Sara Prince at SP4SA@uvahealth.org

Trial Title: Using Closed-Loop Artificial Pancreas Technology to Reduce Glycemic Variability and Subsequently Improve Cardiovascular Health in Type 1 Diabetes (AP-CVD).
IRB-HSR#220180
NCT05653518
PI: Dr. W. Benjamin Horton, MD
CRC: Lee Hartline

This study will examine cardiovascular effects to your heart while using the artificial pancreas (AP) technology. The AP technology is a system of devices that closely mimics the glucose regulating function of a healthy 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 if the changes in your blood glucose levels will be reduced and, therefore, reduce some of the cardiovascular biomarkers that represent harmful effects while using the AP. A biomarker is a biological molecule found in blood.  

The University of Virginia Center for Diabetes Technology is seeking adults 18-40 years old diagnosed with type 1 diabetes for a research study. The purpose of this study is to examine the cardiovascular effects while using the artificial pancreas (AP) technology.  

If you participate in this study: 

• you may be asked to wear a Tandem t:slim insulin pump with Control-IQ Technology and a CGM for up to 13 weeks or you will be asked to wear only a CGM for 12 weeks.   
• you will be asked to provide blood samples taken to measure your heart functioning at five different time points in the study. These blood draws will take about 15 minutes to complete.  
• You will be asked to complete cardiac testing at two different times in the study. This testing will take less than an hour to complete.  

 The blood samples, cardiac testing, insulin pump supplies and CGM supplies are provided at no-cost. You will need to provide your own insulin. Compensation: $825.00 for study completion 

For more information, please email: Lee Hartline

Trial Title: Safety and Feasibility Testing of AIDANET in Children Age 6-13 Years (AIDANET Peds).
IRB-HSR#302210
NCT07020936
PI: Dr. Mark DeBoer, MD
CRC: Lianna Smith

Trial Title: Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 Diabetes Using Automated Insulin Delivery (Insulearn Peds).
IRB-HSR#302850
NCT07212179
PI: Anas El Fathi, PhD
CRC: Sara Prince, RN

Inclusion Criteria:

1. Age ≥14.0 and ≤21 years old at time of consent
2. HbA1c ≤ 10%.
3. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
4. Having used an insulin pump within the last three months.
5. Currently using insulin for at least six months

For more information, please email: Sara Prince, RN

Trial Title: A Phase I/II, Open-Arm Study Evaluating the Safety of Islet Transplant on Patients with Type 1 Diabetes.
IRB-HSR: #170020
NCT03698396
PI: Dr. Kenneth Brayman
RC: Robin Kelly, RN

The UVA Transplant Surgery Division seeks adults ages 18 to 70 with Type 1 Diabetes and severe hypoglycemic unawareness for a research study.

The purpose of the study is to determine if islet transplantation will help with glucose stabilization in type 1 diabetics.

• This study involves an islet cell transplant procedure in interventional radiology with inpatient stay to stabilize glucose. It includes follow-up with 29 study visits over 1 year after the transplant.
• Study-related exams, tests and medication provided free of charge.
• No compensation is provided for this study.

For more information, please email: Robin Kelly

• Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System among Adolescents with T1D (Launchpad Lyumjev)
• Short Use of Automated Insulin Delivery (AID-BIT) for Basal Insulin Titration in Type 2 Diabetes: A Pilot Study.
• Automated Insulin Delivery for Inpatients with Dysglycemia (AIDING) Randomized Controlled Trial
• Feasibility of a Bolus Calculator Without Carbohydrate Counting in Type 1 Diabetes Patients Under Multiple Daily Injections (MDI) Therapy: a Supervised Randomized Controlled Trial (InsuLearn).
• Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm (AIDANET+BPS_RL).
• Sex Differences In Glucose Control and Diabetes Management (T1D & T2D).
• An Exploratory 16-Week Pilot Study Of The Effect And Safety Of A Novel CGM-Based Titration Algorithm For Basal Insulin, With Or Without Non-Insulin Anti-diabetic Drugs In T2DM Participants Treated With Basal Insulin (CGM-DTx Degludec).
• A Randomized Trial Evaluating the Efficacy and Safety of Control-IQ Technology in Adults with Type 2 Diabetes Using Basal-Bolus Insulin Therapy (2IQP).
• The Pediatric Artificial Pancreas Automated Initialization trial (PEDAP-AI): A Pilot Study of AI Advisor-Driven Pump Initiation and Parameter Adaption in Young Children with type 1 Diabetes.
• Adaptive Behavioral Control (ABC) in a Closed-Loop System: A Randomized Crossover Clinical Trial.
• Artificial Pancreas – Adolescent Physiology & Psychology Longitudinal Evaluation (AP APPLE).
• Adapting Diabetes Treatment Expert Systems to Patient’s Expectations and Psychobehavioral Characteristics in  Type 1 Diabetes (DSS2).
• Algorithmic Development, Prototyping, and Pilot Clinical Testing of a Therapy Optimization Platform to Support Healthcare Providers in the Management of Type 2 Diabetes Preliminary Data Collection (DSS-HCP-T2).
• Adaptive Motif-Based Control (AMBC): Neural Net Implementation of Automated Insulin Delivery. Neural Net Artificial Pancreas (NAP).
• CloudConnect – International Diabetes Closed-Loop (iDCL) Trial, Clinical Acceptance of the Artificial Pancreas
• Project Nightlight – Web-Based Simulation Tool for Self-Management Support in Type 1 Diabetes Mellitus
• Real-Time Monitoring and Glucose Control During Winter-Sport Exercise in Youth with Type 1 Diabetes: The AP Ski Camp Continued
• Reducing Risks and Improving Glucose Control During Extended Exercise in Youth With T1DM: The AP Ski Camp
• Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform
• At Home Study of a Zone-Model Predictive Control (MPC) Controller and a Health Monitoring System (HMS) With the Diabetes Assistant (DiAs) System and Run-to-Run Adaptation
• SGLT2 Inhibitor Adjunctive Therapy to Closed Loop Control in Type 1 Diabetes Mellitus
• Insulin- Glucose-Glucagon Network: Defining a Type 1 Diabetes Progression Index
• The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System
• A Study of t:Slim X2 With Control-IQ Technology (DCLP5)
• Exercise-Induced Hypoglycemia Prevention in Adults With Type 1 Diabetes Using an Artificial Pancreas
• Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
• Efficacy of inControl Advice: A Decision Support System (DSS) for Diabetes
• CGM Use in Islet Transplant Recipients
• Exercise Activity-Based Bolus Decisions
• Enhancement of Glucagon Counterregulation in Type 1 Diabetes by Basal Amylin Replacement
• Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM
• USS Virginia Closed-Loop Versus SAP Therapy for Hypoglycemia Reduction in T1D
• Dual Hormone