Current Studies

Type 2 Studies Open to Enrollment

Updated 2/3/25

Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification (GEM). Short Use of Automated Insulin Delivery (AID-BIT) for Basal Insulin Titration in Type 2 Diabetes: A Pilot Study.

Trial Title: Short Use of Automated Insulin Delivery (AID-BIT) for Basal Insulin Titration in Type 2 Diabetes: A Pilot Study.
IRB-HSR#230316
NCT06024928
PI: Anas El Fathi, PhD
MD: Dr. Ralf Nass
CRC: Lianna Smith

Setting basal insulin parameters typically takes several weeks and requires frequent calls with your treating physician. The purpose of this study is to see if using an insulin pump could assist, and potentially accelerate, identifying the correct basal rates for you to better manage your type 2 diabetes. This is a randomized study so you will not get to choose which group you are assigned to. Some people enrolled in the study will use an insulin pump to adjust their insulin basal rates, and other people will contact the study physician to adjust their insulin basal rates. Both groups will wear a continuous glucose monitor (CGM) during the study. A CGM measures your blood glucose values every 5 minutes and provides you with a real-time look at your blood glucose readings.

You may be eligible for this study if:

you are 18 years of age or older
have a clinical diagnosis of type 2 diabetes for at least 1 year
currently using an approved long-acting insulin for at least six months (e.g., insulin glargine, insulin degludec)

Study related supplies will be provided to you at no cost (e.g., insulin pump and its supplies, CGM supplies, blood glucometer and strips, ketone meter and strips, etc.).

Compensation up to $200 will be offered for completing the study. If an in-person visit at UVA is necessary during the study, a one-time payment of $100 to pay for gas and mileage will be provided. The study will take about 30 days to complete the study.

We want to assure you that we will keep your information confidential. You do not have to be in this study if you do not want to participate. Your decision to be in any study is totally voluntary. Your care at UVA will not be altered by your decision to participate or not participate.

For more information, please email: Lianna Smith

Type 1 Studies Open to Enrollment

Updated 3/10/25

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).

Trial Title: 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).
IRB-HSR#231610
NCT06411548
PI: Anas El Fathi, PhD
MD: Dr. Ralf Nass
CRC: Viola Holmes, MS, RDN, CDCES

The University of Virginia, Department of Diabetes Technology, seeks adults 18 years and older who use multiple daily injections (MDI) to manage their Type 1 Diabetes to participate in a clinical study. The purpose of this study is to improve blood glucose levels after eating meals even when you are not able to exactly measure the carbohydrates in the meal. This study will test an investigational algorithm (complex mathematical formula) called InsuLearn through a smart insulin pen. The pen will recommend the amount of insulin to bolus with your meal and estimate the carbohydrates. We are looking for participants using multiple daily injections (MDI) treatment and having difficulties with counting carbohydrates.

You may be eligible for this study if:

· You were diagnosed with type 1 diabetes at least one year ago.

· You are using MDI treatment for the last six months.

· You are willing to wear a continuous glucose monitor (CGM) during the study.

· You are willing to use insulin smart pen app to record and deliver your insulin doses.

· You are willing to participate in a 51-hour hotel admission.

The study involves:

· 8 study visits during the 6-week study; all visits except for the hotel admission may be completed remotely.

· Wearing a CGM to measure your blood glucose levels.

· Use a smart insulin pen to deliver your insulin, help calculate insulin doses and estimate your carbohydrates for meals.

· Staying at a hotel to test the study algorithm.

The following study-related tests and supplies are provided free of charge:

· Hemoglobin A1c Test (fingerstick)

· CGM supplies

· Smart Insulin Pen

· Glucometer supplies

Compensation: Up to $350 to complete the study

For more information, please email: Viola Holmes

Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm (AIDANET+BPS_RL).

Trial Title: Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm (AIDANET+BPS_RL).
IRB-HSR#301989
NCT06728059
PI/MD: Dr. Sue Brown
CRC: Sara Prince, RN, CCRP

The UVA Center for Diabetes Technology is conducting a research study to learn more about a new fully closed loop insulin delivery system.

This is a research study about the UVA Automated Insulin Delivery System known as Adaptive NETwork (AIDANET). This system consists of an insulin pump, continuous glucose monitor, and an automated insulin dosing algorithm (complex mathematical formula) that delivers insulin automatically trying to keep blood sugars in target range more often. The purpose of this study is to see if a system called AIDANET (Automated Insulin Delivery Adaptive NETwork) is safe to use. AIDANET adjusts insulin every five minutes to keep glucose levels in target. This system also includes a new feature called the bolus priming system (BPS-RL). BPS-RL uses reinforcement learning (RL) to decide how much insulin to give before meals. RL is a way for the system to learn by trying things and getting feedback. For example, it gets rewards for good choices and penalties for bad ones. Over time, it gets better at making decisions. To improve, BPS-RL looks at patterns in glucose and insulin levels over three days. It uses these patterns to decide the right amount of insulin.

You may be eligible for this study if:

You are 18 years old or older

You were diagnosed with type 1 diabetes at least one year ago

You have been using an automated insulin delivery (AID) insulin pump with a Dexcom G6 or G7 within the least 3 months

Currently using insulin for at least 6 months

Study visits may be in person, telephone, or videoconferencing. Participation in the study will involve:

3 days and 2 nights in a hotel with 24-hour study staff monitoring to ensure the FCL system is working safely

7 days of at home wearing the FCL device

More detailed information will be provided if you are interested in participating.

Compensation is a total of $200 for completing the study. You will be compensated $100 for travel to the hotel study session.

For more information, please email: Sara Prince

Automated Insulin Delivery for Inpatients with Dysglycemia (AIDING) Randomized Controlled Trial A Randomized Trial of the Insulin-only Bionic Pancreas in Cystic Fibrosis Related Diabetes (CFRD). Using Closed-Loop Artificial Pancreas Technology to Reduce Glycemic Variability and Subsequently Improve Cardiovascular Health in Type 1 Diabetes (AP-CVD).

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

ON HOLD: Phase I/II, Open-Arm Study Evaluating the Safety of Islet Transplant on Patients with Type 1 Diabetes.

Interested in Participating in a Trial?

Complete the form here to securely send your information to CDT staff.

Closed to Enrollment

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