Ongoing Trials, Currently Recruiting
The purpose of this study is to demonstrate the safety and effectiveness of Empagliflozin as a supplemental therapy to the Artificial Pancreas system (closed loop control) for individuals with type 1 diabetes. Empagliflozin is a drug approved for use in type 2 diabetes. It works by keeping the kidney from reabsorbing glucose, thereby reducing blood glucose. This study is for adults with type 1 diabetes ages 18-65 with an HbA1c<9%. For more information, please contact Lianna Smith LHS7PX@virginia.edu.
The purpose of this study is to gain experience with adolescents using a new diabetes self-management approach called CloudConnect, a self-help tool that will look at your blood sugars, when you take insulin, eat, and exercise and then determine if there are patterns. Based on these patterns, a report is created explaining things like when you might be at risk for low or high blood sugar and how physical activity and taking insulin at meal times might be affecting your blood sugar. Investigators are looking to see if using CloudConnect is helpful in finding out why blood sugar levels are high or low and how using CloudConnect affects your ability to stabilize your blood sugar levels. For more information, contact Katie Krauthause at firstname.lastname@example.org. Click here for more information. Recruiting.
Ongoing Trials, Done Recruiting
International Diabetes Closed-Loop (iDCL) Trial, Clinical Acceptance of the Artificial Pancreas: The iDCL trial will enroll up to 225 individuals across 7 clinical sites in the United States. The objective of the study is to assess the efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial. This trial is 6 months-long, with a 3 month-long extension phase. There will be approximately 7 required in-person visits during the course of the study. All study participants will wear the Dexcom G6 CGM for the entire duration of the study. Depending on the group (Control or Experimental) to which a participant is randomized, the closed loop system (Tandem t:slim X2 with Control-IQ technology) will be worn by the study participant for either 3 months, 6 months, or 9 months. This study will take place at UVA, Mt.Sinai, Mayo Clinic, Stanford, Barbara Davis Center, Sansum, and Joslin. Done Recruiting.
Project Nightlight:The Nightlight closed-loop algorithm is the first specifically engineered to adapt its mode of operation during the course of every night: first, the Nightlight algorithm mitigates after-dinner high blood sugar levels; then it keeps the person safe from hypoglycemia all night long, and “slides” to a target morning glucose level of 120 mg/dl to reset his/her metabolic state back to normal for the start of a new day. The Nightlight algorithm was tested in studies in Virginia (UVA), New York (Mount Sinai), Minnesota (Mayo Clinic), California (Stanford), France (Montpellier), and Italy (Padova). Now, a new long-term project begins which will use the Nightlight algorithm for months at home. This study is funded by the NIH. Done Recruiting.
Insulin- Glucose-Glucagon Network: Defining a Type 1 Diabetes Progression Index: The onset of type 1 diabetes is not well understood, and the goal of this study is to obtain new information about the early stages of the disease. We are studying the link between the progression of the immune attack and the two main hormones responsible for its regulation: insulin and glucagon.
The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System:The purpose of this study is to gather information about the use of Artificial Pancreas Systems in older (≥65 years old) and younger (6 to 10 years old) populations with T1D, to assess cognitive function related to glycemic control, and to examine whether improved glycemic control positively influences cognitive function. Done Recruiting. Results Soon.
A Study of t:Slim X2 With Control-IQ Technology (DCLP5): The purpose of this study is to learn whether an investigational automated insulin delivery system for children (age 6-13) with type 1 diabetes can safely improve blood glucose control. The system uses continuous glucose monitoring (CGM), an insulin pump (Tandem t:slim X2 with Control-IQ), and a software algorithm (“closed-loop”) to automatically give insulin and control blood glucose. The software algorithm (Control-IQ) runs on the pump and calculates how much insulin your child will automatically receive. Participants will be randomized into one of two groups for the main study data collection period (approximately 4 months) and all participants will use the experimental equipment during the extension phase of the study (approximately 3 months). Individuals randomized to the control group will use their home insulin pump (or study pump if currently using insulin pens) for the main study data collection period and the study insulin pump (Tandem t:slim X2 with Control-IQ) and other study devices during the extension phase data collection. Individuals randomized to the experimental group will use the study insulin pump (Tandem t:slim X2 with Control-IQ) and other study devices during both the main study and extension phase data collection periods (~7 months total). Done Recruiting. Results Soon.
Exercise-Induced Hypoglycemia Prevention in Adults With Type 1 Diabetes Using an Artificial Pancreas: The purpose of this study is to determine whether a novel Model Predictive Control module, added to the proven USS artificial pancreas system, is able to help protect against hypoglycemia during and immediately after physical activity without increase in hyperglycemia. To demonstrate the feasibility of this approach, the novel anticipatory system will be compared to a naïve AP system during highly supervised hotel admissions with afternoon exercise. Participants will be asked to exercise regularly in the late afternoon during a month of data collection to generate the patterns to be anticipated. Done Recruiting. Results Soon.
Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses: The purpose of this study is to evaluate the effectiveness of an Apple Watch – based bolus reminder system. Done Recruiting. Results Soon.
Efficacy of inControl Advice: A Decision Support System (DSS) for Diabetes: The purpose of this study is to gather preliminary data on an advisory system for individuals with type 1 diabetes and to reduce the frequency of hypoglycemia and severe hypoglycemic events who use multiple daily injections (shots) to administer their insulin. This study will take place at Mt. Sinai, Stanford and UVA. Done Recruiting. Results Soon.
CGM Use in Islet Transplant Recipients: The purpose of this study is to understand how glucose changes after having an islet transplantation (infusion of isolated islets from a donor pancreas into another person). This study is intended to help researchers understand how glucose levels change after surgery and how this information can be used in the development of automated insulin delivery systems (i.e. Artificial Pancreas Systems). Done Recruiting. Results Soon.
Exercise Activity-Based Bolus Decisions: The purpose of this study is to demonstrate safety and feasibility of a decision support system aimed at improving activity-related insulin boluses. The aim is to make better bolus decisions by integrating knowledge about daily physical activity (PA) into bolus decisions. Done Recruiting. Results Soon.
Enhancement of Glucagon Counterregulation in Type 1 Diabetes by Basal Amylin Replacement: The purpose of this study is to find out whether the combination of insulin and pramlintide is better than insulin alone at helping the pancreas release glucagon in response to a low blood sugar episode. A secondary goal is to assess whether basal pramlintide will delay gastric emptying. Done Recruiting. Results Soon.
Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM: The purpose of this study is to demonstrate the safety and feasibility of a Decision Support System aimed at reducing your glucose variability. The Decision Support System will be used on our portable medical application platform called Diabetes Assistant (DiAs) and will include your new insulin parameters and an exercise warning system. The exercise warning system is intended to predict your hypoglycemia at the start of exercise and will suggest alternative treatment. Participation in this study will require 5 study visits, including two overnight stays, within approximately 10 weeks. Done Recruiting. Results Soon.
USS Virginia Closed-Loop Versus SAP Therapy for Hypoglycemia Reduction in T1D
: The purpose of this study is to evaluate whether long-term use of an AP system can reduce the occurrence of low blood sugar in subjects with hypoglycemia unawareness (the inability to feel low blood sugars) or a high risk of low blood sugar. Done Recruiting. Results Soon.
Dual Hormone: This is an in-patient overnight trial to study the most suitable combination of insulin and pramlintide to keep blood sugar within a normal range (70-140 mg/dL) overnight. Information from this trial will help us design a new artificial pancreas system that will be tested in future clinical trials. Done Recruiting. Results Soon.
Real-Time Monitoring and Glucose Control During Winter-Sport Exercise in Youth with Type 1 Diabetes: The AP Ski Camp Continued: This study is to test an Artificial Pancreas System called Tandem t:slim X2 Insulin Pump with Control – IQ Technology at a 48-hour diabetes ski camp at Wintergreen Mountain. Study subjects will be randomized to this technology or to their usual care with an added continuous glucose monitor. This study will follow 13-18 years old teenagers who are currently using an insulin pump. Trial Complete. Results.
Reducing Risks and Improving Glucose Control During Extended Exercise in Youth With T1DM: The AP Ski Camp: This purpose of this study is to evaluate the Artificial Pancreas (AP) system Closed-Loop Control (CLC) at a 6-day diabetes ski camp at Wintergreen Mountain. Study subjects will be randomized to this technology or to their usual care with an added continuous glucose monitor. This study will follow 10-25 years old participants who are currently using an insulin pump. Trial Complete. Results.
Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform: The purpose of this study is to learn from parents and pediatric endocrinologists about current insulin pump use and features that they believe could improve young children’s diabetes care. The study will use information gained in focus groups and surveys to create models of a young child automated insulin delivery system, which will be used in an upcoming clinical trial. Trial complete. Results.
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: The purpose of this study is to see if an closed-loop control system can safely be used at home to manage your blood sugar, and if optimizing your basal rates improves the functioning of the closed-loop system. Trial Complete. Results.