Machine-Learning Insulin Delivery for Type 1 Diabetes

(AIDANET+BPS_RL Trial)

Overseen By Sara Prince, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boris Kovatchev, PhD

Must be taking: Insulin

Must not be taking: SGLT-2 inhibitors, Steroids

Disqualifiers: Seizure disorder, Severe hypoglycemia, DKA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve blood sugar control for individuals with Type 1 Diabetes using a smart insulin delivery system. Researchers compare a new advanced system, which includes a Bolus Priming System (BPS_RL, an insulin delivery method), with the current automated system to determine which manages blood sugar more effectively. Participants are divided into two groups, each experiencing both systems at different times. This trial suits individuals who have had Type 1 Diabetes for at least a year, use an insulin pump with continuous glucose monitoring, and are open to trying a new insulin delivery system. As an unphased trial, it offers a unique opportunity to explore innovative diabetes management solutions.

Will I have to stop taking my current medications?

The trial requires that you do not start any new non-insulin glucose-lowering medications during the study. If you are currently using certain medications like SGLT-2 inhibitors or steroids, you may need to stop them before joining the trial.

What prior data suggests that this method is safe for glycemic control in Type 1 Diabetes?

Research shows that the Bolus Priming System (BPS_RL), when used with an automated insulin delivery system for type 1 diabetes, is safe. Past studies tested this system and found it effectively controls blood sugar levels without major safety issues. The system uses machine learning, improving over time at predicting the right amount of insulin needed. These studies reported no significant serious side effects, suggesting users tolerate the system well. This AI-powered device aims to make managing diabetes easier and more effective, offering promise for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the machine-learning insulin delivery system, known as the Bolus Priming System (BPS_RL), because it represents a potential leap forward in managing Type 1 Diabetes. Unlike current options that depend heavily on manual monitoring and insulin adjustments, this system uses advanced machine-learning algorithms to automatically adjust insulin delivery in real-time. This could significantly reduce the burden on patients by minimizing the manual calculations and constant vigilance required with standard insulin pumps and injections. By potentially offering more precise control of blood sugar levels, it might also improve health outcomes and overall quality of life for people living with Type 1 Diabetes.

What evidence suggests that the Bolus Priming System (BPS_RL) is effective for glycemic control in Type 1 Diabetes?

Research shows that automated insulin delivery systems have simplified managing type 1 diabetes by constantly adjusting insulin levels, helping to maintain steady blood sugar levels. In this trial, participants will experience different treatment sequences. One group will start with the AIDANET system and then transition to AIDANET+ BPS_RL, while another group will begin with AIDANET+ BPS_RL and then switch to AIDANET. The Bolus Priming System (BPS_RL) uses a smart learning method called reinforcement learning to enhance these systems, allowing the system to learn and adjust insulin delivery more effectively. Early studies suggest this approach could reduce the risk of low blood sugar and improve overall blood sugar control. Although this treatment is new, the technology behind it has shown promise in earlier tests. ^{1 3 5 6 7}

Who Is on the Research Team?

Sue Brown, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for individuals with Type 1 Diabetes who are interested in improving their glycemic control. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information on who can participate.

Inclusion Criteria

Agrees to use a form of contraception to prevent pregnancy while in the study

Willingness to use the study AIDANET system during the study period

Having used an AID system equipped with Dexcom G6 or G7 CGM within the last three months

Exclusion Criteria

I have had a severe low blood sugar episode with seizure or fainting in the past year.

I have advanced kidney disease or am on dialysis.

My thyroid condition is not well-managed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Establishment

Participants use the AIDANET system at home for 7 days/6 nights to establish a baseline and initialize the control algorithm

1 week

Home use

Hotel Session

Participants are studied at a hotel session for 3 days/2 nights to assess glycemic control using the AIDANET or AIDANET+ BPS_RL systems

3 days

Hotel stay

Home Use Transition

Participants transition to home use of AIDANET+ BPS_RL for 7 days/6 nights

1 week

Home use

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bolus Priming System (BPS_RL)

Trial Overview The trial is testing a new system called AIDANET+ BPS_RL, which uses machine learning to help manage insulin delivery better than the current AIDANET algorithm alone. Participants will experience both methods in different periods to compare effectiveness.

How Is the Trial Designed?

Group I: AIDANET→AIDANET+ BPS_RL Active Control 1 Intervention

Group A: AIDANET followed by AIDANET+ BPS\_RL during the hotel session

Group II: AIDANET+ BPS_RL→AIDANET Active Control 1 Intervention

Group B: AIDANET+BPS\_RL followed by AIDANET during the hotel session

Who Is Running the Clinical Trial?

Boris Kovatchev, PhD

Lead Sponsor

Trials

1

Recruited

120+

Sue Brown

Lead Sponsor

Trials

3

Recruited

100+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

DexCom, Inc.

Industry Sponsor

Trials

151

Recruited

35,700+

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Published Research Related to This Trial

In a 6-month trial with 168 patients, a closed-loop insulin delivery system significantly increased the percentage of time blood glucose levels were within the target range (70-180 mg/dL) by 11 percentage points compared to a sensor-augmented pump, demonstrating improved glycemic control.

The closed-loop system also resulted in a lower mean glycated hemoglobin level and reduced time spent with low blood glucose levels, with no serious hypoglycemic events reported, indicating a safe and effective option for managing type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. Brown, SA., Kovatchev, BP., Raghinaru, D., et al.[2022]

A decision tree model was developed using data from 196 adults with type 1 diabetes to predict the timing of insulin correction boluses, showing better classification performance than traditional logistic regression methods.

By embedding this model into a popular simulation tool, researchers can now conduct in-silico clinical trials that more accurately reflect real patient behaviors and their impact on blood glucose control after meals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Generation of post-meal insulin correction boluses in type 1 diabetes simulation models for in-silico clinical trials: More realistic scenarios obtained using a decision tree approach. Camerlingo, N., Vettoretti, M., Del Favero, S., et al.[2022]

The proposed automatic bolus and adaptive basal (ABAB) therapy for type 1 diabetes significantly outperformed traditional open-loop insulin therapy in a study involving 100 adult subjects, demonstrating better glucose control and reduced variability.

ABAB therapy showed a low hypoglycemia rate of only 3.3% even with increased insulin sensitivity, indicating its safety and robustness against insulin dosing mismatches, making it a promising candidate for future artificial pancreas systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic bolus and adaptive basal algorithm for the artificial pancreatic β-cell. Wang, Y., Dassau, E., Zisser, H., et al.[2011]

A modular safety system integrated into an intelligent insulin dose recommender significantly improved glycemic control in a pilot study with eight adults over six weeks, reducing time spent in hypoglycemia from 0.82% to 0.33%.

The system also increased the percentage of time participants maintained their blood glucose within the target range (3.9-10.0 mmol/l) from 52.8% to 61.3%, demonstrating its efficacy in enhancing safety during insulin dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Modular Safety System for an Insulin Dose Recommender: A Feasibility Study. Liu, C., Avari, P., Leal, Y., et al.[2021]

The study developed algorithms that significantly improved blood glucose control for people with type 1 diabetes using multiple-daily-injections, increasing the time spent in the target glucose range from 66.9% to 93.6% over 20 weeks.

These algorithms adapt insulin delivery based on self-monitoring of blood glucose, suggesting that automated decision support systems can enhance glycemic regulation and reduce the management burden for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Iterative Learning for Insulin Dosage Optimization in Multiple-Daily-Injections Therapy for People With Type 1 Diabetes. Cescon, M., Deshpande, S., Nimri, R., et al.[2021]

The PEPPER system, which provides personalized bolus advice for type 1 diabetes management, was found to be safe but did not significantly improve the percentage of time in range (TIR) compared to a standard bolus calculator, with TIR percentages of 62.5% for PEPPER and 58.4% for control.

Participants using the PEPPER system reported a higher perception of hypoglycemia, even though there was no objective difference in actual time spent in hypoglycemia, indicating a need for further studies to assess the system's overall effectiveness and user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of the PEPPER Adaptive Bolus Advisor and Safety System: A Randomized Control Study. Avari, P., Leal, Y., Herrero, P., et al.[2022]

The study developed a model predictive control (MPC) algorithm for an automated insulin delivery system that significantly improves blood glucose control in Type 1 diabetes by incorporating an insulin on board (IOB) safety constraint.

Simulations showed that using the IOB constraint reduced the risk of hypoglycemic events from 50% to 10%, highlighting its importance in ensuring both safety and efficacy in insulin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety constraints in an artificial pancreatic beta cell: an implementation of model predictive control with insulin on board. Ellingsen, C., Dassau, E., Zisser, H., et al.[2021]

Hybrid closed-loop insulin delivery systems, known as artificial pancreas (AP), significantly improve glucose control in children and adolescents with type 1 diabetes, increasing the time spent in the target glucose range without raising the risk of hypoglycemia.

Despite the effectiveness of these systems for overnight glycemic control, daytime management remains challenging, highlighting the need for careful meal planning and bolusing, as fully automated systems are still under investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial Pancreas Technology Offers Hope for Childhood Diabetes. Schoelwer, MJ., DeBoer, MD.[2022]

Stimuli-responsive, closed-loop insulin delivery systems can potentially improve glycemic control in type 1 diabetes by mimicking natural insulin release in response to changing glucose levels, reducing the burden of self-care for patients.

Although there are still challenges to overcome before these technologies can be used in clinical practice, advancements in reservoir-based insulin delivery devices show promise for significantly enhancing diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimuli-Responsive Insulin Delivery Devices. Fuchs, S., Shariati, K., Ma, M.[2021]

The use of an automated bolus advisor (ABA) in adults with type 1 diabetes led to a reduction in glycated hemoglobin (HbA1c) levels, indicating improved glycemic control, although the difference compared to traditional methods was not statistically significant.

Patients using the ABA reported a lower rate of postprandial hypoglycemia, increased daily glucose measurements, and higher satisfaction and quality of life, suggesting that the ABA is a well-accepted and effective tool for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expert Study: Utility of an Automated Bolus Advisor System in Patients with Type 1 Diabetes Treated with Multiple Daily Injections of Insulin-A Crossover Study. Gonzalez, C., Picón, MJ., Tomé, M., et al.[2017]

The development of an artificial pancreas aims to closely mimic the natural insulin secretion of healthy individuals, focusing on replicating both first-phase and second-phase insulin responses to maintain normal glucose levels.

Recent advancements in algorithms and technology have improved the effectiveness of closed-loop systems that use glucose sensors and insulin pumps, showing promising results in managing insulin-dependent diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed-loop insulin delivery-the path to physiological glucose control. Steil, GM., Panteleon, AE., Rebrin, K.[2019]

A novel control system combining a bolus priming system (BPS) and a multistage model predictive control (MS-MPC) significantly improved post-meal blood glucose control in simulations, achieving the highest time in range at 60.73%.

All tested configurations maintained low hypoglycemia risk (time below 70 mg/dL <0.5%), indicating that the new system enhances glucose management without increasing the risk of low blood sugar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using an Online Disturbance Rejection and Anticipation System to Reduce Hyperglycemia in a Fully Closed-Loop Artificial Pancreas System. Corbett, JP., Garcia-Tirado, J., Colmegna, P., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06728059

Safety and Feasibility of a Machine-Learning Bolus Priming ... In this study, the Bolus Priming System is being tested in a new way. This system uses a type of smart learning called reinforcement learning (RL), which helps ...

2. datascience.virginia.edu datascience.virginia.edu/news/new-uva-clinical-trial-explores-ai-powered-insulin-delivery-better-diabetes-care

New UVA Clinical Trial Explores AI-Powered Insulin Delivery ... A new clinical trial at UVA is aiming to simplify diabetes management by testing an innovative AI-powered device designed to improve automated insulin delivery.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12479459/

A Pilot Study Featuring Flexible Meal Announcement Options Automated insulin delivery (AID) systems have significantly improved the management of type 1 diabetes (T1D) by continuously adjusting insulin ...

4. trial.medpath.com trial.medpath.com/news/dbfed7c66955e331/uva-initiates-clinical-trial-of-ai-enhanced-automated-insulin-delivery-system-for-type-1-diabetes

UVA Initiates Clinical Trial of AI-Enhanced Automated Insulin ... The FDA-approved study, scheduled to commence in March, will evaluate a novel reinforcement learning feature called the "Bolus Priming System with Reinforcement ...

5. nature.com nature.com/articles/s41598-024-62912-4

An automatic deep reinforcement learning bolus calculator ... HAID systems have shown improved glycemic control performance with a reduction in the risk of hypoglycemia and are among the most advanced ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39501832/

Evaluation of an Automated Priming Bolus for Improving ... Our goal was to assess the postprandial glycemic impact of the bolus priming system (BPS), an algorithm delivering fixed insulin doses based on the likelihood ...

7. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/dia.2024.0315

Evaluation of an Automated Priming Bolus for Improving ... Automated insulin delivery (AID) is widely available to people with type 1 diabetes (T1D), providing superior glycemic control versus traditional methods.