AI Bolus Priming for Type 1 Diabetes

(AIDANET AI Trial)

LK
CA
Overseen ByCarlene Alix
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sue Brown
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for managing Type 1 Diabetes by using artificial intelligence (AI) to adjust insulin doses based on meal patterns. The treatment, called AIDANET AI, connects via a smartphone app to an insulin pump and glucose monitor, aiming to regulate blood sugar levels more effectively. Participants will test different system setups for several weeks to evaluate its effectiveness in managing diabetes. This trial suits adults who have had Type 1 Diabetes for at least a year and are already using an automated insulin delivery system. As an unphased trial, it offers the chance to explore innovative diabetes management technology and contribute to advancing future treatment options.

Do I need to stop taking my current medications for the trial?

The trial requires that you do not start any new non-insulin glucose-lowering medications during the study. If you are currently taking such medications, you must have been on a stable dose for at least the past month. Additionally, you cannot use certain medications like SGLT-2 inhibitors or steroids.

What prior data suggests that this AI-based bolus priming method is safe for Type 1 Diabetes patients?

Research has shown that the AIDANET system can safely assist people with Type 1 Diabetes in managing their blood sugar levels. Various studies have demonstrated that the AIDANET system improves blood sugar control, helping maintain levels within a healthy range. Importantly, these studies also indicate that most users find the system easy to use.

For example, one study found that the AIDANET system significantly improved blood sugar levels in 34 people with Type 1 Diabetes. Another study showed that the system can automatically adjust insulin delivery by analyzing blood sugar data in real-time, reducing the time blood sugar levels are outside the target range. So far, trials have reported no major side effects, suggesting that the system is safe to use.

Overall, while more research may be needed to understand long-term effects, initial findings suggest that the AIDANET system is a safe and effective option for managing Type 1 Diabetes.12345

Why are researchers excited about this trial?

Researchers are excited about the AI Bolus Priming for Type 1 Diabetes because it introduces the AIDANET AI system, which offers a unique approach to managing blood sugar levels. Unlike standard treatments that rely heavily on human input, such as traditional insulin pumps or multiple daily injections, AIDANET AI uses artificial intelligence to automate insulin delivery decisions. This technology could potentially enhance precision and ease the burden of constant monitoring for patients. By adapting to individual needs in real-time, AIDANET AI may improve blood sugar control more effectively than current methods, offering a significant advancement in diabetes management.

What evidence suggests that this trial's treatments could be effective for Type 1 Diabetes?

Research has shown that AI-based systems like AIDANET AI can significantly assist people with type 1 diabetes in managing their blood sugar levels. These systems monitor blood sugar in real-time and automatically adjust insulin delivery, allowing individuals to maintain their blood sugar within the optimal range more consistently. In this trial, participants in Group A will progress from their home HCL system to AIDANET and then to AIDANET AI, while Group B will start with AIDANET AI, transition to AIDANET, and finally return to their home HCL systems. A recent study demonstrated that the AIDANET system managed insulin levels as effectively as expert doctors. Various studies have proven AI-driven insulin delivery systems to be safe and effective, offering promising results for improved diabetes management.24678

Who Is on the Research Team?

SB

Sue Brown, MD

Principal Investigator

University of Virginia Center for Diabetes Technology

Are You a Good Fit for This Trial?

This trial is for adults (18+) with type 1 diabetes diagnosed at least a year ago, who already use an automated insulin delivery system. Participants must be willing to use the study's pump and devices, switch to approved insulin if needed, have support in case of emergencies, not be pregnant or breastfeeding, and agree to contraception if able to become pregnant.

Inclusion Criteria

I am willing to use an approved insulin in the study pump as directed.
I have someone nearby who can help me in case of severe low blood sugar emergencies.
6. Participant not currently known to be pregnant or breastfeeding.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into two groups to test different insulin delivery systems over 8 weeks

8 weeks
Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AIDANET AI

Trial Overview

The study compares standard automated insulin delivery with and without AI-based meal prediction (bolus priming) using the AIDANET system. Participants will try both approaches over several weeks using a connected phone app, insulin pump, and continuous glucose monitor.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: GROUP B: 4 weeks AIDANET AI, 2 weeks AIDANET, and 2 weeks HCLExperimental Treatment3 Interventions
Group II: GROUP A: 2 weeks HCL, 2 weeks AIDANET, and 4 weeks AIDANET AIExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

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+

Tandem Diabetes Care, Inc.

Industry Sponsor

Trials
43
Recruited
5,800+

Citations

A Randomized Parallel Clinical Trial of AIDANET, an ...

A randomized cross-over trial assessing glycemic control on Automated insulin delivery as Adaptive Network (AIDANET) algorithm when used in three modes: ...

Effectiveness and safety of AI-driven closed-loop systems in ...

AI-based closed-loop systems can analyze glucose data in real-time and automatically adjust insulin delivery, resulting in reduced time outside target glucose ...

Clinical Trials | Fully Closed Loop Study for Adults ages 18 ...

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 ...

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.

AIDANET for Type 1 Diabetes (MiniNET Trial)

Automated insulin delivery (AID) systems have proven safe and effective in improving glycemic outcomes in individuals with type 1 diabetes. Other People ...

Safety and Feasibility of a Fully Automated Insulin Delivery ...

FCL therapy with the AIDANET system can significantly improve average glycemic control while removing the need for mealtime bolusing for a ...

941-P: Perceptions and Acceptance of Technology in an ...

Additional research is needed to determine user experience and acceptance after longer wear period of the AIDANET system.

AIDANET Algorithm for Type 1 Diabetes

Research has shown that the AIDANET system can help people with Type 1 Diabetes manage their blood sugar levels safely. A small initial study found that AIDANET ...