AIDANET for Type 1 Diabetes

(MiniNET Trial)

Overseen By Sara Prince, RN

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Marc Breton

No Placebo Group

Trial Summary

What is the purpose of this trial?

A randomized 1:1 crossover trial that intends to demonstrate feasibility and safety of the Automated Insulin Delivery as Adaptive NETwork (AIDANET) system run in a new smaller network version, used in full closed loop (FCL) by adults who have been diagnosed with type 1 diabetes (T1D).

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

The trial protocol does not specify if you must stop taking your current medications. However, you cannot start any new non-insulin glucose-lowering agents during the trial, and you cannot use SGLT-2 or SGLT-1/2 inhibitors. If you are on a stable dose of a non-insulin glucose-lowering agent, you may continue it.

What data supports the idea that AIDANET for Type 1 Diabetes is an effective treatment?

The available research shows that automated insulin delivery systems, like AIDANET, can improve blood sugar control in people with Type 1 Diabetes. For example, a study on closed-loop systems, which are similar to AIDANET, found that they help manage blood sugar levels better than traditional methods. These systems use continuous glucose monitoring and automated insulin pumps to adjust insulin delivery, reducing the risk of low blood sugar and making it easier for patients to manage their condition. Compared to other treatments, AIDANET and similar systems offer a more automated and potentially safer way to control blood sugar levels. ^{1 2 3 4 5}

What safety data is available for AIDANET in treating Type 1 Diabetes?

The safety of automated insulin delivery systems, including those similar to AIDANET, has been evaluated in various studies. A six-month trial of closed-loop control systems showed improved glycemic outcomes. The Diabeloop DBLG1 system, another hybrid closed-loop system, demonstrated significant improvements in glycemic control without serious adverse events over a six-month period in real-life conditions. Additionally, a study on AndroidAPS, an open-source automated insulin delivery system, indicated safety and efficacy in young children with Type 1 Diabetes. ^{2 6 7 8 9}

Is AIDANET a promising treatment for Type 1 Diabetes?

Yes, AIDANET is a promising treatment for Type 1 Diabetes because it automates insulin delivery, which can improve blood sugar control and reduce the daily burden of managing the disease. It mimics the natural insulin release of a healthy pancreas, helping to prevent high and low blood sugar levels, even during exercise or at night. ^{2 3 4 5 10}

Research Team

Sue Brown, MD

Principal Investigator

University of Virginia Center for Diabetes Technology

Eligibility Criteria

This trial is for adults with type 1 diabetes interested in a new automated insulin delivery system. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors that could impact the study or their safety.

Inclusion Criteria

I have been using an insulin pump for at least three months.

Willingness not to start any new non-insulin glucose-lowering agent during the trial

Proficient in reading and writing English

Exclusion Criteria

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

Participation in another interventional trial at enrollment

I have a history of adrenal insufficiency.

Treatment Details

Interventions

• AIDANET (Automated Insulin Delivery System)

Trial Overview The trial is testing AIDANET, an Automated Insulin Delivery as Adaptive NETwork system in a smaller network version. It's designed to manage insulin levels automatically and will be compared using a crossover method where participants switch between treatments.

Participant Groups

Group I: Usual Care→AIDANET Active Control 1 Intervention

Participants will complete 7 days/6 nights at home usual care period using their personal equipment. Participants will then use the AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights.

Group II: AIDANET→Usual Care Active Control 1 Intervention

Participants will use AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights and then will complete 7 days/6 nights at home usual care period using their personal equipment.

Who Is Running the Clinical Trial?

Marc Breton

Lead Sponsor

Trials

6

Recruited

200+

Tandem Diabetes Care, Inc.

Industry Sponsor

Trials

43

Recruited

5,800+

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

Findings from Research

The multi-level supervision and controller modification (ML-SCM) module enhances the performance of artificial pancreas systems by continuously monitoring and adjusting insulin delivery based on real-time glucose data, leading to safer blood glucose concentration levels.

In a study involving 30 subjects using a metabolic simulator, the AP system with the ML-SCM module demonstrated improved insulin infusion rates and better glucose control compared to systems without this module, indicating its efficacy in managing type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-level Supervision and Modification of Artificial Pancreas Control System. Feng, J., Hajizadeh, I., Yu, X., et al.[2020]

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]

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]

Automated insulin delivery systems (AID) have significantly improved the management of Type 1 diabetes (T1D) by reducing the daily burden and risk of hypoglycemia, although their use is still limited by factors like acceptance and availability.

Intraperitoneal (IP) insulin delivery has shown promise in improving glycemic control without the need for meal announcements, as it mimics natural insulin secretion more closely, and a new control algorithm has been developed to optimize this delivery method in a fully closed-loop system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In silico design and validation of a time-varying PID controller for an artificial pancreas with intraperitoneal insulin delivery and glucose sensing. Dalla Libera, A., Toffanin, C., Drecogna, M., et al.[2023]

A fully automated multihormone artificial pancreas, which combines insulin and pramlintide, showed comparable glycemic control to an insulin-only system in adults with type 1 diabetes, achieving similar time in target glucose range (81% vs 83%).

The iterative enhancements to the system, including adjustments to dosing algorithms and meal detection, indicate that while the multihormone approach can maintain glycemic control, further optimization is needed before proceeding to larger randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fully Automated Artificial Pancreas for Adults With Type 1 Diabetes Using Multiple Hormones: Exploratory Experiments. Majdpour, D., Tsoukas, MA., Yale, JF., et al.[2022]

The use of the AndroidAPS automated insulin delivery system significantly improved glycemic control in young children with type 1 diabetes, with time in range increasing and HbA1c levels decreasing after switching from a sensor-augmented pump.

No severe hypoglycemia or diabetic ketoacidosis (DKA) events were reported during the use of AndroidAPS, indicating a safe profile, along with reported improvements in quality of life for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-school and school-aged children benefit from the switch from a sensor-augmented pump to an AndroidAPS hybrid closed loop: A retrospective analysis. Petruzelkova, L., Jiranova, P., Soupal, J., et al.[2022]

Automated insulin delivery systems, or 'artificial pancreas' systems, are significantly improving the management of type 1 diabetes by automatically adjusting insulin delivery based on real-time glucose levels.

Clinical trials and real-world evidence show that these systems not only enhance glycemic control but also provide psychosocial benefits for users, indicating a positive impact on overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The changing landscape of automated insulin delivery in the management of type 1 diabetes. Lakshman, R., Boughton, C., Hovorka, R.[2023]

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]

The Diabeloop Generation 1 (DBLG1) hybrid closed-loop artificial pancreas system significantly improved glycemic control in 25 patients with type 1 diabetes over 6 months, reducing HbA1c from 7.9% to 7.1% (P < 0.001) and increasing time in range (TIR) from 53% to 69.7% (P < 0.0001).

The system was safe to use, with no serious adverse events reported, and it also reduced the time spent in hypoglycemia (TIR <70 mg/dL decreased from 2.4% to 1.3%, P = 0.03).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabeloop DBLG1 Closed-Loop System Enables Patients With Type 1 Diabetes to Significantly Improve Their Glycemic Control in Real-Life Situations Without Serious Adverse Events: 6-Month Follow-up. Amadou, C., Franc, S., Benhamou, PY., et al.[2021]

The Artificial Endocrine Pancreas (AEP) uses advanced technology to automatically regulate insulin delivery in people with Type 1 Diabetes Mellitus, aiming to mimic the natural insulin secretion of a healthy pancreas.

The H(infinity) control algorithm effectively manages insulin infusion rates during various metabolic conditions, such as hyperglycemia and exercise, demonstrating good performance in maintaining stable blood glucose levels and reducing the risk of glycemic disturbances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theoretical blood glucose control in hyper- and hypoglycemic and exercise scenarios by means of an H(infinity) algorithm. Quiroz, G., Femat, R.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

Multi-level Supervision and Modification of Artificial Pancreas Control System. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Safety constraints in an artificial pancreatic beta cell: an implementation of model predictive control with insulin on board. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

In silico design and validation of a time-varying PID controller for an artificial pancreas with intraperitoneal insulin delivery and glucose sensing. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Fully Automated Artificial Pancreas for Adults With Type 1 Diabetes Using Multiple Hormones: Exploratory Experiments. [2022]

6. Denmark pubmed.ncbi.nlm.nih.gov

Pre-school and school-aged children benefit from the switch from a sensor-augmented pump to an AndroidAPS hybrid closed loop: A retrospective analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The changing landscape of automated insulin delivery in the management of type 1 diabetes. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Artificial Pancreas Technology Offers Hope for Childhood Diabetes. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Diabeloop DBLG1 Closed-Loop System Enables Patients With Type 1 Diabetes to Significantly Improve Their Glycemic Control in Real-Life Situations Without Serious Adverse Events: 6-Month Follow-up. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Theoretical blood glucose control in hyper- and hypoglycemic and exercise scenarios by means of an H(infinity) algorithm. [2013]