Automated Insulin Delivery System for Type 1 Diabetes

Overseen By Deborah Branigan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must be taking: Insulin

Must not be taking: Corticosteroids, Beta blockers

Disqualifiers: Cardiovascular disease, Renal insufficiency, Liver disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

10 Participants Needed

Trial Summary

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 participate if you are using certain medications like oral or parenteral corticosteroids, beta blockers, or non-dihydropyridine calcium channel blockers. You can continue using metformin if your dose has been stable for at least 3 months and you agree not to change the dose during the study.

Do I need to stop my current medications to join the trial?

The trial requires that you do not use any medication that can lower glucose other than insulin, except for metformin if your dose has been stable for at least 3 months. You also cannot be on chronic immunosuppressive medications, corticosteroids, beta blockers, or certain calcium channel blockers.

What data supports the idea that Automated Insulin Delivery System for Type 1 Diabetes is an effective treatment?

The available research shows that the Automated Insulin Delivery System, also known as the artificial pancreas, is effective in managing Type 1 Diabetes. In a study comparing this system to sensor-augmented pump therapy, the automated system increased the time patients' blood sugar levels stayed within the target range from 61% to 69%. It also reduced the time spent with dangerously low blood sugar levels. This suggests that the automated system provides better glucose control than traditional methods. ^{1 2 3 4 5}

What data supports the effectiveness of the iPancreas automated insulin delivery system treatment for Type 1 Diabetes?

Research shows that the iPancreas automated insulin delivery system improves blood sugar control in people with Type 1 Diabetes. In a study, it increased the time patients spent in the target blood sugar range and reduced the time spent with low blood sugar compared to traditional insulin pump therapy. ^{1 2 3 4 5}

What safety data is available for the Automated Insulin Delivery System for Type 1 Diabetes?

Several studies have evaluated the safety of the Automated Insulin Delivery System, also known as the Artificial Pancreas. A study on a hybrid closed-loop system showed improved glucose control and reduced time spent in hypoglycemia compared to traditional pump therapy. Another study confirmed these findings, demonstrating increased time in target glucose range and reduced time below target levels. Additionally, a safety system for the Artificial Pancreas was designed to ensure reliable operation. These studies indicate that the system is generally safe and effective for managing Type 1 Diabetes. ^{1 2 6 7 8}

Is the automated insulin delivery system safe for humans?

Research shows that the automated insulin delivery system, also known as the artificial pancreas, is generally safe for humans. Studies have demonstrated that it improves glucose control and reduces the time spent with low blood sugar levels compared to traditional insulin pump therapy. ^{1 2 6 7 8}

Is the iPancreas automated insulin delivery system a promising treatment for type 1 diabetes?

Yes, the iPancreas automated insulin delivery system is a promising treatment for type 1 diabetes. It helps improve blood sugar control by automatically adjusting insulin levels based on real-time glucose readings. This system increases the time blood sugar stays within a healthy range and reduces the time it drops too low, making it a valuable tool for managing diabetes. ^{1 3 9 10 11}

How is the iPancreas automated insulin delivery system different from other treatments for type 1 diabetes?

The iPancreas automated insulin delivery system is unique because it uses a control algorithm to automatically adjust insulin delivery based on real-time blood sugar levels, unlike traditional methods that require manual adjustments. This system improves glucose control by increasing the time blood sugar levels stay within the target range and reducing the time spent in low blood sugar states compared to sensor-augmented pump therapy. ^{1 3 9 10 11}

What is the purpose of this trial?

An artificial pancreas (AP) is a control system for automatic insulin delivery. The investigators have implemented a high blood sugar detection and dosing algorithm for use within an AP control system. If a high blood sugar pattern is detected, correction insulin will be calculated and delivered. The investigators will test how well the new algorithm manages glucose compared to the AP control system without high blood sugar detection and dosing. This type of algorithm may improve glucose control for high risk patient populations.

Research Team

Leah Wilson, MD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

This trial is for individuals with Type 1 Diabetes who could benefit from an automated insulin delivery system. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be excluded based on factors that could interfere with the study or their safety.

Inclusion Criteria

Willingness to follow all study procedures, including attending all clinic visits

Lives within 40 miles of OHSU

Able to read, write and understand spoken English

Exclusion Criteria

GMI or A1c <6.5% or >10.5%

I have been diagnosed with adrenal insufficiency.

Diet consisting of less than 50 grams of carbohydrates per day

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Training and Initial Use

Participants complete system training and begin using the iPancreas system under free-living conditions

3 weeks

1 visit (in-person) for training, ongoing monitoring

Algorithm Activation

High blood sugar detection and dosing algorithm is activated after initial data collection

1 week

1 virtual visit for algorithm training

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• iPancreas automated insulin delivery system

Trial Overview The trial is testing a new feature in an artificial pancreas system called iPancreas. It includes a high blood sugar detection algorithm that automatically delivers correction insulin. The goal is to see if it manages glucose levels better than the standard system without this feature.

Participant Groups

Group I: iPancreas automated insulin delivery system Experimental Treatment 1 Intervention

Participants will use the iPancreas automated insulin delivery system for 4 weeks at home. After 3 weeks of collecting high blood sugar pattern data, the high blood sugar pattern detection and dosing feature will be turned on.

iPancreas automated insulin delivery system is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as Medtronic MiniMed 670G System for:

• Type 1 diabetes

Approved in European Union as Medtronic MiniMed 670G System for:

• Type 1 diabetes

Approved in United Kingdom as Medtronic MiniMed 780G System for:

• Type 1 diabetes

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

In a randomized crossover trial involving 36 adults with type 1 diabetes, the automated insulin delivery system significantly increased the time spent in the target glucose range (3.9-10.0 mmol/L) from 61% to 69%, demonstrating improved glucose control compared to sensor-augmented pump therapy.

The automated system also reduced the time spent in hypoglycemia (below 3.9 mmol/L) from 3.5% to 1.6%, emphasizing its safety and efficacy in managing blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison Between Closed-Loop Insulin Delivery System (the Artificial Pancreas) and Sensor-Augmented Pump Therapy: A Randomized-Controlled Crossover Trial. Haidar, A., Legault, L., Raffray, M., et al.[2022]

The open-source AndroidAPS (AAPS) hybrid closed-loop system significantly improved the percentage of time in range (TIR) for participants with type 1 diabetes, increasing it by 18.6% compared to stand-alone insulin pump therapy (76.6% vs. 58.0%).

The AAPS system demonstrated comparable safety to traditional pump therapy, with no serious adverse events or severe hypoglycemia reported, indicating it is a safe option for managing blood glucose levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid Closed Loop Using a Do-It-Yourself Artificial Pancreas System in Adults With Type 1 Diabetes. Nanayakkara, N., Sharifi, A., Burren, D., et al.[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 Fifth Artificial Pancreas Workshop highlighted significant advancements in automated insulin delivery systems since 2016, with several systems now available for commercial use, indicating progress in diabetes management technology.

Key discussions focused on the need for adaptive algorithms and novel AI strategies to enhance personalized diabetes management, emphasizing the importance of interoperability and accessibility for future systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NIH Fifth Artificial Pancreas Workshop 2023: Meeting Report: The Fifth Artificial Pancreas Workshop: Enabling Fully Automation, Access, and Adoption. Aaron, RE., Tian, T., Yeung, AM., et al.[2023]

Focus groups with 15 parents and 5 pediatric endocrinologists highlighted the need for modifications to artificial pancreas systems to make them safer and more effective for children aged 5-8 years with type 1 diabetes, emphasizing features like customizable access and enhanced monitoring.

Parents and physicians expressed strong interest in having artificial pancreas applications for younger children, stressing that these systems should include child-specific functionalities and safety features to improve diabetes management and communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the Safety and Functionality of an Artificial Pancreas System for Use in Younger Children: Input from Parents and Physicians. Gildersleeve, R., Riggs, SL., Cherñavvsky, DR., et al.[2018]

The Health Monitoring System (HMS) for the artificial pancreas device system (APDS) effectively detected 93.5% of hypoglycemic episodes, significantly reducing the time spent below safe glucose levels from 15% to 3%.

In a clinical test, the HMS provided timely alerts during an insulin overdose scenario, demonstrating its crucial role in enhancing the safety and reliability of the APDS by managing potential hypoglycemic events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of the health monitoring system for the artificial pancreas: low glucose prediction module. Harvey, RA., Dassau, E., Zisser, H., et al.[2021]

The FDA and NIH held a workshop to advance the development of artificial pancreas systems for diabetes treatment, focusing on current technologies, challenges, and clinical expectations.

Successful commercialization of artificial pancreas devices will require collaboration between clinical science, system components, and regulatory policies to ensure they are safe and effective for outpatient use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovations in technology for the treatment of diabetes: clinical development of the artificial pancreas (an autonomous system). Klonoff, DC., Zimliki, CL., Stevens, LA., et al.[2021]

The interoperable artificial pancreas system (iAPS) demonstrated safety and effectiveness in managing glucose levels in six adults with type 1 diabetes, showing a significant reduction in time spent below 70 mg/dL during a 48-hour trial under challenging conditions.

Participants using the iAPS had a trend toward improved time in the target glucose range (70-180 mg/dL) compared to standard sensor-augmented pump use, indicating its potential for better glucose control with minimal user intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Clinical Evaluation of the Interoperable Artificial Pancreas System (iAPS) Smartphone App: Interoperable Components with Modular Design for Progressive Artificial Pancreas Research and Development. Deshpande, S., Pinsker, JE., Zavitsanou, S., et al.[2020]

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]

Automated insulin delivery (AID) systems, also known as artificial pancreas systems, have been developed to enhance glycemic control in people with type 1 diabetes by automatically adjusting insulin delivery based on real-time blood glucose levels.

These systems represent a significant advancement in insulin therapy, offering safer and more effective treatment options, although challenges such as high costs and healthcare provider resistance remain, indicating room for further improvement and future developments toward fully automated systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial pancreas systems: experiences from concept to commercialisation. Rodríguez-Sarmiento, DL., León-Vargas, F., García-Jaramillo, M.[2022]

Recent advancements in automated insulin delivery systems, including hybrid and full closed-loop controls, show promise in improving type 1 diabetes management by reducing hypoglycemia and enhancing overall glucose control.

Current studies have primarily been conducted in inpatient settings, indicating a need for future research to evaluate the safety and efficacy of these systems in controlled outpatient trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed-loop artificial pancreas: current studies and promise for the future. Weinzimer, SA.[2021]

References

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

Comparison Between Closed-Loop Insulin Delivery System (the Artificial Pancreas) and Sensor-Augmented Pump Therapy: A Randomized-Controlled Crossover Trial. [2022]

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

Hybrid Closed Loop Using a Do-It-Yourself Artificial Pancreas System in Adults With Type 1 Diabetes. [2023]

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

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

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

NIH Fifth Artificial Pancreas Workshop 2023: Meeting Report: The Fifth Artificial Pancreas Workshop: Enabling Fully Automation, Access, and Adoption. [2023]

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

Improving the Safety and Functionality of an Artificial Pancreas System for Use in Younger Children: Input from Parents and Physicians. [2018]

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

Design of the health monitoring system for the artificial pancreas: low glucose prediction module. [2021]

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

Innovations in technology for the treatment of diabetes: clinical development of the artificial pancreas (an autonomous system). [2021]

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

Design and Clinical Evaluation of the Interoperable Artificial Pancreas System (iAPS) Smartphone App: Interoperable Components with Modular Design for Progressive Artificial Pancreas Research and Development. [2020]

9. England pubmed.ncbi.nlm.nih.gov

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

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

Artificial pancreas systems: experiences from concept to commercialisation. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Closed-loop artificial pancreas: current studies and promise for the future. [2021]