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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new algorithm in an automated insulin delivery system, functioning like an artificial pancreas. The goal is to determine if this feature can better manage high blood sugar levels in people with type 1 diabetes. Participants will use the system for four weeks, activating the new high blood sugar detection and dosing feature after three weeks. Individuals with type 1 diabetes for at least a year who currently use an approved hybrid closed-loop insulin system might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative diabetes management research.

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 prior data suggests that the iPancreas automated insulin delivery system is safe for managing Type 1 Diabetes?

Research has shown that automated insulin delivery systems, such as the iPancreas, are generally safe for people with Type 1 diabetes. These systems help maintain stable blood sugar levels. Studies have not identified any serious problems directly caused by these systems.

For example, one study found that users spent more time with their blood sugar in the target range, suggesting the system functions effectively without major issues. While individual experiences can vary, evidence indicates that these systems are generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The iPancreas automated insulin delivery system is unique because it combines advanced technology to automatically manage insulin dosing for people with Type 1 Diabetes. Unlike traditional insulin pumps and continuous glucose monitors that require manual input and adjustments, the iPancreas system uses an algorithm to detect patterns of high blood sugar and autonomously adjust insulin delivery. This feature aims to maintain optimal blood sugar levels more consistently and reduce the burden on users, offering a more seamless and potentially more effective management of diabetes. Researchers are excited about this system because it promises to enhance the quality of life for patients by simplifying diabetes management and potentially improving long-term health outcomes.

What evidence suggests that the iPancreas automated insulin delivery system is effective for managing Type 1 Diabetes?

Research has shown that automated insulin delivery systems, such as the iPancreas, can significantly improve blood sugar control for individuals with Type 1 diabetes. Studies have found that these systems maintain blood sugar levels within the desired range more effectively than traditional methods. In this trial, participants will use the iPancreas, which includes a new feature that detects high blood sugar and automatically adjusts insulin levels to correct it. Early results suggest this could reduce high blood sugar episodes and enhance overall blood sugar management. This technology holds particular promise for patients who struggle to maintain stable blood sugar levels.

Who Is on the Research Team?

Leah Wilson, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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

Lives within 40 miles of OHSU

Able to read, write and understand spoken English

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

Exclusion Criteria

GMI or A1c <6.5% or >10.5%

Use of an investigational drug within 30 days prior to screening

Diet consisting of less than 50 grams of carbohydrates per day

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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 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]

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]

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]

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 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]

Citations

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nejm.org

nejm.org/doi/full/10.1056/NEJMoa2203913

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This study includes a comprehensive comparison of the relative efficacy of various treatment options for type 1 diabetes through a systematic review and NMA.