Automated Insulin Delivery for Diabetes

(AIDING Trial)

No longer recruiting at 2 trial locations

Overseen By Francisco Pasquel, M.D., M.P.H

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Emory University

Must be taking: Insulin

Must not be taking: Hydroxyurea, Acetaminophen, Ascorbic acid

Disqualifiers: ICU admission, Hyperglycemic crises, Severe anemia, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 10 days or until hospital discharge

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new automated insulin delivery (AID) system to determine if it manages blood sugar levels in hospital patients with diabetes more effectively than usual insulin shots. The trial aims to assess the effectiveness and safety of the AID system compared to regular multiple daily insulin injections with a continuous glucose monitor (CGM). Participants will either use the AID system with Remote Real-Time CGM or continue with traditional insulin shots for up to 10 days or until they leave the hospital. The study seeks individuals with diabetes who are already on insulin therapy and admitted to a general hospital ward. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be willing to use rapid-acting insulin analogs like Humalog, Admelog, or Novolog during the study.

What prior data suggests that this automated insulin delivery system is safe for hospitalized patients with diabetes?

Research has shown that the automated insulin delivery (AID) system, which uses remote real-time continuous glucose monitoring (CGM), is generally safe. Studies found that the tubeless AID system does not significantly increase the risk of severe hypoglycemia (very low blood sugar) or diabetic ketoacidosis (a serious diabetes complication), both important safety considerations.

The AID system also helps people with type 1 diabetes manage their blood sugar better than traditional insulin pumps, proving it effective and well-tolerated by patients. Additionally, the Omnipod 5 version of the AID system is already available in several countries, further supporting its safety.

While all medical devices carry some risks, evidence so far indicates that this AID system is safe for people with diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the Automated Insulin Delivery (AID) system with Remote Real-Time Continuous Glucose Monitoring (CGM) because it offers a new way to manage diabetes. Unlike traditional methods that require manual insulin injections and frequent blood sugar checks, this system automates insulin delivery and continuously monitors glucose levels. The AID system integrates with a smartphone and is remotely monitored, potentially improving convenience and accuracy in managing blood sugar. This innovative approach could lead to better glucose control and more flexibility for patients, making it a promising advancement in diabetes care.

What evidence suggests that the AID system with Remote Real-Time CGM is effective for diabetes?

Studies have shown that the Omnipod 5 Automated Insulin Delivery (AID) system, which integrates with continuous glucose monitoring (CGM), helps people with type 1 diabetes better control their blood sugar. In this trial, participants in the intervention arm will use the Omnipod 5 AID system with integrated Dexcom CGM. Research indicates that this system can improve blood sugar levels compared to a traditional insulin pump with CGM. It automatically adjusts insulin doses based on real-time blood sugar readings, helping to maintain more stable levels. Previous findings suggest it is safe and effective for managing diabetes, even for short-term use, such as during a hospital stay. The Omnipod 5 AID system has shown promising results in maintaining blood sugar levels within a healthy range. ^{1 2 3 5 6}

Who Is on the Research Team?

Francisco Pasquel, M.D., M.P.H

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for hospitalized patients with type 1 or type 2 diabetes who need insulin. Participants will be randomly assigned to one of two groups and followed for up to 10 days or until they leave the hospital.

Inclusion Criteria

Patients anticipated to require less than 48 hours of admission

Severe anemia with hemoglobin <7 g/dL

Patients who previously participated in AIDING feasibility trial or this RCT

Exclusion Criteria

I am unable to give consent for medical procedures.

I am under 18 years old.

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either automated insulin delivery (AID) or multiple daily insulin injections (MDI) with continuous glucose monitoring (CGM) for glucose control

Up to 10 days or until hospital discharge

Daily monitoring and adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AID system with Remote Real-Time CGM

Trial Overview The study compares automated insulin delivery (AID) with a remote continuous glucose monitor (CGM) against standard multiple daily insulin injections plus CGM, focusing on their effectiveness and safety in an inpatient setting.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants in the intervention arm will be assigned to the Omnipod 5 AID system with integrated Dexcom CGM. These devices will communicate with a patient-specific smartphone secured within the patient room and remotely monitored by the nursing station. Nursing staff on medical-surgical units will provide insulin therapy using the investigational device for participants randomized to the intervention arm, including delivering insulin boluses, monitoring CGM values and trends, validating CGM accuracy against POC glucose, and performing routine device exchanges (Pod or CGM) when indicated AID therapy will continue for 10 days or until hospital discharge (if \<10 days)

Group II: Control Active Control 1 Intervention

The control group will follow the hospital's usual practice for subcutaneous insulin for glucose control. It will be managed by the admitting team with the assistance of an inpatient endocrine team. Participants will wear a real-time CGM for 10 days or until hospital discharge (if \<10 days)

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The Omnipod 5 Automated Insulin Delivery (AID) System demonstrated high feasibility and safety in a hospital setting, with participants spending a median of 95% of their time in automated mode and no reported cases of severe hypoglycemia or diabetic ketoacidosis during the study.

Among the 16 participants with sufficient data, the system achieved a time-in-range (TIR) of 68%, indicating effective glucose control, and all participants expressed satisfaction with the system, suggesting it could be a promising alternative to traditional insulin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Insulin Delivery with Remote Real-Time Continuous Glucose Monitoring for Hospitalized Patients with Diabetes: A Multicenter, Single-Arm, Feasibility Trial. Davis, GM., Hughes, MS., Brown, SA., et al.[2023]

Automated insulin delivery (AID) systems have been shown to be safe and effective in improving blood sugar control for individuals with type 1 diabetes, supported by large randomized controlled studies and recent commercial approvals.

Despite their success, AID systems still face challenges in being optimized for specific groups such as young children, athletes, pregnant women, seniors, and those with hypoglycemia unawareness, indicating a need for further advancements in technology tailored to these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Automated Insulin Delivery Systems for Individuals with Type 1 Diabetes: Tailored Solutions for Subpopulations. Aiello, EM., Deshpande, S., Ozaslan, B., et al.[2022]

The development of diabetes technology, particularly continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM), has significantly advanced the management of diabetes, leading to the creation of closed-loop systems known as the 'artificial pancreas' (AP).

The first hybrid closed-loop system for diabetes management has been approved by the FDA, marking a significant step towards making advanced, automated diabetes treatment accessible for patients in the digital age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated closed-loop control of diabetes: the artificial pancreas. Kovatchev, B.[2020]

Automated insulin delivery (AID) systems, which combine rapid insulin analogs, insulin pumps, continuous glucose monitors, and control algorithms, have been shown to optimize metabolic control for individuals with type 1 diabetes.

The increasing availability and use of AID systems in the U.S. and Europe suggest they are becoming a key technology for achieving better glycemic control, as highlighted by the largest studies reviewed in this article.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Status and Emerging Options for Automated Insulin Delivery Systems. Forlenza, GP., Lal, RA.[2023]

Wearable continuous glucose monitoring (CGM) sensors provide near real-time blood glucose measurements, significantly improving diabetes management for insulin-dependent individuals by enhancing safety and effectiveness of therapy.

CGM devices help reduce the incidence and duration of hypoglycemia, decrease glycemic variability, and support better insulin dosage decisions, showcasing their beneficial impact on diabetes treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring Sensors for Diabetes Management: A Review of Technologies and Applications. Cappon, G., Vettoretti, M., Sparacino, G., et al.[2020]

In a study involving 60 type 1 diabetic patients using continuous subcutaneous insulin infusion (CSII) and real-time continuous glucose monitoring (RT-CGM), the use of an algorithm in the first 16 weeks led to a significant reduction in A1C levels, with more patients achieving A1C levels of 7% or lower compared to those without the algorithm.

However, the algorithm did not increase the time spent in the target glucose range, and once RT-CGM was discontinued, A1C levels returned to baseline, indicating the importance of continuous monitoring for maintaining glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an algorithm to guide patients with type 1 diabetes treated with continuous subcutaneous insulin infusion on how to respond to real-time continuous glucose levels: a randomized controlled trial. Jenkins, AJ., Krishnamurthy, B., Best, JD., et al.[2022]

Continuous glucose monitoring (CGM) technology has significantly improved the management of type 1 diabetes by enabling automated insulin delivery systems, which adjust insulin rates based on real-time glucose levels.

The effectiveness and safety of these automated insulin delivery (AID) systems depend heavily on the accuracy of CGM devices, highlighting the need for future CGM technologies to meet high accuracy standards for safe integration into AID systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Future of Automated Insulin Delivery Systems. Castle, JR., DeVries, JH., Kovatchev, B.[2018]

Fully closed-loop automated insulin delivery (AID) significantly improved glycaemic control in patients with type 2 diabetes, increasing the time spent in the target glucose range by an average of 337 minutes per day across seven randomized controlled trials involving 390 patients.

The use of fully closed-loop AID also reduced the time spent in hyperglycaemia by 326 minutes per day, with no significant increase in hypoglycaemia risk, indicating a safer profile compared to conventional insulin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does fully closed-loop automated insulin delivery improve glycaemic control in patients with type 2 diabetes? A meta-analysis of randomized controlled trials. Amer, BE., Yaqout, YE., Abozaid, AM., et al.[2023]

Recent advancements in continuous glucose monitoring (CGM) devices have significantly improved diabetes management by increasing the time patients spend within glycemic targets and enhancing overall glycemic control.

The development of a closed-loop artificial pancreas, which automates insulin delivery using computer algorithms, shows promise in quickly managing blood sugar levels, potentially leading to a safe and effective semi-automated system for diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can we really close the loop and how soon? Accelerating the availability of an artificial pancreas: a roadmap to better diabetes outcomes. Kowalski, AJ.[2022]

In a six-month trial involving 168 individuals with type 1 diabetes, the use of automated insulin delivery (closed-loop control) significantly improved glycemic control across all subgroups, regardless of whether participants used insulin pumps or multiple daily injections.

Participants experienced increased time in the target glucose range (70-180 mg/dL), with improvements ranging from 54% to 73% depending on their baseline device use, indicating that the closed-loop system is effective for a diverse group of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes in Pump- and CGM-Baseline Use Subgroups in the International Diabetes Closed-Loop Trial. Ekhlaspour, L., Raghinaru, D., Forlenza, GP., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37578778/

Automated Insulin Delivery with Remote Real-Time ... - PubMed We tested the feasibility, safety, and effectiveness of the Omnipod 5 AID System with real-time continuous glucose monitoring (CGM) for up to 10 days in ...

2. diabetesjournals.org diabetesjournals.org/care/article/47/12/2248/157388/Efficacy-and-Safety-of-a-Tubeless-AID-System

Efficacy and Safety of a Tubeless AID System Compared With ... Use of the tubeless AID system led to improved glycemic outcomes compared with pump therapy with CGM among adults with type 1 diabetes, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9160549/

Clinical Implementation of the Omnipod 5 Automated ... This article reviews the features of the Omnipod 5 Automated Insulin Delivery System and how it compares to other AID systems available on or currently under ...

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.16321

Practical considerations for using the Omnipod® 5 Automated ... This article reviews the features and current multinational availability of the Omnipod® 5 Automated Insulin Delivery System and summarizes the latest evidence

5. liebertpub.com liebertpub.com/doi/10.1089/dia.2023.0578

Real-World Evidence of Omnipod® 5 Automated Insulin ... The Omnipod 5 Automated Insulin Delivery System was associated with favorable glycemic outcomes for people with type 1 diabetes (T1D) in two pivotal clinical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11655411/

Efficacy and Safety of a Tubeless AID System Compared With ... Use of the tubeless AID system led to improved glycemic outcomes compared with pump therapy with CGM among adults with type 1 diabetes.