Automated Insulin Delivery for Diabetes

(AIDING Trial)

Recruiting at 2 trial locations

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

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

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

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized controlled trial will test the efficacy and safety of automated insulin delivery (AID) in hospitalized patients with diabetes (type 1 or type 2) requiring insulin therapy who are admitted to general medical/surgical floors. The main objectives of this study are: * To test the efficacy and safety of AID versus multiple daily insulin injections (MDI) + CGM in the inpatient setting * To determine differences in CGM-derived metrics between AID and MDI plus CGM in the hospital and explore differences in treatment effect according to individual characteristics. Participants will be: * Randomized to AID + remote CGM (intervention) or multiple daily insulin injections (MDI) + CGM (control group) * Followed for a total of 10 days or until hospital discharge (if less than 10 days).

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 data supports the effectiveness of the treatment Automated Insulin Delivery (AID) system with Remote Real-Time CGM for diabetes?

Research shows that Automated Insulin Delivery (AID) systems, which combine insulin pumps and continuous glucose monitors (CGM), are effective in managing blood sugar levels in people with diabetes. In a study with hospitalized patients, the AID system helped maintain blood sugar within the target range 68% of the time, with no severe low blood sugar events, indicating its potential effectiveness and safety. ^{1 2 3 4 5}

Is automated insulin delivery safe for humans?

Automated insulin delivery systems have been shown to be safe in humans, with studies reporting no severe hypoglycemia (dangerously low blood sugar) or diabetic ketoacidosis (a serious diabetes complication) events. These systems have been tested in both hospital settings and outpatient studies, proving their safety for people with diabetes. ^{1 2 3 4 6}

How does the Automated Insulin Delivery (AID) system with Remote Real-Time CGM differ from other diabetes treatments?

The Automated Insulin Delivery (AID) system with Remote Real-Time Continuous Glucose Monitoring (CGM) is unique because it automates insulin delivery based on real-time glucose levels, reducing the need for manual adjustments. This system uses an algorithm to determine insulin delivery rates, aiming to maintain optimal blood sugar levels more effectively than traditional methods, which rely heavily on patient intervention. ^{1 7 8 9 10}

Research Team

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

Principal Investigator

Emory University

Eligibility Criteria

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

I am currently admitted to the ICU.

Patients anticipated to require less than 48 hours of admission

I am receiving outpatient artificial insulin delivery.

Exclusion Criteria

I am unable to give consent for medical procedures.

I am under 18 years old.

Pregnant women

Trial Timeline

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

Treatment Details

Interventions

• AID system with Remote Real-Time CGM (Automated Insulin Delivery)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

References

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

Future of Automated Insulin Delivery Systems. [2018]

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

Current Status and Emerging Options for Automated Insulin Delivery Systems. [2023]

3. United States 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. [2023]

4. England 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. [2023]

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

Outcomes in Pump- and CGM-Baseline Use Subgroups in the International Diabetes Closed-Loop Trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Review of Automated Insulin Delivery Systems for Individuals with Type 1 Diabetes: Tailored Solutions for Subpopulations. [2022]

7. United States 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. [2022]

8. United States 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. [2022]

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

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

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring Sensors for Diabetes Management: A Review of Technologies and Applications. [2020]