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Automated Insulin Delivery

Automated Insulin Delivery for Diabetes (AIDING Trial)

Phase 3

Waitlist Available

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

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients admitted to ICU

Patients who are pregnant or breastfeeding at the time of enrollment

Must not have

Adults unable to consent

Individuals who are not yet adults (infants, children, teenagers)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 days (or hospital discharge if before 10 days)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test a new automated insulin delivery system for patients with diabetes in the hospital. The study will compare the effectiveness and safety of the automated system versus the standard multiple daily insulin injections with continuous glucose

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical risks associated with insulin therapy such as low blood sugar levels, allergic reactions at injection sites, and possible inaccuracies in glucose monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently admitted to the ICU.

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I am not pregnant or breastfeeding.

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I have type 2 diabetes, use insulin only as needed, and my blood sugar is under 180 mg/dl.

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I am currently experiencing severe uncontrolled diabetes symptoms.

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I have high blood sugar due to stress, not diabetes, and my HbA1c is below 6.5%.

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I cannot or will not use specific rapid-acting insulins in the study.

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I am able to understand and consent to participate in a study.

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I use more than 150 units of insulin daily.

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I am currently taking hydroxyurea, acetaminophen (>4 grams/day), or high dose ascorbic acid.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give consent for medical procedures.

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I am under 18 years old.

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I have difficulty making decisions due to cognitive impairment.

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I understand English or Spanish well enough to participate in surveys and interviews.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 days (or hospital discharge if before 10 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 days (or hospital discharge if before 10 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 days (or hospital discharge if before 10 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy: Time spent in glucose target range

Safety: Time spent below the target glucose range

Secondary study objectives

Mean hospitalization glucose

TAR >250mg/dl

TBR <70 mg/dl

Other study objectives

Glycemic events above 300 mg/dl

Glycemic events below 54 mg/dl

Number of Diabetes-related Ketoacidosis Events

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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: ControlActive Control1 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)

0 / 13Eligibility criteria met