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Smart insulin pump could transform hospital diabetes care

NCT ID NCT06418880

Disease control Sponsor: Emory University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an automated insulin delivery system (the Omnipod 5) in 130 hospitalized adults with type 1 or type 2 diabetes. Patients were randomly assigned to use the automated system or standard insulin injections plus a continuous glucose monitor. The goal was to see if the automated system kept blood sugar in a healthy range more safely and effectively during their hospital stay.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Omnipod 5 automated insulin delivery system
What this could lead to
If it works, this could offer a safer, more effective way to manage blood sugar in hospitalized diabetes patients, reducing complications.
What could go wrong
This is a completed Phase 3 trial with 130 participants, but results may not apply to all hospital settings or patients. The device may have technical issues or not outperform standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

130 people

The number who actually took part.

Started

Jan 2025

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: • Any person ≥18 years of age with diabetes mellitus (except cystic fibrosis- and pregnancy-related) admitted to general (non-ICU) medical-surgical hospital services which require inpatient insulin therapy (i.e.,TID or T2D with ≥2 glucose values ≥180mg/dl) Exclusion Criteria: * Patients admitted to ICU * Patients anticipated to require less than 48 hours admission. * Current evidence of hyperglycemic crises (diabetic ketoacidosis or hyperosmolar hyperglycemic state) * Severe anemia with hemoglobin \<7 g/dL * Evidence of hemodynamic instability * Hypoxia (SpO2 \<92% on supplemental oxygen) * Pre-admission or inpatient total-daily insulin dose \>150 units daily * T2D patients on sliding scale insulin therapy alone (no scheduled basal or bolus insulin) and with glucose levels below 180 mg/dl * Patients without diabetes with stress hyperglycemia (not related to steroids or medical nutrition therapy) and with HbA1c \<6.5% * Patients on AID as outpatient * Patients who previously participated in AIDING feasibility trial or this RCT * Patients with a condition impeding their ability to consent or answer questionnaires or notify staff of symptoms. * Patients who are pregnant time of enrollment * Patients who are unable or unwilling to use rapid-acting insulin analogs (Humalog, Admelog, or Novolog) during the study * Use of hydroxyurea, high dose of acetaminophen (\>4 grams/day), or high dose ascorbic acid

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 1 diabetes Type 2 diabetes

Contacts and locations

Locations

  • Grady Health System (non-CRN)

    Atlanta, Georgia, 30322, United States

  • Stanford University School of Medicine

    Stanford, California, 94305, United States

  • University of Virginia School of Medicine

    Charlottesville, Virginia, 22903, United States

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