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New automated insulin system tested for hospital diabetes care

NCT ID NCT07646067

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new automated insulin delivery system for people with type 1 or type 2 diabetes in a hospital setting. Six participants will have their blood sugar controlled by the system for 24 hours while eating standard meals. The goal is to see if the system can keep blood sugar levels in a safe range without causing dangerously low sugar.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 6 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 70 years

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: * Participants with type 1 and type 2 diabetes are eligible to be included in the study only if they meet all the following criteria: 1. Are 18-70 years of age, inclusive. 2. Can understand and sign an informed consent, communicate with the investigator, and understand and comply with the protocol requirements. 3. Have had a diagnosis of type 1 or type 2 diabetes for a period of at least 3 months. 4. Use insulin injections at home for glucose control. 5. Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%. 6. Have a hemoglobin in the range for sex: 1. Females: 7-15.5 grams/dL. 2. Males: 7-17.5 grams/dl. 7. Have adequate venous access sites in upper extremities. 8. Body weight between 40 - 150 kg. Exclusion Criteria: 1. Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening. 2. Have a known hypersensitivity to any of the components of study treatment. 3. Have skin disease/injury at Dexcom G6 CGM insertion site(s) that would prevent insertion of the CGM. 4. Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant. 5. Have a medical condition that in the opinion of the investigator could affect study participation and/or personal well-being. 6. Have a clinically significant history or presence of any of the following conditions: 1. Hepatic failure or has alanine aminotransferase (ALT) greater than 3 times the upper limit of normal. 2. Has an estimated GFR \<30 ml/min/1.73 m2 or End Stage Kidney Disease on renal replacement therapy. 3. Have congestive heart failure greater than class 1 on the NYHA classification system. 4. Have a history of seizures. 5. Have a history of cerebrovascular accident. 6. Have a history of ischemic heart disease. 7. For female subjects of potential childbearing age (age 18 to 55) they will be excluded if: 1. Pregnant. 2. Refuse to agree to a pregnancy test at the time of enrollment. 3. Have a positive urine pregnancy test at the time of enrollment. 8. Have a positive Influenza or COVID test within 14 days of visit 3. 9. Have any viral lower respiratory related symptoms (e.g., cough, chest tightness, respiratory distress) in the 14-day period prior to visit 3. 10. Have a known unprotected Influenza or COVID exposure in the 14-day period prior to visit 3. 11. Are currently being treated with Hydroxyurea, a medication which may cause the Dexcom G6 CGM to produce glucose readings that are higher than the actual glucose value.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.