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New insulin boosts artificial pancreas performance in type 1 diabetes trial

NCT ID NCT05508061

Disease control Sponsor: Inreda Diabetic B.V. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a faster-acting insulin (Lyumjev) works better than standard insulin (Humalog) in a dual-hormone artificial pancreas for people with type 1 diabetes. Twelve adults who already used the artificial pancreas took part. Each person used both insulins for 30 days to compare glucose control and safety.

What this could mean

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

Active substance
Insulin Lispro (Lyumjev and Humalog)
What this could lead to
If Lyumjev works better, it could improve blood sugar control and reduce high glucose episodes for people using an artificial pancreas.
What could go wrong
This is a small, early-stage trial with only 12 people. Results may not apply to everyone, and faster insulin could increase hypoglycemia risk.

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

12 people

The number who actually took part.

Started

Oct 2022

Finished

Mar 2023

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 75 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: * Diagnosed with diabetes mellitus type 1; * Treated with the Inreda AP system for a minimum of 1 month; * Age between 18 and 75 years; * Willing and able to sign informed consent. Since subjects are treated with the Inreda AP, the following inclusion criteria will be met: * Treated with sensor augmented pump (SAP) or CSII for a minimum of 6 months; * HbA1c \< 97 mmol/mol; * BMI \< 35 kg/m\^2; * No use of acetaminophen, as this may influence the sensor glucose measurements. Exclusion Criteria: * Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire; * Pregnancy and/or breastfeeding; * Use of oral antidiabetic agents; * Insulinoma; * Hypersensitivity reactions to Lyumjev or any of the excipients.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

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

Type 1 diabetes

Contacts and locations

Locations

  • Hospital Gelderse Vallei

    Ede, Gelderland, 6716 RP, Netherlands

  • Rijnstate Hospital

    Arnhem, Gelderland, 6815 AD, Netherlands

  • Slingeland Hospital

    Doetinchem, Gelderland, 7009 BL, Netherlands

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