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Smart insulin pump aims to end dangerous nighttime blood sugar swings

NCT ID NCT02438189

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial tests a smart insulin pump algorithm designed to automatically adjust insulin delivery during the night to keep blood sugar levels in a safe range. The algorithm predicts when blood sugar might drop too low and pauses insulin, and when it might rise too high, it gives extra insulin. The study involves about 30 people with type 1 diabetes who use an insulin pump, and it compares nights with the algorithm on versus off to see if it improves time in the target range and reduces dangerous highs and lows.

What this could mean

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

Active substance
A smart insulin pump algorithm that automatically adjusts insulin delivery overnight to prevent blood sugar from going too high or too low.
What this could lead to
If successful, this could lead to a more automated insulin pump system that helps people with type 1 diabetes maintain safer blood sugar levels overnight, reducing the risk of dangerous nighttime episodes.
What could go wrong
This is a small, early feasibility study, so results may not apply to everyone. The algorithm may not always predict correctly, and there is a risk of severe hypoglycemia or diabetic ketoacidosis, though the trial monitors for these.

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

33 people

The number who actually took part.

Started

Jun 2015

Finished

Mar 2016

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

15 to 45 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: * Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required. * Age 15.0 to \<46.0 years * HbA1c \<10.0% * Measured with DCA2000 or equivalent device for assessing eligibility * HbA1c measurements performed as part of usual clinical care within 2 weeks prior to obtaining informed consent for participation in the trial may be used. * Uninterrupted internet access while study system is being used overnight and for upload of study data in the morning * Living with a significant other or family member ("companion") committed to participating in all study activities, and being present and available to provide assistance when the system is being used at night * An understanding of and willingness to follow the protocol and sign the informed consent Exclusion Criteria: * Diabetic ketoacidosis in the past 3 months * Hypoglycemic seizure or loss of consciousness in the past 6 months * History of seizure disorder (except for hypoglycemic seizure) * History of any heart disease including coronary artery disease, heart failure, or arrhythmias * Cystic fibrosis * Current use of oral/inhaled glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study. * History of ongoing renal disease (other than microalbuminuria). Creatinine level must have been obtained within the last year if subject has diabetes of \>10 years duration. If creatinine is \>1.5 mg/dL (132 µmol/L), the subject is excluded. * Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as: * Inpatient psychiatric treatment in the past 6 months * Uncontrolled adrenal disorder * Abuse of alcohol * Pregnancy Negative urine pregnancy test required for females who have experienced menarche as well as agreement from subject and parent/guardian to use a form of contraception to prevent pregnancy while participant is in the study. Subjects who become pregnant will be discontinued from the study. * Liver disease as defined by an ALT greater than 3 times the upper limit of normal

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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.

Contacts and locations

Locations

  • Barbara Davis Center for Childhood Diabetes

    Aurora, Colorado, 80045, United States

  • St. Joseph's Health Care

    London, Ontario, N6A4V2, Canada

  • Stanford University

    Stanford, California, 94305, United States

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