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Smart pump learns your workout routine to stop dangerous sugar drops

NCT ID NCT03859401

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 artificial pancreas system that learns a person's exercise patterns to prevent low blood sugar (hypoglycemia) during and after moderate exercise. Fifteen adults with type 1 diabetes used the system for about 4 months, comparing it to a standard version. The goal was to see if the smart system could reduce dangerous low blood sugar episodes around exercise time.

What this could mean

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

Active substance
artificial pancreas system (EnMPC controller)
What this could lead to
If it works, this could help people with type 1 diabetes exercise more safely with fewer dangerous low blood sugar episodes.
What could go wrong
This was a very small, early-stage trial with only 15 participants. The system may not work for everyone or in real-world conditions outside the clinic.

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

15 people

The number who actually took part.

Started

Apr 2019

Finished

Jan 2020

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 to 65 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: * Age ≥18 and ≤65 years * Clinical diagnosis of Type 1 Diabetes for at least one year * Currently using an insulin pump for at least 6 months * Uses insulin parameters such as carbohydrate ratio and correction factors consistently on their insulin pump in order to dose insulin for meals or corrections * Access to internet and willingness to upload data during the study * Willingness to be physically active for at least 30 minutes per day at least 4 times per week * Willingness to perform the required exercise regimen during Data Collection Period * Willingness to not perform regular exercise outside of the study-regimented exercise window * For females, not currently pregnant or breastfeeding. If a female is of child-bearing potential and sexually active, she must agree to use a form of contraception to prevent pregnancy while participating in the study. * An understanding and willingness to follow the protocol and sign informed consent. Exclusion Criteria: * History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment. * Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment. * Pregnancy or intent to become pregnant during the trial. * Currently being treated for a seizure disorder * Coronary artery disease or heart failure, unless written clearance is received from a cardiologist or primary care provider and documentation of a negative stress test within the year * History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted) * Clinically significant electrocardiogram (ECG) at time of Screening, as interpreted by the study medical physician. * Use of non-insulin glucose-lowering agent (including GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals) with the exception of participants who have been on a stable dose of Metformin for at least 3 months. * A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples: * Inpatient psychiatric treatment in the past 6 months * Presence of a known adrenal disorder * Abnormal liver function test results (Transaminase \>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function * Uncontrolled thyroid disease * Use of an automated insulin delivery mechanism that is not FDA approved during the data collection phase * Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team * Inability to be physically active for at least 30 minutes per day for at least 4 times per week * Current enrollment in another clinical trial, unless approved by the investigators of both studies or if clinical trial is a non-interventional registry trial.

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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

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

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