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Smart insulin systems aim to simplify diabetes management

NCT ID NCT02994277

Disease control Sponsor: Hospital Italiano de Buenos Aires 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This pilot study tested two computer algorithms designed to automatically control blood sugar levels in people with type 1 diabetes. Five adults who already use an insulin pump and continuous glucose monitor participated. The goal was to see if the systems could keep blood sugar in a safe range without constant user input.

What this could mean

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

Active substance
Closed-loop insulin delivery system (UVa and ITBA/UNLP algorithms)
What this could lead to
If successful, this could lead to a more automated way to manage blood sugar in type 1 diabetes, reducing the need for constant manual adjustments.
What could go wrong
This is a very small pilot study with only 5 participants, so results may not apply to everyone. The technology may still have technical failures or safety issues.

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

5 people

The number who actually took part.

Start date

Nov 2016

Finished

Jul 2017

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: * Patient have been diagnosed with T1DM at least two years ago and have been using an insulin pump and a CGM for at least 6 months prior to the trial first visit. * Patient is \>18 and \<65 years. * Patient has HbA1c \> 6.5 % and \< 10%. * Woman in premenopausal age agrees to use contraceptive methods. * Woman in premenopausal age has negative B-HCG in the tests performed in the trial. * Patient is trained in carbohydrates counting. * Patient has signed informed consent and has the ability to understand the nature and intent of the study including the ability to comply with study procedures and is willing to keep scheduled visits. Exclusion Criteria: * Patient has been hospitalized for diabetic ketoacidosis in the last 12 months. * Patient has experienced severe hypoglycemia with loss of consciousness in the last 12 months. * Patient has a history of coronary disease or cardiac failure. * Patient with uncontrolled arterial hypertension. * Patient with a condition that makes the researcher believe that it might increase the chance of hypoglycemia. * Patient has symptoms compatible with an active infectious disease. * Patient has Cystic Fibrosis. * Pregnant women, or women with the intention of getting pregnant; women breastfeeding. * Patient has been hospitalized for psychiatric treatment in the last 6 months. * Patient with a diagnosis of an adrenal disease. * Patient has abnormal laboratory values for liver function: transaminase \> 2x upper limit of normal. * Patient has abnormal laboratory values for renal function: GFR \< 60 ml/min/1.73m2 * Patient has active gastroparesis. * Patient is under oncological treatment. * Patient has taken acetaminophen 72 hours previous to the study.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 1 diabetes mellitus

As listed by the trial registrant

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

Diabetes

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