Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Smart pen cap could help tame blood sugar in type 1 diabetes

NCT ID NCT06845891

Disease control Sponsor: Fernando Sebastián Valles 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study tested a smart cap that attaches to insulin pens to help people with type 1 diabetes track their injections and glucose data. 42 adults used the device or a blinded version for comparison. The goal was to see if it reduces time spent with high blood sugar and improves overall glucose control.

What this could mean

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

Active substance
Connected smart cap device for insulin pens
What this could lead to
If it works, this could help people with type 1 diabetes better manage their blood sugar and reduce complications.
What could go wrong
This is a small, single-center study with only 42 participants. The device is an add-on tool, not a cure, and results may not apply to everyone.

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

42 people

The number who actually took part.

Started

Feb 2025

Finished

Jun 2025

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 years and older

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: * Men and women aged 18 years or older. * Diagnosis of type 1 diabetes mellitus (T1DM). * Users of flash continuous glucose monitoring (FGM) sensors with \>70% of recorded data, including intake and insulin dose logs. * Adequate therapeutic adherence, with no missed appointments in the past year. * Time above range (TAR \>180 mg/dL) \>25%. * Ability to provide informed consent to participate in the study. * Access to technology for follow-up, including a smartphone with internet connectivity and compatibility with the Insulcloud app. Exclusion Criteria: * Current pregnancy. * Severe acute illness. * Exclusion criteria for the use of real-time continuous glucose monitoring (RT-CGM) systems as per the Framework Agreement of the Community of Madrid for RT-CGM use (SERMAS). * Inability to provide informed consent or to meet the study requirements for any reason.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Diabetes management are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Diabetes management Type 1 diabetes mellitus Type 1 diabetes mellitus (T1DM)

Contacts and locations

Locations

  • Hospital Universitario de La Princesa

    Madrid, Madrid, 28006, Spain

More trials for these conditions

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