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Smart pen could make insulin dosing easier for teens with diabetes

NCT ID NCT05515939

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 3 times

Summary

This study tests whether a Bluetooth-enabled smart insulin pen, called InPen, can help teenagers with type 1 diabetes better control their blood sugar. The device helps calculate insulin doses and tracks injections, which may reduce errors. The trial involves 34 teens aged 13-21 who use multiple daily injections and have poor blood sugar control.

What this could mean

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

Active substance
InPen smart insulin pen (device)
What this could lead to
If it works, this could give teens with type 1 diabetes a simpler way to manage insulin doses and improve blood sugar control.
What could go wrong
This is a small, early-stage study with only 34 participants, so results may not apply to everyone. The device is a tool, not a cure, and success depends on consistent use.

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.

Participants

About 34 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

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.

Who is studied

Patients aged 13-21 years of age with Type 1 Diabetes who will be initiating treatment with the InPen insulin pen device

Ages

13 to 21 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: 1. Patients from 13-21 years of age (inclusive) at the time of enrollment. 2. Patients diagnosed with type 1 diabetes for more than 6 months. 3. Patients with uncontrolled T1D as defined by an elevated HbA1c \> 8% within the last 3 months prior to the start of the study. 4. Patients using multiple daily injections of insulin (MDI); basal- bolus regimen requiring three or more injections per day. 1. Basal insulin requirement: one or two dose per day of a long-acting insulin analog: insulin glargine U-100 (Lantus or Basaglar), insulin glargine U-300 (Toujeo), insulin detemir (Levemir), or insulin degludec (Tresiba). 2. Bolus insulin requirement: three or more doses per day of a rapid-acting insulin analog: insulin lispro (Humalog or Admelog) or insulin aspart (Novolog or Fiasp). 5. Completion of basic diabetes education program within first year of diagnosis including management of hyperglycemia and hypoglycemia. 6. Patients not actively using InPen (including discontinuation of the InPen for at least 12 weeks). Exclusion Criteria: 1. Pediatric patients with T1D with health conditions that may impact glycemic control (e.g., uncontrolled hypothyroidism or hyperthyroidism or prolonged use (more than 2 weeks) of exogenous steroids), pregnancy, language barrier, or inability to obtain informed consent from patient and/or caregiver. 2. Patients who are unable to obtain insurance approval to cover the cost for the InPen device and insulin cartridges for the InPen. 3. Patients with T1D who are allergic to Humalog and Novolog insulin analogs. 4. Patients/caregivers who are unwilling to switch to the InPen device and/or insulin cartridges required for the use of the InPen device. 5. Patients who do not own a smartphone or tablet that is compatible with the InPen App.

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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

  • Wayne State University

    Detroit, Michigan, 48221, United States

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