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Smart pen tracks insulin doses to improve diabetes control

NCT ID NCT05069545

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether using a smart insulin pen (NovoPen 6) with two insulins (Tresiba and Fiasp) helps people with type 1 diabetes achieve better blood sugar levels. About 411 adults took part for 9-11 months, using their own continuous glucose monitor and a mobile app to see insulin doses alongside glucose readings. The goal was to see if having this data together improves time spent in the target blood sugar range.

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

411 people

The number who actually took part.

Started

Oct 2021

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants will use Tresiba® and Fiasp® in NovoPen® 6 as prescribed to participants by the study doctor

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: * Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). * Male or female, age above or equal to 18 years at the time of signing consent. * Diagnosed with T1DM (Type 1 Diabetes Mellitus) for above or equal to 1 year (365 days) at the time of signing consent. * On treatment with Tresiba® for more than or equal to 1 month (30 days) and Fiasp® for for more than or equal to 3 months (90 days) at the time of signing consent. * The decision to initiate the use of commercially available NovoPen® 6 as a part of treatment with Tresiba® and Fiasp® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study. * Current user of a rtCGM (Real-Time Continuous Glucose Monitoring) or isCGM (Intermittent-scanning Continuous Glucose Monitoring) for greather than or equal to 2 months (60 days) of which the last 14 days must be on rtCGM or isCGM, which can integrate the data with diabetes treatment support solution from either Glooko or Abbott, at the time of signing consent. * Willingness to continue using a rtCGM or isCGM for the duration of the study, which can integrate the data with diabetes treatment support solution from either Glooko or Abbott. * Current user of a diabetes treatment support solution from either Glooko or Abbott, which can integrate the NovoPen® 6 injection data and the rtCGM/isCGM data, and willingness to continue using the same solution for the duration of the study. Exclusion Criteria: * Previous participation in this study. Participation is defined as having given consent in this study. * Treatment with any investigational drug within 30 days prior to enrolment into the study. * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. * Use of any smart pen or smart cap for the diabetes treatment prior to the signing consent.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

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

Diabetes mellitus, type 1

Contacts and locations

Locations

  • Aarhus Universitetshospital Diabetes og Hormonsygdomme

    Aarhus N, 8200, Denmark

  • Ap-Hp-Hopital Bichat-Claude Bernard-1

    Paris, 75877, France

  • Bispebjerg Hospital, IC-Forskning

    Copenhagen, 2400, Denmark

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91106, France

  • Centre Hospitalier Universitaire de Caen Normandie- Cote de Nacre

    Caen, 14033, France

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000, Belgium

  • Centre Hospitalier Universitaire de Montpellier-Hopital Lapeyronie

    Montpellier, 34295, France

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2

    Toulouse, 31054, France

  • Centrum for Diabetes, Academical Specialist Centrum

    Stockholm, 113 65, Sweden

  • Chru de Nancy - Hopital Brabois

    Vandœuvre-lès-Nancy, 54511, France

  • Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie

    Brussels, 1200, Belgium

  • Diabetesmottagningen, Medicinkliniken, Södra Älvsborgs Sjukhus

    Borås, 501 82, Sweden

  • Diabetesmottagningen, Södra Älvsborgs Sjukhus

    Borås, 501 82, Sweden

  • Endokrinologiska kliniken, Malmö

    Malmö, 205 02, Sweden

  • Frölunda Specialistsjukhus

    Västra Frölunda, 42144, Sweden

  • HUB - Hôpital Erasme

    Brussels, 1070, Belgium

  • Hospices Civils de Lyon-Hopital Lyon Sud-2

    Pierre-Bénite, 69495, France

  • Imeldaziekenhuis - Bonheiden - Department of Endocrinology

    Bonheiden, 2820, Belgium

  • Medicinkliniken Sundsv

    Sundsvall, 851 86, Sweden

  • Medicinmottagning1 Universitetssjukhuset Örebro

    Örebro, 701 85, Sweden

  • Medicinsk Afdeling B, Herning Centralsygehus

    Herning, 7400, Denmark

  • Regionshospitalet Silkeborg - Endokrinologisk afd.

    Silkeborg, 8600, Denmark

  • UZ Leuven - Endocrinology

    Leuven, 3000, Belgium

  • UZA - UZ Antwerpen - Department of Endocrinology

    Edegem, 2650, Belgium

  • Uppsala universitetssjukhus

    Uppsala, 751 85, Sweden

  • hôpital Saint Joseph Saint Luc

    Lyon, 69365, France

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