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App helps diabetes patients get insulin doses right

NCT ID NCT06153537

Disease control Sponsor: Novo Nordisk A/S 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study looked at whether a mobile app called 'Dose Check' helps people with type 2 diabetes control their blood sugar when used with the insulin Tresiba. 179 adults in Saudi Arabia used the app alongside their regular insulin for about 6-7 months. Researchers measured changes in HbA1c (a blood sugar marker) and how many patients hit their personal blood sugar targets.

What this could mean

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

Active substance
insulin degludec (Tresiba) and a mobile app called Dose Check
What this could lead to
If successful, this could show that using a smartphone app alongside insulin helps people with type 2 diabetes better manage their blood sugar levels in everyday life.
What could go wrong
This is a completed observational study with no control group, so results may not prove cause and effect. The app and insulin are already approved, so the main question is how well they work together in real-world settings.

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

179 people

The number who actually took part.

Started

Nov 2023

Finished

Mar 2025

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 with T2DM and aged less than or equal to 21 years.

Ages

21 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 21 years at the time of signing informed consent. * Diagnosed with type 2 diabetes mellitus (T2DM) above or equal to 12 weeks prior to signing consent. * The decision to initiate treatment with commercially available Dose Check app as a part of treatment along with Tresiba as per the local label, has been made by the participant and the treating physician before and independently from the decision to include the participant in this study. * Available HbA1c value less than or equal to 12 weeks prior to the 'Informed consent and initiation of Dose Check app visit' (V1) or HbA1c measurement taken in relation with the 'Informed consent and initiation of Dose Check app visit (V1)' (V1) or planned soon after V1 (less than or equal to 7 days), if in line with local clinical practice. * Willingness to continue using the Dose Check app on a compatible smartphone according to the intended use for the entire duration of the study. Exclusion Criteria: * Previous participation in this study. Participation is defined as having signed informed consent in this study. * Women known to be pregnant or breastfeeding, or women planning to become pregnant during the conduct of the study. * Treatment with any investigational drug or software as medical device (SaMD) within 30 days prior to enrolment into the study. * Diagnosed with type 1 diabetes mellitus. * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. * Hypersensitivity to the active substance or any of the excipients as specified in the Tresiba local label. * On treatment with Tresiba for above 3 months or at dose above 20 units at Informed consent and initiation of Dose Check app visit (V1).

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus type 2

Contacts and locations

Locations

  • Al Hammadi

    Riyadh, 11564, Saudi Arabia

  • Al Hammadi

    Riyadh, 12474, Saudi Arabia

  • Al Mowasat Khobar

    Khobar, 34234, Saudi Arabia

  • Almoosa Specialist Hospital

    Ihsaa, 22141, Saudi Arabia

  • Dr. Sulaiman Al Habib Medical Group- Olaya

    Riyadh, 11643, Saudi Arabia

  • Dr. Sulaiman Al Habib Medical Group- Swedi

    Riyadh, 12987, Saudi Arabia

  • Dr. Sulaiman Al Habib- Al Qassim

    Buraidah, Al Qassim, 51431, Saudi Arabia

  • King Fahad Hospital of the University

    Khobar, 34445, Saudi Arabia

  • King Fahd Medical City, Riyadh, KSA

    Riyadh, 12231, Saudi Arabia

  • My clinic

    Jeddah, Saudi Arabia

  • Saudi German Hospital

    Jeddah, 23521, Saudi Arabia

  • Saudi German Hospital

    Khamis Mushait, 62451, Saudi Arabia

  • Saudi airlines Medical Services

    Jeddah, 21231, Saudi Arabia

  • Sulaiman Al Habib- Al Khobar

    Khobar, 34423, Saudi Arabia

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