A Research Study in Saudi Arabia to Understand How the Dose Check App Used With Tresiba Treatment Helps to Control Blood Sugar Level (DEAL-2)

January 7, 2026 updated by: Novo Nordisk A/S

A Multi-centre, Prospective, Non-interventional, Single-arm Study Investigating Glycaemic Control Associated With the Use of Dose Check App and Insulin Degludec in Patients With Type 2 Diabetes Mellitus in Saudi Arabia Under Real-world Setting

This study looks at how a mobile based app called 'Dose Check' used along with Tresiba helps to control blood sugar level in participants with type 2 diabetes mellitus. Participants will get Tresiba as prescribed by the study doctor or participants will continue already prescribed treatment with Tresiba. Participants will also be prescribed to use Dose Check app by the study doctor and will be asked to install the Dose Check app in their mobile phone, which will support participants with the correct dose of Tresiba. This study will last for about 6 to 7 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

179

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Ihsaa, Saudi Arabia, 22141
        • Almoosa Specialist Hospital
      • Jeddah, Saudi Arabia, 23521
        • Saudi German Hospital
      • Jeddah, Saudi Arabia, 21231
        • Saudi Airlines Medical services
      • Jeddah, Saudi Arabia
        • My clinic
      • Khamis Mushait, Saudi Arabia, 62451
        • Saudi German Hospital
      • Khobar, Saudi Arabia, 34234
        • Al Mowasat Khobar
      • Khobar, Saudi Arabia, 34423
        • Sulaiman Al Habib- Al Khobar
      • Khobar, Saudi Arabia, 34445
        • King Fahad Hospital of the University
      • Riyadh, Saudi Arabia, 11643
        • Dr. Sulaiman Al Habib Medical Group- Olaya
      • Riyadh, Saudi Arabia, 12474
        • Al Hammadi
      • Riyadh, Saudi Arabia, 12987
        • Dr. Sulaiman Al Habib Medical Group- Swedi
      • Riyadh, Saudi Arabia, 12231
        • King Fahd Medical City, Riyadh, KSA
      • Riyadh, Saudi Arabia, 11564
        • Al Hammadi
    • Al Qassim
      • Buraidah, Al Qassim, Saudi Arabia, 51431
        • Dr. Sulaiman Al Habib- Al Qassim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Insulin degludec + dose check
Participants will be treated with commercially available insulin degludec used with Dose Check app according to local label and routine clinical practice at the discretion of the treating physician.
Drug: Insulin degludec
Participants will be treated with commercially available insulin degludec used with Dose Check app according to local label and routine clinical practice at the discretion of the treating physician.
Other Names:
  • Tresiba

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycated haemoglobin (HbA1c)
Time Frame: From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
Measured in percentage point.
From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants reaching individual HbA1c target set by physician
Time Frame: end of study visit (week 26 [-4 to +8 weeks])
Measured as number of participants (yes/no).
end of study visit (week 26 [-4 to +8 weeks])
Participants reaching physician set individual fasting blood glucose (FBG) target
Time Frame: From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
Measured as number of participants (yes/no).
From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
Time to physician set individual FBG target from first reported FBG
Time Frame: From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
Measured in weeks.
From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
Participants achieving target level FBG according to clinical guidance
Time Frame: From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
Measured as number of participants (yes/no).
From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
Change in laboratory measured FPG
Time Frame: From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
Measured in milligrams per deciliter (mg/dL).
From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2023

Primary Completion (Actual)

March 24, 2025

Study Completion (Actual)

March 24, 2025

Study Registration Dates

First Submitted

November 23, 2023

First Submitted That Met QC Criteria

November 23, 2023

First Posted (Actual)

December 1, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-7588
  • U1111-1288-8138 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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