NCT06153537Completed
A Research Study in Saudi Arabia to Understand How the Dose Check App Used With Tresiba Treatment Helps to Control Blood Sugar Level
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
Source: ClinicalTrials.gov · Last updated 9 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 179 (actual)
- First submitted
- 23 Nov 2023
- Start date
- 29 Nov 2023
- Primary completion date
- 24 Mar 2025
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- NCT number
- NCT06153537
What you commit to
- Study type: Observational
- Participants enrolled: 179
- From 29 Nov 2023 to the primary completion date, 24 Mar 2025
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in this study. Participation is defined as having signed informed consent in this study.
- Treatment with any investigational drug or software as medical device (SaMD) within 30 days prior to enrolment into the study.
- 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).
Other illness
- Diagnosed with type 1 diabetes mellitus.
- Hypersensitivity to the active substance or any of the excipients as specified in the Tresiba local label.
Other
- Women known to be pregnant or breastfeeding, or women planning to become pregnant during the conduct of the study.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Who the study is looking for
- 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.
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. Sulaiman Al Habib- Al Qassim Coordinator of this site? Confirm its status | Buraidah | Saudi Arabia | Unknown status |
| Almoosa Specialist Hospital Coordinator of this site? Confirm its status | Ihsaa | Saudi Arabia | Unknown status |
| My clinic Coordinator of this site? Confirm its status | Jeddah | Saudi Arabia | Unknown status |
| Saudi Airlines Medical services Coordinator of this site? Confirm its status | Jeddah | Saudi Arabia | Unknown status |
| Saudi German Hospital Coordinator of this site? Confirm its status | Jeddah | Saudi Arabia | Unknown status |
| Saudi German Hospital Coordinator of this site? Confirm its status | Khamis Mushait | Saudi Arabia | Unknown status |
| Sulaiman Al Habib- Al Khobar Coordinator of this site? Confirm its status | Khobar | Saudi Arabia | Unknown status |
| Al Mowasat Khobar Coordinator of this site? Confirm its status | Khobar | Saudi Arabia | Unknown status |
| King Fahad Hospital of the University Coordinator of this site? Confirm its status | Khobar | Saudi Arabia | Unknown status |
| King Fahd Medical City, Riyadh, KSA Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| Dr. Sulaiman Al Habib Medical Group- Swedi Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| Dr. Sulaiman Al Habib Medical Group- Olaya Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| Al Hammadi Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.