Diabetes Mellitus, Type 2DEAL-2NCT06153537
A Research Study in Saudi Arabia to Understand How the Dose Check App Used With Tresiba Treatment Helps to Control Blood Sugar Level
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 14 sites in Saudi Arabia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin degludec
- How many people
- 179 participants
- Where
- 14 sitesSaudi Arabia
- Study dates
- 29 Nov 2023to 24 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with T2DM and aged less than or equal to 21 years.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Saudi Arabia14 sites
Dr. Sulaiman Al Habib- Al Qassim
Buraidah, Al Qassim, 51431
Almoosa Specialist Hospital
Ihsaa, 22141
Saudi airlines Medical Services
Jeddah, 21231
Saudi German Hospital
Jeddah, 23521
My clinic
Jeddah
Saudi German Hospital
Khamis Mushait, 62451
Al Mowasat Khobar
Khobar, 34234
Sulaiman Al Habib- Al Khobar
Khobar, 34423
King Fahad Hospital of the University
Khobar, 34445
Al Hammadi
Riyadh, 11564
Dr. Sulaiman Al Habib Medical Group- Olaya
Riyadh, 11643
King Fahd Medical City, Riyadh, KSA
Riyadh, 12231
Al Hammadi
Riyadh, 12474
Dr. Sulaiman Al Habib Medical Group- Swedi
Riyadh, 12987
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin degludec
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin degludecDrug
Also called Tresiba
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Insulin degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated haemoglobin (HbA1c)
Measured in percentage point.
Measured: From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
Secondary outcomes (5)
Participants reaching individual HbA1c target set by physician
Measured as number of participants (yes/no).
Measured: end of study visit (week 26 [-4 to +8 weeks])
Participants reaching physician set individual fasting blood glucose (FBG) target
Measured as number of participants (yes/no).
Measured: 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
Measured in weeks.
Measured: From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
Participants achieving target level FBG according to clinical guidance
Measured as number of participants (yes/no).
Measured: From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
Change in laboratory measured FPG
Measured in milligrams per deciliter (mg/dL).
Measured: From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start29 Nov 2023
- Primary completion24 Mar 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153537
- Sponsor's protocol ID
- NN1250-7588
- Other IDs
- U1111-1288-8138
- Acronym
- DEAL-2
- Status last verified
- Jan 2026
- First submitted
- 23 Nov 2023
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06153537
- Acronym / sponsor ID
- DEAL-2 / NN1250-7588
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin degludec + dose check | – | Drug: Insulin degludecParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with T2DM and aged less than or equal to 21 years.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin degludecAlso: TresibaParticipants 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 + dose check |
Primary outcome
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.
5 secondary outcomes
Participants reaching individual HbA1c target set by physician
Time frame: 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])
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])
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])
Change in laboratory measured FPG
Time frame: From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 14 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycated haemoglobin (HbA1c) (time frame: From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.