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

Diabetes Mellitus, Type 2 Clinical Trial

— DEAL-2  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06153537
• Other study ID #: NN1250-7588
• Secondary ID: U1111-1288-8138
• Status: Enrolling by invitation
• Start date: November 29, 2023
• Est. completion date: January 27, 2025

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 175
• Est. completion date: January 27, 2025
• Est. primary completion date: January 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	Sulaiman Al Habib- Al Khobar	Al Khobar
Saudi Arabia	King Fahad Hospital of the University	Alkhobar
Saudi Arabia	Dr. Sulaiman Al Habib- Al Qassim	Buraidah	Al Qassim
Saudi Arabia	Almoosa Specialist Hospital	Ihsaa
Saudi Arabia	My clinic	Jeddah
Saudi Arabia	Saudi airlines Medical Services	Jeddah
Saudi Arabia	Saudi German Hospital	Jeddah
Saudi Arabia	Saudi German Hospital	Khamis Mushait
Saudi Arabia	Al Mowasat Khobar	Khobar
Saudi Arabia	Al Hammadi	Riyadh
Saudi Arabia	Dr. Sulaiman Al Habib Medical Group- Swedi	Riyadh
Saudi Arabia	King Fahd Medical City, Riyadh, KSA	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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