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

NCT06153537 | Completed

• 2 other identifiers: NN1250-7588U1111-1288-8138
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Participants reaching individual HbA1c target set by physician

  end of study visit (week 26 [-4 to +8 weeks])

• Participants reaching physician set individual fasting blood glucose (FBG) target

  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

  From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])

• Participants achieving target level FBG according to clinical guidance

  From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])

• Change in laboratory measured FPG

  From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])

Study Arms (1)

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

Interventions

Insulin degludec DRUG

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.

Also known as: Tresiba

Insulin degludec + dose check

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (14)

Dr. Sulaiman Al Habib- Al Qassim

Buraidah, Al Qassim, 51431, Saudi Arabia

Location

Almoosa Specialist Hospital

Ihsaa, 22141, Saudi Arabia

Location

Saudi airlines Medical Services

Jeddah, 21231, Saudi Arabia

Location

Saudi German Hospital

Jeddah, 23521, Saudi Arabia

Location

My clinic

Jeddah, Saudi Arabia

Location

Saudi German Hospital

Khamis Mushait, 62451, Saudi Arabia

Location

Al Mowasat Khobar

Khobar, 34234, Saudi Arabia

Location

Sulaiman Al Habib- Al Khobar

Khobar, 34423, Saudi Arabia

Location

King Fahad Hospital of the University

Khobar, 34445, Saudi Arabia

Location

Al Hammadi

Riyadh, 11564, Saudi Arabia

Location

Dr. Sulaiman Al Habib Medical Group- Olaya

Riyadh, 11643, Saudi Arabia

Location

King Fahd Medical City, Riyadh, KSA

Riyadh, 12231, Saudi Arabia

Location

Al Hammadi

Riyadh, 12474, Saudi Arabia

Location

Dr. Sulaiman Al Habib Medical Group- Swedi

Riyadh, 12987, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 1, 2023
• Study Start: November 29, 2023
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

SA (14)