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Completed

NCT Number: NCT06153537

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Sulaiman Al Habib- Al Qassim, Buraidah, Al Qassim, Saudi Arabia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: Tresiba

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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).

  5. 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).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: DEAL-2

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 1, 2023
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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