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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

179 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-29

Study Completion Date

2025-03-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Tresiba®

NCT01984372

Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

COMPLETED

A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Saudi Arabia, as Part of Local Clinical Practice

NCT05230589

Diabetes Mellitus, Type 2

COMPLETED

Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients

NCT04075513

Type 1 Diabetes Mellitus

COMPLETED PHASE4

Effect of Short-term Basal Insulin Initiation in Newly Diagnosed Type 2 Diabetes on 1-year Glycemic Control

NCT06107153

Type2diabetes

COMPLETED PHASE3

Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens

NCT01365507

Diabetes Diabetes Mellitus, Type 2

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Insulin degludec

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tresiba

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No