Clinical trial NCT06153537: A Research Study in Saudi Arabia to Understand How the Dose Check App Used With Tresiba Treatment Helps to Control Blood Sugar Level
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-12-01
Enrollment: 179
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with T2DM and aged less than or equal to 21 years.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in glycated haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
Secondary outcomes:
measure: Participants reaching individual HbA1c target set by physician
timeFrame: end of study visit (week 26 [-4 to +8 weeks])
measure: Participants reaching physician set individual fasting blood glucose (FBG) target
timeFrame: From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
measure: Time to physician set individual FBG target from first reported FBG
timeFrame: From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
measure: Participants achieving target level FBG according to clinical guidance
timeFrame: From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
measure: Change in laboratory measured FPG
timeFrame: From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks])
Other outcomes:
Locations:
city: Buraidah
country: Saudi Arabia
facility: Dr. Sulaiman Al Habib- Al Qassim
state: Al Qassim
city: Al Khobar
country: Saudi Arabia
facility: Sulaiman Al Habib- Al Khobar
city: Alkhobar
country: Saudi Arabia
facility: King Fahad Hospital of the University
city: Ihsaa
country: Saudi Arabia
facility: Almoosa Specialist Hospital
city: Jeddah
country: Saudi Arabia
facility: Saudi airlines Medical Services
city: Jeddah
country: Saudi Arabia
facility: Saudi German Hospital
city: Jeddah
country: Saudi Arabia
facility: My clinic
city: Khamis Mushait
country: Saudi Arabia
facility: Saudi German Hospital
city: Khobar
country: Saudi Arabia
facility: Al Mowasat Khobar
city: Riyadh
country: Saudi Arabia
facility: King Fahd Medical City, Riyadh, KSA
city: Riyadh
country: Saudi Arabia
facility: Al Hammadi
city: Riyadh
country: Saudi Arabia
facility: Dr. Sulaiman Al Habib Medical Group- Swedi
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: