A Research Study in Italy to Understand How the Dose Check App Used With Xultophy® Treatment Helps to Control Blood Sugar Level

Study Overview
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Brief Summary
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This will study look at how a mobile based app called 'Dose Check' used along with Xultophy® helps to control blood sugar level in participants with type 2 diabetes mellitus (T2DM). Participants will get Xultophy® as prescribed by study doctor or will continue already prescribed treatment with Xultophy®. Participants will also be prescribed to use Dose Check app by study doctor. Participants will be asked to install the Dose Check app in their mobile phone, which will support with the correct dose of Xultophy®. The study will last for about 6 to 7 months.

Official Title
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A Multi-centre, Prospective, Non-interventional, Single-arm Study Investigating Glycaemic Control Associated With the Use of Dose Check App and IDegLira in Patients With Type 2 Diabetes Mellitus in Italy Under Real-world Setting

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: IDegLira


Participation Criteria
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Eligibility Criteria
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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 T2DM >=12 weeks prior to signing consent. The decision to initiate treatment with commercially available Dose Check app as a part of treatment along with Xultophy® as per the local label has been made by the patient and the treating physician before and independently from the decision to include the participant in this study. Participants who are insulin naïve (an exception is short-term insulin treatment for acute illness for a total of less than (<) 14 days) or already on treatment with Xultophy® at Visit 1 for less than or equal to (<=) 3 months and <=15 dose steps. Available HbA1c value <=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), 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 Xultophy® local label.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IDegLira + Dose Check<br>Participants will be treated with commercially available IDegLira used with Dose Check app according to local label and routine clinical practice at the discretion of the treating physician. | Drug: IDegLira<br>* Pre-filled pen injection.<br>* Other names: Xultophy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycated haemoglobin (HbA1c) | Measured in Percentage point. | From baseline (week 0) to end of the study (EOS) visit (week 26) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants reaching individual HbA1c target set by physician | Measured as count of participants (yes/no). | At EOS visit (week 26) | 
| Participants reaching physician set individual fasting blood glucose (FBG) target | Measured as count of participants (yes/no). | From baseline (week 0) to EOS visit (week 26) | 
| Time to physician set individual FBG target from first reported FBG | Measured in number of weeks. | From baseline (week 0) to EOS visit (week 26) | 
| Participants achieving target level FBG according to clinical guidance | Measured as count of participants (yes/no). | From baseline (week 0) to EOS visit (week 26) | 
| Change in laboratory measured FPG | Measured in milligrams per deciliter (mg/dL). | From baseline (week 0) to EOS visit (week 26) |