Status:
WITHDRAWN
A Research Study in Italy to Understand How the Dose Check App Used With Xultophy® Works in the Treatment of People Living With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
21+ years
Brief Summary
This study will look at how a mobile based app called 'Dose Check' used along with Xultophy® helps the treatment in participants with type 2 diabetes mellitus (T2DM). Participants will get Xultophy® a...
Eligibility Criteria
Inclusion
- 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 naive (including the following situations: i. already on treatment with Xultophy® at V1 for less than or equal to (\<=) 12 months and for \<= 15 dose steps and ii. short-term insulin use for acute illness for a total of \<14 days)
- 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
- 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 a 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.
Key Trial Info
Start Date :
November 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 2 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06113341
Start Date
November 7 2024
End Date
March 2 2026
Last Update
October 1 2024
Active Locations (19)
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1
Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro, Cz, Italy, 88100
2
Azienda Ospedaliero Universitario Policlinico "G. Martino"
Gazi, ME, Italy, 98124
3
Azienda Ospedaliera Cannizzaro
Catania, Sicily, Italy, 95126
4
A.O. SS Antonio e Biagio e Cesare Arrigo
Alessandria, Italy, 15121