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
Reason given: The study has been cancelled due to the study's rejection from the local Italian ethics Committee
Key facts
- Where
- Alessandria, Bari, Catania, Catanzaro, Chivasso, Cittadella, Fano, Gazi, Iglesias, Negrar, Oliveto Citra, Palermo, Pisa, Ponderano, Ravenna, Reggio Emilia, and Roma, ItalySee the 18 sites
Where in Italy
- A.O. SS Antonio e Biagio e Cesare ArrigoAlessandria, ItalyNo longer taking part
- Azienda Ospedaliera Ospedale Policlinico ConsorzialeBari, ItalyNo longer taking part
- Azienda Ospedaliera "Cannizzaro"Catania, ItalyNo longer taking part
- Azienda Ospedaliero Universitaria Renato DulbeccoCatanzaro, ItalyNo longer taking part
- Ospedale di ChivassoChivasso, ItalyNo longer taking part
- Presidio Ospedale di Cittadella Azienda ULSS 6 EuganeaCittadella, ItalyNo longer taking part
- Ospedale Santa CroceFano, ItalyNo longer taking part
- Azienda Ospedaliero Universitario Policlinico "G. Martino"Gazi, ItalyNo longer taking part
- Presidio Ospedaliero Santa BarbaraIglesias, ItalyNo longer taking part
- IRCCS Ospedale Sacro Cuore Don CalabriaNegrar, ItalyNo longer taking part
- Ospedale San Francesco d'AssisiOliveto Citra, ItalyNo longer taking part
- ARNAS Ospedali Civico Di Cristina BenfratelliPalermo, ItalyNo longer taking part
- Azienda Ospedaliero-Universitaria Pisana - Ospedale CisanelloPisa, ItalyNo longer taking part
- Nuovo Ospedale Degli InfermiPonderano, ItalyNo longer taking part
- DIABETOLOGIA Ravenna AUSL della RomagnaRavenna, ItalyNo longer taking part
- AUSL Reggio EmiliaReggio Emilia, ItalyNo longer taking part
- A.O.U. Policlinico Umberto IRoma, ItalyNo longer taking part
- Fondazione Univ. Policlinico A.GemelliRoma, ItalyNo longer taking part
Trial details
- Who runs it
- Novo Nordisk A/S
- Trial code
- NCT06113341
- Record updated
- 1 October 2024
- Original description
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® 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 be supported with the correct dose of Xultophy®. The study will last for about 6 to 8 months.Read full original descriptionShow less
A Multi-centre, Prospective, Single-arm, Non-interventional Study Describing the Use of the Dose Check App in People Living With Type 2 Diabetes Mellitus and Treated With IDegLira in a Real-world Setting in Italy
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® 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 be supported with the correct dose of Xultophy®. The study will last for about 6 to 8 months.
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; 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; Hypersensitivity to the active substance or any of the excipients as specified in the Xultophy® local label; Women known to be pregnant or breastfeeding, or women planning to become pregnant during the conduct of the study; Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.