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

Withdrawn

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® 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.

Recruitment & Eligibility

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 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 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 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.

Arm && Interventions

Group	Intervention	Description
IDegLira + Dose Check	IDegLira	Participants will be treated with commercially available Xultophy® (IDegLira) used with Dose Check app according to local label and routine clinical practice at the discretion of the treating physician.

Primary Outcome Measures

Name	Time	Method
Participant downloaded and actively used the app (Yes/No)	From baseline (week 0) to end of the study (EOS) visit (week 26)	Measured as count of participants.

Secondary Outcome Measures

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

Locations (18): Azienda Ospedaliero-Universitaria Renato Dulbecco
🇮🇹
Catanzaro, Italy
Ospedale San Francesco d'Assisi
🇮🇹
Oliveto Citra, Italy
Presidio Ospedaliero Santa Barbara
🇮🇹
Iglesias, Italy
Azienda Ospedaliero Universitario Policlinico "G. Martino"
🇮🇹
Gazi, ME, Italy
Azienda Ospedaliera Cannizzaro
🇮🇹
Catania, Sicily, Italy
A.O. SS Antonio e Biagio e Cesare Arrigo
🇮🇹
Alessandria, Italy
Azienda Ospedaliera Ospedale Policlinico Consorziale
🇮🇹
Bari, Italy
Ospedale di Chivasso
🇮🇹
Chivasso, Italy
Presidio Ospedale di Cittadella Azienda ULSS 6 Euganea
🇮🇹
Cittadella, Italy
Ospedale Santa Croce
🇮🇹
Fano, Italy
IRCCS Ospedale Sacro Cuore Don Calabria
🇮🇹
Negrar Di Valpolicella, Italy
ARNAS Ospedali Civico Di Cristina Benfratelli
🇮🇹
Palermo, Italy
Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello
🇮🇹
Pisa, Italy
Nuovo Ospedale degli Infermi
🇮🇹
Ponderano, Italy
DIABETOLOGIA Ravenna AUSL della Romagna
🇮🇹
Ravenna, Italy
AUSL Reggio Emilia
🇮🇹
Reggio Emilia, Italy
A.O.U. Policlinico Umberto I
🇮🇹
Roma, Italy
Fondazione Univ. Policlinico A.Gemelli
🇮🇹
Roma, Italy