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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06113341
• Other study ID #: NN9068-7589
• Secondary ID: U1111-1288-8131
• Status: Not yet recruiting
• Start date: May 7, 2024
• Est. completion date: September 2, 2025

Study information

• Verified date: March 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 266
• Est. completion date: September 2, 2025
• Est. primary completion date: February 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• IDegLira
Pre-filled pen injection.

Locations

Country	Name	City	State
Italy	A.O. SS Antonio e Biagio e Cesare Arrigo	Alessandria
Italy	Azienda Ospedaliera Ospedale Policlinico Consorziale	Bari
Italy	Azienda Ospedaliera Cannizzaro	Catania	Sicily
Italy	Azienda Ospedaliero-Universitaria Renato Dulbecco	Catanzaro	Cz
Italy	Azienda Ospedaliero-Universitaria Renato Dulbecco	Catanzaro
Italy	Ospedale di Chivasso	Chivasso
Italy	Presidio Ospedale di Cittadella Azienda ULSS 6 Euganea	Cittadella
Italy	Ospedale Santa Croce	Fano
Italy	Azienda Ospedaliero Universitario Policlinico "G. Martino"	Gazi	ME
Italy	Presidio Ospedaliero Santa Barbara	Iglesias
Italy	IRCCS Ospedale Sacro Cuore Don Calabria	Negrar Di Valpolicella
Italy	Ospedale San Francesco d'Assisi	Oliveto Citra
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

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant downloaded and actively used the app (Yes/No)	Measured as count of participants.	From baseline (week 0) to end of the study (EOS) visit (week 26)
Secondary	Change in glycated haemoglobin (HbA1c)	Measured as percentage (%) points.	From baseline (week 0) to EOS visit (week 26)
Secondary	Participants reaching individual HbA1c target set by physician	Measured as count of participants (yes/no).	At EOS visit (week 26)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Change in laboratory measured FPG	Measured in milligrams per deciliter (mg/dL).	From baseline (week 0) to EOS visit (week 26)