Clinical trial NCT06113341: 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
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of participants diagnosed with T2DM greater than or equal to (\>=) 12 weeks and aged \>=21 years at the time of signing informed consent.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Participant downloaded and actively used the app (Yes/No)
timeFrame: From baseline (week 0) to end of the study (EOS) visit (week 26)
Secondary outcomes:
measure: Change in glycated haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to EOS visit (week 26)
measure: Participants reaching individual HbA1c target set by physician
timeFrame: At EOS visit (week 26)
measure: Participants reaching physician set individual fasting blood glucose (FBG) target
timeFrame: From baseline (week 0) to EOS visit (week 26)
measure: Time to physician set individual FBG target from first reported FBG
timeFrame: From baseline (week 0) to EOS visit (week 26)
measure: Participants achieving target level FBG according to clinical guidance
timeFrame: From baseline (week 0) to EOS visit (week 26)
measure: Change in laboratory measured FPG
timeFrame: From baseline (week 0) to EOS visit (week 26)
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Azienda Ospedaliero-Universitaria Renato Dulbecco
state: Cz
city: Gazi
country: Italy
facility: Azienda Ospedaliero Universitario Policlinico "G. Martino"
state: ME
city: Catania
country: Italy
facility: Azienda Ospedaliera Cannizzaro
state: Sicily
city: Alessandria
country: Italy
facility: A.O. SS Antonio e Biagio e Cesare Arrigo
city: Bari
country: Italy
facility: Azienda Ospedaliera Ospedale Policlinico Consorziale
city: Catanzaro
country: Italy
facility: Azienda Ospedaliero-Universitaria Renato Dulbecco
city: Chivasso
country: Italy
facility: Ospedale di Chivasso
city: Cittadella
country: Italy
facility: Presidio Ospedale di Cittadella Azienda ULSS 6 Euganea
city: Fano
country: Italy
facility: Ospedale Santa Croce
city: Iglesias
country: Italy
facility: Presidio Ospedaliero Santa Barbara
city: Negrar Di Valpolicella
country: Italy
facility: IRCCS Ospedale Sacro Cuore Don Calabria
city: Oliveto Citra
country: Italy
facility: Ospedale San Francesco d'Assisi
city: Palermo
country: Italy
facility: ARNAS Ospedali Civico Di Cristina Benfratelli
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello
city: Ponderano
country: Italy
facility: Nuovo Ospedale degli Infermi
city: Ravenna
country: Italy
facility: DIABETOLOGIA Ravenna AUSL della Romagna
city: Reggio Emilia
country: Italy
facility: AUSL Reggio Emilia
city: Roma
country: Italy
facility: A.O.U. Policlinico Umberto I
city: Roma
country: Italy
facility: Fondazione Univ. Policlinico A.Gemelli
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: