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
NCT ID: NCT06113341
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2024-11-07
2026-03-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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IDegLira + Dose Check
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.
IDegLira
Pre-filled pen injection.
Interventions
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IDegLira
Pre-filled pen injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro, Cz, 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
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
Presidio Ospedaliero Santa Barbara
Iglesias, , Italy
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, , 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, , Italy
Countries
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Other Identifiers
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U1111-1288-8131
Identifier Type: OTHER
Identifier Source: secondary_id
NN9068-7589
Identifier Type: -
Identifier Source: org_study_id
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