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

September 27, 2024 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Alessandria, Italy, 15121
        • A.O. SS Antonio e Biagio e Cesare Arrigo
      • Bari, Italy, 70120
        • Azienda Ospedaliera Ospedale Policlinico Consorziale
      • Catanzaro, Italy, 88100
        • Azienda Ospedaliero-Universitaria Renato Dulbecco
      • Chivasso, Italy, 10034
        • Ospedale di Chivasso
      • Cittadella, Italy, 35013
        • Presidio Ospedale di Cittadella Azienda ULSS 6 Euganea
      • Fano, Italy, 61032
        • Ospedale Santa Croce
      • Iglesias, Italy, 09016
        • Presidio Ospedaliero Santa Barbara
      • Negrar Di Valpolicella, Italy, 37024
        • IRCCS Ospedale Sacro Cuore Don Calabria
      • Oliveto Citra, Italy, 84020
        • Ospedale San Francesco d'Assisi
      • Palermo, Italy, 90127
        • ARNAS Ospedali Civico Di Cristina Benfratelli
      • Pisa, Italy, 56124
        • Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello
      • Ponderano, Italy, 13875
        • Nuovo Ospedale Degli Infermi
      • Ravenna, Italy, 48121
        • DIABETOLOGIA Ravenna AUSL della Romagna
      • Reggio Emilia, Italy, 42123
        • AUSL Reggio Emilia
      • Roma, Italy, 00161
        • A.O.U. Policlinico Umberto I
      • Roma, Italy, 00168
        • Fondazione Univ. Policlinico A.Gemelli
    • Cz
      • Catanzaro, Cz, Italy, 88100
        • Azienda Ospedaliero-Universitaria Renato Dulbecco
    • ME
      • Gazi, ME, Italy, 98124
        • Azienda Ospedaliero Universitario Policlinico "G. Martino"
    • Sicily
      • Catania, Sicily, Italy, 95126
        • Azienda Ospedaliera Cannizzaro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: IDegLira
Pre-filled pen injection.
Other Names:
  • Xultophy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participant downloaded and actively used the app (Yes/No)
Time Frame: From baseline (week 0) to end of the study (EOS) visit (week 26)
Measured as count of participants.
From baseline (week 0) to end of the study (EOS) visit (week 26)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participants reaching individual HbA1c target set by physician
Time Frame: At EOS visit (week 26)
Measured as count of participants (yes/no).
At EOS visit (week 26)
Participants reaching physician set individual fasting blood glucose (FBG) target
Time Frame: From baseline (week 0) to EOS visit (week 26)
Measured as count of participants (yes/no).
From baseline (week 0) to EOS visit (week 26)
Time to physician set individual FBG target from first reported FBG
Time Frame: From baseline (week 0) to EOS visit (week 26)
Measured in number of weeks.
From baseline (week 0) to EOS visit (week 26)
Participants achieving target level FBG according to clinical guidance
Time Frame: From baseline (week 0) to EOS visit (week 26)
Measured as count of participants (yes/no).
From baseline (week 0) to EOS visit (week 26)
Change in laboratory measured FPG
Time Frame: From baseline (week 0) to EOS visit (week 26)
Measured in milligrams per deciliter (mg/dL).
From baseline (week 0) to EOS visit (week 26)
Change in glycated haemoglobin (HbA1c)
Time Frame: From baseline (week 0) to EOS visit (week 26)
Measured as percentage (%) points.
From baseline (week 0) to EOS visit (week 26)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 23, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9068-7589
  • U1111-1288-8131 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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