A Research Study in Italy to Understand How the Dose Chec... | NCT06113341

ID	Type	Description	Link
U1111-1288-8131	Other Identifier	World Health Organization (WHO)

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study has been cancelled due to the study's rejection from the local Italian ethics Committee

Expanded Access Info

Start Date

Nov 7, 2024Estimated

Primary Completion Date

Feb 23, 2025Estimated

Completion Date

Mar 2, 2026Estimated

First Submitted Date

Oct 27, 2023

First Submission Date that Met QC Criteria

Oct 27, 2023

First Posted Date

Nov 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2024

Last Update Posted Date

Oct 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IDegLira	Drug	Pre-filled pen injection.	IDegLira + Dose Check	Xultophy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Change in glycated haemoglobin (HbA1c)	Measured as percentage (%) points.	From baseline (week 0) to EOS visit (week 26)
Participants reaching individual HbA1c target set by physician	Measured as count of participants (yes/no).

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Ospedaliero-Universitaria Renato Dulbecco		Catanzaro	Cz	88100	Italy
Azienda Ospedaliero Universitario Policlinico "G. Martino"

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases