Insulin Injection Practices in Spain

NCT ID: NCT06421467

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2024-10-31

Brief Summary

In this era of pharmaceutical and technological advancements, gaining insights into prevalent insulin administration practices under real-life conditions becomes pivotal for healthcare professionals. The investigators aim to explore insulin injection habits through an online survey among a broad, unselected group of participants with type 1 and type 2 diabetes undergoing daily prandial and/or basal insulin treatment. Eligible participants will access and complete the survey at their convenience after providing online informed consent within the study period

Detailed Description

HYPOTHESIS The study hypothesis posits that there is significant variability in the practices of insulin administration among patients with diabetes using daily insulin injections. This diversity in administration practices may have a notable impact on the overall efficacy of treatment regimens and the successful management of the disease, thereby emphasizing the need for a comprehensive understanding of these practices to enhance patient outcomes and optimize diabetes care.

OBJECTIVES The main objective of the study is to comprehensively assess and characterize the diverse insulin administration practices among individuals with diabetes using injections, focusing on both prandial and basal insulin. By employing an online survey methodology and targeting a broad demographic through a diabetes information platform Canal Diabetes, the investigators aim to gain valuable insights into the variability, challenges, and overall patterns of insulin administration. The findings will contribute to a better understanding of real-world practices, facilitating improvements in patient guidance and optimizing diabetes care strategies.

STUDY DESIGN The study follows a cross-sectional observational design, allowing the investigators to capture a snapshot of the current insulin administration practices via an online questionnaire among the diverse population of diabetes patients using multiple insulin injections.

STUDY PROCEDURE AND SCHEDULE The study, focusing on insulin administration practices among participants with diabetes using multiple insulin injections, will employ a two-month online survey accessible on the designated online platform Canal Diabetes. Recruitment efforts through the diabetes information platform Canal Diabetes will inform eligible participants about the study's voluntary nature, emphasizing response confidentiality. Participants meeting the criteria, will access and complete the online informed consent and survey at their convenience within the designated two-month period. Post-survey, collected data will be securely stored and anonymized for subsequent analysis.

STUDY DURATION The anticipated duration of this study will be 4 months, with subject recruitment set to begin in July 2024 and aiming for the completion of statistical analysis by the 31st of October 2024.

GOOD CLINICAL PRACTICE The procedures set out in this study protocol, pertaining to the conduct, evaluation, and documentation of this study, are designed to ensure that the sponsor and investigator (in this case the same person) comply with the principle of the good clinical practice guidelines and the Declaration of Helsinki in the conduct, evaluation and documentation of this study. The study will also be carried out in keeping with local legal requirements.

SUBJECTS INFORMATION AND INFORMED CONSENT Prior to taking the online questionnaire, participants will be required to provide explicit consent to participate in the study. An online informed consent document, encompassing details about the study and the consent form, will be prepared and supplied to participants. This document will be presented in a language accessible to participants, and clear contact information will be provided for any questions that may arise.

ENSURING DATA CONFIDENTIALITY The study database will not contain any information that could allow the individual identification of the study participants. The data obtained will be used exclusively for the purposes described in this research project. The information will be treated as confidential and will be stored and processed in accordance with the provisions of EU Regulation 2016/679 of the European Parliament and the Council of 27 April 2016 on the protection of personal data and the free movement of such data, as well as Organic Law 3/2018 of December.

Conditions

Diabetes

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Individuals aged 18 or above
• Individuals diagnosed with diabetes (type 1 or type 2 diabetes)
• Individuals receiving multiple daily doses of insulin

Exclusion Criteria

• Individuals utilizing continuous subcutaneous insulin infusion
• Individuals engaging in sensor-augmented pump therapy
• Individuals using automatic insulin delivery systems

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Fundación para la Investigación del Hospital Clínico de Valencia

OTHER

Sponsor Role: lead

Responsible Party

Francisco Javier Ampudia Blasco

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

F. Javier Ampudia-Blasco

Role: PRINCIPAL_INVESTIGATOR

HCUV-INCLIVA

Locations

INCLIVA

Valencia, , Spain

Countries

Spain

Central Contacts

Ana Palanca

Role: CONTACT

ana.palanca@gmail.com

961973517

F. Javier Ampudia-Blasco

Role: CONTACT

ampudia_fra@gva.es

961973500

Other Identifiers

EPID-ES

Identifier Type: -

Identifier Source: org_study_id