Clinical trial NCT06421467: Insulin Injection Practices in Spain
Official title: Insulin Injection Practices in People With Diabetes in Spain
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2024-05-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals aged 18 or above, diagnosed with either Type 1 or Type 2 diabetes, who actively incorporate insulin injections-both prandial and basal-into their treatment plan, with a minimum requirement of at least one injection of prandial insulin and/or basal insulin.

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.

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

Primary outcomes:
measure: Number of total insulin injections
timeFrame: through study completion, an average of 16 weeks
measure: Number of prandial insulin injections
timeFrame: through study completion, an average of 16 weeks
measure: Number of basal insulin injections
timeFrame: through study completion, an average of 16 weeks
measure: Timing of prandial insulin injection
timeFrame: through study completion, an average of 16 weeks
measure: Time interval before prandial insulin injection
timeFrame: through study completion, an average of 16 weeks
measure: Time interval after prandial insulin injection
timeFrame: through study completion, an average of 16 weeks
measure: Insulin overdosing
timeFrame: through study completion, an average of 16 weeks
measure: Insulin underdosing
timeFrame: through study completion, an average of 16 weeks
measure: Insulin administration site
timeFrame: through study completion, an average of 16 weeks
measure: Site rotation
timeFrame: through study completion, an average of 16 weeks
measure: Change of the insulin needle
timeFrame: through study completion, an average of 16 weeks
measure: Use of smart pens
timeFrame: through study completion, an average of 16 weeks
measure: Type of prandial insulin
timeFrame: through study completion, an average of 16 weeks
measure: Daily dose of prandial insulin
timeFrame: through study completion, an average of 16 weeks
measure: Type of basal insulin
timeFrame: through study completion, an average of 16 weeks
measure: Daily dose of basal insulin
timeFrame: through study completion, an average of 16 weeks
measure: Last HbA1c
timeFrame: through study completion, an average of 16 weeks
measure: Date of last HbA1c
timeFrame: through study completion, an average of 16 weeks
measure: Diabetic ketoacidosis
timeFrame: through study completion, an average of 16 weeks
measure: Hypoglycemic episodes
timeFrame: through study completion, an average of 16 weeks
measure: Hyperglycemic episodes
timeFrame: through study completion, an average of 16 weeks
measure: Age of diabetes onset
timeFrame: through study completion, an average of 16 weeks
measure: Self-monitoring of capillary glucose
timeFrame: through study completion, an average of 16 weeks
measure: Glucose monitoring in real-time or intermittently scanned
timeFrame: through study completion, an average of 16 weeks
measure: Lack of daily glucose monitoring
timeFrame: through study completion, an average of 16 weeks
measure: Lack of correction based on glucose values
timeFrame: through study completion, an average of 16 weeks
measure: Time in Range (%TIR)
timeFrame: through study completion, an average of 16 weeks
measure: Time Below Range (%TbR)
timeFrame: through study completion, an average of 16 weeks
measure: Time Above Range (%TaR)
timeFrame: through study completion, an average of 16 weeks
measure: Mean glucose (mg/dL)
timeFrame: through study completion, an average of 16 weeks
measure: Coefficient of variation of continuous glucose sensor values (CV)
timeFrame: through study completion, an average of 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: INCLIVA
Study officials:
affiliation: HCUV-INCLIVA
name: F. Javier Ampudia-Blasco
role: PRINCIPAL_INVESTIGATOR
References: