Insulin Injection Practices in Spain

Diabetes Clinical Trial

Official title:

Insulin Injection Practices in People With Diabetes in Spain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06421467
• Other study ID #: EPID-ES
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: Ana Palanca
• Phone: 961973517
• Email: ana.palanca[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
Spain	INCLIVA	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia	Novo Nordisk A/S

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of total insulin injections	Number of total insulin injections per day	through study completion, an average of 16 weeks
Primary	Number of prandial insulin injections	Number of prandial insulin injections per day	through study completion, an average of 16 weeks
Primary	Number of basal insulin injections	Number of basal insulin injections per day	through study completion, an average of 16 weeks
Primary	Timing of prandial insulin injection	Timing of prandial insulin injection: before meals, during meals, after meals, or at some point during the day	through study completion, an average of 16 weeks
Primary	Time interval before prandial insulin injection	If insulin administration occurs before starting the meal: time interval (minutes)	through study completion, an average of 16 weeks
Primary	Time interval after prandial insulin injection	If insulin administration occurs after the meal: time interval (minutes)	through study completion, an average of 16 weeks
Primary	Insulin overdosing	Insulin overdosing when correcting abnormal glucose values (Y/N)	through study completion, an average of 16 weeks
Primary	Insulin underdosing	Insulin overdosing when correcting abnormal glucose values (Y/N)	through study completion, an average of 16 weeks
Primary	Insulin administration site	Insulin administration site: abdomen, thigh, arm	through study completion, an average of 16 weeks
Primary	Site rotation	Injection site rotation: (Yes/No)	through study completion, an average of 16 weeks
Primary	Change of the insulin needle	Frequency in the change of the insulin needle	through study completion, an average of 16 weeks
Primary	Use of smart pens	Use of smart pens (Y/N)	through study completion, an average of 16 weeks
Primary	Type of prandial insulin	Type of prandial insulin used	through study completion, an average of 16 weeks
Primary	Daily dose of prandial insulin	Daily dose of prandial insulin (IU/kg)	through study completion, an average of 16 weeks
Primary	Type of basal insulin	Type of basal insulin used	through study completion, an average of 16 weeks
Primary	Daily dose of basal insulin	Daily dose of basal insulin (IU/kg)	through study completion, an average of 16 weeks
Primary	Last HbA1c	Last HbA1c value	through study completion, an average of 16 weeks
Primary	Date of last HbA1c	Date of last HbA1c value	through study completion, an average of 16 weeks
Primary	Diabetic ketoacidosis	Diabetic ketoacidosis (DKA) in the last year (Y/N)	through study completion, an average of 16 weeks
Primary	Hypoglycemic episodes	Severe hypoglycemic episodes in the last year (Y/N)	through study completion, an average of 16 weeks
Primary	Hyperglycemic episodes	Hyperglycemic episodes with medical support in the last year (Y/N)	through study completion, an average of 16 weeks
Primary	Age of diabetes onset	Age of diabetes onset (years/months)	through study completion, an average of 16 weeks
Primary	Self-monitoring of capillary glucose	Self-monitoring of capillary blood glucose (SMBG) (Y/N)	through study completion, an average of 16 weeks
Primary	Glucose monitoring in real-time or intermittently scanned	Continuous glucose monitoring (CGM) in real-time or intermittently scanned (Y/N)	through study completion, an average of 16 weeks
Primary	Lack of daily glucose monitoring	Lack of daily glucose monitoring (Y/N)	through study completion, an average of 16 weeks
Primary	Lack of correction based on glucose values	Lack of correction based on glucose values (Y/N)	through study completion, an average of 16 weeks
Primary	Time in Range (%TIR)	If CGM user, CGM parameters from the last 28 days: Time in Range (%TIR)	through study completion, an average of 16 weeks
Primary	Time Below Range (%TbR)	If CGM user, CGM parameters from the last 28 days: Time Below Range (%TbR)	through study completion, an average of 16 weeks
Primary	Time Above Range (%TaR)	If CGM user, CGM parameters from the last 28 days: Time Above Range (%TaR)	through study completion, an average of 16 weeks
Primary	Mean glucose (mg/dL)	If CGM user, CGM parameters from the last 28 days: mean glucose (mg/dL)	through study completion, an average of 16 weeks
Primary	Coefficient of variation of continuous glucose sensor values (CV)	If CGM user, CGM parameters from the last 28 days: coefficient of variation of continuous glucose sensor values (CV)	through study completion, an average of 16 weeks