- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06421467
Insulin Injection Practices in Spain
Insulin Injection Practices in People With Diabetes in Spain
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ana Palanca
- Phone Number: 961973517
- Email: ana.palanca@gmail.com
Study Contact Backup
- Name: F. Javier Ampudia-Blasco
- Phone Number: 961973500
- Email: ampudia_fra@gva.es
Study Locations
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Valencia, Spain, 46010
- INCLIVA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of total insulin injections
Time Frame: through study completion, an average of 16 weeks
|
Number of total insulin injections per day
|
through study completion, an average of 16 weeks
|
Number of prandial insulin injections
Time Frame: through study completion, an average of 16 weeks
|
Number of prandial insulin injections per day
|
through study completion, an average of 16 weeks
|
Number of basal insulin injections
Time Frame: through study completion, an average of 16 weeks
|
Number of basal insulin injections per day
|
through study completion, an average of 16 weeks
|
Timing of prandial insulin injection
Time Frame: through study completion, an average of 16 weeks
|
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
|
Time interval before prandial insulin injection
Time Frame: through study completion, an average of 16 weeks
|
If insulin administration occurs before starting the meal: time interval (minutes)
|
through study completion, an average of 16 weeks
|
Time interval after prandial insulin injection
Time Frame: through study completion, an average of 16 weeks
|
If insulin administration occurs after the meal: time interval (minutes)
|
through study completion, an average of 16 weeks
|
Insulin overdosing
Time Frame: through study completion, an average of 16 weeks
|
Insulin overdosing when correcting abnormal glucose values (Y/N)
|
through study completion, an average of 16 weeks
|
Insulin underdosing
Time Frame: through study completion, an average of 16 weeks
|
Insulin overdosing when correcting abnormal glucose values (Y/N)
|
through study completion, an average of 16 weeks
|
Insulin administration site
Time Frame: through study completion, an average of 16 weeks
|
Insulin administration site: abdomen, thigh, arm
|
through study completion, an average of 16 weeks
|
Site rotation
Time Frame: through study completion, an average of 16 weeks
|
Injection site rotation: (Yes/No)
|
through study completion, an average of 16 weeks
|
Change of the insulin needle
Time Frame: through study completion, an average of 16 weeks
|
Frequency in the change of the insulin needle
|
through study completion, an average of 16 weeks
|
Use of smart pens
Time Frame: through study completion, an average of 16 weeks
|
Use of smart pens (Y/N)
|
through study completion, an average of 16 weeks
|
Type of prandial insulin
Time Frame: through study completion, an average of 16 weeks
|
Type of prandial insulin used
|
through study completion, an average of 16 weeks
|
Daily dose of prandial insulin
Time Frame: through study completion, an average of 16 weeks
|
Daily dose of prandial insulin (IU/kg)
|
through study completion, an average of 16 weeks
|
Type of basal insulin
Time Frame: through study completion, an average of 16 weeks
|
Type of basal insulin used
|
through study completion, an average of 16 weeks
|
Daily dose of basal insulin
Time Frame: through study completion, an average of 16 weeks
|
Daily dose of basal insulin (IU/kg)
|
through study completion, an average of 16 weeks
|
Last HbA1c
Time Frame: through study completion, an average of 16 weeks
|
Last HbA1c value
|
through study completion, an average of 16 weeks
|
Date of last HbA1c
Time Frame: through study completion, an average of 16 weeks
|
Date of last HbA1c value
|
through study completion, an average of 16 weeks
|
Diabetic ketoacidosis
Time Frame: through study completion, an average of 16 weeks
|
Diabetic ketoacidosis (DKA) in the last year (Y/N)
|
through study completion, an average of 16 weeks
|
Hypoglycemic episodes
Time Frame: through study completion, an average of 16 weeks
|
Severe hypoglycemic episodes in the last year (Y/N)
|
through study completion, an average of 16 weeks
|
Hyperglycemic episodes
Time Frame: through study completion, an average of 16 weeks
|
Hyperglycemic episodes with medical support in the last year (Y/N)
|
through study completion, an average of 16 weeks
|
Age of diabetes onset
Time Frame: through study completion, an average of 16 weeks
|
Age of diabetes onset (years/months)
|
through study completion, an average of 16 weeks
|
Self-monitoring of capillary glucose
Time Frame: through study completion, an average of 16 weeks
|
Self-monitoring of capillary blood glucose (SMBG) (Y/N)
|
through study completion, an average of 16 weeks
|
Glucose monitoring in real-time or intermittently scanned
Time Frame: through study completion, an average of 16 weeks
|
Continuous glucose monitoring (CGM) in real-time or intermittently scanned (Y/N)
|
through study completion, an average of 16 weeks
|
Lack of daily glucose monitoring
Time Frame: through study completion, an average of 16 weeks
|
Lack of daily glucose monitoring (Y/N)
|
through study completion, an average of 16 weeks
|
Lack of correction based on glucose values
Time Frame: through study completion, an average of 16 weeks
|
Lack of correction based on glucose values (Y/N)
|
through study completion, an average of 16 weeks
|
Time in Range (%TIR)
Time Frame: through study completion, an average of 16 weeks
|
If CGM user, CGM parameters from the last 28 days: Time in Range (%TIR)
|
through study completion, an average of 16 weeks
|
Time Below Range (%TbR)
Time Frame: through study completion, an average of 16 weeks
|
If CGM user, CGM parameters from the last 28 days: Time Below Range (%TbR)
|
through study completion, an average of 16 weeks
|
Time Above Range (%TaR)
Time Frame: through study completion, an average of 16 weeks
|
If CGM user, CGM parameters from the last 28 days: Time Above Range (%TaR)
|
through study completion, an average of 16 weeks
|
Mean glucose (mg/dL)
Time Frame: through study completion, an average of 16 weeks
|
If CGM user, CGM parameters from the last 28 days: mean glucose (mg/dL)
|
through study completion, an average of 16 weeks
|
Coefficient of variation of continuous glucose sensor values (CV)
Time Frame: through study completion, an average of 16 weeks
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: F. Javier Ampudia-Blasco, HCUV-INCLIVA
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EPID-ES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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