## Protocol Section
### Identification Module
**NCT ID:** NCT06421467

**Brief Title:** Insulin Injection Practices in Spain

**Official Title:** Insulin Injection Practices in People With Diabetes in Spain

#### Organization Study ID Info
**ID:** EPID-ES
#### Organization
**Class:** OTHER
**Full Name:** Fundación para la Investigación del Hospital Clínico de Valencia
### Status Module
#### Completion Date
**Date:** 2024-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-19
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Novo Nordisk A/S

#### Lead Sponsor

**Class:** OTHER

**Name:** Fundación para la Investigación del Hospital Clínico de Valencia

#### Responsible Party

**Investigator Affiliation:** Fundación para la Investigación del Hospital Clínico de Valencia

**Investigator Full Name:** Francisco Javier Ampudia Blasco

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Diabetes

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 400

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Number of total insulin injections per day

**Measure:** Number of total insulin injections

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Number of prandial insulin injections per day

**Measure:** Number of prandial insulin injections

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Number of basal insulin injections per day

**Measure:** Number of basal insulin injections

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Timing of prandial insulin injection: before meals, during meals, after meals, or at some point during the day

**Measure:** Timing of prandial insulin injection

**Time Frame:** through study completion, an average of 16 weeks

**Description:** If insulin administration occurs before starting the meal: time interval (minutes)

**Measure:** Time interval before prandial insulin injection

**Time Frame:** through study completion, an average of 16 weeks

**Description:** If insulin administration occurs after the meal: time interval (minutes)

**Measure:** Time interval after prandial insulin injection

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Insulin overdosing when correcting abnormal glucose values (Y/N)

**Measure:** Insulin overdosing

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Insulin overdosing when correcting abnormal glucose values (Y/N)

**Measure:** Insulin underdosing

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Insulin administration site: abdomen, thigh, arm

**Measure:** Insulin administration site

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Injection site rotation: (Yes/No)

**Measure:** Site rotation

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Frequency in the change of the insulin needle

**Measure:** Change of the insulin needle

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Use of smart pens (Y/N)

**Measure:** Use of smart pens

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Type of prandial insulin used

**Measure:** Type of prandial insulin

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Daily dose of prandial insulin (IU/kg)

**Measure:** Daily dose of prandial insulin

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Type of basal insulin used

**Measure:** Type of basal insulin

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Daily dose of basal insulin (IU/kg)

**Measure:** Daily dose of basal insulin

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Last HbA1c value

**Measure:** Last HbA1c

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Date of last HbA1c value

**Measure:** Date of last HbA1c

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Diabetic ketoacidosis (DKA) in the last year (Y/N)

**Measure:** Diabetic ketoacidosis

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Severe hypoglycemic episodes in the last year (Y/N)

**Measure:** Hypoglycemic episodes

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Hyperglycemic episodes with medical support in the last year (Y/N)

**Measure:** Hyperglycemic episodes

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Age of diabetes onset (years/months)

**Measure:** Age of diabetes onset

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Self-monitoring of capillary blood glucose (SMBG) (Y/N)

**Measure:** Self-monitoring of capillary glucose

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Continuous glucose monitoring (CGM) in real-time or intermittently scanned (Y/N)

**Measure:** Glucose monitoring in real-time or intermittently scanned

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Lack of daily glucose monitoring (Y/N)

**Measure:** Lack of daily glucose monitoring

**Time Frame:** through study completion, an average of 16 weeks

**Description:** Lack of correction based on glucose values (Y/N)

**Measure:** Lack of correction based on glucose values

**Time Frame:** through study completion, an average of 16 weeks

**Description:** If CGM user, CGM parameters from the last 28 days: Time in Range (%TIR)

**Measure:** Time in Range (%TIR)

**Time Frame:** through study completion, an average of 16 weeks

**Description:** If CGM user, CGM parameters from the last 28 days: Time Below Range (%TbR)

**Measure:** Time Below Range (%TbR)

**Time Frame:** through study completion, an average of 16 weeks

**Description:** If CGM user, CGM parameters from the last 28 days: Time Above Range (%TaR)

**Measure:** Time Above Range (%TaR)

**Time Frame:** through study completion, an average of 16 weeks

**Description:** If CGM user, CGM parameters from the last 28 days: mean glucose (mg/dL)

**Measure:** Mean glucose (mg/dL)

**Time Frame:** through study completion, an average of 16 weeks

**Description:** If CGM user, CGM parameters from the last 28 days: coefficient of variation of continuous glucose sensor values (CV)

**Measure:** Coefficient of variation of continuous glucose sensor values (CV)

**Time Frame:** through study completion, an average of 16 weeks

### Eligibility Module

**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 Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ana.palanca@gmail.com

**Name:** Ana Palanca

**Phone:** 961973517

**Role:** CONTACT

**Contact 2:**

**Email:** ampudia_fra@gva.es

**Name:** F. Javier Ampudia-Blasco

**Phone:** 961973500

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Valencia

**Country:** Spain

**Facility:** INCLIVA

**Zip:** 46010

#### Overall Officials

**Official 1:**

**Affiliation:** HCUV-INCLIVA

**Name:** F. Javier Ampudia-Blasco

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
