Insulin Injection Practices in Spain

NCT06421467 | Not Yet Recruiting

• 1 other identifier: EPID-ES
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes

Outcome Measures

Primary Outcomes (31)

• Number of total insulin injections

  Number of total insulin injections per day

  through study completion, an average of 16 weeks

• Number of prandial insulin injections

  Number of prandial insulin injections per day

  through study completion, an average of 16 weeks

• Number of basal insulin injections

  Number of basal insulin injections per day

  through study completion, an average of 16 weeks

• 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

• 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

• Time interval after prandial insulin injection

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

  through study completion, an average of 16 weeks

• Insulin overdosing

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

  through study completion, an average of 16 weeks

• Insulin underdosing

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

  through study completion, an average of 16 weeks

• Insulin administration site

  Insulin administration site: abdomen, thigh, arm

  through study completion, an average of 16 weeks

• Site rotation

  Injection site rotation: (Yes/No)

  through study completion, an average of 16 weeks

• Change of the insulin needle

  Frequency in the change of the insulin needle

  through study completion, an average of 16 weeks

• Use of smart pens

  Use of smart pens (Y/N)

  through study completion, an average of 16 weeks

• Type of prandial insulin

  Type of prandial insulin used

  through study completion, an average of 16 weeks

• Daily dose of prandial insulin

  Daily dose of prandial insulin (IU/kg)

  through study completion, an average of 16 weeks

• Type of basal insulin

  Type of basal insulin used

  through study completion, an average of 16 weeks

• Daily dose of basal insulin

  Daily dose of basal insulin (IU/kg)

  through study completion, an average of 16 weeks

• Last HbA1c

  Last HbA1c value

  through study completion, an average of 16 weeks

• Date of last HbA1c

  Date of last HbA1c value

  through study completion, an average of 16 weeks

• Diabetic ketoacidosis

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

  through study completion, an average of 16 weeks

• Hypoglycemic episodes

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

  through study completion, an average of 16 weeks

• Hyperglycemic episodes

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

  through study completion, an average of 16 weeks

• Age of diabetes onset

  Age of diabetes onset (years/months)

  through study completion, an average of 16 weeks

• Self-monitoring of capillary glucose

  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

  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

  Lack of daily glucose monitoring (Y/N)

  through study completion, an average of 16 weeks

• Lack of correction based on glucose values

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

  through study completion, an average of 16 weeks

• 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

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

INCLIVA

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• F. Javier Ampudia-Blasco

  HCUV-INCLIVA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Palanca

CONTACT

961973517; ana.palanca@gmail.com

F. Javier Ampudia-Blasco

CONTACT

961973500; ampudia_fra@gva.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: May 20, 2024
• Study Start: July 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Locations

ES (1)