Insulin Injection Practices in People With Diabetes in Spain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Type of prandial insulin
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18 or above
- •Individuals diagnosed with diabetes (type 1 or type 2 diabetes)
- •Individuals receiving multiple daily doses of insulin
排除标准
- •Individuals utilizing continuous subcutaneous insulin infusion
- •Individuals engaging in sensor-augmented pump therapy
- •Individuals using automatic insulin delivery systems
结局指标
主要结局
Type of prandial insulin
时间窗: through study completion, an average of 16 weeks
Type of prandial insulin used
Use of smart pens
时间窗: through study completion, an average of 16 weeks
Use of smart pens (Y/N)
Type of basal insulin
时间窗: through study completion, an average of 16 weeks
Type of basal insulin used
Diabetic ketoacidosis
时间窗: through study completion, an average of 16 weeks
Diabetic ketoacidosis (DKA) in the last year (Y/N)
Time interval before prandial insulin injection
时间窗: through study completion, an average of 16 weeks
If insulin administration occurs before starting the meal: time interval (minutes)
Time interval after prandial insulin injection
时间窗: through study completion, an average of 16 weeks
If insulin administration occurs after the meal: time interval (minutes)
Insulin overdosing
时间窗: through study completion, an average of 16 weeks
Insulin overdosing when correcting abnormal glucose values (Y/N)
Insulin underdosing
时间窗: through study completion, an average of 16 weeks
Insulin overdosing when correcting abnormal glucose values (Y/N)
Change of the insulin needle
时间窗: through study completion, an average of 16 weeks
Frequency in the change of the insulin needle
Hypoglycemic episodes
时间窗: through study completion, an average of 16 weeks
Severe hypoglycemic episodes in the last year (Y/N)
Hyperglycemic episodes
时间窗: through study completion, an average of 16 weeks
Hyperglycemic episodes with medical support in the last year (Y/N)
Self-monitoring of capillary glucose
时间窗: through study completion, an average of 16 weeks
Self-monitoring of capillary blood glucose (SMBG) (Y/N)
Lack of daily glucose monitoring
时间窗: through study completion, an average of 16 weeks
Lack of daily glucose monitoring (Y/N)
Time Below Range (%TbR)
时间窗: through study completion, an average of 16 weeks
If CGM user, CGM parameters from the last 28 days: Time Below Range (%TbR)
Daily dose of prandial insulin
时间窗: through study completion, an average of 16 weeks
Daily dose of prandial insulin (IU/kg)
Number of prandial insulin injections
时间窗: through study completion, an average of 16 weeks
Number of prandial insulin injections per day
Timing of prandial insulin injection
时间窗: 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
Insulin administration site
时间窗: through study completion, an average of 16 weeks
Insulin administration site: abdomen, thigh, arm
Site rotation
时间窗: through study completion, an average of 16 weeks
Injection site rotation: (Yes/No)
Age of diabetes onset
时间窗: through study completion, an average of 16 weeks
Age of diabetes onset (years/months)
Lack of correction based on glucose values
时间窗: through study completion, an average of 16 weeks
Lack of correction based on glucose values (Y/N)
Time Above Range (%TaR)
时间窗: through study completion, an average of 16 weeks
If CGM user, CGM parameters from the last 28 days: Time Above Range (%TaR)
Number of total insulin injections
时间窗: through study completion, an average of 16 weeks
Number of total insulin injections per day
Glucose monitoring in real-time or intermittently scanned
时间窗: through study completion, an average of 16 weeks
Continuous glucose monitoring (CGM) in real-time or intermittently scanned (Y/N)
Coefficient of variation of continuous glucose sensor values (CV)
时间窗: 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)
Number of basal insulin injections
时间窗: through study completion, an average of 16 weeks
Number of basal insulin injections per day
Daily dose of basal insulin
时间窗: through study completion, an average of 16 weeks
Daily dose of basal insulin (IU/kg)
Last HbA1c
时间窗: through study completion, an average of 16 weeks
Last HbA1c value
Date of last HbA1c
时间窗: through study completion, an average of 16 weeks
Date of last HbA1c value
Mean glucose (mg/dL)
时间窗: through study completion, an average of 16 weeks
If CGM user, CGM parameters from the last 28 days: mean glucose (mg/dL)
Time in Range (%TIR)
时间窗: through study completion, an average of 16 weeks
If CGM user, CGM parameters from the last 28 days: Time in Range (%TIR)
次要结局
未报告次要终点
研究者
Francisco Javier Ampudia Blasco
Principal Investigator
Fundación para la Investigación del Hospital Clínico de Valencia