Benefits of Smart Pens in People With Type 1 Diabetes: a Real-word Retrospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Type of smart pen prescribed
研究概览
简要总结
This study aims to address persistent challenges in achieving recommended control goals for patients with type 1 diabetes through innovative interventions. Specifically, the research focuses on assessing the effectiveness of smart insulin pens combined with glucose monitoring devices as a promising treatment option for individuals on multiple daily insulin injections. The study will analyze electronic health records from adults (≥ 18 years) attending the Diabetes Unit of the University Clinical Hospital of Valencia. Participants who are or have used smart insulin pens will be compared with a control group matched for age, sex, duration of diabetes, and HbA1c value at baseline (1:1). Data will be collected on participant characteristics, smart pen usage, glycemic control parameters, and daily insulin doses. The study also aims to identify adverse events associated with the use of smart pens. Ethical considerations include ensuring the anonymity of participant data, and the study is designed to comply with European (EU) data protection regulations. The retrospective nature ensures no interference with physicians' prescription habits.
详细描述
Rationale:
Despite ongoing advancements in type 1 diabetes management, a significant number of patients continue to struggle in attaining recommended control goals, posing an elevated risk of complications and a diminished quality of life. Hence, there is a need for innovative interventions that genuinely improve diabetes management and associated clinical outcomes. Smart insulin pens, coupled with glucose monitoring devices, emerge as a promising treatment option for individuals on multiple daily insulin injections who may not be suitable candidates for continuous subcutaneous insulin infusion (CSII) therapy. These easy-to-use devices offer significant advantages, such as automated tracking of administered insulin doses along with information other relevant diabetes-related data, facilitating treatment optimization, and helping overcome barriers to achieve better glucose control where both patients and healthcare professionals can implement treatment plans with agility, adopting a more proactive and personalized approach to diabetes care.
While certain recent studies have shown positive outcomes in glycemic control and quality of life linked to the utilization of these devices, there is still a gap in understanding their impact under real-life conditions. Hence, conducting clinical studies within the framework of routine clinical practice becomes imperative to thoroughly assess their application and effects on individuals with type 1 diabetes undergoing multiple daily insulin injections.
The purpose of this study is to provide real-world evidence on the effectiveness of smart pens in enhancing glycemic control and identify specific patient subgroups for targeted interventions.
Hypothesis:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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 type 1 diabetes
- •Individuals receiving multiple daily doses of insulin
- •Individuals using a glucose monitoring device
- •Individuals who use or have used smart insulin pens since their introduction to the market
排除标准
- •Individuals with other types of diabetes
- •Individuals utilizing continuous subcutaneous insulin infusion devices
- •Individuals using automatic insulin delivery systems
结局指标
主要结局
Type of smart pen prescribed
时间窗: up to 24 months
Type of smart pen prescribed (smart pen prescription)
Type of basal insulin prescribed
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Type of basal insulin prescribed (basal insulin prescription)
Omission of basal insulin
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Omission of basal insulin doses (Yes/No)
Adherence to smart insulin pen usage based on the number of days with data uploads
时间窗: up to 24 months (from the time of the first prescription and throughout the study follow-up)
Adherence to data transfer in the mobile application when using the smart pen: at month 6, 12, 18, 24
Daily dose of basal insulin
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Daily dose of basal insulin (UI/kg)
Number of basal insulin injections
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Number of basal insulin injections per day
Daily dose of prandial insulin
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Daily dose of prandial insulin (UI/kg)
Time using the glucose monitoring device
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Percentage of time using the glucose monitoring device
Time Above Range (%TaR)
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Time Above Range (%TaR): at month -3, 0, 3, 6, 12, 18, and 24.
Diabetic ketoacidosis
时间窗: up to 12 months
Diabetic ketoacidosis (DKA) in the year prior to the initiation of the smart pen (Yes/No)
Type of prandial insulin prescribed
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Type of insulin prescribed for prandial use (prandial insulin prescription)
Number of prandial insulin injections
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Number of prandial insulin injections per day
Omission of prandial insulin
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Omission of prandial insulin doses (Yes/No)
Number of total insulin injections
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Number of total insulin injections per day
Coefficient of variation of continuous glucose sensor values (CV)
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Coefficient of variation of continuous glucose sensor values (CV): at month -3, 0, 3, 6, 12, 18, and 24.
Total daily insulin dose
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Total daily insulin dose (UI/kg)
Self-monitoring of capillary glucose
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Self-monitoring of capillary blood glucose (SMBG) (Y/N)
Glucose monitoring device
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Glucose monitoring in real-time or intermittently scanned (Yes/No)
HbA1c concentration
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
HbA1c concentration: at month -3, 0, 3, 6, 12, 18, and 24.
Time in Range (%TIR)
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Time in Range (%TIR): at month -3, 0, 3, 6, 12, 18, and 24.
Time Below Range (%TbR)
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Time Below Range (%TbR): at month -3, 0, 3, 6, 12, 18, and 24.
Mean glucose (mg/dL)
时间窗: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Mean glucose (mg/dL): at month -3, 0, 3, 6, 12, 18, and 24.
Type of adverse event from the initiation of the prescription of smart insulin pens.
时间窗: up to 24 months (from the time of the first prescription and throughout the study follow-up)
Type of adverse event from the initiation of the prescription of smart insulin pens (if any adverse event occurred): severe hypoglycemia, DKA (Diabetic Ketoacidosis), ketosis, other
Months post smart pen prescription when the adverse event occurred.
时间窗: up to 24 months (from the time of the first prescription and throughout the study follow-up)
Number of months post smart pen prescription when the adverse event occurred (nº).
Exclusive use of smart pen
时间窗: up to 24 months (from the time of the first prescription and throughout the study follow-up)
Exclusive use of smart insulin pens or mixed use with disposable pens (Yes/No)
Severe hypoglycemia
时间窗: up to 12 months
Severe hypoglycemia in the year prior to the initiation of the smart pen (Yes/No)
Smart pen persistence
时间窗: up to 24 months (from the time of the first prescription and throughout the study follow-up)
Persistence in the use of smart insulin pens after prescription: at month 6, 12, 18, 24 Persistence defined as the percentage of patients continuing treatment since the first smart pen prescription until discontinuation.
Duration of diabetes
时间窗: up to 12 months
Duration of diabetes at the time of the first smart pen prescription (years)
BMI
时间窗: From three months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
BMI (kg/m2): at month -3, 0, 6, 12, 18, 24
Age
时间窗: up to 12 months
Age at the time of the first smart pen prescription (years)
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