Benefits of Smart Pens in Type 1 Diabetes - Trial NCT06415097
Access comprehensive clinical trial information for NCT06415097 through Pure Global AI's free database. This phase not specified trial is sponsored by Fundación para la Investigación del Hospital Clínico de Valencia and is currently Not yet recruiting. The study focuses on Type 1 Diabetes. Target enrollment is 100 participants.
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Study Focus
Sponsor & Location
Fundación para la Investigación del Hospital Clínico de Valencia
Timeline & Enrollment
N/A
Jul 01, 2024
Dec 01, 2024
Primary Outcome
Type of smart pen prescribed,Type of basal insulin prescribed,Daily dose of basal insulin,Number of basal insulin injections,Omission of basal insulin,Type of prandial insulin prescribed,Daily dose of prandial insulin,Number of prandial insulin injections,Omission of prandial insulin,Total daily insulin dose,Number of total insulin injections,Self-monitoring of capillary glucose,Glucose monitoring device,Time using the glucose monitoring device,HbA1c concentration,Time in Range (%TIR),Time Below Range (%TbR),Time Above Range (%TaR),Mean glucose (mg/dL),Coefficient of variation of continuous glucose sensor values (CV),Type of adverse event from the initiation of the prescription of smart insulin pens.,Months post smart pen prescription when the adverse event occurred.,Adherence to smart insulin pen usage based on the number of days with data uploads,Smart pen persistence,Exclusive use of smart pen,Duration of diabetes,Diabetic ketoacidosis,Severe hypoglycemia,BMI,Age
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06415097
Device Trial