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NCT06415097

Benefits of Smart Pens in Type 1 Diabetes

Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

View on ClinicalTrials.gov

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.

Official title: Benefits of Smart Pens in People With Type 1 Diabetes: a Real-word Retrospective Study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2024-07

Completion Date

2024-12

Last Updated

2024-05-16

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Insulin Smart Pen

Retrospective analysis of electronic health records for individuals with type 1 diabetes receiving multiple daily doses of insulin, combined with glucose monitoring devices and who have used or are currently using insulin smart pens.

Locations (1)

INCLIVA

Valencia, Spain