Clinical Study: Analysis of Glycemic Control and Satisfaction With a Connected Smart Cap in Patients With Type 1 Diabetes Mellitus

Launched by FERNANDO SEBASTIÁN VALLES · Feb 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a device called Cap INSULCLOCK, which is designed to help adults with type 1 diabetes manage their condition better. The device attaches to insulin pens and records important information about insulin injections, blood sugar levels, food intake, and physical activity. By using this device, researchers hope to see if it can improve blood sugar control, help patients stick to their treatment plans, and make them feel more satisfied with their diabetes management. The study will involve 42 participants who will be divided into two groups: one will use the device as intended, while the other will use it without knowing if it's active.

To be eligible for the trial, participants need to be at least 18 years old, have a diagnosis of type 1 diabetes, and use a continuous glucose monitoring system successfully. They should also have a good record of keeping up with their medical appointments and be able to use a smartphone for follow-up. Throughout the study, participants will wear a continuous glucose monitor for 14 days and provide feedback on their experience. This trial aims to see if using the Cap INSULCLOCK can help people maintain better blood sugar levels and ultimately improve their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women aged 18 years or older.
• • Diagnosis of type 1 diabetes mellitus (T1DM).
• • Users of flash continuous glucose monitoring (FGM) sensors with \>70% of recorded data, including intake and insulin dose logs.
• • Adequate therapeutic adherence, with no missed appointments in the past year.
• • Time above range (TAR \>180 mg/dL) \>25%.
• • Ability to provide informed consent to participate in the study.
• • Access to technology for follow-up, including a smartphone with internet connectivity and compatibility with the Insulcloud app.
• Exclusion Criteria:
• • Current pregnancy.
• • Severe acute illness.
• • Exclusion criteria for the use of real-time continuous glucose monitoring (RT-CGM) systems as per the Framework Agreement of the Community of Madrid for RT-CGM use (SERMAS).
• • Inability to provide informed consent or to meet the study requirements for any reason.