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

PHASE4CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

February 26, 2025

Primary Completion Date

June 19, 2025

Study Completion Date

June 19, 2025

Conditions
Type 1 Diabetes MellitusType 1 Diabetes Mellitus (T1DM)Diabetes Management
Interventions
DEVICE

CONNECTED SMART CAP

The intervention in this study consists of attaching a smart cap to the insulin pen of individuals with type 1 diabetes who use flash glucose monitoring and experience a time above range (TAR \>180 mg/dL) for more than 25% of the time. This metric has been associated with diabetes-related complications, and the objective of this study is to determine whether this simple device could help reduce this underexplored parameter.

Trial Locations (1)

28006

Hospital Universitario de La Princesa, Madrid

All Listed Sponsors
lead

Fernando Sebastián Valles

OTHER

NCT06845891 - Clinical Study: Analysis of Glycemic Control and Satisfaction With a Connected Smart Cap in Patients With Type 1 Diabetes Mellitus | Biotech Hunter | Biotech Hunter