NCT06845891

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

Estudio clínico: Analisis de Control Glucemico y Satisfaccion Con un Cap Conectado en Pacientes Con dm Tipo 1

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Fernando Sebastián Valles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study evaluates the impact of the Cap INSULCLOCK device on glycemic control, treatment adherence, and patient satisfaction in adults with type 1 diabetes mellitus (T1DM). Despite advances in pharmacology and technology, a significant proportion of individuals with T1DM fail to achieve recommended glycemic targets, partly due to the complexity of insulin therapy and suboptimal adherence. Cap INSULCLOCK is a device that attaches to insulin pens, automatically recording injections and integrating data on glucose levels, insulin administration, food intake, and physical activity, with real-time Bluetooth transmission. Its use may enhance adherence and optimize metabolic control. This study is a randomized, low-intervention clinical trial conducted at a single center, enrolling 42 patients, who will be randomized into two groups: one using the activated device and a control group using the device in a blinded mode. The primary objective is to assess differences in time above range (TAR \>180 mg/dL) over the last 14 days of continuous glucose monitoring (CGM). Secondary objectives include evaluating HbA1c levels, time in range (TIR), frequency of hypoglycemic episodes, and patient satisfaction. Data will be analyzed using advanced statistical methods, and the intervention is expected to improve adherence, reduce glycemic variability, and enhance quality of life in individuals with T1DM

Conditions

• Type 1 Diabetes Mellitus
• Type 1 Diabetes Mellitus (T1DM)
• Diabetes Management

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-26
• Primary completion: 2025-06-19
• Completion: 2025-06-19
• First posted: 2025-02-25
• Last updated: 2025-09-15

Locations

1 site across 1 country: Spain