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

Fernando Sebastián Valles42 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 1 Diabetes Mellitus

Interventions

CONNECTED SMART CAPDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Time Above Range >180 mg/dL

Time Above Range (TAR) refers to the percentage of time that an individual's glucose levels exceed 180 mg/dL during a given period, in this case, the last 14 days as recorded by a continuous or flash glucose monitoring system. This metric reflects hyperglycemic burden and has been associated with an increased risk of diabetes-related complications. Clinical guidelines generally recommend keeping TAR below 25% to optimize glycemic control and reduce long-term adverse outcomes.

Time frame: 14 days

Secondary Outcomes

Time in range (70 - 180 mg/dL),

Time in Range (TIR) refers to the percentage of time an individual's glucose levels remain within the target range of 70-180 mg/dL over the last 14 days, as recorded by a continuous or flash glucose monitoring system. TIR is a key glycemic metric reflecting overall glucose control, with higher percentages being associated with a lower risk of diabetes-related complications. Clinical guidelines recommend maintaining TIR above 70% as a primary therapeutic goal for individuals with diabetes.