Clinical Study: Analysis of Glycemic Control and Satisfaction With a Connected Smart Cap in Patients With Type 1 Diabetes Mellitus (CAPSDM1)

Fernando Sebastián Valles

Status and phase: Completed; Phase 4

Conditions: Diabetes Management; Type 1 Diabetes Mellitus; Type 1 Diabetes Mellitus (T1DM)

Treatments: Device: CONNECTED SMART CAP

Study type: Interventional

Funder types: Other

Identifiers

NCT06845891

5350 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Connected smart cap

Experimental group

Description:

This arm will have access to the cap, which is connected to the digital application that records the timing of insulin injections and provides reminders in case of missed doses.

Treatment:

Device: CONNECTED SMART CAP

cap disconnected

Active Comparator group

Description:

This treatment arm will receive the cap without connectivity, thereby lacking access to the information provided by the digital application, including the timing of insulin injections, injection events, and reminder notifications.

Treatment:

Device: CONNECTED SMART CAP