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

NCT06845891 | Completed Phase 4 DMC

• 1 other identifier: 5350
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diabetes tecnhology; Type 1 diabetes; Smart cap; Time above range

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days

Secondary Outcomes (1)

• Time in range (70 - 180 mg/dL),

  14 days

Study Arms (2)

Connected smart cap

EXPERIMENTAL

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.

Device: CONNECTED SMART CAP

cap disconnected

ACTIVE COMPARATOR

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.

Device: CONNECTED SMART CAP

Interventions

CONNECTED SMART CAP DEVICE

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.

Connected smart cap; cap disconnected

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Current pregnancy.
• Severe acute illness.
• Inability to provide informed consent or to meet the study requirements for any reason.

Sponsors & Collaborators

• Fernando Sebastián Valles: lead

Study Sites (1)

Hospital Universitario de La Princesa

Madrid, Madrid, 28006, Spain

Location

Related Publications (1)

• Sebastian-Valles F, Sager-La Ganga C, Justel Enriquez A, Jimenez Blanco S, Navas-Moreno V, Arranz Martin JA, Marazuela M. Analysis of glycaemic control and treatment satisfaction with a connected smart pen cap in adults with type 1 diabetes: a randomised, open-label, parallel-group trial. Diabetologia. 2026 Feb 3. doi: 10.1007/s00125-026-06674-w. Online ahead of print.

  PMID: 41634174 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The healthcare provider will introduce the study to each individual with type 1 diabetes who meets the inclusion and exclusion criteria during routine medical visits. Subsequently, the research team will contact each participant and randomly assign the device. Given that the total study duration for each patient is two months, the study will conclude for each individual at their follow-up visit with the healthcare provider. Blinding will not be feasible for either participants or investigators, as the control group will not have access to the real-time data provided by the cap, which is linked to the digital application of the glucose monitoring sensor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 25, 2025
• Study Start: February 26, 2025
• Primary Completion: June 19, 2025
• Study Completion: June 19, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)