An interventional study of CONNECTED SMART CAP in Type 1 Diabetes Mellitus, Type 1 Diabetes Mellitus (T1DM) and Diabetes Management, sponsored by Fernando Sebastián Valles. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Fernando Sebastián Valles · Not applicable, Interventional, and Treatment
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
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 42 is close to the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →This is the only study on the registry with Fernando Sebastián Valles as lead sponsor.
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Exclusion Criteria:
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
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
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.
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
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.
Time frame: 14 days
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Plan to share: No — The individual participant data (IPD) will not be shared due to ethical and regulatory considerations regarding patient confidentiality
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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