CompletedPhase 4

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

Spain42 participantsStarted 2025-02-26

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time Above Range >180 mg/dL

Timeframe: 14 days

Trial details

NCT IDNCT06845891

SponsorFernando Sebastián Valles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-19

View on ClinicalTrials.gov More Type 1 Diabetes Mellitus trials