Relieving Carb Counting Via Flexible-userinteraction Multiple-input Control Architectures (NCT07031492) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Relieving Carb Counting Via Flexible-userinteraction Multiple-input Control Architectures
Spain10 participantsStarted 2025-09
Plain-language summary
Developing algorithms for Automated Insulin Delivery (AID) systems that alleviate the burden of meal announcements, culminating in the FLEX-AP system. This fully automated artificial pancreas system is designed to operate without meal or exercise announcements while allowing for optional user input. FLEX-APaims to achieve a balance between glycemic control and user quality of life by incorporating user preferences into its operation.
The FLEX-AP system features a flexible control architecture tailored to handle unannounced meals and exercise. It also allows for optional meal announcements and offers guidance for mitigating hypoglycemia, such as counterregulatory actions like rescue carbohydrate intake for patients who prefer it. The proposed benefit of FLEX-AP is to improve glycemic control while respecting individual preferences, which sets it apart from existing AID systems.
Who can participate
Age range
18 Years – 60 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:
* Aged 18-60 years inclusive.
* T1D as per the American Diabetes Association classification for \>12 months prior to the screening visit.
* Minimed 780G®-hybrid closed-loop system users for at least 6 months. Use of automatic mode (Smartguard) \> 80% of the time.
* A1c level below 9.0% at Screening visit.
* Assessment of albuminuria and retinal tests, which should have yielded negative results for advanced medical complications.
* Willing and able to adhere to the study protocol
Exclusion Criteria:
* Not having met the previous criteria for inclusion.
* Females who are pregnant or intend to become pregnant during the study period; a positive pregnancy test at screening will result in exclusion.
* Breastfeeding.
* Use of any non-insulin glucose-lowering therapy within three months prior to study initiation.
* Presence of moderate/severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) \<40 mL/min/1.73 m².
* History of severe hypoglycemia (defined as coma or convulsion requiring assistance from others) or diabetic ketoacidosis in the six months prior to study initiation.
* Hypoglycemia unawareness (defined as Clarke Test score greater than 3).
* Occurrence of an acute cardiovascular event (e.g., myocardial infarction, unstable angina, stroke) within twelve months prior to study initiation.
* History of drug or alcohol abuse. History of any active or suspected malignancy.
* Clinically significant microvascular complications (such…
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
1
Efficacy of the FLEX-AP system
Timeframe: 4 weeks
2
Safety of the FLEX-AP system
Timeframe: 4 weeks
Trial details
NCT IDNCT07031492
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal