Automated insulin system that works without meal announcements for type 1 diabetes
Tests an automated insulin device that adjusts doses without meal announcements.
Plain-language title generated from the registry record
Registry title: Relieving Carb Counting Via Flexible-userinteraction Multiple-input Control Architectures
Key facts
- Where
- Madrid, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07031492, who can take part
Where in Spain
- Hospital Universitario Ramón y CajalMadrid, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Trial code
- NCT07031492
- Record updated
- 22 June 2025
- Original description
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.Read full original descriptionShow less
Beyond Hybrid Artificial Pancreas Systems: Relieving Carb Counting Via Flexible-userinteraction Multiple-input Control Architectures
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.
Inclusion: 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: Not having met the previous criteria for inclusion; History of severe hypoglycemia (defined as coma or convulsion requiring assistance from others) or diabetic ketoacidosis in the six months prior to study initiation; Occurrence of an acute cardiovascular event (e.g., myocardial infarction, unstable angina, stroke) within twelve months prior to study initiation; Scheduled surgery during the study period; History of drug or alcohol abuse. History of any active or suspected malignancy; Clinically significant microvascular complications (such as macroalbuminuria, preproliferative and proliferative retinopathy), cardiovascular, hepatic, neurological, endocrine, or other systemic conditions, apart from T1D, that may hinder the implementation of the clinical study protocol or the interpretation of study results; Presence of any comorbid medical or psychological condition deemed by the investigators to render the individual unsuitable for study participation; Known allergy to insulin NovoRapid; 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; Females who are pregnant or intend to become pregnant during the study period; a positive pregnancy test at screening will result in exclusion; Breastfeeding; Hypoglycemia unawareness (defined as Clarke Test score greater than 3); Diabetic gastroparesis; Adherence to a very low carbohydrate diet, defined as a carbohydrate intake of less than 40 grams per day; Regular practice of competitive or very high intensity physical activity.