NCT07031492Not yet recruiting
Relieving Carb Counting Via Flexible-userinteraction Multiple-input Control Architectures
Beyond Hybrid Artificial Pancreas Systems: Relieving Carb Counting Via Flexible-userinteraction Multiple-input Control Architectures
Source: ClinicalTrials.gov · Last updated 22 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 16 May 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Diseases
- Type 1 diabetes
- NCT number
- NCT07031492
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 1 Sept 2025 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.