Relieving Carb Counting Via Flexible-userinteraction Multiple-input Control Architectures

NCT ID: NCT07031492

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

Although AID systems have significantly advanced, carbohydrate counting remains a burdensome and error-prone task for patients, often leading to suboptimal postprandial glycemic control. Furthermore, even with accurate carbohydrate estimation, other macronutrients impact glycemic responses, complicating management. Hybrid AID systems that rely on meal announcements to manage glycemic excursions, but theses exhibit a limited efficacy when managing moderate-to-large unannounced meals, underscoring the need for systems with improved adaptability and functionality.

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.

The first clinical trial that uses the FLEX-AP system (NCT06082973) was approved by the Spanish regulatory agency (AEMPS) in April 2024 and it is currently ongoing. This study evaluates the FLEX-AP in a hospital setting under unannounced exercise challenges to assess the functionality of counter-regulatory actions recommendation, comparing rescue carbohydrates versus mini-doses of glucagon.

The rationale of this study is to advance the evaluation of the FLEX-AP system for fully automated postprandial glucose control under inpatient and outpatient conditions, going beyond in-silico studies. This study is designed to determine safety and efficacy of the FLEX-AP system in a controlled ambulatory condition, emulating real-life conditions. Patients will operate the system as fully-automated for meals under 70 grams of carbohydrates, announcing larger meals as safety measure in this first ambulatory study. This study will provide essential insights for engineers to understand complex meal dynamics better, facilitating further refinement of the FLEX-AP algorithm required for pivotal studies.

Conditions

T1DM - Type 1 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Implementation of FLEX-AP system

This is a preliminary, exploratory non-randomized, longitudinal, crossover study involving patients with T1D who are habitual userss of the Minimed 780G hybrid closed-loop system. This study consists of two sequentials phases, starting wiht the Minimed 780G hybrid closed-loop system and transitioning to the FLEX-AP system, with no randomization of treatment order.

Group Type: EXPERIMENTAL

FLEX-AP system will be implemented to T1D patients

Intervention Type: DEVICE

A FLEX-AP system will be implemented to T1D patients after they have been given a Minimed 780G hybrid closed-loop system

Interventions

FLEX-AP system will be implemented to T1D patients

A FLEX-AP system will be implemented to T1D patients after they have been given a Minimed 780G hybrid closed-loop system

Intervention Type: DEVICE

Eligibility Criteria

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 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.
• Diabetic gastroparesis.
• Scheduled surgery during the study period.
• Adherence to a very low carbohydrate diet, defined as a carbohydrate intake of less than 40 grams per day.
• 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.
• Regular practice of competitive or very high intensity physical activity.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat Politècnica de València

OTHER

Sponsor Role: collaborator

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge Bondia, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat Politecnica Valencia, Spain

Locations

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Countries

Spain

Central Contacts

Lía Nattero-Chávez, MD

Role: CONTACT

marialia.nattero@salud.madrid.org

+34 913369029

Jorge Bondia, PhD

Role: CONTACT

jbondia@isa.upv.es

+34 913369029

Facility Contacts

Lía Nattero-Chávez, MD

Role: primary

+34 913369029

Jorge Bondía, PhD

Role: backup

jbondia@isa.upv.es

+34 913369029

References

Shalit R, Minsky N, Laron-Hirsh M, Cohen O, Kurtz N, Roy A, Grosman B, Benedetti A, Tirosh A. Unannounced Meal Challenges Using an Advanced Hybrid Closed-Loop System. Diabetes Technol Ther. 2023 Sep;25(9):579-588. doi: 10.1089/dia.2023.0139.

Reference Type: BACKGROUND

PMID: 37335759 (View on PubMed)

Tornese G, Carletti C, Giangreco M, Nistico D, Faleschini E, Barbi E. Carbohydrate Tolerance Threshold for Unannounced Snacks in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-Loop System. Diabetes Care. 2022 Jun 2;45(6):1486-1488. doi: 10.2337/dc21-2643.

Reference Type: BACKGROUND

PMID: 35522033 (View on PubMed)

Other Identifiers

FLEX-AP

Identifier Type: -

Identifier Source: org_study_id