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

NCT07031492 | Not Yet Recruiting

• 1 other identifier: FLEX-AP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

T1DM - Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Efficacy of the FLEX-AP system

  Percentage of time spent in target sensor glucose range (70-180 mg/dL, Time in range (TIR)) during the FLEX-AP controlled ambulatory phase in Automatic mode.

  4 weeks

• Safety of the FLEX-AP system

  To assess the safety of the FLEX-AP system in a controlled ambulatory setting simulating real-life conditions:Number of symptomatic hypoglycemia events, Number of severe hypoglycemia events, Episodes of diabetic ketoacidosis (DKA) or ketosis, Technical issues related to the insulin pump and dermatological issues related to device use.

  4 weeks

Secondary Outcomes (17)

• Continuous glucose monitoring (CGM) data during the FLEX-AP controlled ambulatory phase in automatic mode will be analyzed according to the following standardized CGM metrics for clinical trials.

  4 weeks

• Continuous glucose monitoring (CGM) data during the FLEX-AP controlled ambulatory phase in automatic mode will be analyzed according to the following standardized CGM metrics for clinical trials.

  4 weeks

• Continuous glucose monitoring (CGM) data during the FLEX-AP controlled ambulatory phase in automatic mode will be analyzed according to the following standardized CGM metrics for clinical trials.

  4 weeks

• Continuous glucose monitoring (CGM) data during the FLEX-AP controlled ambulatory phase in automatic mode will be analyzed according to the following standardized CGM metrics for clinical trials.

  4 weeks

• Continuous glucose monitoring (CGM) data during the FLEX-AP controlled ambulatory phase in automatic mode will be analyzed according to the following standardized CGM metrics for clinical trials.

  4 weeks

Study Arms (1)

Implementation of FLEX-AP system

EXPERIMENTAL

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.

Device: FLEX-AP system will be implemented to T1D patients

Interventions

FLEX-AP system will be implemented to T1D patients DEVICE

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

Implementation of FLEX-AP system

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead
• Universitat Politècnica de València: collaborator

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Related Publications (2)

• 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.

  PMID: 37335759 BACKGROUND

• 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.

  PMID: 35522033 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jorge Bondia, PhD

  Universitat Politecnica Valencia, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lía Nattero-Chávez, MD

CONTACT

+34 913369029; marialia.nattero@salud.madrid.org

Jorge Bondia, PhD

CONTACT

+34 913369029; jbondia@isa.upv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intented purpose of FLEX-AP is to improve the glycemic control of patients with Type 1 Diabetes (T1D) against events of unannounced meals by automating the calculation of the regulatory action (insulin infusion). To this end, FLEX-AP will periodically ( each 5 min) receive the glucose value fron a continuous glucose monitoring (CGM). Then, FLEX-AP´s control algorithm will use the received glucose value (input to the algorithm) to compute a new value of insulin infusion. Then, it will send the calculated insuline infusion to the pump. Complementarily, it will alert users to hyperglycemia an d hypoglicemia. 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 orde

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 22, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

ES (1)