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

Launched by FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSITARIO RAMON Y CAJAL · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new type of artificial pancreas system called FLEX-AP designed to help people with Type 1 Diabetes manage their blood sugar more easily. Unlike current devices that require users to announce meals or exercise, FLEX-AP can work automatically without needing this information, though users can still choose to provide input if they want. The system aims to keep blood sugar levels in a healthy range while making daily diabetes management less of a burden and more tailored to individual needs.

People who might be eligible for this study are adults aged 18 to 60 who have had Type 1 Diabetes for at least a year and have been using a specific insulin pump system (Minimed 780G) regularly for six months or more. To join, participants should have fairly good blood sugar control (A1c below 9%) and no serious diabetes complications or other health issues that could affect the study. During the trial, participants can expect to try out the FLEX-AP system and receive guidance on managing low blood sugar if it occurs. This study is not yet recruiting, but it offers a promising step toward making diabetes care more flexible and less demanding.

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ALL

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.