T1DM - Type 1 Diabetes MellitusFLEX-APNCT07031492
Relieving Carb Counting Via Flexible-userinteraction Multiple-input Control Architectures
A study testing FLEX-AP system will be implemented to T1D patients in people with T1DM - Type 1 Diabetes Mellitus, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- T1DM - Type 1 Diabetes Mellitus
- What is being tested?
- FLEX-AP system will be implemented to T1D patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Lía Nattero-Chávez, MD, +34 913369029
Jorge Bondía, PhD, +34 913369029, jbondia@isa.upv.es
About this study
Official title: 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.
Read the 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
- Being tested
- FLEX-AP system will be implemented to T1D patients
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLEX-AP system will be implemented to T1D patientsDevice
A FLEX-AP system will be implemented to T1D patients after they have been given a Minimed 780G hybrid closed-loop system
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: FLEX-AP system will be implemented to T1D patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
- Percentage of participants able to maintain TIR>70% (70-180 mg/dL). This outcome will be calculated for two time periods: 1) daytime (06:00 - 23:59 hours), and 2) nighttime (00:00 - 05:59 hours).
Measured: 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.
- TIR, defined as % CGM time 70-140 mg/dL. This outcomes will be calculated for two time periods: 1) daytime (06:00 - 23:59 hours), and 2) night time (00:00 - 05:59 hours).
Measured: 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.
- % CGM time in Level 1 hypoglycemia (CGM <70 mg/dL and > 54 mg/dL). This outcomes will be calculated for two time periods: 1) daytime (06:00 - 23:59 hours), and 2) night time (00:00 - 05:59 hours).
Measured: 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.
- % CGM time in Level 2 hypoglycemia (CGM ≤ 54 mg/dL). This outcome will be calculated for two time periods: 1) daytime (06:00 - 23:59 hours), and 2) night time (00:00 - 05:59 hours).
Measured: 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.
- % CGM time in Level 1 hyperglycemia (CGM >180 mg/dL and ≤ 250 mg/dL). This outcome will be calculated for two time periods: 1) daytime (06:00 - 23:59 hours), and 2) night time (00:00 - 05:59 hours).
Measured: 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.
- % CGM time in Level 2 hyperglycemia (CGM > 250 mg/dL). This outcome will be calculated for two time periods: 1) daytime (06:00 - 23:59 hours), and 2) night time (00:00 - 05:59 hours).
Measured: 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.
- Mean sensor glucose and glucose variability (expressed primarily as coefficient of variation and second as an SD). This outcome will be calculated for two time periods: 1) daytime (06:00 - 23:59 hours), and 2) night time (00:00 - 05:59 hours).
Measured: 4 weeks
The glycemic outcome within the postprandial period will be assessed, in an exploratory analysis, with the 5-h postprandial percent TIR (70-180 mg/dL)
This will be conducted for the unannounced and announced breakfast in the FLEX-AP controlled hospital phase, comparing with their counterparts in the Minimed 780G® controlled hospital phase. Postprandial periods assessment during the FLEX-AP controlled ambulatory phase in Automatic mode will also be conducted.
Measured: 4 weeks
The glycemic outcome within the postprandial period will be assessed, in an exploratory analysis, the 5-h postprandial glucose incremental area under the curve.
This will be conducted for the unannounced and announced breakfast in the FLEX-AP controlled hospital phase, comparing with their counterparts in the Minimed 780G® controlled hospital phase. Postprandial periods assessment during the FLEX-AP controlled ambulatory phase in Automatic mode will also be conducted.
Measured: 4 weeks
Efficacy of the FLEX-AP system
Total daily insulin during the FLEX-AP controlled ambulatory phase in Automatic mode will be also calculated for exploratory purposes. Active sustance: aspart, formulation: cartridge containing 3ml of insulin solution: 100 IU/ ml, 1 U equals 6 nmol
Measured: 4 weeks
Efficacy of the FLEX-AP system
The number of manual correction boluses during the FLEX-AP controlled ambulatory phase in Automatic mode will be also calculated for exploratory purposes. Modifications of insulin dose according glucose range ( 70-180 mg/dl)
Measured: 4 weeks
Efficacy of the FLEX-AP system
Number of unannounced meals during the FLEX-AP controlled ambulatory phase in Automatic mode.
Measured: 4 weeks
To evaluate the patients perceptions
The patient will complete the PROMs assessment questionnaires at the end of the FLEX-AP controlled ambulatory phase in Automatic mode: Perceptions, Ideas, Reflections and Expectations questionnaire (INSPIRE)
Measured: 4 weeks
To evaluate the patients perceptions
The patient will complete the PROMs assessment questionnaires at the end of the FLEX-AP controlled ambulatory phase in Automatic mode: Hypoglycemia Fear Survey (HFS)
Measured: 4 weeks
To evaluate the patients perceptions
The patient will complete the PROMs assessment questionnaires at the end of the FLEX-AP controlled ambulatory phase in Automatic mode: Diabetes Distress Scale (DDS).
Measured: 4 weeks
To evaluate the patients perceptions
The patient will complete the PROMs assessment questionnaires at the end of the FLEX-AP controlled ambulatory phase in Automatic mode: Diabetes Quality of Life (DQoL).
Measured: 4 weeks
To evaluate the patients perceptions
The patient will complete the PROMs assessment questionnaires at the end of the FLEX-AP controlled ambulatory phase in Automatic mode: System Usability Scale (SUS)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for T1DM - Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Politècnica de València
- Responsible party
- Sponsor
- Investigators
- Jorge Bondia, PhD, Principal investigator, Universitat Politecnica Valencia, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031492
- Sponsor's protocol ID
- FLEX-AP
- Acronym
- FLEX-AP
- Status last verified
- Jun 2025
- First submitted
- 16 May 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37335759Tornese 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.
PubMed 35522033
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond Hybrid Artificial Pancreas Systems: Relieving Carb Counting Via Flexible-userinteraction Multiple-input Control Architectures
- ClinicalTrials.gov ID
- NCT07031492
- Acronym / sponsor ID
- FLEX-AP / FLEX-AP
- Conditions
- T1DM - Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Universitat Politècnica de València
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Implementation of FLEX-AP system | Experimental | Device: FLEX-AP system will be implemented to T1D patientsThis 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLEX-AP system will be implemented to T1D patientsA FLEX-AP system will be implemented to T1D patients after they have been given a Minimed 780G hybrid closed-loop system | Device | Implementation of FLEX-AP system |
Primary outcome
Efficacy of the FLEX-AP system
Time frame: 4 weeks
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.
Safety of the FLEX-AP system
Time frame: 4 weeks
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.
17 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks
The glycemic outcome within the postprandial period will be assessed, in an exploratory analysis, with the 5-h postprandial percent TIR (70-180 mg/dL)
Time frame: 4 weeks
The glycemic outcome within the postprandial period will be assessed, in an exploratory analysis, the 5-h postprandial glucose incremental area under the curve.
Time frame: 4 weeks
Efficacy of the FLEX-AP system
Time frame: 4 weeks
Efficacy of the FLEX-AP system
Time frame: 4 weeks
Efficacy of the FLEX-AP system
Time frame: 4 weeks
To evaluate the patients perceptions
Time frame: 4 weeks
To evaluate the patients perceptions
Time frame: 4 weeks
To evaluate the patients perceptions
Time frame: 4 weeks
To evaluate the patients perceptions
Time frame: 4 weeks
To evaluate the patients perceptions
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Background: PubMed 37335759Shalit 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.
- Background: PubMed 35522033Tornese 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jorge Bondia, PhD principal investigator
Universitat Politecnica Valencia, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLEX-AP system will be implemented to T1D patients in people with T1DM - Type 1 Diabetes Mellitus, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lía Nattero-Chávez, MD (+34 913369029, marialia.nattero@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the FLEX-AP system (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07031492, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.