Closed Loop Glucose Control in a Simulated ICU Setting
9 juin 2026 mis à jour par: Ideal Medical Technologies
Demonstration of an Expert Rule-Based Automated Insulin Delivery (AID) System for People With Type 1 and Type 2 Diabetes
This is a proof of concept safety study of a rule-based closed loop glucose control system designed for use in the intensive care unit setting.
The persons with type 1 and type 2 diabetes in this study will have their glucose controlled to a range of 100-140 mg/dL by a fully autonomous novel rule-based closed loop glucose control system for a period of 24 hours. The subjects will consume three standardized meals and receive a continuous intravenous infusion of dextrose (D-glucose) during the 24 hour study period. Meals will not be announced to the glucose control system.
Aperçu de l'étude
Statut
Pas encore de recrutement
Intervention / Traitement
Description détaillée
Tight glucose control in the intensive care unit (ICU) setting is difficult to achieve. The investigators hypothesize that a closed loop glucose control system that is rule-based will improve upon the glucose control currently achieved by the current open loop manual methods, and that this improved glucose control may improve the outcomes of critically ill patients.
This Earl Feasibility Study will test the ability of a prototype rule-based closed loop glucose control system named FUSION, to provide safe and effective glucose control in subjects with type 1 and type 2 diabetes in a clinical research center (CRC) setting. Subjects with type 1 diabetes have been chosen as safe and effective glucose control is difficult to achieve in these subjects during meal challenges. Subjects with type 2 diabetes have been chosen as they are insulin resistant, which makes their insulin resistance profile similar to that of ICU patients. As this is a safety study of a new medical device, the controlled environment of the CRC is preferable to the less controlled environment of an ICU setting.
The prototype FUSION system to be used in this study will consist to two Dexcom G6 continuous glucose monitors (CGM), the rule-based glucose control software run on an all-in-one medical computer, and two syringe pumps. The prototype system is housed on a medical cart. Based on the average glucose value of the two Dexcom G6 CGM's, and the algorithms of the FUSION systems rule-based glucose control software, the FUSION system will make rate adjustments every 5-10 minutes to the intravenous infusion rates of short acting insulin (NovoLog) and dextrose (D10NS) under its control, in an attempt to keep the subjects glucose in the range of 100-140 mg/dL. The FUSION system only requires entry of the subjects study identification number and weight in kilograms to initiate the system.
For safety reasons, the subjects will have their blood glucose independently measured every 10-60 minutes on the point of care Nova StatStrip system, throughout the 24 hour study period.
The study has halting criteria to avoid recurrent instances of severe hypoglycemia (< 54 mg/dL).
The average of the two CGM's, that is used by the FUSION system for glucose control, will be used for statistical analysis.
Type d'étude
Interventionnel
Inscription (Estimé)
6
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Leon M DeJournett, MD
- Numéro de téléphone: 1-828-337-9960
- E-mail: leondej@idealmedtech.com
Sauvegarde des contacts de l'étude
- Nom: Jeremy DeJournett, EE
- Numéro de téléphone: 1-828-545-9110
- E-mail: jeremy@idealmedtech.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
Participants with type 1 and type 2 diabetes are eligible to be included in the study only if they meet all the following criteria:
- Are 18-70 years of age, inclusive.
- Can understand and sign an informed consent, communicate with the investigator, and understand and comply with the protocol requirements.
- Have had a diagnosis of type 1 or type 2 diabetes for a period of at least 3 months.
- Use insulin injections at home for glucose control.
- Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%.
Have a hemoglobin in the range for sex:
- Females: 7-15.5 grams/dL.
- Males: 7-17.5 grams/dl.
- Have adequate venous access sites in upper extremities.
- Body weight between 40 - 150 kg.
Exclusion Criteria:
- Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening.
- Have a known hypersensitivity to any of the components of study treatment.
- Have skin disease/injury at Dexcom G6 CGM insertion site(s) that would prevent insertion of the CGM.
- Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant.
- Have a medical condition that in the opinion of the investigator could affect study participation and/or personal well-being.
Have a clinically significant history or presence of any of the following conditions:
- Hepatic failure or has alanine aminotransferase (ALT) greater than 3 times the upper limit of normal.
- Has an estimated GFR <30 ml/min/1.73 m2 or End Stage Kidney Disease on renal replacement therapy.
- Have congestive heart failure greater than class 1 on the NYHA classification system.
- Have a history of seizures.
- Have a history of cerebrovascular accident.
- Have a history of ischemic heart disease.
For female subjects of potential childbearing age (age 18 to 55) they will be excluded if:
- Pregnant.
- Refuse to agree to a pregnancy test at the time of enrollment.
- Have a positive urine pregnancy test at the time of enrollment.
- Have a positive Influenza or COVID test within 14 days of visit 3.
- Have any viral lower respiratory related symptoms (e.g., cough, chest tightness, respiratory distress) in the 14-day period prior to visit 3.
- Have a known unprotected Influenza or COVID exposure in the 14-day period prior to visit 3.
- Are currently being treated with Hydroxyurea, a medication which may cause the Dexcom G6 CGM to produce glucose readings that are higher than the actual glucose value.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Système de contrôle du glucose à boucle fermée fusion Étude de sécurité
Tous les sujets seront traités avec le système de contrôle de glucose en boucle fermée de fusion jusqu'à 24 heures maximum
|
Le système FUSION sera utilisé pour contrôler la glycémie des sujets dans une plage de 100 à 140 mg/dL.
Les données seront collectées jusqu'à 24 heures ou à la fin anticipée de la session d'étude.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Primary Safety Measure
Délai: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time up to 24 hours
|
The percentage of all glucose values <70 mg/dL
|
From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time up to 24 hours
|
|
Primary Efficacy Measure
Délai: From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours
|
The percentage of all glucose values within the glucose range of 70-180 mg/dL
|
From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percent of All Glucose Values Within Glucose Range <54 mg/dL
Délai: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours
|
The percentage of all glucose values that are less than 54 mg/dL
|
From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours
|
|
Percent of All Glucose Values Within Glucose Range 54-69 mg/dL
Délai: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of up to 24 hours.
|
The percentage of all glucose values that are within the glucose range of 54-69 mg/dL
|
From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of up to 24 hours.
|
|
Number of Hypoglycemic Events (<70 mg/dL)
Délai: From beginning of use of the FUSION System until end of use of the FUSION System, which will be a period of time of up to 24 hours.
|
The total number of hypoglycemic events less than 70 mg/dL as measured by a continuous series of glucose values less than 70 mg/dL for at least 15 minutes duration.
|
From beginning of use of the FUSION System until end of use of the FUSION System, which will be a period of time of up to 24 hours.
|
|
Percent of All Glucose Values Within Glucose Range 70-100 mg/dL
Délai: From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours
|
The percentage of all glucose values within the glucose range of 70-100 mg/dL
|
From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours
|
|
Percent of All Glucose Values Within Glucose Range 70-140 mg/dL
Délai: From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours
|
The percentage of all glucose values within the glucose range of 70-140 mg/dL
|
From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours
|
|
Percent of All Glucose Values Within Glucose Range 100-140 mg/dL
Délai: From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours
|
The percentage of all glucose values within the glucose range of 100-140 mg/dL
|
From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours
|
|
Percent of All Glucose Values Within Glucose Range >140 mg/dL
Délai: From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours
|
The percentage of all glucose values greater than 140 mg/dL
|
From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours
|
|
Percent of All Glucose Values Within Glucose Range >180 mg/dL
Délai: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours
|
The percentage of all glucose values that are greater than 180 mg/dL
|
From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours
|
|
Percent of All Glucose Values Within Glucose Range >250 mg/dL
Délai: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours
|
The percentage of all glucose values that are greater than 250 mg/dL
|
From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours
|
|
Average glucose value in mg/dL
Délai: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours
|
The average of all measured glucose values in mg/dL
|
From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours
|
|
Measure of dispersion - Coefficient of Variation
Délai: From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours
|
The Coefficient of variation of glucose will be calculated by dividing the standard deviation of the average glucose value by the average glucose value, then multiplying this value by 100.
|
From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours
|
|
Clarke Error Grid Analysis of Continuous Glucose Monitor Data
Délai: From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours
|
The study data will be used to determine the percentage of the two Dexcom G6 CGM's glucose values in each zone using a Clarke error grid analysis.
This same calculation will be performed on the average of the two Dexcom G6 CGM systems used by the FUSION system for purposes of glucose control.
|
From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours
|
|
FDA integrated Continuous Glucose Monitor Standards
Délai: From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours
|
The study data will be used to determine if each individual Dexcom G6 CGM system, and their average value meet FDA criteria for integrated Continuous Glucose Monitor (iCGM) accuracy for the glucose zones <70 mg/dL, 70-180 mg/dL, and >180 mg/dL.
|
From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours
|
|
Hemoglobin A1c Percentage Level
Délai: As measured from a blood draw within two weeks prior to the start of the 24-hour closed loop glucose control session
|
The subjects hemoglobin A1c measurement from a blood draw taken within 2 weeks of the start of the closed loop glucose control session
|
As measured from a blood draw within two weeks prior to the start of the 24-hour closed loop glucose control session
|
|
C-Peptide Level
Délai: As measured from a blood draw within two weeks prior to the start of the 24-hour closed loop glucose control session
|
The subjects C-peptide level will be measured prior to the start of the closed loop glucose control session.
|
As measured from a blood draw within two weeks prior to the start of the 24-hour closed loop glucose control session
|
|
Total Daily Dose of Insulin in Units/Kilogram
Délai: As documented within two weeks prior to the start of the 24-hour closed loop glucose control session
|
The subjects total daily dose of insulin used prior to the start of the closed loop glucose control session was calculated by adding up all of the insulin doses used by the subjects (both short and long acting insulin) in units and dividing this value by the subjects weight in Kilograms
|
As documented within two weeks prior to the start of the 24-hour closed loop glucose control session
|
|
Weight in Kilograms
Délai: As measured just prior to the start of the 24-hour closed loop glucose control session
|
Average weight in kilograms of the subjects
|
As measured just prior to the start of the 24-hour closed loop glucose control session
|
|
Body Mass Index
Délai: As measured just prior to the start of the 24-hour closed loop glucose control session
|
The body mass index will be calculated by dividing the subjects weight in kilograms by the square of their height in meters
|
As measured just prior to the start of the 24-hour closed loop glucose control session
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Leon M DeJournett, MD, Ideal Medical Technologies
- Chercheur principal: Francisco Pasquel, MD, MPH, Emory School Of Medicine
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- DeJournett L, DeJournett J. In Silico Testing of an Artificial-Intelligence-Based Artificial Pancreas Designed for Use in the Intensive Care Unit Setting. J Diabetes Sci Technol. 2016 Nov 1;10(6):1360-1371. doi: 10.1177/1932296816653967. Print 2016 Nov.
- DeJournett J, DeJournett L. Comparative Simulation Study of Glucose Control Methods Designed for Use in the Intensive Care Unit Setting via a Novel Controller Scoring Metric. J Diabetes Sci Technol. 2017 Nov;11(6):1207-1217. doi: 10.1177/1932296817711297. Epub 2017 Jun 22.
- DeJournett J, Nekludov M, DeJournett L, Wallin M. Performance of a closed-loop glucose control system, comprising a continuous glucose monitoring system and an AI-based controller in swine during severe hypo- and hyperglycemic provocations. J Clin Monit Comput. 2021 Apr;35(2):317-325. doi: 10.1007/s10877-020-00474-2. Epub 2020 Jan 31.
- DeJournett L. Essential elements of the native glucoregulatory system, which, if appreciated, may help improve the function of glucose controllers in the intensive care unit setting. J Diabetes Sci Technol. 2010 Jan 1;4(1):190-8. doi: 10.1177/193229681000400124.
- Sardu C, D'Onofrio N, Balestrieri ML, Barbieri M, Rizzo MR, Messina V, Maggi P, Coppola N, Paolisso G, Marfella R. Outcomes in Patients With Hyperglycemia Affected by COVID-19: Can We Do More on Glycemic Control? Diabetes Care. 2020 Jul;43(7):1408-1415. doi: 10.2337/dc20-0723. Epub 2020 May 19.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juillet 2026
Achèvement primaire (Estimé)
1 décembre 2026
Achèvement de l'étude (Estimé)
1 décembre 2027
Dates d'inscription aux études
Première soumission
9 juin 2026
Première soumission répondant aux critères de contrôle qualité
9 juin 2026
Première publication (Réel)
12 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025P013846
- 5R44DK133084-02 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .