- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03092310
Feasibility Evaluation of an Artificial Pancreas With Glucose Prediction Trust Index
Feasibility Evaluation of an Artificial Pancreas With an Enhanced Model Predictive Control (eMPC) Controller and a Health Monitoring System (HMS) With a Glucose Prediction Trust Index
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a feasibility study of an artificial pancreas (AP) system with our previously validated target eMPC and HMS algorithms, with the addition of a trust index of the predicted glucose value integrated into the portable Artificial Pancreas System (pAPS). The system will be evaluated on up to 20 subjects, with the goal of 10 subjects completing a 48-hour closed-loop session at one clinical site (William Sansum Diabetes Center). During the session subjects will bolus for all meals and snacks and perform a 45-minute walking session.
The purpose of this pilot study is to establish that closed-loop insulin delivery with a target enchanted model predictive control (eMPC)/Health Monitoring System (HMS) algorithms with a trust index of the predicted glucose value is safe and effective, to analyze and learn to improve upon the accuracy of the predicted glucose values, and to collect efficacy data to inform a future larger study.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Santa Barbara, California, Estados Unidos, 93105
- William Sansum Diabetes Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age ≥ 18 and ≤ 75 years at the time of screening.
- Clinical diagnosis of type 1 diabetes for at least one year.
- Has been using an insulin pump for at least 6 months at the time of screening.
- HbA1c < 10%, as performed by point of care or central laboratory testing. A1c will be assessed at the screening visit, or if already completed within 2 months of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
- Serum creatinine of < 2.0 mg/dL. Serum creatinine will be assessed at the screening visit, or if already completed within 2 months of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
- Bolus for all meals and snacks that contain ≥ 5 grams of carbohydrate.
- Willing to perform at least 7 fingerstick blood glucose tests a day.
- Willing to refrain from taking acetaminophen products for the duration of the clinical trial. If acetaminophen is taken, subject is to avoid making any insulin dosing decisions based on CGM for at least 12 hours.
- Willing to abide by the study protocol and use study-provided devices, including the Omnipod, Dexcom CGM, glucometer, ketone meter and pAPS tablet.
Exclusion Criteria:
- Pregnancy
- One or more episodes of hypoglycemia requiring an emergency room visit or hospitalization in the past 6 months.
- One or more episodes of hyperglycemia requiring an emergency room visit or hospitalization in the past 6 months.
- Known unstable cardiac disease or untreated cardiac disease, as revealed by history or physical examination.
- Dermatological conditions that would preclude wearing a CGM sensor or Pod.
- One or more seizures in the past year.
- Screening A1c ≥ 10% or serum creatinine ≥ 2.0 mg/dL.
- Any condition that could interfere with participating in the trial, based on investigator judgment.
- Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals), defined as using any of these medications within 30 days of the screening visit or during the study.
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Artificial Pancreas
The artificial pancreas device will employ its enhanced Model Predictive Control (MPC) algorithm with a target glucose level of 110 mg/dL with a trust index for MPC-predicted glucose values, weighing future glucose predictions and only acting on predictions with higher weight in the trust index.
The Health Monitoring System algorithm uses the same CGM data as the MPC control algorithm but utilizes a separate algorithm for trending and predictions of future glucose values.
Using a redundant and independent algorithm is an important safety feature of the overall AP device.
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Artificial Pancreas Device
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percent time within the target glucose range of 70-180 mg/dl overall as assessed by continuous glucose monitoring (CGM).
Periodo de tiempo: 48 hours
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The primary endpoint for this pilot study will be time within the target glucose range of 70-180 mg/dl overall as assessed by continuous glucose monitoring (CGM), during closed-loop use, determining if the combination of eMPC and the assessment of trust index can provide safe and effective glucose control.
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48 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Assessment of the trust index predictions vs. standard eMPC glucose predictions.
Periodo de tiempo: 48 hours
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During closed-loop use, assessment of the trust index predictions vs. standard eMPC glucose predictions (frequency of moving away from nominal weights of predicted glucose).
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48 hours
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Frequency of hypoglycemia during closed-loop use.
Periodo de tiempo: 48 hours
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Frequency of hypoglycemia during closed-loop use, defined as percent time glucose is below predefined thresholds of 70 mg/dl, 60 mg/dl and 50 mg/dL.
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48 hours
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Frequency of hyperglycemia during closed-loop use.
Periodo de tiempo: 48 hours
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Frequency of hyperglycemia during closed-loop use, defined as percent time glucose is above predefined thresholds of 180 mg/dl, 250 mg/dl, and 300 mg/dL.
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48 hours
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Percent time within the target glucose range of 70-140 mg/dl during closed-loop use.
Periodo de tiempo: 48 hours
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Percent time within the target glucose range of 70-140 mg/dl overall as assessed by continuous glucose monitoring (CGM), during closed-loop use.
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48 hours
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Percent time glucose is within range 70-150 mg/dl postprandial within 5 hours following meals, during closed-loop use.
Periodo de tiempo: 48 hours
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Percent time glucose is within range 70-150 mg/dl postprandial within 5 hours following meals, during closed-loop use.
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48 hours
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Standard Deviation and Coefficient of Variation of glucose values
Periodo de tiempo: 48 hours
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To measure glycemic variability, the standard deviation and coefficient of variation of glucose values (as measured by continuous glucose monitoring) will be determined during the 48 hours of closed-loop use.
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48 hours
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Markers of hypo- and hyperglycemia
Periodo de tiempo: 48 hours
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Markers of hypo- and hyperglycemia, to include LBGI (Low blood glucose index) and HBGI (High blood glucose index), during closed-loop use.
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48 hours
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Insulin Doses Given
Periodo de tiempo: 48 hours
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Change in total daily doses and post prandial insulin doses given during the 48 hours of closed-loop use.
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48 hours
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Number of treatments given for hypoglycemia (defined as carbohydrates given for treatment of a documented or suspected low blood sugar), during the 48 hours of closed-loop use.
Periodo de tiempo: 48 hours
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Treatments for hypoglycemia given during the 48 hours of closed-loop use.
Hypoglycemia treatments may be given in response to alerts from the HMS, if blood glucose < 70 mg/dL, or at the request of the subject or investigator.
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48 hours
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Number of alerts given by the HMS to prevent hypoglycemia
Periodo de tiempo: 48 hours
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Number of alerts given by the HMS to prevent hypoglycemia during closed-loop use.
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48 hours
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Failure analysis of the devices/connectivity issues that may occur (# disconnects and device restarts).
Periodo de tiempo: 48 hours
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Failure analysis of the devices/connectivity issues that may occur during closed-loop use.
This includes number of CGM communication losses with 3 or more missed points, and number of times the entire system required a restart.
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48 hours
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Eyal Dassau, PhD, Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University
- Investigador principal: Francis J Doyle III, PhD, Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University
- Investigador principal: Alejandro Leguna, PhD, Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00020556
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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