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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03859401
Exercise-Induced Hypoglycemia Prevention in Adults With Type 1 Diabetes Using an Artificial Pancreas
Hypoglycemia Prevention During and After Moderate Exercise in Adults With Type 1 Diabetes Using an Artificial Pancreas With Exercise Behavior Recognition
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Exercise remains a challenge to AP systems; more specifically, by the time exercise is detected it is often too late to avoid hypoglycemia without the ingestion of rapid carbohydrates or the use of rescue injections, such as glucagon. To this avail, the investigators propose to add a novel Model Predictive Control module to the proven USS system. This module is designed to compute insulin doses every 5 minutes that are designed to "optimally" maintain glycaemia around a target of 120mg/dL. The optimality is defined mathematically as minimizing deviations from basal rate injections and the distance between current and future (up to 2h) glycaemia from a physiologically feasible trajectory back down (or up) to a pre-specified target. Furthermore, the novel control system, labelled Multi Stage MPC or Ensemble MPC, accounts for a preset number of exercise scenarios during the prediction horizon, these scenarios being derived from the user historical record; this setup allows the control system to anticipate expected exercise bouts up to 2h in advance while maintaining the condition for optimal glycemic control.
By adding such module to a well validated system, the investigators expect an improvement in protection against hypoglycemia during and immediately after physical activity without increase in hyperglycemia. To demonstrate the feasibility of this approach, the novel anticipatory system will be compared to a naïve AP system during highly supervised hotel admissions with afternoon exercise. Participants will be asked to exercise regularly in the late afternoon during a month of data collection to generate the patterns to be anticipated.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908
- University of Virginia
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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 ≤65 years
- Clinical diagnosis of Type 1 Diabetes for at least one year
- Currently using an insulin pump for at least 6 months
- Uses insulin parameters such as carbohydrate ratio and correction factors consistently on their insulin pump in order to dose insulin for meals or corrections
- Access to internet and willingness to upload data during the study
- Willingness to be physically active for at least 30 minutes per day at least 4 times per week
- Willingness to perform the required exercise regimen during Data Collection Period
- Willingness to not perform regular exercise outside of the study-regimented exercise window
- For females, not currently pregnant or breastfeeding. If a female is of child-bearing potential and sexually active, she must agree to use a form of contraception to prevent pregnancy while participating in the study.
- An understanding and willingness to follow the protocol and sign informed consent.
Exclusion Criteria:
- History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment.
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment.
- Pregnancy or intent to become pregnant during the trial.
- Currently being treated for a seizure disorder
- Coronary artery disease or heart failure, unless written clearance is received from a cardiologist or primary care provider and documentation of a negative stress test within the year
- History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
- Clinically significant electrocardiogram (ECG) at time of Screening, as interpreted by the study medical physician.
- Use of non-insulin glucose-lowering agent (including GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals) with the exception of participants who have been on a stable dose of Metformin for at least 3 months.
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
- Inpatient psychiatric treatment in the past 6 months
- Presence of a known adrenal disorder
- Abnormal liver function test results (Transaminase >2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
- Uncontrolled thyroid disease
- Use of an automated insulin delivery mechanism that is not FDA approved during the data collection phase
- Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team
- Inability to be physically active for at least 30 minutes per day for at least 4 times per week
- Current enrollment in another clinical trial, unless approved by the investigators of both studies or if clinical trial is a non-interventional registry trial.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Control - Experimental Admissions
Subjects will be randomized following the Data Collection Phase in a 1:1 ratio.
Subjects in the Control-Experimental Arm will undergo the Control Admission first, utilizing an artificial pancreas (AP) controller that does not anticipate exercise (rMPC - naïve model predictive control), followed by the Experimental Admission, which will utilize an AP controller that has the ability to anticipate exercise (EnMPC - ensemble model predictive control).
During the 36-hour admissions, subjects will begin using the study AP system (control or experimental) on Day 1 around midday with a scheduled exercise activity in the evening.
Day 2 will consist of minimal activity and subjects will be discharged in the evening on Day 2.
|
This AP controller has the ability to anticipate exercise activity by use of trends seen during the Data Collection Period.
This AP controller does not have the ability to anticipate exercise activity.
|
Experimental: Experimental - Control Admissions
Subjects will be randomized following the Data Collection Phase in a 1:1 ratio.
Subjects in the Experimental-Control Arm will undergo the Experimental Admission first, utilizing an artificial pancreas (AP) controller that has the ability to anticipate exercise (EnMPC), followed by the Control Admission, which will utilize an AP controller that does not have the ability to anticipate exercise (rMPC).
During the 36-hour admissions, subjects will begin using the study AP system (control or experimental) on Day 1 around midday with a scheduled exercise activity in the evening.
Day 2 will consist of minimal activity and subjects will be discharged in the evening on Day 2.
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This AP controller has the ability to anticipate exercise activity by use of trends seen during the Data Collection Period.
This AP controller does not have the ability to anticipate exercise activity.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of hypoglycemic occurrences in relation to exercise activity
Periodo de tiempo: 2 Hours
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Number of hypoglycemic occurrences immediately before, during, and immediately after exercise (~5-7pm) as defined by more than one consecutive CGM values below 70 mg/dL or hypoglycemic treatment per glycemic guidelines.
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2 Hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percent CGM below 50 mg/dL
Periodo de tiempo: 36 Hours
|
Percent CGM below 50 mg/dL
|
36 Hours
|
Percent CGM below 54 mg/dL
Periodo de tiempo: 36 Hours
|
Percent CGM below 54 mg/dL
|
36 Hours
|
Percent CGM below 60 mg/dL
Periodo de tiempo: 36 Hours
|
Percent CGM below 60 mg/dL
|
36 Hours
|
Percent CGM below 70 mg/dL
Periodo de tiempo: 36 Hours
|
Percent CGM below 70 mg/dL
|
36 Hours
|
Percent CGM between 70 and 180 mg/dL
Periodo de tiempo: 36 Hours
|
Percent CGM between 70 and 180 mg/dL
|
36 Hours
|
Percent CGM above 180 mg/dL
Periodo de tiempo: 36 Hours
|
Percent CGM above 180 mg/dL
|
36 Hours
|
Percent CGM above 250 mg/dL
Periodo de tiempo: 36 Hours
|
Percent CGM above 250 mg/dL
|
36 Hours
|
Percent CGM above 300 mg/dL
Periodo de tiempo: 36 Hours
|
Percent CGM above 300 mg/dL
|
36 Hours
|
Average CGM
Periodo de tiempo: 36 Hours
|
Average CGM
|
36 Hours
|
CGM Coefficient of Variation
Periodo de tiempo: 36 Hours
|
Coefficient of Variation of the CGM Values
|
36 Hours
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CGM-based Low Blood Glucose Index
Periodo de tiempo: 36 Hours
|
CGM-based Low Blood Glucose Index
|
36 Hours
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CGM-based High Blood Glucose Index
Periodo de tiempo: 36 Hours
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CGM-based High Blood Glucose Index
|
36 Hours
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Total Amount of Insulin Used
Periodo de tiempo: 36 Hours
|
Total Amount of Insulin Used
|
36 Hours
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Number of Hypoglycemic Episodes
Periodo de tiempo: 36 Hours
|
Number of Hypoglycemic Episodes as defined by contiguous CGM below 70 mg/dL
|
36 Hours
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Number of Rescue Carbohydrates Administrations
Periodo de tiempo: 36 Hours
|
Number of Rescue Carbohydrates Administrations
|
36 Hours
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Total Amount of Rescue Carbohydrates
Periodo de tiempo: 36 Hours
|
Total Amount of Rescue Carbohydrates
|
36 Hours
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marc Breton, PhD, University of Virginia
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
- 180039
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
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