- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07507708
[Ensayo de dispositivo que no está aprobado o autorizado por la FDA de EE. UU.] (INSIGHT)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The UVA AIDANET algorithm is intended for use by patients with T1D to control the subcutaneous infusion of insulin and aid in their T1D self-management. AIDANET automatically adjusts insulin delivery every 5 minutes in response to CGM values. AIDANET can be used with meal announcement (hybrid closed loop, HCL), without meal announcement (full closed loop, FCL), and with meal anticipation (anticipatory closed loop, ACL).
The purpose of this study is to demonstrate superior glycemic control when using anticipation within our latest Automated Insulin Delivery as Adaptive NETwork (AIDANET) in FCL with Anticipation (AIDANET+ACL) vs. AIDANET in FCL without Anticipation.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Andrea Riana, MD
- Número de teléfono: (434) 249-6251
- Correo electrónico: rys6hm@uvahealth.org
Copia de seguridad de contactos de estudio
- Nombre: Laura Kollar, RN
- Número de teléfono: (434) 982-6479
- Correo electrónico: llk7m@uvahealth.org
Ubicaciones de estudio
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22903
- Reclutamiento
- University of Virginia Center for Diabetes Technology
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Sub-Investigador:
- Mark DeBoer, MD
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Sub-Investigador:
- Samina Afreen, MD
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Sub-Investigador:
- Marcela Moscoso-Vasquez, PhD
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Contacto:
- Sue Brown, MD
- Número de teléfono: 4349820602
- Correo electrónico: sab2f@uvahealth.org
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Sub-Investigador:
- Driscoll Kimberly, PhD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Participant Inclusion Criteria
- Age ≥18.0 years old at time of consent
- Clinical diagnosis, based on investigator assessment, of T1D for > 1 year.
- Having used an FDA approved AID system within the last 6 months (can be intermittent use).
- Currently using insulin for >6 months.
- Willingness to switch to use an FDA-approved personal insulin for the study pump (e.g., lispro or aspart, or biosimilar FDA-approved products) as directed by the study team.
- Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff who either lives with participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency.
- Participant not currently known to be pregnant or breastfeeding.
- If participant can become pregnant, they must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all participants of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- Willingness to wear a Dexcom CGM during each of the study phases.
- Willingness to use the study AIDANET system (CGM, pump, and phone) during the relevant study periods.
- Willingness not to start any new non-insulin glucose-lowering agent during the trial.
- Willingness to participate in all study procedures including in person training.
- Access to internet at home and willingness to upload data during the study as needed.
- Investigator has confidence that the participant can successfully operate all study devices and can adhere to the protocol.
- Participant is proficient in reading and verbal communication in English.
Participant Exclusion Criteria The participant must not have any exclusion criteria to be eligible to participate in the study.
- Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors,). Participants may be on a stable dose of such an agent for at least the past month.
- Current use of sulfonylurea medications.
- Uncontrolled microvascular complications such as active proliferative retinopathy not being treated or not responsive to current treatment.
- Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic DKA.
- Hemophilia or any other bleeding disorder.
- History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.
- History of DKA event in the last 12 months.
- Currently on peritoneal or hemodialysis.
- Currently being treated for adrenal insufficiency.
- Currently being treated for a seizure disorder.
- Hypothyroidism or hyperthyroidism that is not adequately treated.
- Use of oral or injectable steroids at the time of enrollment.
- Known ongoing adhesive intolerance that is not well managed.
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
- Participation in another interventional trial at the time of enrollment.
- Participant with a direct supervisor at work/school who is involved in the conduct of the 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 |
|---|---|
|
Comparador activo: Group A: AID first followed by AIDANET+ACL then AIDANET+FCL
Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm.
Participants will then complete 4 weeks of AIDANET + Anticipatory Closed Loop (ACL) and 4 weeks of AIDANET + Fully Closed-Loop (FCL)
|
Usual Care
All participants will use AIDANET in FCL mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.
All insulin will be delivered automatically.
The algorithm will review past behaviors to determine the amount of insulin that will be needed for a meal.
|
|
Comparador activo: Group B: AID first followed by AIDANET+FCL then AIDANET+ACL
Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm.
Participants will then complete 4 weeks of AIDANET + Fully Closed Loop (FCL) and 4 weeks of AIDANET+ Anticipatory Closed Loop (ACL).
|
Usual Care
All participants will use AIDANET in FCL mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.
All insulin will be delivered automatically.
The algorithm will review past behaviors to determine the amount of insulin that will be needed for a meal.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time in range 70-140 mg/dL as computed by the study CGM
Periodo de tiempo: 8 weeks
|
Computed as the number of estimated glucose values ≥70mg/dL and <140mg/dL divided by the number of valid values (defined as a number between 39 and 401)
|
8 weeks
|
|
Time in range 70-140 mg/dL as computed by the study CGM
Periodo de tiempo: 8 weeks
|
Outcome is computed if:
|
8 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sue A Brown, MD, University of Virginia Center for Diabetes Technology
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- 302996
- 5R01DK129553 (Subvención/contrato del NIH de EE. UU.)
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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