Real-world Effectiveness and Safety of Omnipod 5 in Adults With Type 1 Diabetes: a 12-month Observational Study.
8 de julio de 2026 actualizado por: Giuseppe Lepore, Papa Giovanni XXIII Hospital
This retrospective observational cohort study aims to evaluate the real-world effectiveness and safety of the Omnipod® 5 Automated Insulin Delivery System in adults with type 1 diabetes receiving routine clinical care at a tertiary diabetes center.
Continuous glucose monitoring metrics and glycated hemoglobin values obtained before initiation of Omnipod 5 and approximately after six, twelve and eighteen months of use will be compared to assess changes in glycemic control.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Automated insulin delivery systems have demonstrated significant improvements in glycemic outcomes in randomized clinical trials. However, evidence from routine clinical practice remains essential to evaluate effectiveness across broader patient populations and routine care settings.
This retrospective observational cohort study will include consecutive adults with type 1 diabetes who initiated treatment with the Omnipod® 5 Automated Insulin Delivery System during routine clinical practice at ASST Papa Giovanni XXIII Hospital, Bergamo, Italy.
Clinical and continuous glucose monitoring (CGM) data routinely collected during clinical follow-up will be extracted from medical records. Glycemic outcomes obtained before initiation of Omnipod 5 will be compared with those recorded after approximately six, twelve and eighteen months of system use.
The primary objective is to evaluate changes in Time in Range (70-180 mg/dL). Secondary objectives include assessment of HbA1c, Time Above Range, Time Below Range, glycemic variability, the proportion of participants achieving recommended international CGM targets; the prevalence of acute diabetes complications (severe hypoglycemia, diabetic ketoacidosis); and rates and causes of system dropout.
Tipo de estudio
De observación
Inscripción (Actual)
300
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Italy
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Bergamo, Italy, Italia, 20126
- ASST Papa Giovanni XXIII Bergamo
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Adult individuals with type 1 diabetes treated at the Diabetes Unit of ASST Papa Giovanni XXIII Hospital who initiated Omnipod® 5 as part of routine clinical care.
Descripción
Inclusion Criteria:
- Adults aged ≥18 years
- Diagnosis of type 1 diabetes
- Initiation of Omnipod® 5 during routine clinical care
- Availability of baseline CGM data
- Availability of at least six-month follow-up CGM data
Exclusion Criteria
- Missing baseline CGM data
- Missing follow-up CGM data
- Discontinuation of Omnipod® 5 before outcome assessment
- Other conditions judged by investigators to preclude reliable evaluation
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Time in Range (70-180 mg/dL)
Periodo de tiempo: Baseline, approximately 6 months. approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
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Change from baseline in Time in Range (70-180 mg/dL), defined as the percentage of time spent with glucose values within the target glucose range (70-180 mg/dL), as measured by continuous glucose monitoring (CGM), at approximately 6, 12, and 18 months after initiation of therapy with the Omnipod 5 system.
|
Baseline, approximately 6 months. approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in HbA1c (mmol/mol or %)
Periodo de tiempo: Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
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Change in glycated hemoglobin (HbA1c) from baseline to approximately 6, 12, and 18 months after starting therapy with the Omnipod 5 system.
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Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
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Change in Time Below Range Level 1 (54-69 mg/dL)
Periodo de tiempo: Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
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Change from baseline in Time Below Range Level 1 (54-69 mg/dL), defined as the percentage of time spent in the glucose range 54-69 mg/dL, as measured by continuous glucose monitoring (CGM), at approximately 6, 12, and 18 months after initiation of therapy with the Omnipod 5 system.
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Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
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Change in Time Below Range Level 2 (<54 mg/dL)
Periodo de tiempo: Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
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Change from baseline in Time Below Range Level 2 (<54 mg/dL), defined as the percentage of time spent with glucose values <54 mg/dL, as measured by continuous glucose monitoring (CGM), at approximately 6, 12, and 18 months after initiation of therapy with the Omnipod 5 system.
|
Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
|
|
Change in Time Above Range Level 1 (>180 mg/dL)
Periodo de tiempo: Baseline, approximately 6 months, approximately 12 months, and approximately 18 months Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
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Change from baseline in Time Above Range Level 1 (181-250 mg/dL), defined as the percentage of time spent in the glucose range181-250 mg/dL, as measured by continuous glucose monitoring (CGM), at approximately 6, 12, and 18 months after initiation of the therapy with the Omnipod 5 system.
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Baseline, approximately 6 months, approximately 12 months, and approximately 18 months Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
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Change in Time Above Range Level 2 (>250 mg/dL)
Periodo de tiempo: Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
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Change from baseline in Time Above Range Level 2 (<250 mg/dL), defined as the percentage of time spent with glucose values >250 mg/dL, as measured by continuous glucose monitoring (CGM), at approximately 6, 12, and 18 months after initiation of therapy with the Omnipod 5 system.
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Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
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Change from baseline in the number of participants experiencing at least one episode of severe hypoglycemia
Periodo de tiempo: Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.
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Change from baseline in the number of participants experiencing at least one episode of severe hypoglycemia during each follow-up period.
Severe hypoglycemia is defined according to the American Diabetes Association as an event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
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Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.
|
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Change from baseline in the total number of severe hypoglycemia episodes
Periodo de tiempo: Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
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Change from baseline in the total number of severe hypoglycemic episodes occurring during each follow-up period.
Severe hypoglycemia is defined according to the American Diabetes Association as an event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
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Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
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Change from baseline in the number of participants experiencing at least one episode of diabetic ketoacidosis
Periodo de tiempo: Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.
|
Change from baseline in the number of participants experiencing at least one episode of diabetic ketoacidosis during each follow-up period.
Diabetic ketoacidosis will be identified according to the diagnosis documented in the medical record and standard clinical diagnostic criteria.
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Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.
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Change from baseline in the total number of diabetic ketoacidosis episodes
Periodo de tiempo: Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.
|
Change from baseline in the total number of diabetic ketoacidosis episodes occurring during each follow-up period.
Diabetic ketoacidosis will be identified according to the diagnosis documented in the medical record and standard clinical diagnostic criteria.
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Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Nicolò Borella, MD, Endocrine Disease and Diabetes Unit, ASST Papa Giovanni XXIII Bergamo, Italy
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Forlenza GP, DeSalvo DJ, Aleppo G, Wilmot EG, Berget C, Huyett LM, Hadjiyianni I, Mendez JJ, Conroy LR, Ly TT, Sherr JL. Real-World Evidence of Omnipod(R) 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes. Diabetes Technol Ther. 2024 Aug;26(8):514-525. doi: 10.1089/dia.2023.0578. Epub 2024 Feb 16.
- Forlenza GP, Buckingham BA, Brown SA, Bode BW, Levy CJ, Criego AB, Wadwa RP, Cobry EC, Slover RJ, Messer LH, Berget C, McCoy S, Ekhlaspour L, Kingman RS, Voelmle MK, Boyd J, O'Malley G, Grieme A, Kivilaid K, Kleve K, Dumais B, Vienneau T, Huyett LM, Lee JB, O'Connor J, Benjamin E, Ly TT. First Outpatient Evaluation of a Tubeless Automated Insulin Delivery System with Customizable Glucose Targets in Children and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2021 Jun;23(6):410-424. doi: 10.1089/dia.2020.0546. Epub 2021 Jan 18.
- Brown SA, Forlenza GP, Bode BW, Pinsker JE, Levy CJ, Criego AB, Hansen DW, Hirsch IB, Carlson AL, Bergenstal RM, Sherr JL, Mehta SN, Laffel LM, Shah VN, Bhargava A, Weinstock RS, MacLeish SA, DeSalvo DJ, Jones TC, Aleppo G, Buckingham BA, Ly TT; Omnipod 5 Research Group. Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes. Diabetes Care. 2021 Jul;44(7):1630-1640. doi: 10.2337/dc21-0172. Epub 2021 Jun 7.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
7 de enero de 2026
Finalización primaria (Actual)
30 de junio de 2026
Finalización del estudio (Actual)
30 de junio de 2026
Fechas de registro del estudio
Enviado por primera vez
1 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de julio de 2026
Publicado por primera vez (Actual)
10 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Tubeless AID systems
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
No individual participant data will be shared because this is a retrospective observational study based on routinely collected clinical data.
The dataset may contain potentially identifiable health information, and the informed consent/ethics approval does not specifically include permission for public sharing of individual-level data.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .