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El ensayo clínico NCT04414579 (PLATEAU) para Diabetes mellitus tipo 1 está desconocido. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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The Efficacy and Safety of Faster Insulin Aspart (Fiasp®) Compared to Conventional Insulin Aspart (NovoLog®) as Correction Bolus (PLATEAU) Fase IV 45 Iniciado por investigador
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El ensayo clínico NCT04414579 (PLATEAU) está diseñado para estudiar el tratamiento de Diabetes mellitus tipo 1. Es un estudio intervencionista de Fase IV. Su estado actual es: desconocido. El estudio se inició el 27 de marzo de 2019, con el objetivo de reclutar a 45 participantes. Dirigido por Mountain Diabetes and Endocrine Center, se espera que finalice el 1 de marzo de 2021. Los datos se actualizaron por última vez en ClinicalTrials.gov el 24 de noviembre de 2020.
Resumen
The purpose of this investigator-initiated trial is to compare the efficacy in terms of time to recovery from hyperglycemia as measured by time to arrest of hyperglycemic excursion ("glucose plateau point", primary endpoint) and return to premeal glucose target if feasible (secondary endpoint) between Fiasp and conventional insulin aspart when used as a correction bolus. These endpoints will be determined by CGM (Dex...Mostrar más
Descripción detallada
Patients with type 1 DM using CSII require bolus insulin for two purposes: first, to cover carbohydrate intake to control postprandial glucose, and second, to correct episodes of hyperglycemia. The latter function is referred to as a "correction dose" or "correction bolus". Insulin pumps have bolus calculators which calculate correction doses based on the patient's individualized BG target and insulin sensitivity fac...Mostrar más
Título oficial
The Efficacy and Safety of Faster Insulin Aspart (Fiasp®) Compared to Conventional Insulin Aspart (NovoLog®) as Correction Bolus in Patients With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion (CSII) and Continuous Glucose Monitoring (CGM): a Cross-over Controlled Trial
Condiciones médicas
Diabetes mellitus tipo 1Publicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:Otros ID del estudio
- PLATEAU
- GPP2019
Número del NCT
Inicio del estudio (real)
2019-03-27
Última actualización
2020-11-24
Fecha de finalización (estimada)
2021-03
Inscripción (prevista)
45
Tipo de estudio
Intervencionista
FASE
Fase IV
Estado general
Desconocido
Palabras clave
continuous glucose monitoring
continuous subcutaneous insulin infusion
hyperglycemia
correction bolus
continuous subcutaneous insulin infusion
hyperglycemia
correction bolus
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Diseño cruzado
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
Sin intervenciónNo Intervention: Conventional Insulin Aspart (NovoLog®) In the aspart group, the subject will only take aspart through the their pump. This study population will have an established expertise in diabetes self-management with previous knowledge of insulin pump therapy and Dexcom Continuous Glucose Monitoring (CGM). Allowing the subjects to use their insulin pumps for bolus insulin delivery, as they are accustomed, will minimize the chances of skipping meal boluses and corr...Mostrar más | N/A |
Comparador activoFaster Insulin Aspart (Fiasp®) In the Fiasp group, the subject will only take aspart through the their pump. This study population will have an established expertise in diabetes self-management with previous knowledge of insulin pump therapy and Dexcom Continuous Glucose Monitoring (CGM). Allowing the subjects to use their insulin pumps for bolus insulin delivery, as they are accustomed, will minimize the chances of skipping meal boluses and corre...Mostrar más | Faster Insulin Aspart (Fiasp®) Subjects will be randomized either to use Fiasp or conventional insulin aspart in CSII. CSII settings (basal, bolus, and correction factors) will be optimized using a meal challenge for a 2-week run in period followed by a 10-week period of CSII use with the assigned insulin. After a 12-week maintenance period, each group will cross over to the other insulin (conventional insulin aspart or Fiasp) by CSII for a second...Mostrar más |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Time to stabilization of rising blood sugar by CGM after correction bolus | Time (in minutes) to stabilization of rising blood sugar (GPP) by CGM after correction bolus during the final 2 week maintenance period. Two categories of correction dose will be analyzed: 1) those following an isolated correction dose (taken independently of a meal dose), and 2) those taken as part of a combination bolus with a meal dose. | 2 weeks |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Incidence of early hypoglycemia | Incidence of early hypoglycemia (Blood glucose \< 54 mg/dl within 1 and 2 hours) following correction bolus with each insulin (Key Safety Endpoint) | 25 weeks |
Change in Insulin Sensitivity Factor | Change in Insulin Sensitivity Factor, if any, required for hypoglycemia prevention using Fiasp as recorded by continuous subcutaneous insulin infusion device setting report | 25 weeks |
Change in Insulin On Board | Change in Insulin On Board, if any, required for prevention of late hyperglycemia using Fiasp as recorded by continuous subcutaneous insulin infusion device setting report | 25 weeks |
GlycoMark differences between arms | GlycoMark (1,5 anhydroglucitol, a marker of postprandial glucose excursion) during use of each insulin. | 25 weeks |
HbA1c differences between arms | HbA1c during use of each insulin | 25 weeks |
Percent time spent in target range, hyperglycemic range, and hypoglycemic range | Percent time spent in target range, hyperglycemic range and hypoglycemic range by Continuous Glucose Monitoring (CGM) on each insulin during the final 2 weeks of each treatment period. Target ranges include 70-180 mg/dL. Hyperglycemia ranges to be captured will include Category 1: 181-250 mg/dL and Category 2: above 250 mg/dL. Hypoglycemia ranges to be captured include Category 1: 69-54 mg/dL and Category 2: below 54 mg/dL. | 4 weeks |
Standard deviation differences between arms | Standard deviation of mean blood glucose as determined by CGM on each insulin | 4 weeks |
Treatment related impact measures between arms | Treatment related impact measures on each insulin using TRIM D questionnaire | 6 weeks |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Male and female patients > 18 years of age
- Type 1 DM of > 1 year duration
- Use of any open loop insulin pump, Tandem T-Slim with Basal IQ, Insulet Omnipod Dash, or any other investigator-approved insulin pumps with Dexcom CGM G5, G6, or newer version for > 6 months
- Good baseline glycemic control (HbA1c < 7.5%; low risk of hypoglycemia by CGM as defined by Dexcom Clarity report)
- No episodes of severe hypoglycemia in the previous 3 months
- Pump download shows regular meal bolusing, accurate carbohydrate counting ability, and willingness to use exercise markers in Dexcom
- CGM download shows regular use (>85% of time) and regular calibration if using G5 sensor (G6 requires no calibration)
- Females using adequate contraception
- Use of CGM other than Dexcom G5 or G6 or a newer Dexcom CGM version
- Suboptimal baseline glycemic control (HbA1c > 7.5%)
- Pump or CGM download shows suboptimal use of devices (lack of meal boluses, frequent overrides of pump, excessive pump suspension, inadequate calibration or inconsistent usage of CGM)
- Serious comorbidities including CVD with recent event, actively treated malignancy, renal dysfunction with eGFR < 45 ml/min, or any other condition which in the opinion of the investigator would preclude subject's ability to participate in trial
- Females unwilling to use contraception, planning pregnancy or breastfeeding
- Use of any other glucose-lowering agents than insulin
- Hypersensitivity to insulin aspart or one of the excipients in faster insulin aspart
- Known diabetic gastroparesis
Mountain Diabetes and Endocrine CenterParte responsable del estudio
Wendy Lane MD, Investigador principal, Wendy Lane, MD, Principal Investigator, Mountain Diabetes and Endocrine Center
Contactos centrales del estudio
Contacto: Wendy S Lane, MD, 8286849588, [email protected]
Contacto: Melinda L Buford, RN, BSN, 8286849588, [email protected]
1 Centros del estudio en 1 países
North Carolina
Mountain Diabetes and Endocrine Center, Asheville, North Carolina, 28803, United States
Melinda L Buford, RN, BSN, Contacto, 828-684-9588, [email protected]
Stephen L Weinrib, MD, Subinvestigador
Lynn L Baru, MD, Subinvestigador
Michael D Skrzynski, ANP, Subinvestigador
Reclutando