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El ensayo clínico NCT05076292 para Diabetes tipo 1, Hipoglucemia está completado. 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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Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes 22 Ejercicio Prevención
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT05076292 fue un estudio intervencionista para Diabetes tipo 1, Hipoglucemia. Su estado actual es: completado. El estudio se inició el 23 de noviembre de 2021, con el objetivo de reclutar a 22 participantes. Dirigido por Steno Diabetes Center Copenhagen, la fecha de finalización prevista fue el 8 de agosto de 2023. Los datos se actualizaron por última vez en ClinicalTrials.gov el 5 de diciembre de 2023.
Resumen
The primary aim of the study is to compare the efficacy of single-administration low-dose glucagon and split-administration low-dose glucagon to placebo for prevention of exercise-induced hypoglycemia in people with type 1 diabetes using insulin pumps and multiple daily injections (MDI).
The secondary aim is to compare the accuracy of three continuous glucose monitors (CGM) during and after exercise in inpatient and...
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A randomized, single-blinded, placebo-controlled three-arm cross-over study will be conducted to assess the study objectives. 22 participants with type 1 diabetes will complete three study visits in random order. At every visit the participants will exercise for 60 min receiving different low doses of glucagon before or before and after exercise compared with placebo.
During the visits and in an outpatient period th...
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Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes
Condiciones médicas
Diabetes tipo 1HipoglucemiaOtros ID del estudio
- 78618
- 2021-001342-34 (Número EudraCT)
Número del NCT
Inicio del estudio (real)
2021-11-23
Última actualización
2023-12-05
Fecha de finalización (estimada)
2023-08-08
Inscripción (prevista)
22
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Completado
Palabras clave
Type 1 Diabetes
Exercise
Hypoglycemia
Glucagon
Continuous Glucose Monitoring
Exercise
Hypoglycemia
Glucagon
Continuous Glucose Monitoring
Objetivo principal
Prevención
Método de asignación
Aleatorizado
Modelo de intervención
Diseño cruzado
Enmascaramiento
Simple ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
Experimental150 ug glucagon before exercise 150 ug glucagon will be administered subcutaneously just before exercise and placebo will be administered after exercise. | GlucaGen 150 ug or 75\*2 ug glucagon will be administered subcutaneously to the participants before and after exercise. |
Experimental2*75 ug glucagon before exercise and after exercise 75 ug glucagon will be administered subcutaneously just before exercise and another 75 ug of glucagon will be administered immediately after exercise. | GlucaGen 150 ug or 75\*2 ug glucagon will be administered subcutaneously to the participants before and after exercise. |
Comparador activoSaline as placebo Saline as placebo will be administered in the same amount as glucagon before and after exercise. | solución salina Saline will be used as placebo before and after exercise. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Incidence rate of hypoglycemia (PG < 3.9 mmol/l) | From 0-180 minutes post-intervention |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Percentage of time below range (PG < 3.9) | From 0-180 minutes post-intervention | |
Percentage of time in range (PG ≥ 3.9 mmol/l and ≤ 10.0 mmol/l) | From 0-180 minutes post-intervention | |
Time (min) to hypoglycemia (PG < 3.9 mmol/l) | From 0-180 minutes post-intervention | |
Change in plasma glucose levels | From 0-180 minutes post-intervention | |
Incidence rate of hyperglycemia (PG > 10 mmol/l) | From 0-180 minutes post-intervention | |
Nadir plasma glucose concentration | From 0-180 minutes post-intervention | |
Peak plasma glucose concentration | From 0-180 minutes post-intervention | |
Incremental peak in plasma glucose concentration | From 0-180 minutes post-intervention | |
Mean plasma glucose concentration | From 0-180 minutes post-intervention | |
Plasma glucose Area Under the Curve (AUC) | From 0 to 180 min post-intervention | |
Percentage of time in hyperglycemia (PG > 10 mmol/l) | From 0-180 minutes post-intervention | |
Change in visual analogue scale (VAS) for nausea, headache, stomachache, injection site pain and palpitations from intervention (tintervention = 0) to 180 min post-intervention | From 0-180 minutes post-intervention | |
Mean absolute relative difference (MARD) during the 60-minutes exercise session (using SMBG as the reference value) | During exercise | |
MARD during the three-day outpatient period (using the 5 daily SMBG as the reference value) | During the three-day outpatient period | |
MARD during the three-hour inpatient study visit (using YSI as reference value) | During exercise | |
Rate-of change (ROC) accuracy (using SMBG and YSI as the reference value) | During exercise and during the three-day outpatient period | |
Point accuracy with the Clarke Error Grid Analysis (CEGA) (using SMBG and YSI as the reference value) | During exercise and during the three-day outpatient period |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Age ≥ 18
- T1D ≥ 2 years
- Use of insulin pump or MDI therapy for ≥ 6 months
- Current use of insulin aspart
- HbA1c ≤ 70mmol/mol (8.5%)
- Body mass index (BMI) ≤ 30 kg/m2
- Performs exercise ≥1 time per week
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start
- Professional athletes or highly active individuals ( ≥ 5 hours of exercise per week)
- Known or suspected allergies to glucagon or related products
- History of hypersensitivity or allergic reaction to glucagon or lactose
- Allergy to the patch of the CGM devices
- Patients with pheochromocytoma, insulinoma or gastroparesis
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrollment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (>12 months since last period) are not required to use contraception)
- Inability to understand the individual information and to give informed consent
- Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject
- Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation
Steno Diabetes Center CopenhagenNo hay datos de contacto.
1 Centros del estudio en 1 países
Sissel Banner Lundemose, Gentofte Municipality, 2820, Denmark