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The Summer Camp Study 2: Blood Glucose Control With a Bi-Hormonal Endocrine Pancreas

19 de octubre de 2017 actualizado por: Steven J. Russell, MD, PhD, Massachusetts General Hospital

The Summer Camp Study 2: Outpatient Automated Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas in a Pediatric Population Ages 6-11 at the Clara Barton Diabetes Camps

This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improve glycemic control vs. usual care for young people with type 1 diabetes ages 6-11 years old in a diabetes camp environment.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

19

Fase

  • No aplica

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

  • Estados Unidos
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Massachusetts General Hospital

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

6 años a 11 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria

  • Age 6-11 years with type 1 diabetes for at least one year
  • Diabetes managed using an insulin infusion pump for ≥ three months
  • Willing to wear two infusion sets and continuous glucose monitoring (CGM) sensor and change sets frequently (at least one new glucagon infusion set daily)
  • Otherwise healthy (mild chronic disease such as asthma will be allowed if well controlled that do not require medications that result in exclusion)

Exclusion Criteria

  • Unable to provide informed consent, informed assent or parental consent
  • Unable to comply with study procedures
  • Current participation in another diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the subject
  • End stage renal disease on dialysis (hemodialysis or peritoneal dialysis)
  • Pregnancy (positive urine human chorionic gonadotropin [HCG])
  • History of liver disease that is expected to interfere with the anti-hypoglycemia action of glucagon (e.g. liver failure or cirrhosis). Other liver disease (i.e. active hepatitis, steatosis, active biliary disease, any tumor of the liver, hemochromatosis, glycogen storage disease) may exclude the subject if it causes significant compromise to liver function or may do so in an unpredictable fashion
  • Personal history of cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma
  • History of prolonged QT or arrhythmia, congenital heart disease or current known cardiac disease
  • Acute illness (other than non-vomiting viral illness) or exacerbation of chronic illness other than type 1 diabetes (T1D) at the time of the study
  • Seizure disorder, history of any seizure within the last two years, or ongoing treatment with anticonvulsants
  • Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year), or treatment with second generation anti-psychotic medications, which are known to affect glucose regulation.
  • Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to radio-frequency (RF) interference
  • Use of oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, dipeptidyl peptidase 4 (DPP-4) inhibitors, sodium-glucose linked transporter 2 (SGLT-2) inhibitors) anti-diabetic medications
  • History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
  • Unwilling or unable to completely avoid acetaminophen during the comparator and bionic pancreas arms of the study
  • History of eating disorder such as anorexia, bulimia, or diabulemia or omission of insulin to manipulate weight
  • History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment
  • Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures

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

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Bionic Pancreas
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
Dispositivo: Bionic Pancreas
Automated blood glucose control via a closed-loop bionic pancreas device.
Otros nombres:
  • Páncreas biónico de la Universidad de Boston
Experimental: Usual Care
Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Otro: Usual Care
As a comparator control, usual diabetes camp care with the participant's own insulin pump.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5
Periodo de tiempo: Days 2 to 5 of each period
Glucose reading were taken every 5 minutes by the CGM. The CGM glucose results during Days 2 through 5 were averaged.
Days 2 to 5 of each period
Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 5
Periodo de tiempo: Days 2 to 5 of each period
Glucose reading were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than 60 mg/dL [3.3 millimoles/liter (mmol/L)] during Days 2 through 5 was calculated.
Days 2 to 5 of each period

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean CGMG Values
Periodo de tiempo: Day 1 and Days 1-5 in each period
Glucose reading were taken every 5 minutes by the CGM. The glucose results for each time frame were averaged.
Day 1 and Days 1-5 in each period
Percentage of Time With CGMG Concentration by Ranges During Day 1
Periodo de tiempo: Day 1 of each period
Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dL(2.8 mmol/L), < 70 mg/dL (3.9 mmol/L), 70-180 mg/dL (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).
Day 1 of each period
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5
Periodo de tiempo: Days 1 to 5 of each period
Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dl (2.8 mmol/L), < 70 mg/dl (3.9 mmol/L), 70-180 mg/dl (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).
Days 1 to 5 of each period
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5
Periodo de tiempo: Days 2 to 5 of each period
Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dl (2.8 mmol/L), < 70 mg/dl (3.9 mmol/L), 70-180 mg/dl (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).
Days 2 to 5 of each period
Percentage of Participants With Mean CGMG Glucose <154 mg/dL
Periodo de tiempo: Day 1, Days 1-5, and Days 2-5 of each period
Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.0%.
Day 1, Days 1-5, and Days 2-5 of each period
Percentage of Participants With Mean CGMG Glucose <169 mg/dL
Periodo de tiempo: Day 1, Days 1-5, and Days 2-5 of each period
Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.
Day 1, Days 1-5, and Days 2-5 of each period
Percentage of Participants With Mean CGMG Glucose <183 mg/dL
Periodo de tiempo: Day 1, Days 1-5, and Days 2-5 of each period
Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.
Day 1, Days 1-5, and Days 2-5 of each period
Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
Periodo de tiempo: Days 1-5
A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.
Days 1-5
Mean Plasma Glucose Values
Periodo de tiempo: Day 1, Days 1 to 5, and Days 2 to 5 of each period
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. The plasma glucose results on Day 1, Days 1 to 5 and Days 2 to 5 were averaged.
Day 1, Days 1 to 5, and Days 2 to 5 of each period
Percentage of Time With Plasma Glucose Values by Ranges on Day 1
Periodo de tiempo: Day 1 of each period
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dl (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dl (2.8 mmol/L).
Day 1 of each period
Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5
Periodo de tiempo: Days 1 to 5 of each period
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dL (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dL (2.8 mmol/L).
Days 1 to 5 of each period
Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5
Periodo de tiempo: Days 2 to 5 of each period
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dl (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dl (2.8 mmol/L).
Days 2 to 5 of each period
Percentage of Participants With Mean Plasma Glucose <154 mg/dL
Periodo de tiempo: Day 1, Days 1 to 5, and Days 2 to 5 of each period
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.0%.
Day 1, Days 1 to 5, and Days 2 to 5 of each period
Percentage of Participants With Mean Plasma Glucose <169 mg/dL
Periodo de tiempo: Day 1, Days 1 to 5, and Days 2 to 5 of each period
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.
Day 1, Days 1 to 5, and Days 2 to 5 of each period
Percentage of Participants With Mean Plasma Glucose <183 mg/dL
Periodo de tiempo: Day 1, Days 1 to 5, and Days 2 to 5 of each period
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.
Day 1, Days 1 to 5, and Days 2 to 5 of each period
Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
Periodo de tiempo: Days 1-5
A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.
Days 1-5
Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care
Periodo de tiempo: Day 1, Days 1-5, and Days 2-5 of the Usual Care Period
The percentage of days during the Usual Care period that participants used CGM data as part of their diabetes management.
Day 1, Days 1-5, and Days 2-5 of the Usual Care Period
Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL
Periodo de tiempo: Day 1, Days 1-5, and Days 2-5 of each period
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L. The total number of carbohydrate interventions are reported.
Day 1, Days 1-5, and Days 2-5 of each period
Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL
Periodo de tiempo: Day 1, Days 1-5, and Days 2-5 of each period
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L.
Day 1, Days 1-5, and Days 2-5 of each period
Insulin Total Daily Dose
Periodo de tiempo: 11 days
Insulin total daily dose is reported in units per kilogram per day (U/kg/day).
11 days
Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm
Periodo de tiempo: Day 1, Days 1-5, and Days 2-5 of each period
Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).
Day 1, Days 1-5, and Days 2-5 of each period
Daily Basal Insulin Dose in the Bionic Pancreas Period
Periodo de tiempo: Day 1 through Day 5
The bionic pancreas automatically adapted insulin dosing to each individual's needs. When CGM data were not available (because of sensor failure or during the warm-up time after sensor replacement), the bionic pancreas automatically delivered a dose of basal insulin based on the mean basal dosing it had calculated at that time on previous days. Daily basal insulin dose is reported in units per kilogram (kg) per day (U/kg).
Day 1 through Day 5
Daily Bolus Insulin Dose in the Bionic Pancreas Period
Periodo de tiempo: Day 1 through Day 5
The first time the bionic pancreas was used in each participant, a partial meal-priming bolus based on the participant's body mass (0.05 units/kg) was delivered. After the first use, the size of the meal-priming bolus was adapted by the bionic pancreas to 75% of the 4-hour prandial insulin used for that meal type and size. Daily bolus insulin dose is reported in units per kilogram (kg) per day (U/kg).
Day 1 through Day 5
Carbohydrate Intake
Periodo de tiempo: Day 1, Days 1-5 and Days 2-5
Carbohydrate intake included meals, snacks and unscheduled carbohydrates administered when a participant's blood glucose was <80 mg/dl (or for symptoms at any glucose level). Carbohydrate intake per day was averaged and is reported in grams (g) per kilogram (kg) per day (g/kg/day).
Day 1, Days 1-5 and Days 2-5
Number of Unscheduled Infusion Set Changes
Periodo de tiempo: Day 1
Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.
Day 1
Number of Unscheduled Infusion Set Changes
Periodo de tiempo: Days 1-5
Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.
Days 1-5
Number of Unscheduled Infusion Set Changes
Periodo de tiempo: Days 2-5
Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.
Days 2-5
Number of Bionic Pancreas Local Infusion Site Reactions
Periodo de tiempo: Day 1, Days 1-5 and Days 2-5
Local infusion site reactions are defined as pain at the infusion site of the Bionic Pancreas. Itching and redness may have also been present.
Day 1, Days 1-5 and Days 2-5
Mean Nausea Index Score Using a Visual Analogue Scale (VAS)
Periodo de tiempo: Day 1, Days 1-5, and Days 2-5 in each period
Participants rated their nausea using a 0 to 10 centimeter (cm) VAS where 0=least severe nausea to 10=most severe nausea. The average nausea index scores from Day 1 to Day 5 were calculated
Day 1, Days 1-5, and Days 2-5 in each period
Number of Severe Hypoglycemic Events
Periodo de tiempo: Day 1, Days 1-5 and Days 2-5
A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.
Day 1, Days 1-5 and Days 2-5
Percentage of Time Participants Were Not Under Bionic Pancreas Control During the Bionic Pancreas Period
Periodo de tiempo: 5 days
Percentage of time that the Bionic pancreas was not functioning properly due to loss of wireless connectivity.
5 days
Percentage of Time Without CGM Monitoring Data
Periodo de tiempo: 5 days
Percentage of time without CGM monitoring data is the time when the participant's CGM device lost its CGM signal.
5 days
Change From Baseline in Body Weight
Periodo de tiempo: 5 days
The change in body weight collected at Day 5 of each period relative to Baseline. A negative change from Baseline indicates a reduction in body weight and a positive change from Baseline indicates an increase in body weight.
5 days
Reliability Index
Periodo de tiempo: Day 1, Days 1-5, and Days 2-5 in each period
Reliability index was calculated as the percentage of time values were actually recorded by CGM.
Day 1, Days 1-5, and Days 2-5 in each period
List of Technical Faults Associated With the Bionic Pancreas Including Cause and Resolution
Periodo de tiempo: 5 days
5 days
Number of Unscheduled CGM Sensor Changes
Periodo de tiempo: 5 days
The number of time a CGM sensor was replaced due to falling out or failing to report a glucose value.
5 days
Percentage of Participants Using a Glucagon-Like Peptide-1 (GLP-1) Agonist During the Usual Care Period
Periodo de tiempo: 5 days
The percentage of participants who used a GLP-1 agonist to manage their diabetes during the Usual Care period.
5 days
Percentage of Participants Using Pramlintide During the Usual Care Period
Periodo de tiempo: 5 days
The percentage of participants who used pramlintide to manage their diabetes during the Usual Care period.
5 days

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Massachusetts General Hospital

Colaboradores

Boston University

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

Enlaces Útiles

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

1 de junio de 2014

Finalización primaria (Actual)

1 de agosto de 2014

Finalización del estudio (Actual)

1 de agosto de 2014

Fechas de registro del estudio

Enviado por primera vez

2 de abril de 2014

Primero enviado que cumplió con los criterios de control de calidad

2 de abril de 2014

Publicado por primera vez (Estimar)

7 de abril de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de octubre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

19 de octubre de 2017

Última verificación

1 de octubre de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2014P000630

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. .

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