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The Set-Point Study: Evaluating Effects of Changing Glucose Target on Bionic Pancreas Performance

19 de octubre de 2018 actualizado por: Steven J. Russell, MD, PhD, Massachusetts General Hospital
The current study is designed to determine the effect on mean glucose, hypoglycemia, glucagon usage, and insulin usage of adjusting upward the glucose target of the bi-hormonal bionic pancreas, and determine whether there is a target at which adequate glycemic control is achieved by an insulin-only bionic pancreas with minimal hypoglycemia.

Descripción general del estudio

Estado

Terminado

Descripción detallada

We have two specific aims:

Aim 1 is to conduct an outpatient study testing multiple configurations of the bionic pancreas in 24 adult subjects with type 1 diabetes in a random cross-over study versus usual care with an insulin pump. These bionic pancreas configurations include the insulin only BP at 145 mg/dl set point, 130 mg/dl set point, 120 mg/dl set point and 110 mg/dl set point and the bihormonal BP at 130 mg/dl set point, 115 mg/dl set point and 110 mg/dl set point. These arms are all compared to usual care.

Aim 2 is to evaluate the incremental utility of glucagon in the context of automated insulin delivery by the bionic pancreas in preventing hypoglycemia during exercise in the fasted state. The 130 mg/dl set points and 110 mg/dl set points also participate in this fasted exercise visit. These two set points are double blinded, so neither the subjects nor the study staff are aware which arm is bihormonal and which arm is insulin only.

Tipo de estudio

Intervencionista

Inscripción (Actual)

24

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

    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Masscahusetts 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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Type 1 Diabetes Subjects: Age ≥ 18 years and have had clinical type 1 diabetes for at least one year, and managed using an insulin pump for ≥ 6 months Type 2 Diabetes subjects: Age ≥ 18 years and have type 2 diabetes managed with rapid acting insulin in an insulin pump, or multiple daily injections including both long acting and short acting insulin

  • Prescription medication regimen stable for > 1 month (except for medications that will not affect the safety of the study and are not expected to affect any outcome of the study, in the judgment of the principal investigator)
  • Live within a 60 minute drive-time radius of the central monitoring location
  • Willing to remain within a 120 minute drive-time radius of the central monitoring location throughout the study
  • Have someone over 18 years of age who lives with them, has access to where they sleep, is willing to be in the house when the subject is sleeping, and is willing to receive calls from the study staff and check the welfare of the study subject if telemetry shows a technical problem or severe biochemical hypoglycemia without subject response and the subject does not answer their telephone (up to two individuals can share this role, but they must be willing to carefully coordinate with each other and the subject so that one of them is clearly designated as having this responsibility at any given time)
  • Willing to wear two infusion sets and one CGM sensor and change sets frequently (at least one new glucagon infusion set daily during bi-hormonal arms, and insulin infusion set every other day throughout the study)
  • Have a mobile phone they are willing to keep with them and answer calls from study staff

Exclusion Criteria:

  • Unable to provide informed consent (e.g. impaired cognition or judgment)
  • Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory, unable to speak and read English)
  • 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
  • Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception
  • Need to go outside of the designated geographic boundaries during the study
  • Current alcohol abuse (intake averaging > 3 drinks daily in last 30 days), use of marijuana within 1 month of enrollment, or other substance abuse (use within the last 6 months of controlled substances other than marijuana without a prescription)
  • Unwilling or unable to refrain from drinking more than 2 drinks in an hour or more than 4 drinks in a day or use of marijuana during the trial
  • Unwilling or unable or to avoid use of drugs that may dull the sensorium, reduce sensitivity to symptoms of hypoglycemia, or hinder decision making during the period of participation in the study (use of beta blockers will be allowed as long as the dose is stable and the subject does not meet the criteria for hypoglycemia unawareness while taking that stable dose, but use of benzodiazepines or narcotics, even if by prescription, may be excluded according to the judgment of the principal investigator)
  • 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.
  • Renal failure on dialysis
  • Personal history of cystic fibrosis, pancreatitis, pancreatic tumor, or any other pancreatic disease besides type 1 diabetes
  • Any known history of coronary artery disease including, but not limited to, history of myocardial infarction, stress test showing ischemia, history of angina, or history of intervention such as coronary artery bypass grafting, percutaneous coronary intervention, or enzymatic lysis of a presumed coronary occlusion)
  • Abnormal EKG consistent with coronary artery disease or increased risk of malignant arrhythmia including, but not limited to, evidence of active ischemia, prior myocardial infarction, proximal LAD critical stenosis (Wellen's sign), prolonged QT interval (> 440 ms). Non-specific ST segment and T wave changes are not grounds for exclusion in the absence of symptoms or history of heart disease. A reassuring evaluation by a cardiologist after an abnormal EKG finding may allow participation.
  • Congestive heart failure (established history of CHF, lower extremity edema, paroxysmal nocturnal dyspnea, or orthopnea)
  • History of TIA or stroke
  • Seizure disorder, history of any non-hypoglycemic seizure within the last two years, or ongoing treatment with anticonvulsants
  • History of hypoglycemic seizures (grand-mal) or coma in the last year
  • History of pheochromocytoma: fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor:

oEpisodic or treatment refractory (requiring 4 or more medications to achieve normotension) hypertension oParoxysms of tachycardia, pallor, or headache oPersonal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease

  • History of adrenal disease or tumor
  • Hypertension with systolic BP ≥160 mm Hg or diastolic BP ≥100 despite treatment
  • 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 anti-psychotic medications that are known to affect glucose regulation.
  • Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference
  • Unable to completely avoid acetaminophen for duration of study
  • History of adverse reaction to glucagon (including allergy) besides nausea and vomiting
  • Established history of allergy or severe reaction to adhesive or tape that must be used in the study
  • History of eating disorder within the last 2 years, 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
  • Type 1 diabetes subjects: Use of oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, DPP-4 inhibitors, SGLT-2 inhibitors) anti-diabetic medications
  • Type 2 diabetes subjects: Use of oral anti-diabetic medications other than metformin
  • Lives in or frequents areas with poor Verizon wireless network coverage (which would prevent remote monitoring)
  • Any factors that, in the opinion of the principal investigator would interfere with the safe completion of the study

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
Comparador activo: Usual Care
Comparator week to all closed-loop control, utilizing usual diabetes care and the subject's own insulin pump.
Participant cares for their diabetes according to their usual practice, with blinded CGM monitoring. No medication will be administered by the study in this intervention.
Experimental: 145 mg/dl Set Point - insulin only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 145 mg/dl and using only an insulin pump.
Participant wears the bionic pancreas, including an insulin and/or glucagon pump depending on which arm they are in. The 100 mg/dl arm for type 1 diabetes patients will deliver insulin and glucagon. The 100 mg/dl arm for type 2 diabetes patients will deliver just insulin. The 115 mg/dl arm will deliver insulin and glucagon. The 120 mg/dl arm will deliver just insulin. The 145 mg/dl arm will deliver just insulin. The 130 mg/dl and 110 mg/dl arms will deliver insulin and placebo, or insulin and glucagon, and will be double blinded.
Experimental: 130 mg/dl Set Point - insulin only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
Participant wears the bionic pancreas, including an insulin and/or glucagon pump depending on which arm they are in. The 100 mg/dl arm for type 1 diabetes patients will deliver insulin and glucagon. The 100 mg/dl arm for type 2 diabetes patients will deliver just insulin. The 115 mg/dl arm will deliver insulin and glucagon. The 120 mg/dl arm will deliver just insulin. The 145 mg/dl arm will deliver just insulin. The 130 mg/dl and 110 mg/dl arms will deliver insulin and placebo, or insulin and glucagon, and will be double blinded.
Experimental: 130 mg/dl Set Point - bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
Participant wears the bionic pancreas, including an insulin and/or glucagon pump depending on which arm they are in. The 100 mg/dl arm for type 1 diabetes patients will deliver insulin and glucagon. The 100 mg/dl arm for type 2 diabetes patients will deliver just insulin. The 115 mg/dl arm will deliver insulin and glucagon. The 120 mg/dl arm will deliver just insulin. The 145 mg/dl arm will deliver just insulin. The 130 mg/dl and 110 mg/dl arms will deliver insulin and placebo, or insulin and glucagon, and will be double blinded.
Experimental: 115 mg/dl Set Point - bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump.
Participant wears the bionic pancreas, including an insulin and/or glucagon pump depending on which arm they are in. The 100 mg/dl arm for type 1 diabetes patients will deliver insulin and glucagon. The 100 mg/dl arm for type 2 diabetes patients will deliver just insulin. The 115 mg/dl arm will deliver insulin and glucagon. The 120 mg/dl arm will deliver just insulin. The 145 mg/dl arm will deliver just insulin. The 130 mg/dl and 110 mg/dl arms will deliver insulin and placebo, or insulin and glucagon, and will be double blinded.
Experimental: 100 mg/dl Set Point - bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump.
Participant wears the bionic pancreas, including an insulin and/or glucagon pump depending on which arm they are in. The 100 mg/dl arm for type 1 diabetes patients will deliver insulin and glucagon. The 100 mg/dl arm for type 2 diabetes patients will deliver just insulin. The 115 mg/dl arm will deliver insulin and glucagon. The 120 mg/dl arm will deliver just insulin. The 145 mg/dl arm will deliver just insulin. The 130 mg/dl and 110 mg/dl arms will deliver insulin and placebo, or insulin and glucagon, and will be double blinded.
Experimental: 110 mg/dl Set Point - insulin only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
Participant wears the bionic pancreas, including an insulin and/or glucagon pump depending on which arm they are in. The 100 mg/dl arm for type 1 diabetes patients will deliver insulin and glucagon. The 100 mg/dl arm for type 2 diabetes patients will deliver just insulin. The 115 mg/dl arm will deliver insulin and glucagon. The 120 mg/dl arm will deliver just insulin. The 145 mg/dl arm will deliver just insulin. The 130 mg/dl and 110 mg/dl arms will deliver insulin and placebo, or insulin and glucagon, and will be double blinded.
Experimental: 110 mg/dl Set Point - bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
Participant wears the bionic pancreas, including an insulin and/or glucagon pump depending on which arm they are in. The 100 mg/dl arm for type 1 diabetes patients will deliver insulin and glucagon. The 100 mg/dl arm for type 2 diabetes patients will deliver just insulin. The 115 mg/dl arm will deliver insulin and glucagon. The 120 mg/dl arm will deliver just insulin. The 145 mg/dl arm will deliver just insulin. The 130 mg/dl and 110 mg/dl arms will deliver insulin and placebo, or insulin and glucagon, and will be double blinded.
Experimental: 120 mg/dl Set Point - insulin only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump.
Participant wears the bionic pancreas, including an insulin and/or glucagon pump depending on which arm they are in. The 100 mg/dl arm for type 1 diabetes patients will deliver insulin and glucagon. The 100 mg/dl arm for type 2 diabetes patients will deliver just insulin. The 115 mg/dl arm will deliver insulin and glucagon. The 120 mg/dl arm will deliver just insulin. The 145 mg/dl arm will deliver just insulin. The 130 mg/dl and 110 mg/dl arms will deliver insulin and placebo, or insulin and glucagon, and will be double blinded.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Continuous Glucose Monitor (CGM) Glucose Values
Periodo de tiempo: Days 2 and 3
Glucose values were collected from the Dexcom G4 CGM device every 5 minutes and an average (calculated mean with associated standard deviation) CGM glucose level (mg/dl) was calculated from days 2 and 3 of the study arm.
Days 2 and 3
Percentage of Time With CGM < 60 mg/dl
Periodo de tiempo: Days 2 and 3
For this calculation we analyzed data from every 5 minutes of CGM data for days 2 and 3 of each study arm. We looked specifically at the percentage time of those roughly 48 hours that had any glucose values less than 60 mg/dl. The final value presented is the percent of time per 2 days of the study arm spent in a specific hypoglycemia range of less than 60 mg/dl with an associated standard deviation.
Days 2 and 3
Number of Subjects Discordant for Reaching a BG < 60 mg/dl for > 2 Consecutive Plasma Glucose Measurements During Inpatient Exercise Visit
Periodo de tiempo: Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)
During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes
Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean CGM Glucose
Periodo de tiempo: Days 1 through 3
Average glucose according to continuous glucose monitor readings including the 1 day washout
Days 1 through 3
Nausea Severity
Periodo de tiempo: Days 1-3
The average severity of nausea, as recorded on a 10 centimeter visual analog scale by the daily e-mail survey they receive. Scores were determined by how many centimeters the subject marked as a surrogate for their nausea level on a daily basis. Any value more than 0 cm indicates some degree of nausea with a score of 10 cm being the worst nausea imaginable. A score less than 3 cm indicates a mild level of nausea.
Days 1-3
Percentage of Time Spent in: < 50 mg/dl, < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, >250 mg/dl
Periodo de tiempo: Days 2-3
The fraction of time spent in each of these ranges according to continuous glucose monitor readings
Days 2-3
Percentage of Subjects With Mean CGM < 154 mg/dl
Periodo de tiempo: Days 2-3
The percentage of subjects who's mean CGM glucose level is < 154 mg/dl, which is an estimated hemoglobin a1c < 7%, which is the ADA goal for therapy
Days 2-3
Area Between the Glucose Curve and 60 mg/dl Calculated From BG Measurements
Periodo de tiempo: Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)
Plasma glucose values to create this curve included time points from time 0 to a maximum of 360 minutes, with a sampling frequency of at least every 10 minutes throughout.
Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)
Area Between the Glucose Curve and 60 mg/dl Calculated From CGM Measurements
Periodo de tiempo: Day 4 in-clinic Exercise Visit (type 1 diabetes only, 110 and 130 mg/dl arms only)
CGM glucose values to create this curve included time points from time 0 to a maximum of 360 minutes, with a sampling frequency of every 5 minutes
Day 4 in-clinic Exercise Visit (type 1 diabetes only, 110 and 130 mg/dl arms only)
Time From Start of Exercise to First BG Measurement < 60 mg/dl
Periodo de tiempo: Day 4 in-clinic Exercise Visit (type 1 diabetes only, 110 and 130 mg/dl arms only)
During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes
Day 4 in-clinic Exercise Visit (type 1 diabetes only, 110 and 130 mg/dl arms only)
Time From Start of Exercise to First CGM Measurement < 60 mg/dl
Periodo de tiempo: Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)
During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes
Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)
Grams of Carbohydrates Given to the Subject to Treat Hypoglycemia
Periodo de tiempo: Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)
During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes
Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)
Total Glucagon Dosing by the Bihormonal Bionic Pancreas From the Start of Exercise Until the End of the Visit
Periodo de tiempo: Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)
During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes
Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)

Colaboradores e Investigadores

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Publicaciones y enlaces útiles

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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 agosto de 2015

Finalización primaria (Actual)

1 de diciembre de 2017

Finalización del estudio (Actual)

1 de diciembre de 2017

Fechas de registro del estudio

Enviado por primera vez

22 de julio de 2015

Primero enviado que cumplió con los criterios de control de calidad

24 de julio de 2015

Publicado por primera vez (Estimar)

27 de julio de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de noviembre de 2018

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

19 de octubre de 2018

Última verificación

1 de octubre de 2018

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

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INDECISO

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. .

Ensayos clínicos sobre Diabetes tipo 1

Ensayos clínicos sobre Usual Care

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