Bionic pancreas device glycemic control in patients with diabetes type 1 -
The latest version of a bionic pancreas device has been successfully tested in two clinical trials of five days - an adult and one adolescent - which imposed minimum restrictions on patient activities. A team of researchers from Boston University (BU) and Massachusetts General Hospital (MGH) results in a study report New England Journal of Medicine Online paper issued to coincide with a presentation (abstract # 237-OR) to the diabetes Association Sessions Scientific American. The device control blood sugar in type 1 diabetes patients using insulin doses of the hormone glucagon and sugar in the blood awareness.
"In both studies this device far exceeded our expectations in terms of its ability to regulate glucose to prevent hypoglycemia and automatically adapt to the very different needs of adults - some of which were very sensitive to insulin - and teenagers, who typically require higher doses of insulin, "said Edward Damiano, PhD, of the BU Department of biomedical engineering, project principal investigator and lead author of NEJM report . "There is no current therapy standard of care that could match the results we have seen."
Firas El-Khatib Ph.D., of the BU Department of Biomedical Engineering, adds: "One of the main virtues of this device is its ability to start controlling blood sugar levels instantly, based solely on the patient's weight, and continuously adapt its decision on insulin and glucagon dosage to treat a wide range of dosage requirements. "El-Khatib co-developed the bionic pancreas device with Damiano and is co-senior author of the report NEJM Steven Russell, MD, PhD, of the MGH diabetes Unit ,.
Russell - who led the clinical trials reported in this document - Damiano, and El-Khatib previously published a 2010 report science Translational Medicine that describes the successful use of the first-generation system in the control of blood sugar in adults for 27 hours, but this study took place in an environment. controlled inpatient where participants were essentially in bed for the entire period and ate meals prescribed. "The key element of the current version of this device is that it is portable, allowing participants to stay in something close to their usual environment, exercise and eat whatever they want," says Russell.
additional hospital tests conducted after the 2010 paper extended the period of study in two days and includes teenagers as well as adults. But the development of a device that could be tested safely in outpatient environment presented several challenges, the first of which was a control system that could not only adapt to the changing needs every minute of an individual, but also to the very different needs of adults and adolescents. the rapid growth and change hormonal adolescence produces insulin requirements that are two to three times higher than adults of the same body weight, Damiano says. and even if the dosage needs of adults are more predictable, contract typical of a disease as a stomach cold or upset can radically change the need for insulin over a period of days or weeks.
With software enhancements that enable the adapter device with varied individual needs of dosing, the new version is also based on improvement of equipment, including a smartphone (iPhone 4S) able to communicate without over practice with two pumps delivering doses of insulin and glucagon. Every five minutes the smartphone receives a blood glucose reading from a continuous glucose monitor attached, which it uses to calculate and administer a dose of insulin or glucagon. The smartphone includes an application on which the patient information between immediately before eating. But instead of complex computing patients are usually to estimate their intake of carbohydrates, this application request if the consumed meal will be breakfast, lunch or dinner and if the carbohydrate content will be typical, larger or smaller than usual.
two studies reported in the NEJM paper data over five days reflecting on the bionic pancreas system with five days of usual care participants using their own insulin pumps. The trial enrolled 20 adult participants who were living at home and managed their own care during the usual period of care. As the bionic pancreas, participants need to stay in an area of three-square-mile downtown Boston, which allowed the free constant wireless monitoring of sugar levels in the blood by the staff of the 'study. They were accompanied by a study nurse 24 hours a day and stayed in a hotel; but were otherwise free to do as they chose, including the exercise in a gym and eating in restaurants.
The trial teenagers enrolled 32 participants, ages 12 to 20, attending a camp for youth with type 1 diabetes, which followed the same schedule of activities and meals as other campers during both phases of the trial. They were followed closely by the study and the camp staff and the wireless monitoring during their time on the bionic pancreas. Participants in both phases of both trials were alerted if sugar levels in the blood fell in a range requiring carbohydrate administration, including at night surveillance.
In both studies, the time on the bionic pancreas produces what Russell calls, "two results that almost never go together. Glucose average of participants has decreased while sugar incidents blood also dropped. the fear of hypoglycemia may limit attempts to bring the average blood sugar levels in the range that significantly reduces the risk of long term complications, so it was remarkable that we have seen these two results both groups had two fairly good levels in the usual care arm -. 159 average for adults and teenagers - but the difference while they were on the bionic pancreas was dramatic, with an average sugar levels in the blood 133 for adults and 142 for teens. " Fewer cases of hypoglycemia on the bionic pancreas also reduces the need for carbohydrate to raise blood sugar doses.
Damiano, whose 15 year old son was diagnosed with type 1 diabetes at the age of 11 months, says that having a device like this could mean for patients. . "The most practical difference would be not having to think on the 24/7 diabetes, not having to constantly make decisions about things that those of us without ever type 1 have to think of another real problem would be relieved is fear - fear of going to bed at night and not know if your sugar levels in the blood will drop dangerously low during sleep Even our study participants, who controlled them. significantly better blood glucose levels than national averages on their usual treatment, ran high levels during the night, but still had significant hypoglycemia.
"and another extremely frustrating aspect of diabetes would be completely eliminated by this device is the huge sense of failure when you stare the glucose meter and, despite what you do to control your blood sugar is not in or near the normal range, "he says. " But of course, you did not fail; the tools at your disposal failed. The bionic pancreas we work to relieve this sense of failure and provide a bridge to the often promised but still elusive cure for type 1 diabetes "
Two monitoring tests are underway, one of which will be a real home study requiring that participants are less than an hour of study site. this trial, which will compare 11 days on the bionic pancreas with 11 days of usual care will be coordinated through Russell MGH team and completed four centers - MGH, the University of Massachusetts Medical Center in Worcester, the University of North Carolina at Chapel Hill, and Stanford University - and will start on June 16th MGH second study, conducted at Clara Barton Camp and Camp Joslin in central. Massachusetts, will enroll children aged 6 to 11 and is currently recruiting participants already in the camps. information on these two trials and the whole the project is available http://www.bionicpancreas.org/.
"In both studies this device far exceeded our expectations in terms of its ability to regulate glucose to prevent hypoglycemia and automatically adapt to the very different needs of adults - some of which were very sensitive to insulin - and teenagers, who typically require higher doses of insulin, "said Edward Damiano, PhD, of the BU Department of biomedical engineering, project principal investigator and lead author of NEJM report . "There is no current therapy standard of care that could match the results we have seen."
Firas El-Khatib Ph.D., of the BU Department of Biomedical Engineering, adds: "One of the main virtues of this device is its ability to start controlling blood sugar levels instantly, based solely on the patient's weight, and continuously adapt its decision on insulin and glucagon dosage to treat a wide range of dosage requirements. "El-Khatib co-developed the bionic pancreas device with Damiano and is co-senior author of the report NEJM Steven Russell, MD, PhD, of the MGH diabetes Unit ,.
Russell - who led the clinical trials reported in this document - Damiano, and El-Khatib previously published a 2010 report science Translational Medicine that describes the successful use of the first-generation system in the control of blood sugar in adults for 27 hours, but this study took place in an environment. controlled inpatient where participants were essentially in bed for the entire period and ate meals prescribed. "The key element of the current version of this device is that it is portable, allowing participants to stay in something close to their usual environment, exercise and eat whatever they want," says Russell.
additional hospital tests conducted after the 2010 paper extended the period of study in two days and includes teenagers as well as adults. But the development of a device that could be tested safely in outpatient environment presented several challenges, the first of which was a control system that could not only adapt to the changing needs every minute of an individual, but also to the very different needs of adults and adolescents. the rapid growth and change hormonal adolescence produces insulin requirements that are two to three times higher than adults of the same body weight, Damiano says. and even if the dosage needs of adults are more predictable, contract typical of a disease as a stomach cold or upset can radically change the need for insulin over a period of days or weeks.
With software enhancements that enable the adapter device with varied individual needs of dosing, the new version is also based on improvement of equipment, including a smartphone (iPhone 4S) able to communicate without over practice with two pumps delivering doses of insulin and glucagon. Every five minutes the smartphone receives a blood glucose reading from a continuous glucose monitor attached, which it uses to calculate and administer a dose of insulin or glucagon. The smartphone includes an application on which the patient information between immediately before eating. But instead of complex computing patients are usually to estimate their intake of carbohydrates, this application request if the consumed meal will be breakfast, lunch or dinner and if the carbohydrate content will be typical, larger or smaller than usual.
two studies reported in the NEJM paper data over five days reflecting on the bionic pancreas system with five days of usual care participants using their own insulin pumps. The trial enrolled 20 adult participants who were living at home and managed their own care during the usual period of care. As the bionic pancreas, participants need to stay in an area of three-square-mile downtown Boston, which allowed the free constant wireless monitoring of sugar levels in the blood by the staff of the 'study. They were accompanied by a study nurse 24 hours a day and stayed in a hotel; but were otherwise free to do as they chose, including the exercise in a gym and eating in restaurants.
The trial teenagers enrolled 32 participants, ages 12 to 20, attending a camp for youth with type 1 diabetes, which followed the same schedule of activities and meals as other campers during both phases of the trial. They were followed closely by the study and the camp staff and the wireless monitoring during their time on the bionic pancreas. Participants in both phases of both trials were alerted if sugar levels in the blood fell in a range requiring carbohydrate administration, including at night surveillance.
In both studies, the time on the bionic pancreas produces what Russell calls, "two results that almost never go together. Glucose average of participants has decreased while sugar incidents blood also dropped. the fear of hypoglycemia may limit attempts to bring the average blood sugar levels in the range that significantly reduces the risk of long term complications, so it was remarkable that we have seen these two results both groups had two fairly good levels in the usual care arm -. 159 average for adults and teenagers - but the difference while they were on the bionic pancreas was dramatic, with an average sugar levels in the blood 133 for adults and 142 for teens. " Fewer cases of hypoglycemia on the bionic pancreas also reduces the need for carbohydrate to raise blood sugar doses.
Damiano, whose 15 year old son was diagnosed with type 1 diabetes at the age of 11 months, says that having a device like this could mean for patients. . "The most practical difference would be not having to think on the 24/7 diabetes, not having to constantly make decisions about things that those of us without ever type 1 have to think of another real problem would be relieved is fear - fear of going to bed at night and not know if your sugar levels in the blood will drop dangerously low during sleep Even our study participants, who controlled them. significantly better blood glucose levels than national averages on their usual treatment, ran high levels during the night, but still had significant hypoglycemia.
"and another extremely frustrating aspect of diabetes would be completely eliminated by this device is the huge sense of failure when you stare the glucose meter and, despite what you do to control your blood sugar is not in or near the normal range, "he says. " But of course, you did not fail; the tools at your disposal failed. The bionic pancreas we work to relieve this sense of failure and provide a bridge to the often promised but still elusive cure for type 1 diabetes "
Two monitoring tests are underway, one of which will be a real home study requiring that participants are less than an hour of study site. this trial, which will compare 11 days on the bionic pancreas with 11 days of usual care will be coordinated through Russell MGH team and completed four centers - MGH, the University of Massachusetts Medical Center in Worcester, the University of North Carolina at Chapel Hill, and Stanford University - and will start on June 16th MGH second study, conducted at Clara Barton Camp and Camp Joslin in central. Massachusetts, will enroll children aged 6 to 11 and is currently recruiting participants already in the camps. information on these two trials and the whole the project is available http://www.bionicpancreas.org/.
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