Bionic Pancreas Shown to Manage Blood-Sugar Levels for Type 1 Diabetics
A wearable device that automatically regulates blood-sugar levels was found to help people with Type 1 diabetes better manage their condition, potentially expanding the field of treatments for the chronic disease.
The iLet bionic pancreas made by Concord, Mass.-based Beta Bionics helped people with Type 1 diabetes reduce average blood-sugar levels more effectively than other treatment methods including similar devices, according to a study published Wednesday in the New England Journal of Medicine.
The Food and Drug Administration hasn’t cleared the iLet, a type of automated insulin-delivery system, for distribution in the U.S. The agency in 2019 granted it breakthrough-device designation to speed the review process. The agency said it wouldn’t comment on pending applications. The FDA has cleared automated insulin-delivery systems from three other companies:
Medtronic
PLC, Tandem Diabetes Care and
Insulet Corp.
Almost 2 million people in the U.S. have Type 1 diabetes, a potentially fatal condition, according to the American Diabetes Association. The disease arises when the pancreas makes insufficient amounts of insulin, a hormone that regulates the sugar glucose in the blood. Without insulin, glucose buildups can cause complications including heart and kidney disease. Too much insulin can lead to low blood-sugar levels that can also be dangerous.
People with Type 1 diabetes need the right amount of insulin at the right time to avoid such complications. That has long involved multiple fingerstick blood tests and insulin injections a day, said
Laurel Messer,
a co-author of the iLet study. Only about one-fifth of people with Type 1 diabetes in the U.S. maintain average blood-sugar levels within the recommended range, research has shown.
“There’s a daily psychological burden of having to do math all day,” said Dr. Messer, a researcher at the Barbara Davis Center for Childhood Diabetes at the University of Colorado.
Automated insulin-delivery systems aim to make the process simpler. They measure glucose levels every few minutes and send insulin into the bloodstream as needed.
Hundreds of thousands of patients with Type 1 and Type 2 diabetes use the Medtronic, Tandem and Insulet devices, studies show. The devices are available with a prescription for around $6,000, some of which is typically covered by insurance, Dr. Messer said. Insulin cartridges and other supplies can cost hundreds of dollars a month without insurance, she said.
Beta Bionics co-founder
Ed Damiano
said the iLet, whose name is a nod to the pancreatic islets of Langerhans containing cells that make insulin, would have a similar price. Dr. Damiano, a professor of biomedical engineering at Boston University whose son has Type 1 diabetes, said the iLet requires less input from users and healthcare providers than other devices.
Other automated insulin-delivery systems prompt patients or healthcare providers to estimate a ratio of insulin to carbohydrates, Dr. Damiano said. They prompt users to indicate how much insulin to administer or how many carbohydrates they plan to consume before each meal. Larger doses of insulin need to be administered right before meals to help regulate the excess glucose consumed through carbohydrates.
Users of iLet input their body weight when the device is first set up, Dr. Damiano said, and indicate before each meal whether it is smaller, typical or larger than usual for them without having to count the carbohydrates in the meal. iLet users can stop insulin from being administered but not manually adjust doses.
Dr. Damiano compared the iLet to a driverless car. “Some people really need to hold the wheel and it would make them really nervous,” he said. “But we hope to lift the anxiety in many people who would benefit from it.”
The iLet should be charged for a few minutes every day, Dr. Damiano said. As with other automated insulin-delivery systems, it can hold about two to three days worth of insulin at a time, he said.
In the randomized-control study published on Wednesday, over 200 adults and children with Type 1 diabetes used the iLet for about three months. Their results were compared with about 100 people with the same condition using other insulin-delivery methods, including other automated insulin-delivery systems, non-automated insulin pumps and daily insulin injections.
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What hopes and concerns do you have about this medical advancement? Join the conversation below.
Average blood-sugar levels among iLet users decreased, the study said. The other group showed no change in average blood-sugar levels. There was no statistically significant difference in severe hypoglycemia between the two groups.
Jason Baker,
an assistant professor of medicine at Weill Cornell Medicine in New York, said no insulin-delivery system could be considered fully automated. Dr. Baker, who has Type 1 diabetes, said patients should occasionally augment the systems with fingerstick blood tests to ensure it is working properly.
“A lot of people struggle against burnout with diabetes,” he said. “New systems could reinvigorate them, re-engage them and give them hope.”
Write to Dominique Mosbergen at [email protected]
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
A wearable device that automatically regulates blood-sugar levels was found to help people with Type 1 diabetes better manage their condition, potentially expanding the field of treatments for the chronic disease.
The iLet bionic pancreas made by Concord, Mass.-based Beta Bionics helped people with Type 1 diabetes reduce average blood-sugar levels more effectively than other treatment methods including similar devices, according to a study published Wednesday in the New England Journal of Medicine.
The Food and Drug Administration hasn’t cleared the iLet, a type of automated insulin-delivery system, for distribution in the U.S. The agency in 2019 granted it breakthrough-device designation to speed the review process. The agency said it wouldn’t comment on pending applications. The FDA has cleared automated insulin-delivery systems from three other companies:
Medtronic
PLC, Tandem Diabetes Care and
Insulet Corp.
Almost 2 million people in the U.S. have Type 1 diabetes, a potentially fatal condition, according to the American Diabetes Association. The disease arises when the pancreas makes insufficient amounts of insulin, a hormone that regulates the sugar glucose in the blood. Without insulin, glucose buildups can cause complications including heart and kidney disease. Too much insulin can lead to low blood-sugar levels that can also be dangerous.
People with Type 1 diabetes need the right amount of insulin at the right time to avoid such complications. That has long involved multiple fingerstick blood tests and insulin injections a day, said
Laurel Messer,
a co-author of the iLet study. Only about one-fifth of people with Type 1 diabetes in the U.S. maintain average blood-sugar levels within the recommended range, research has shown.
“There’s a daily psychological burden of having to do math all day,” said Dr. Messer, a researcher at the Barbara Davis Center for Childhood Diabetes at the University of Colorado.
Automated insulin-delivery systems aim to make the process simpler. They measure glucose levels every few minutes and send insulin into the bloodstream as needed.
Hundreds of thousands of patients with Type 1 and Type 2 diabetes use the Medtronic, Tandem and Insulet devices, studies show. The devices are available with a prescription for around $6,000, some of which is typically covered by insurance, Dr. Messer said. Insulin cartridges and other supplies can cost hundreds of dollars a month without insurance, she said.
Beta Bionics co-founder
Ed Damiano
said the iLet, whose name is a nod to the pancreatic islets of Langerhans containing cells that make insulin, would have a similar price. Dr. Damiano, a professor of biomedical engineering at Boston University whose son has Type 1 diabetes, said the iLet requires less input from users and healthcare providers than other devices.
Other automated insulin-delivery systems prompt patients or healthcare providers to estimate a ratio of insulin to carbohydrates, Dr. Damiano said. They prompt users to indicate how much insulin to administer or how many carbohydrates they plan to consume before each meal. Larger doses of insulin need to be administered right before meals to help regulate the excess glucose consumed through carbohydrates.
Users of iLet input their body weight when the device is first set up, Dr. Damiano said, and indicate before each meal whether it is smaller, typical or larger than usual for them without having to count the carbohydrates in the meal. iLet users can stop insulin from being administered but not manually adjust doses.
Dr. Damiano compared the iLet to a driverless car. “Some people really need to hold the wheel and it would make them really nervous,” he said. “But we hope to lift the anxiety in many people who would benefit from it.”
The iLet should be charged for a few minutes every day, Dr. Damiano said. As with other automated insulin-delivery systems, it can hold about two to three days worth of insulin at a time, he said.
In the randomized-control study published on Wednesday, over 200 adults and children with Type 1 diabetes used the iLet for about three months. Their results were compared with about 100 people with the same condition using other insulin-delivery methods, including other automated insulin-delivery systems, non-automated insulin pumps and daily insulin injections.
SHARE YOUR THOUGHTS
What hopes and concerns do you have about this medical advancement? Join the conversation below.
Average blood-sugar levels among iLet users decreased, the study said. The other group showed no change in average blood-sugar levels. There was no statistically significant difference in severe hypoglycemia between the two groups.
Jason Baker,
an assistant professor of medicine at Weill Cornell Medicine in New York, said no insulin-delivery system could be considered fully automated. Dr. Baker, who has Type 1 diabetes, said patients should occasionally augment the systems with fingerstick blood tests to ensure it is working properly.
“A lot of people struggle against burnout with diabetes,” he said. “New systems could reinvigorate them, re-engage them and give them hope.”
Write to Dominique Mosbergen at [email protected]
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
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