Tag Archive for: bionic pancreas

iLet Bionic Pancreas

Empowering Type 1 diabetes management with new technology

iLet Bionic Pancreas

The iLet Bionic Pancreas was recently cleared by the U.S. Food and Drug Administration (FDA) and is now commercially available.

In 2021, Children’s National Hospital participated in a multi-center clinical trial to test the efficacy of the iLet Bionic Pancreas — a device that automatically regulates blood sugar levels in patients with Type 1 diabetes. The iLet Bionic Pancreas was recently cleared by the U.S. Food and Drug Administration (FDA) and is now commercially available.

“The bionic pancreas serves as an additional resource empowering patients to effectively manage their Type 1 diabetes with confidence,” says Fran Cogen, M.D., CDCES, director emerita of the Childhood and Adolescent Diabetes Program at Children’s National. “It requires minimal input from the patient.”

During initialization of the pump, patients will no longer need to enter carbohydrate amounts, just their weight. After the patient indicates whether they are having a usual meal, smaller than usual meal, or larger than usual meal, the device’s algorithms will adjust insulin doses automatically.

“Patients will not need to add correction insulin,” says Dr. Cogen. “There are 3 algorithms – one to adjust background insulin, one to adjust insulin needed to cover carbohydrates and one to adjust insulin needed to correct high blood sugars. The background insulin dosing will also be adjusted if the blood sugars decrease or become low.”

The FDA approved the iLet Bionic Pancreas for patients 6 years and older with Type 1 diabetes. Users will be required to pair the pump with a continuous glucose monitor as the pump is dependent on the monitor’s information. The results of the trial, primarily funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, were published in the New England Journal of Medicine.

iLet Bionic Pancreas

Multicenter trial finds bionic pancreas improves Type 1 diabetes management

iLet Bionic Pancreas

Compared to other available artificial pancreas technologies, the bionic pancreas requires less user input and provides more automation because the device’s algorithms continually adjust insulin doses automatically.

A device known as a bionic pancreas, which uses next-generation technology to automatically deliver insulin, was more effective at maintaining blood glucose levels within normal range than standard-of-care management among people with Type 1 diabetes, a new multicenter clinical trial found.

The trial, conducted partly at Children’s National Hospital, was primarily funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, and published in the New England Journal of Medicine.

Automated insulin delivery systems – also called artificial pancreas or closed-loop control systems – track a person’s blood glucose levels using a continuous glucose monitor and automatically deliver the hormone insulin using a pump. These systems replace reliance on insulin delivery by multiple daily injections, pumps without automation and testing glucose levels using more labor-intensive systems, such as fingersticks.

“A diagnosis of Type 1 diabetes can be overwhelming for a child and their family,” said Fran Cogen, M.D., C.D.C.E.S., principal investigator at Children’s National and director of the Childhood and Adolescent Diabetes Program. “It is extremely important to monitor and manage glucose levels throughout the day to prevent serious complications like eye problems, kidney disease, heart and blood vessel disease. This new technology may give patients and families a sense of relief from some of the daily stressors that come with the diagnosis of this chronic disease.”

Compared to other available artificial pancreas technologies, the bionic pancreas requires less user input and provides more automation because the device’s algorithms continually adjust insulin doses automatically. Users of the bionic pancreas also do not have to count carbohydrates, nor initiate doses of insulin to correct for high blood glucose. In addition, healthcare providers do not need to make periodic adjustments to the device’s settings.

The 13-week trial, conducted at Children’s National and 15 other U.S. clinical sites, enrolled 326 participants ages 6 to 79 years who had Type 1 diabetes and had been using insulin for at least one year. Participants were randomly assigned to either a treatment group using the bionic pancreas device or a standard-of-care control group using their personal pre-study insulin delivery method.

The study found:

  • In participants using the bionic pancreas, glycated hemoglobin improved from 7.9% to 7.3%, yet remained unchanged among the standard-of-care control group.
  • The bionic pancreas group participants spent 11% more time within the targeted blood glucose range compared to the control group.
  • Results were similar in youth and adult participants.
  • Improvements in blood glucose control were greatest among participants who had higher blood glucose levels at the beginning of the study.

Hyperglycemia caused by equipment problems was the most frequently reported adverse event in the bionic pancreas group. The number of mild hypoglycemia events and frequency of severe hypoglycemia were not different in the two groups.

“The results of this study will bring hope to patients, families and providers that there are technologies being created to help ease the burden of diabetes management and keep glucose levels more stable,” said Kimberly Boucher, M.S.H.S., B.S.N., R.N., clinical research manager of Endocrinology at Children’s National.

The study is one of several pivotal trials funded by NIDDK to advance artificial pancreas technology and look at factors including safety, efficacy, user-friendliness, physical and emotional health of participants, and cost. To date, these trials have provided the important safety and efficacy data needed for regulatory review and licensure to make the technology commercially available. The Jaeb Center for Health Research in Tampa, Florida, served as coordinating center.

Funding for the study was provided by NIDDK grant 1UC4DK108612 to Boston University, by an Investigator-Initiated Study award from Novo Nordisk, and by Beta Bionics, Inc., which also provided the experimental bionic pancreas devices used in the study. Insulin and some supplies were donated by Novo Nordisk, Eli Lilly, Dexcom and Ascensia Diabetes Care. Partial support for the development of the experimental bionic pancreas device was provided by NIDDK SBIR grant 1R44DK120234 to Beta Bionics, Inc.

You can read the full study, Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes, in the New England Journal of Medicine.

iLet-Bionic-Pancreas

Children’s National to test bionic pancreas

iLet-Bionic-Pancreas

The iLet bionic pancreas helps patients manage their diabetes by both monitoring blood glucose levels and administering insulin and glucagon.

The final results of this clinical trial were published on September 29, 2022 in the New England Journal of Medicine.

Children’s National Hospital has been selected to participate in a multi-center clinical trial to test the efficacy of the iLet bionic pancreas — a device that automatically regulates blood sugar levels in patients with Type 1 diabetes.

Patients generally manage diabetes by constantly monitoring their blood sugar levels and administering insulin when necessary. Unfortunately, too much insulin can cause hypoglycemia, or low blood sugar, which can result in hypoglycemic seizures, coma or rarely, death. Thus, it is extremely important for people with diabetes to regulate their insulin dosages and maintain their blood sugar levels within a range decided by the family and diabetes team.

“The burden of caring for diabetes on a daily basis is grueling,” says Seema Meighan, FNP, a nurse practitioner involved in the upcoming clinical trial. “It is by far one of the most challenging chronic diseases to manage, and requires vigilant participation 100 percent of the time to stay well controlled.”

The iLet bionic pancreas helps patients manage their diabetes by both monitoring blood glucose levels and administering insulin and glucagon — a pancreatic hormone that raises blood sugar levels.

“In a traditional infusion pump, patients only have access to insulin to control glucose levels,” explains Meighan. “This can become problematic when it comes to hypoglycemia. The hope with a bi-hormonal system is that glucagon can be delivered during times that the glucose is low in order to stabilize levels without user interaction.”

Developed at Boston University by Edward Damiano, Ph.D., and Firas El-Khatib, Ph.D., the iLet is a hand-held device about the size of an iPhone but twice as thick, and can easily fit into a pocket. The unit consists of a dual chamber infusion pump that can be configured to deliver only insulin, only glucagon or both hormones. The device uses a wireless glucose sensor on the patient’s body to test blood sugar levels every five minutes. It then determines which hormone is needed and administers it via catheters connected to the patient.

In short-term studies, the iLet was able to maintain blood glucose levels close to normal in both adults and children in carefully controlled environments.

In 2016, the Children’s National Hospital Division of Endocrinology and Diabetes, led by diabetologist Fran Cogen, M.D., C.D.C.E.S., was one of several pediatric sites that were selected to participate in pivotal clinical trials to further test the efficacy of the bionic pancreas. In June 2020, the team at Children’s National began enrolling patients to test iLet devices that only deliver insulin. Once these initial studies are completed, the team will perform an additional trial to test iLet devices configured to deliver both insulin and glucagon.

“This trial is important as it represents the first dual chamber pump to manage glucose levels,” says Meighan. “It could potentially change the way we treat diabetes entirely. It represents a hope to our patients and families that one day this disease will have far less of a daily burden than it currently does.”

Currently, there are 18 patients enrolled in the clinical trial. An initial test run on two patients was successfully completed in November 2020. In early January 2021, the first patient was started on the bionic pancreas to begin the randomized controlled study and three additional patients, who completed the screening process, will join the study shortly. The screening and initiation of the study will continue in the remaining patients.