Tag Archive for: continuous glucose monitor

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.

insulin pump

Diabetes technology use in the cystic fibrosis community

insulin pump

Although diabetes technologies are associated with improvements in glycemic control and health-related quality of life among people with type 1 diabetes (T1D), the use and perceptions of continuous glucose monitors (CGM) and insulin pumps within the cystic fibrosis (CF) community have not been well documented.

In a recent study published in Diabetes Technology & Therapeutics, Brynn Marks, M.D., MS-HPEd, and co-authors, found that compared to T1D, rates of sustained diabetes technology use in the cystic fibrosis-related diabetes (CFRD) community are low, despite perceived benefits. The authors conclude that better insurance coverage to mitigate cost, better patient education and confirmation that these technologies improve health and patient-reported outcomes may increase uptake.

Read the full article in Diabetes Technology & Therapeutics.

Brynn Marks

Bringing diabetes technology to patients and providers

Brynn Marks

Brynn Marks, M.D., endocrinologist at Children’s National Hospital, was diagnosed with Type 1 diabetes at the age of five years old and knows too well the struggles that may come with managing this chronic condition. After finding the right, knowledgeable provider as a teen, Dr. Marks realized that she wanted to become an endocrinologist and be that resource and support for others with Type 1.

Developments in diabetes technologies, including continuous glucose monitors (CGM) and insulin pumps, hold great promise for improving diabetes control while also improving quality of life for those living with Type 1. However, the pace of development also presents challenges for busy clinicians who must keep up with rapid developments in the field. Dr. Marks is focused on making sure patients and providers have the latest information and training on diabetes technologies with the goal that they can be more effectively used by more people in the real world.

“These diabetes technologies are very important for kids and teens with diabetes because they can help them to live life as normally as possible while affording the freedom they need to just be kids,” says Dr. Marks.

Dr. Marks’ recent research includes a study where she used an app to deliver medical education about diabetes technology. Participants received authentic, case-based scenarios focused on the technologies to help them apply knowledge of these technologies to real-world clinical scenarios involving insulin pumps and CGMs. All of the education was delivered through questions and explanations in an effort to keep the learners engaged with the curriculum. The questions were repeated over 3-4 months to improve learning and long-term knowledge retention. The study showed that knowledge and confidence about these technologies improved and ultimately led to better patient care.

Dr. Marks presented two posters at a recent International Society for Pediatric and Adolescent Diabetes (ISPAD) meeting related to her efforts to make these technologies more accessible:

Experiential Learning in T1D Technology Education: Knowledge of Parents and Clinicians: Dr. Marks enrolled different groups of learners in the diabetes technology curriculum mentioned above, including parents of children with Type 1 diabetes, attending physicians, pediatric endocrine fellows and certified diabetes educators. Results showed minimal difference among those groups in terms of knowledge about the pumps and CGMs. Interestingly, clinicians who had the opportunity to wear the technologies for educational purposes had greater knowledge than clinicians who did not have the same opportunity. Based on these results, Dr. Marks advocated that opportunities to wear pumps and CGMs should be a routine part of education for clinicians working with these technologies.

A Qualitative Analysis of Clinicians’ Experiences Wearing CGM: Dr. Marks explored the reactions of clinicians without diabetes who were given the opportunity to wear continuous glucose monitors for 1 week. Participants reported that the opportunity to wear these technologies improved their knowledge and gave them greater empathy for patients using CGM.

Dr. Marks’ work to date has identified strategies to improve knowledge about insulin pumps and CGM. Moving forward, she will continue to study the best ways to educate parents and clinicians about these diabetes technologies in hopes of improving the day to day lives of the children they care for.