Nav: Home

Islet transplant effective to treat type 1 diabetes complicated by severe hypoglycemia

April 18, 2016

Chicago -Northwestern Medicine researchers are co-investigators in a breakthrough clinical trial that found transplanted human islets prevent hypoglycemic events and provide excellent glycemic control for patients with Type 1 diabetes with severe hypoglycemia. The results of the multi-center, single arm, phase III study are published in Diabetes Care on Monday, April 18. The research was funded by National Institute of Health (NIH) grants through the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute for Diabetes and Digestive and Kidney Disease (NIDDK).

Islet transplantation is an investigational therapy for individuals with Type 1 diabetes in which insulin-producing cells, or islets, from a donor pancreas are transplanted into another person. In patients with diabetes, the pancreas does not properly produce insulin. Using a minimally invasive radiologic technique, islet transplantation infuses working cells that can control blood glucose and possibly eliminate the need for insulin therapy. Islets begin to release insulin soon after transplantation with increased function occurring over time.

"Islet transplantation is heralding a new era of breakthrough therapies for Type 1 diabetes that isn't controlled by conventional treatments," said co-author Xunrong Luo, MD, PhD, director of the Islet Cell Transplantation Program at Northwestern Memorial Hospital and Associate Professor of Medicine and Surgery at Northwestern University Feinberg School of Medicine. "These results make a clear case for islet transplantation as a viable treatment option for individuals with Type 1 diabetes complicated by severe hypoglycemia. Our research found that transplanted islet cells provided glycemic control, restored hypoglycemia awareness and protection from severe hypoglycemic events."

Hypoglycemia, or abnormally low blood sugar (glucose), is often associated with exogenous insulin administration by diabetics. Glucose is the body's main source of energy and when its levels drop, individuals may experience symptoms ranging from confusion, irritability and dizziness to more severe complications such as seizures and unconsciousness. Diabetics who use insulin therapy to control glucose levels can develop a complication called impaired awareness of hypoglycemia (IHA) in which the ability to recognize the onset of low blood sugar becomes diminished or absent resulting in severe hypoglycemia. These severe hypoglycemic events (SHE) can cause accidents, injuries, coma and death.

Investigators at eight sites in North America, including Northwestern Memorial, enrolled 48 adults who had Type 1 diabetes for more than five years. They found that nearly 88 percent of the 48 subjects who received islet transplants were free of severe hypoglycemic events, had restored hypoglycemia awareness and had excellent glycemic control at one year. Researchers also reported subjects had an insulin independence rate of 52 percent at year one. At year two, 71 percent of subjects were free of severe hypoglycemic events, had restored hypoglycemia awareness and excellent glycemic control. No study-related deaths or disabilities occurred, with five enrollees experiencing transplant-related complications and two had infections attributed to immunosuppression. Researchers will do prolonged follow up on the enrollees to determine the long-term outcomes of islet transplant for Type 1 diabetes.

In addition to demonstrating clinical efficacy of human islet transplantation, this trial has generated a standardized good manufacturing practice process for human islet manufacturing, and has defined product release criteria and testing methods that can be adhered to by multiple transplant sites. The manufacturing and clinical data generated by this study can now be cross-referenced by individual transplant centers for the purpose of filing a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for purified human pancreatic islets.

"The next step for this compelling research is to seek FDA approval for islet transplantation as a standard of care therapy for Type 1 diabetes," said Luo. "The success of this license-enabling study symbolizes the importance and power of team-science in the modern era of research. When scientists and institutions work together, we're more successful in developing new therapies and propelling medicine forward."

Northwestern Medicine has been at forefront of islet transplantation playing a pivotal role in its development as an innovative therapy for Type 1 diabetes. Northwestern Memorial established the first islet transplant program in Illinois and remains one of most active programs in the country with more than 30 islet transplants to date. Very few islet transplants are performed in the United States at only a limited number of academic institutions.
-end-
For more information on Northwestern Medicine's Pancreas and Islet Cell Transplant program, visit: http://pancreas.nm.org/.

About Northwestern Medicine

To learn more about Northwestern Medicine, please visit: http://news.nm.org/about-northwestern-medicine.html.

Northwestern Memorial HealthCare

Related Diabetes Articles:

The role of vitamin A in diabetes
There has been no known link between diabetes and vitamin A -- until now.
Can continuous glucose monitoring improve diabetes control in patients with type 1 diabetes who inject insulin
Two studies in the Jan. 24/31 issue of JAMA find that use of a sensor implanted under the skin that continuously monitors glucose levels resulted in improved levels in patients with type 1 diabetes who inject insulin multiple times a day, compared to conventional treatment.
Complications of type 2 diabetes affect quality of life, care can lead to diabetes burnout
T2D Lifestyle, a national survey by Health Union of more than 400 individuals experiencing type 2 diabetes (T2D), reveals that patients not only struggle with commonly understood complications, but also numerous lesser known ones that people do not associate with diabetes.
Type 2 diabetes and obesity -- what do we really know?
Social and economic factors have led to a dramatic rise in type 2 diabetes and obesity around the world.
A better way to predict diabetes
An international team of researchers has discovered a simple, accurate new way to predict which women with gestational diabetes will develop type 2 diabetes after delivery.
The Lancet Diabetes & Endocrinology: Older Americans with diabetes living longer without disability, US study shows
Older Americans with diabetes born in the 1940s are living longer and with less disability performing day to day tasks than those born 10 years earlier, according to new research published in The Lancet Diabetes & Endocrinology journal.
Reverse your diabetes -- and you can stay diabetes-free long-term
A new study from Newcastle University, UK, has shown that people who reverse their diabetes and then keep their weight down remain free of diabetes.
New cause of diabetes
Although insulin-producing cells are found in the endocrine tissue of the pancreas, a new mouse study suggests that abnormalities in the exocrine tissue could cause cell non-autonomous effects that promotes diabetes-like symptoms.
The Lancet Diabetes & Endocrinology: Reducing sugar content in sugar-sweetened drinks by 40 percent over 5 years could prevent 1.5 million cases of overweight and obesity in the UK and 300,000 cases of diabetes
A new study published in The Lancet Diabetes & Endocrinology journal suggests that reducing sugar content in sugar sweetened drinks (including fruit juices) in the UK by 40 percent over five years, without replacing them with any artificial sweeteners, could prevent 500,000 cases of overweight and 1 million cases of obesity, in turn preventing around 300,000 cases of type 2 diabetes, over two decades.
Breastfeeding lowers risk of type 2 diabetes following gestational diabetes
Women with gestational diabetes who consistently and continuously breastfeed from the time of giving birth are half as likely to develop type 2 diabetes within two years after delivery, according to a study from Kaiser Permanente published today in Annals of Internal Medicine.

Related Diabetes Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Anthropomorphic
Do animals grieve? Do they have language or consciousness? For a long time, scientists resisted the urge to look for human qualities in animals. This hour, TED speakers explore how that is changing. Guests include biological anthropologist Barbara King, dolphin researcher Denise Herzing, primatologist Frans de Waal, and ecologist Carl Safina.
Now Playing: Science for the People

#SB2 2019 Science Birthday Minisode: Mary Golda Ross
Our second annual Science Birthday is here, and this year we celebrate the wonderful Mary Golda Ross, born 9 August 1908. She died in 2008 at age 99, but left a lasting mark on the science of rocketry and space exploration as an early woman in engineering, and one of the first Native Americans in engineering. Join Rachelle and Bethany for this very special birthday minisode celebrating Mary and her achievements. Thanks to our Patreons who make this show possible! Read more about Mary G. Ross: Interview with Mary Ross on Lash Publications International, by Laurel Sheppard Meet Mary Golda...