Breaking News
February 15, 2019 - Genetic variations in a fourth gene associated with higher ALL risk in Hispanic children
February 15, 2019 - Disruptive behavioral problems in kindergarten linked with lower employment earnings in adulthood
February 15, 2019 - New bioengineered device enhances the production of T-cells
February 15, 2019 - HDL proteome behaves like a tiny Velcro ball that is rolling on surfaces
February 15, 2019 - Puerto Rican children more likely to have poor or decreasing use of asthma inhalers
February 15, 2019 - Quality of patient care does not improve after physician-hospital integration
February 15, 2019 - Synopsys release new software for implant design and patient-specific planning
February 15, 2019 - 6 out of 10 hip replacements last 25 years or longer
February 15, 2019 - Health Tip: What You Should Know About Antibiotics
February 15, 2019 - New research challenges medical consensus that adenoids and tonsils significantly shrink during teenage years
February 15, 2019 - Discovery of weakness in a rare cancer could be exploited with drugs
February 15, 2019 - UVA scientists find potential explanation for mysterious cell death in Alzheimer’s, Parkinson’s
February 15, 2019 - New rules requiring female athletes to lower testosterone levels are based on flawed data
February 15, 2019 - Researchers comprehensively sequence the human immune system
February 15, 2019 - Researchers study animal venoms to identify new medicines for treating diseases
February 15, 2019 - Movement of wrist bones revealed by MRI and computer modeling
February 15, 2019 - Philips introduces new premium digital X-ray room to help shorten patient wait times
February 15, 2019 - Women fare worse than men following aortic heart surgery, study finds
February 15, 2019 - High-protein and low-calorie diet helps older adults lose weight safely, shows study
February 15, 2019 - Drug microdosing effects may not measure up to big expectations
February 15, 2019 - Discharged, Dismissed: ERs Often Miss Chance To Set Overdose Survivors On ‘Better Path’
February 15, 2019 - A digitized lab environment to be showcased at smartLAB 2019
February 15, 2019 - Scientists uncover main mechanisms of fluconazole drug resistance
February 15, 2019 - New study seeks to understand how colibactin causes cancer
February 15, 2019 - Photoacoustic imaging accurately measures the temperature of deep tissues
February 15, 2019 - Large study finds no association between phthalate exposure and breast cancer risk
February 15, 2019 - New research explains presence of ‘natural’ magnetism in human cells
February 15, 2019 - Bio-Rad launches new digital PCR system and kit for monitoring treatment response in CML patients
February 15, 2019 - Scientists shed light on damaging cell effects linked to aging
February 15, 2019 - High intensity exercise may improve health by increasing gut microbiota diversity
February 15, 2019 - Apellis’ APL-2 Receives Orphan Drug Designation from the FDA for the Treatment of Autoimmune Hemolytic Anemia
February 15, 2019 - Couples creating art or playing board games release ‘love hormone’
February 15, 2019 - Glimpsing The Future At Gargantuan Health Tech Showcase
February 15, 2019 - Common herbicide found to increase the risk of lymphoma
February 15, 2019 - Over-abundance of energy to cells could increase cancer risk
February 15, 2019 - Oxford Genetics appoints Jocelyne Bath as new Chief Operating Officer
February 15, 2019 - Castration-resistant metastatic prostate cancer responds to combination of immune checkpoint inhibitors
February 15, 2019 - Large-scale clinical trial begins to study liver transplantation between people with HIV
February 15, 2019 - Cannabis use among adolescents linked with increased risk of depression in adulthood
February 15, 2019 - Fractures, head injuries common in electric scooter accidents, UCLA study finds
February 15, 2019 - Prenatal maternal depression has important consequences for infant temperament, study shows
February 15, 2019 - Stereotactic body radiotherapy effective in treating men with low- or intermediate-risk prostate cancer
February 15, 2019 - Zogenix Submits New Drug Application to U.S. Food & Drug Administration for Fintepla for the Treatment of Dravet Syndrome
February 15, 2019 - Certain birthmarks warrant quick treatment, pediatricians say
February 15, 2019 - New machine learning method predicts if atypical ductal hyperplasia will turn cancerous
February 15, 2019 - Whole-genome sequencing and sharing real-time data could limit spread of foodborne bacteria
February 15, 2019 - FDA warns doctor for illegally marketing unapproved implantable device
February 15, 2019 - New injury documentation tool may provide better evidence for elder abuse cases
February 15, 2019 - Physiological age is a better predictor of survival than chronological age, shows study
February 15, 2019 - New study reveals high success rate for hip and knee replacements
February 15, 2019 - Prenatal exposures to BPA may pose threat to human ovarian function
February 15, 2019 - Suspicious spots on the lungs of children with rhabdomyosarcoma do not behave like metastases
February 15, 2019 - Diet drinks daily could raise stroke risk says study
February 15, 2019 - Many Systematic Reviews Do Not Fully Report Adverse Events
February 15, 2019 - Seven tips to protect your child from burns
February 15, 2019 - Keynote speakers announced for CBD Expo MIDWEST
February 15, 2019 - New DNA methylation GrimAge tool allows you to predict lifespan and healthspan
February 15, 2019 - New AI-driven platform analyze how pathogens infect human cells
February 15, 2019 - Increased activity of EHMT2 gene deficient neurons could cause autism in humans
February 15, 2019 - Recurring UTIs may mask symptoms of bladder or kidney cancer
February 15, 2019 - Researchers conduct extensive comparison of drugs used in treating neuroendocrine tumors
February 15, 2019 - Depression prevention for pregnant women and new mothers – new recommendations
February 15, 2019 - AHA News: Are There Health Benefits From Chocolate?
February 15, 2019 - The involvement of the gut in Parkinson’s disease: hype or hope?
February 15, 2019 - New PET imaging agent may help measure efficacy or failure of hormone therapy for breast cancer
February 15, 2019 - Preventing infections could help combat antimicrobial resistance
February 15, 2019 - Study investigates the role of estrogen in controlling glucose homeostasis
February 15, 2019 - Exposure to chemical in weedkiller Roundup raises risk of some cancers, study finds
February 15, 2019 - Smoking and drinking during pregnancy – stigma drives women to secrecy
February 15, 2019 - Low FODMAP diet reduces stomach issues caused by exercise
February 15, 2019 - Novel approach uses small amounts of tissue to quantify PD-L1 expression levels in tumors
February 15, 2019 - Breast pumps could be transmitting asthma-causing bacteria in babies, finds study
February 15, 2019 - The Pistoia Alliance Launches Next Phase of Blockchain Project to Develop Life Science R&D Use Cases
February 15, 2019 - The search for environmental causes of Parkinson’s disease moves forward
February 15, 2019 - Women scientists inhibited by funding methods that favor men, researchers say
February 14, 2019 - Few primary care physicians lack enough knowledge of cancer treatment options
February 14, 2019 - Prime real estate is determined by previous owner in the squirrel world
February 14, 2019 - Discovery of a ‘master switch’ within the immune system
February 14, 2019 - Health officers with surgical training are a safe alternative for performing C-sections
February 14, 2019 - Researchers discover mechanism on how body’s antimicrobial shield regulates microbiome
Islet transplantation improves quality of life for people with hard-to-control type 1 diabetes

Islet transplantation improves quality of life for people with hard-to-control type 1 diabetes

image_pdfDownload PDFimage_print

News Release

Wednesday, March 21, 2018

NIH-funded study finds consistent, dramatic improvements among clinical trial participants.

Quality of life for people with type 1 diabetes who had frequent severe hypoglycemia — a potentially fatal low blood glucose (blood sugar) level — improved consistently and dramatically following transplantation of insulin-producing pancreatic islets, according to findings published online March 21 in Diabetes Care. The results come from a Phase 3 clinical trial funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), both part of the National Institutes of Health.

The greatest improvements were seen in diabetes-related quality of life. Islet recipients also reported better overall health status after transplant, despite the need for lifelong treatment with immune-suppressing drugs to prevent transplant rejection. Researchers observed these improvements even among transplant recipients who still required insulin therapy to manage their diabetes.

The trial enrolled 48 people with type 1 diabetes who had hypoglycemia unawareness — an impaired ability to sense drops in blood glucose levels — and experienced frequent episodes of severe hypoglycemia despite receiving expert care.

Previously reported clinical outcomes from the trial showed that islet transplantation prevents severe hypoglycemia and improves blood glucose awareness and control. The study was conducted by the NIH-funded Clinical Islet Transplantation Consortium.

“Although insulin therapy is life-saving, type 1 diabetes remains an extremely challenging condition to manage,” said NIAID Director Anthony S. Fauci, M.D. “For people unable to safely control type 1 diabetes despite optimal medical management, islet transplantation offers hope for improving not only physical health but also overall quality of life.”

Pancreatic islets release the hormone insulin, which helps control blood glucose levels. In type 1 diabetes, the body’s immune system attacks and destroys the insulin-producing cells in islets. People with the disease must take insulin to live, but insulin injections or pumps cannot control blood glucose levels as precisely as insulin released naturally from the pancreas. Even with diligent monitoring, blood glucose can often reach levels that are higher or lower than normal.

A low blood glucose level, or hypoglycemia, typically is accompanied by tremors, sweating, nausea and/or heart palpitations. These symptoms prompt the person to eat or drink to raise their blood glucose. However, some people do not experience these early warning signs. This impaired awareness of hypoglycemia raises the risk of potentially life-threatening severe hypoglycemic events, during which the person is unable to treat himself or herself. These episodes can lead to accidents, injuries, coma and death.

“People with type 1 diabetes who are at high risk for hypoglycemic events have to practice caution every moment, even while sleeping. It is an exhausting endeavor that—like the events themselves—can keep them from living full lives,” said NIDDK Director Griffin P. Rodgers, M.D. “Although islet transplantation remains experimental, we are very encouraged by these findings, as we are by the rapid improvements in other treatments to help people with type 1 diabetes monitor and manage their blood glucose, including artificial pancreas technology.”

All 48 study participants received at least one islet transplant. One year after their first transplant, 42 participants (88 percent) were free of severe hypoglycemic events, had established near-normal blood glucose control, and had restored awareness of hypoglycemia. Only a small number of functional insulin-producing cells are necessary to restore hypoglycemic awareness, but this amount may not be sufficient to fully regulate a person’s blood glucose levels. Approximately half of the transplant recipients needed to continue taking insulin to control their blood glucose levels. 

The study design incorporated four well-established, commercially available quality-of-life surveys that were given to participants repeatedly before and after islet transplantation. Two of the surveys were specific for diabetes, while two assessed health more generally.

“This study was very rigorous both in terms of the number of measures used to assess quality of life and the number of evaluations performed,” said paper co-author Nancy D. Bridges, M.D., chief of the Transplantation Branch at NIAID. “Islet transplant recipients not only reported a decrease in concerns and fears related to their diabetes, but also felt better overall, despite the need to take daily immunosuppressive drugs to prevent transplant rejection.”

Reported improvements in quality of life were similar among islet recipients who still needed to take insulin to manage their diabetes and those who did not. The researchers concluded that elimination of severe hypoglycemia and the associated fears accounted for these improvements, appearing to outweigh concerns about the need to continue insulin injections.

Islet transplantation is an investigational therapy in the United States. While promising for people whose type 1 diabetes cannot be controlled with standard treatments, the procedure is not appropriate for most people with type 1 diabetes, as there are risks associated with the transplant procedure, such as bleeding, as well as side effects of immunosuppressive medications, such as decreased kidney function and increased susceptibility to infections.

In the NIH-funded trial, investigators at eight study sites in North America used a standardized manufacturing protocol to prepare purified islets from the pancreases of deceased human donors. The study was designed, after discussions with the U.S. Food and Drug Administration, to provide evidence to support licensure of the manufactured islet product. NIAID, the regulatory sponsor of the study, has submitted final reports and clinical trial data to FDA, laying the groundwork for individual universities and companies to submit biologics license applications for the manufacture of purified human pancreatic islets.

For more information about the study, see ClinicalTrials.gov using identifier NCT00434811. The study was funded by NIAID and NIDDK, both components of NIH, under grant numbers U01AI089317, U01AI089316, U01AI065191, U01DK085531, U01DK070431, U01DK070431, U01DK070460, U01AI065193, U01DK070430 and U01AI065192. The work was partially supported by the National Center for Advancing Translational Sciences, NIH, under grant numbers UL1TR000454, UL1RR025741, UL1TR000150, UL1TR000004, UL1TR000050, UL1TR000460, M01RR000400, UL1TR000114, M01RR00040 and UL1TR000003.

NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

The NIDDK, part of the NIH, conducts and supports basic and clinical research and research training on some of the most common, severe, and disabling conditions affecting Americans. The Institute’s research interests include: diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic, and hematologic diseases. For more information, visit www.niddk.nih.gov.

About the National Institutes of Health (NIH):
NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH…Turning Discovery Into Health®

###

Tagged with:

About author

Related Articles