Breaking News
July 21, 2018 - Genome research suggests presence of enteric fever in medieval Europe
July 21, 2018 - Risk of Sensory Deficits Drops With Rising Gestational Age
July 21, 2018 - Mum’s sleep matters—the effect of sleep on an unborn baby
July 21, 2018 - UC San Diego researchers awarded two grants for investigating stem cell-based therapies
July 21, 2018 - Cellular ‘garbage disposal’ may actually work on some of the proteins to neuronal development
July 21, 2018 - More Pregnant Women Having Heart Attacks
July 21, 2018 - Acne Breakouts | NIH News in Health
July 21, 2018 - Change health messaging to focus on potential impact to help stop the next pandemic
July 21, 2018 - Frailty associated with poor survival rates in young heart patients
July 21, 2018 - New discovery could save millions of lives from fatal fungal infections
July 21, 2018 - OBD presents latest data on the use of EpiSwitch™ in predicting patient response to immunotherapy and identifying lymphoma subtypes
July 21, 2018 - Childhood adversity increases susceptibility to addiction via immune response
July 21, 2018 - Scientists identify potential target for the treatment of binge eating
July 21, 2018 - Whole-brain LIPUS therapy improves cognitive dysfunction in mice simulating dementia, Alzheimer’s
July 21, 2018 - Digital media use raising risk of ADHD symptoms among the young
July 21, 2018 - Phase 3 study of tanezumab in patients with osteoarthritis pain meets all three co-primary endpoints
July 21, 2018 - Restoring mitochondrial function to reverse aging-related skin wrinkles, hair loss in mice
July 21, 2018 - SP PennTech introduces RW-500 rotary vial washer for biotech, pharmaceutical applications
July 21, 2018 - Researchers to study molecular mechanisms behind susceptibility of males to autism
July 21, 2018 - Fourth Published Clinical Trial Confirms Long-Term Safety of Niagen Supplementation at High Doses and Shows Potential for Improvement in Liver Health
July 21, 2018 - Greening vacant urban land reduces feelings of depression for surrounding residents
July 21, 2018 - Parents say intense gun violence in PG-13 movies appropriate for teens 15 and older
July 21, 2018 - Collaborative study to assess effects of exercise training for cognitive deficits in MS
July 21, 2018 - FAU researchers find possible cause of Parkinson’s disease in the patients’ immune system
July 21, 2018 - Protective qualities of ‘good cholesterol’ reduce after menopause
July 21, 2018 - Researchers develop new way to uncover hidden breast cancer tumors
July 21, 2018 - FDA approves first drug for treatment of adult AML patients with specific genetic mutation
July 21, 2018 - Top AI companies join hands to discover novel drugs for DMD
July 21, 2018 - Ferring announces FDA approval of ZOMACTON for injection in four new pediatric indications
July 20, 2018 - Researchers design proteins that can self-assemble into complex structures
July 20, 2018 - AVITA Medical expands management team to support launch of RECELL device to treat burns
July 20, 2018 - FDA Approves Tibsovo (ivosidenib) for Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation
July 20, 2018 - Developmental screening and surveillance rates remain low, new study suggests
July 20, 2018 - TGen opens tissue donation portal to advance DIPG research
July 20, 2018 - Health impact of highly processed summertime staples
July 20, 2018 - Exergaming can improve health in overweight and obese children, study shows
July 20, 2018 - Postmenopausal factors may impact heart-protective qualities of ‘good cholesterol’
July 20, 2018 - MRI and blood test combination results in improved prostate cancer diagnosis
July 20, 2018 - Update Health Professional and Consumer on Recent Recalled Products
July 20, 2018 - Researchers trace Parkinson’s damage in the heart
July 20, 2018 - Wearable device designed to measure cortisol in sweat
July 20, 2018 - Scientists demonstrate a new regulation mechanism for skeletal muscles
July 20, 2018 - Exposure to mobile phone radiation may negatively impact memory performance in adolescents
July 20, 2018 - SUSU scientists find alternative method to treat post-traumatic stress disorder syndrome
July 20, 2018 - Gestational diabetes may increase offspring’s heart disease risk
July 20, 2018 - New vaccine could protect unborn babies from Zika virus
July 20, 2018 - Researchers find high mercury and methylmercury concentrations in traditional Tibetan medicine
July 20, 2018 - Brief Safety Plan Intervention in ER Can Cut Suicidal Behavior
July 20, 2018 - The Mount Sinai Hospital receives accreditation as geriatric emergency department
July 20, 2018 - Toward a better understanding of Parkinson’s disease
July 20, 2018 - Med school communications office wins four national awards | News Center
July 20, 2018 - Professional baseball players with faster hand-eye coordination may have better batting performance
July 20, 2018 - Study looks into mechanisms that control sleep and wakefulness
July 20, 2018 - Scientists identify melanoma biomarkers that could help tailor immunotherapy treatments
July 20, 2018 - Research reveals long-term efficacy of drug used to treat common cause of kidney failure
July 20, 2018 - Timing of dinner associated with breast and prostate cancer risks
July 20, 2018 - Health Tip: Performing the Heimlich Maneuver
July 20, 2018 - Nearly all adolescents have eating, activity or weight-related issues
July 20, 2018 - Sage launches new web-based tool that helps explore curated genomic analyses of Alzheimer’s
July 20, 2018 - High-performance porous polymeric material for chromatography applications
July 20, 2018 - New molecule shows great promise for future treatment of many cancers
July 20, 2018 - New research project investigates alternative treatments for eye infections
July 20, 2018 - Immune T cells are built to react as fast as possible, shows study
July 20, 2018 - ZHX2 protein could offer a new treatment strategy for kidney cancer
July 20, 2018 - EKF’s Quo-Lab POC HbA1c analyzer meets international quality targets for diabetes testing
July 20, 2018 - Health burdens of very high risk drinking are potentially large, study reveals
July 20, 2018 - Using miniature drug-filled nanocarriers to target headaches and tumors
July 20, 2018 - Researchers uncover cause for progression of prostate cancer to incurable stage
July 20, 2018 - Studies highlight issues regarding black lung, opioid overdose, police violence and more
July 20, 2018 - AbbVie submits supplemental NDA to FDA for venetoclax to treat acute myeloid leukemia
July 20, 2018 - Researchers are one step closer to developing eye drops to treat age-related macular degeneration (AMD)
July 20, 2018 - Patients maintain muscle mass five years after surgically induced weight loss
July 20, 2018 - AMSBIO introduces new, powerful CRISPR/Cas9 gene editing kits
July 20, 2018 - PureTech Health collaborates with Roche to advance oral administration of antisense oligonucleotides
July 20, 2018 - Analysis reveals disparities in cancer death rates among minority groups
July 20, 2018 - Dr Maddy Parsons receives Royal Microscopical Society Life Science Medal
July 20, 2018 - Study finds link between DNA methylation and non-alcoholic fatty liver disease
July 20, 2018 - Military personnel with head trauma and football players with suspected CTE show similar brain changes
July 20, 2018 - Vidac Pharma Announces Initiation of Phase 2b Clinical Trial of VDA-1102 Ointment in Patients with Actinic Keratosis
July 20, 2018 - KKR is buying Envision Healthcare in a nearly $10B deal
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