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Multi-center Trial In Adult And Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System At Home

Multi-center Trial In Adult And Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System At Home

Home Clinical Trials Search Clinical Trials Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System at Home The purpose of this study is to evaluate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting. A diverse population of patients with type 1 diabetes will be studied. The study population will have a large range for duration of diabetes and glycemic control, as measured by glycosylated hemoglobin (A1C). They will be enrolled in the study regardless of their prior diabetes regimen, including using Multiple Daily Injections (MDI), Continuous Subcutaneous Insulin Infusion (CSII) or Sensor-Augmented Pump therapy (SAP) This is a 6 month, multi-center, randomized, parallel, adaptive study in type 1 diabetes with a 6 month continuation period. The study will have three periods: Run-in Period: The run-in period can be up to 60 days during which time a blinded CGM sensor will be worn for two weeks. Study Period: There will be a 6 month randomized study period with two arms: The HCL system and Control. Continuation Period: There will be a 6 month continuation period during which time all subjects will use the HCL system with Auto Mode. Up to 1500 subjects will be enrolled in order to have 1120 subjects complete the study. Up to 70 investigational Centers in the US, Europe and Canada will be enrolled. Continue reading >>

Research - Atlanta Diabetes Associates

Research - Atlanta Diabetes Associates

Atlanta Diabetes Associates Clinical Research Our mission is to provide patients and sponsors with the highest quality of clinical research available today. We strive to deliver efficient and accurate research data and strictly adhere to protocol guidelines, while maintaining patient safety as our number one priority. Participate in current enrollment research. This iframe contains the logic required to handle Ajax powered Gravity Forms. Enlist Atlanta Diabetes Associates to conduct your study. This iframe contains the logic required to handle Ajax powered Gravity Forms. To test whether MYL-1501D product from Process VI once daily is non-inferior to MYL-1501D product from Process V once daily based on change in HbA1c when administered in combination with mealtime insulin lispro. This iframe contains the logic required to handle Ajax powered Gravity Forms. Change in average number of hypoglycemic events per patient between CGM use compared to BGM use This iframe contains the logic required to handle Ajax powered Gravity Forms. The primary outcome will be a treatment group comparison of the percentage of sensor values in the hypoglycemic range (<70 mg/dL), adjusted for the baseline values and factors used to stratify randomization in a regression model. Residual values will be examined for an approximate normal distribution. If values are highly skewed, then a transformation or non-parametric methods will be used instead. The BGM Group will be wearing a blinded CGM for one week at 3 time points in the study (in addition to baseline). For analysis, sensor data from the CGM Group will be used from these same time periods to match up with the blinded CGM placed for the BGM Group. The CGM data will be pooled across each time point of CGM data collection for the primary analy Continue reading >>

Retain Trial For Newly Diagnosed Type 1 Diabetes Enrolls Patients | Joslin Diabetes Center

Retain Trial For Newly Diagnosed Type 1 Diabetes Enrolls Patients | Joslin Diabetes Center

RETAIN Trial for Newly Diagnosed Type 1 Diabetes Enrolls Patients Immune Tolerance Network study will examine effect of anti-inflammatory drug BOSTON and SEATTLE March 2, 2011 The Immune Tolerance Network (ITN) has enrolled the first participant in a two-part, phase II clinical research trial evaluating the effect of intravenous alpha 1-antitrypsin (AAT) on preserving the function of insulin-producing cells in patients recently diagnosed with type 1 diabetes. ARALAST NP is one marketed formulation of AAT. The Research Trial of ARALAST NP in New-onset Type 1 Diabetes (RETAIN) is seeking 82 eligible participants at 15 clinical research centers across the U.S. The first participant was enrolled at Emory University/Childrens Hospital of Atlanta. The RETAIN trial is being conducted by the ITN, and supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and by the Juvenile Diabetes Research Foundation (JDRF). Additional funding for the study is provided by the Special Statutory Funding Program for Type 1 Diabetes Research, a special appropriation for research on the prevention and cure for type 1 diabetes. Baxter Healthcare Corporation is providing the ARALAST NP supply for the study. Type 1 diabetes is a chronic autoimmune disease. It develops when the T cells of the immune system mistakenly attack and destroy the bodys own insulin-producing beta cells in the pancreas. The body uses insulin to maintain normal levels of blood glucose. This is an exciting time for autoimmune disease researchparticularly in type 1 diabetes, said Gerald Nepom, M.D., director of the ITN. The ITNs mission is to conduct innovative, high impact studies in hopes of improving therapy and gaining a better understanding of the mec Continue reading >>

Type 1 Diabetes - Atlanta Ga

Type 1 Diabetes - Atlanta Ga

This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials . Do you or a loved one have type 1 diabetes but still struggle to manage your blood sugar? Do something about your type 1 diabetes by learning more about clinical research studies in your area. AcurianHealth is working with doctors in your area to connect people with type 1 diabetes to local clinical research studies. Depending on if you qualify for a study, you may receive: Free study-related diabetes medication, and in some cases, FDA-approved medication Free, confidential care from a local doctor who specializes in diabetes If you have type 1 diabetes, we'd like to share information about these studies. Please call toll free 1-877-237-6024 between 8AM and 12 Midnight, Monday through Saturday, Sunday 9AM and 2PM Eastern Time. Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials . 1998-2018 | All trademarks are property of their legal owners. | All Rights Reserved ClinicalConnection.com is a resource that provides information on clinical trials conducted worldwide. ClinicalConnection.com does not conduct or endorse clinical trials. Please consult your physician before participating. Continue reading >>

Georgia & Alabama Office Of The American Diabetes Association

Georgia & Alabama Office Of The American Diabetes Association

Life isn't fair for people with diabetes. First, there is the simple fact of coping with a chronic illness. Second, there are the barriers that prevent people with diabetes from enjoying the same opportunities at the rest of the population. Our Advocacy efforts work to bring down the barriers and fund critical diabetes research. Take action and become a Diabetes Advocate today ! Your involvement as an American Diabetes Association volunteerwhether on a local or national levelwill help improve lives of everyone impacted by diabetes, maybe even someone close to you. There are many ways for you to get involveda little time can have a big impact. Healthy Recipes: Delicious Recipe Kits Delivered - 2017-03-chefd.html We've teamed up with Chef'd to bring you healthy recipe kits. Ways to Give : Vacation for Donations - ways-to-give-201710-hotelscom.html Travel bookings completed through Hotels.com give 5% back to the Association. Shopdiabetes.org: Your Stress-Free System for Family Dinners! - 2017-03-book-oclock-scramble.html A year of delicious meals to help prevent and manage diabetes. Ask the Experts: Learn to Live Well with Diabetes - ask-the-experts.html Get answers during live Q&A with diabetes experts. Healthy Recipes: Build a Better Breakfast - 2017-01-breakfast-recipes.html Ensure a healthy start to your day with this guide. Podcast Series: In It Together celebrates the steps you take - in-it-together.html Continue reading >>

Atlanta Pediatric Research | Emory + Children's + Gt | Atlanta Pediatric Research Alliance

Atlanta Pediatric Research | Emory + Children's + Gt | Atlanta Pediatric Research Alliance

***For information on participating in any study, please contact Karen Lindsley*** TrialNet Pathway to Prevention: Pathway to Prevention screening is the first step for all TrialNet prevention studies. Screening is offered free to relatives of people with T1D to evaluate their personal risk of developing the disease. This unique screening can identify the early stages of T1D years before any symptoms appear. It also helps researchers learn more about how T1D develops and plan new studies exploring ways to prevent it. You qualify for free risk screening if you: are between the ages of 1 and 45 and have a parent, brother/sister, or child with T1D are between the ages of 1 and 20 and have an aunt/uncle, cousin, grandparent, niece/nephew, or half-brother/sister with T1D Type 1 Diabetes Prevention - Abatacept : TrialNet is testing the drug Abatacept to see if it can delay or prevent progression of early stage T1D (stage 1 to stage 2) and ultimately prevent clinical diagnosis (stage 3). In earlier studies for people newly diagnosed with Type 1, Abatacept helped slow down disease progression. You must have have tested positive for certain autoantibodies during TrialNet screening to qualify. Simponi (T1GER) : Combating -cell Loss in Type 1 Diabetes using an Investigational Study Drug Have received a Type 1 diabetes diagnosis within the last three months PLATE : a clotting investigation in Type 1 Diabetes observating the clotting abilities of T1D patients and how living with diabetes alters the blood's ability to clot Have received a Type 1 Diabetes diagnosis 2 or more years ago Not currently be on glucocorticoid therapy GUMP : aninvestigative study to better understand the pain-reducing aspects and efficacy of microneedles for the daily and routine administration of insulin in Continue reading >>

Type 1 Diabetes And Type 2 Diabetes Not The Only Diabetes, Study Says

Type 1 Diabetes And Type 2 Diabetes Not The Only Diabetes, Study Says

RELATED:Loneliness increases your risk of Type 2 diabetes, study suggests And in Type 2, the most common category of diabetes accounting for 90-95 percent of all cases, the bodys cells either stop responding to insulin or the beta cells cant produce enough of the hormone. People suffering from either type of the disease have blood sugar levels that can become too high. This condition is called hyperglycemia and can lead to kidney disease, heart disease and more if its not properly controlled or treated. But the characteristics of those suffering with Type 2 diabetes varied significantly, especially when it came to risk of diabetic kidney disease. RELATED:Scientists create first human-sheep hybrids what that means for the future of organ transplants The researchers proposed fiveclusters of the disease instead. Cluster 1 (6-15 percent of patients involved): Broadly the same as the Type 1 diabetes, Cluster 1 diabetes typically hits people when they are young and seemingly healthy. Its characterized by insulin deficiency and the presence of autoantibodies. Cluster 2 (9-20 percent): While these patients look similar to those in Cluster 1 in the beginning (healthy and young), this type of diabetes is not characterized by autoantibodies. Cluster 3 (11-17 percent): Those with Cluster 3 diabetes have are severely insulin-resistant, are generally overweight and and have a higher risk of kidney disease. Cluster 4 (18-23 percent): Most common in obese patients, Cluster 4 diabetes is associated with mild obesity-related factors. Cluster 5 (39-47 percent):Patients in this mild age-related diabetes cluster developed symptoms at significantly older ages than in other groups. This is the most common form of diabetes. RELATED: 4 bizarre ways people are trying to beat death and aging In Continue reading >>

Diabetes Care | Children's Healthcare Of Atlanta

Diabetes Care | Children's Healthcare Of Atlanta

Childrens Healthcare of Atlanta (CHOA) provides free access to certain materials and information, documentation, forms, questionnaires and diagrams relating to the study, prevention, and treatment of concussions via this website and its related pages, including without limitation, for your reference or download (collectively, the Concussion Program Materials) as described in this License agreement (Agreement). By accessing the Concussion Program Materials, you accept and agree to the terms and conditions of this Agreement. 1. Right to Access and Use. CHOA hereby provides you a fully-paid, nontransferable, nonexclusive, personal right and license to access, download, or otherwise use any Concussion Program Materials solely for the following purposes: (i) if you are accessing the materials as a parent, you may use the Concussion Program Materials for your personal, non-commercial use to educate yourself and your family on concussion prevention and treatment for a child; (ii) if you are accessing the materials as an athletics coach or on behalf of a school organization, you may use the Concussion Program Materials to promote concussion safety to your staff, students and athletes and to create appropriate concussion management procedures; and (iii) if you are a healthcare provider, you may use the Concussion Program Materials for your personal, professional development to enhance your medical knowledge in the field of concussions. You acknowledge the Concussion Program Materials are not to be used as definitive diagnostic tools with any specific patient and your independent medical judgment will be used to treat any patient. You must maintain all CHOA proprietary notices on the Concussion Program Materials. You may not copy, modify, adapt, reverse engineer or create deriva Continue reading >>

The Environmental Determinants Of Diabetes In The Young (teddy) Web Site

The Environmental Determinants Of Diabetes In The Young (teddy) Web Site

Finding diabetes early can prevent serious illness and complications Most of the new cases of type 1 diabetes occur in children who have no family history of the disease. Type 1 diabetes is one of the most common and serious long-term diseases in children. It is a disease where the body's immune system attacks the cells that make insulin. Insulin helps sugar (glucose) get into your cells so it can be used as energy. Children with type 1 diabetes must take insulin several times a day to stay alive and healthy. Right now, there is no cure for type 1 diabetes. T1D is a serious disease affecting 1 out of every 300 (1/300) children in the United States. T1D occurs when special cells in the pancreas, called beta cells, are destroyed by the body's own immune system. When the beta cells are destroyed, the body can no longer make insulin. Insulin is needed to keep blood sugar levels normal. If there is no insulin, your body can't use the sugars from the food you eat, causing serious illness or even death. A child with T1D must take insulin shots or use an insulin pump every day to stay well. Insulin has to be taken every day for the rest of the life of a child with diabetes. Continue reading >>

Sotagliflozin In Combination With Optimized Insulin Therapy In Adults With Type 1diabetes: The North American Intandem1 Study.

Sotagliflozin In Combination With Optimized Insulin Therapy In Adults With Type 1diabetes: The North American Intandem1 Study.

1. Diabetes Care. 2018 Sep;41(9):1970-1980. doi: 10.2337/dc18-0343. Epub 2018 Jun24. Sotagliflozin in Combination With Optimized Insulin Therapy in Adults With Type 1Diabetes: The North American inTandem1 Study. Buse JB(1), Garg SK(2), Rosenstock J(3), Bailey TS(4), Banks P(5), Bode BW(6),Danne T(7), Kushner JA(8), Lane WS(9), Lapuerta P(5), McGuire DK(10), PetersAL(11), Reed J(12), Sawhney S(5), Strumph P(5). (1)Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC [email protected] (2)Departments of Medicine and Pediatrics, Barbara Davis Center for Diabetes, University of Colorado Denver, Aurora, CO. (3)Dallas Diabetes Research Center at Medical City, Dallas, TX. (5)Lexicon Pharmaceuticals, Inc., The Woodlands, TX. (6)Atlanta Diabetes Associates, Emory University School of Medicine, Atlanta, GA. (7)Department of Diabetes, Endocrinology, and Clinical Research, Children's and Youth Hospital Auf der Bult, Hannover Medical School, Hannover, Germany. (8)McNair Medical Institute and Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, TX. (9)Mountain Diabetes and Endocrine Center, Asheville, NC. (10)Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX. (11)Keck School of Medicine of the University of Southern California, Los Angeles, CA. (12)Endocrine Research Solutions, Inc., Roswell, GA. OBJECTIVE: Evaluate the efficacy and safety of the dual sodium-glucosecotransporter 1 (SGLT1) and SGLT2 inhibitor sotagliflozin in combination withoptimized insulin in type 1 diabetes (T1D).RESEARCH DESIGN AND METHODS: The inTandem1 trial, a double-blind, 52-week phase 3trial, randomized North American adults with T1D to placebo (n = 268),sotagliflozin 200 mg (n = 263), or Continue reading >>

Research

Research

Home Division of Endocrinology, Metabolism and Lipids Emory University's Division of Endocrinology, Metabolism and Lipids faculty are heavily involved in basic and clinical research in a variety of areas. Division residents and fellows are strongly encouraged to participate in ongoing basic and clinical research projects. Osteoporosis, Bone biology and Vitamin D metabolism The Division of Endocrinology, Metabolism and Lipids has a very strong group of researchers in basic and clinical/translational bone biology. The group is led by Dr. Roberto Pacifici who is an expert in post-menopausal osteoporosis and osteoimmunology. Dr. Weitzmann has interests in T and B cell biology and HIV in bone pathophysiology. Dr. Beck and Tangpricha studies phosphate and vitamin D metabolism, respectively. Dr. Alvarez investigates the interaction between nutrition, diabetes and body composition. Dr. Nanes is an expert in TNF induced bone loss. Diabetes, Gene Therapy, and Fuel Metabolism The Emory Division of Endocrinology, Metabolism and Lipids has several ongoing patient-oriented clinical studies in the area of diabetes and metabolism.A major area of interest involves studies to determine mechanisms underlying the metabolic decompensation in minority populations with a history of hyperglycemic crises.The division of endocrinology serves as the coordinating center for several investigator-initiated research trials in inpatient diabetes care and in the management of elderly patients in long-term care facilities. In addition, members of the division at Grady Hospital and VA Medical Centers serve as principal investigators in several NIH and American diabetes Association multi-center trials in the area of diabetes and metabolism. Although most of the current research in diabetes and metabolism Continue reading >>

Breakthroughs In Type 1 Diabetes At Emory University

Breakthroughs In Type 1 Diabetes At Emory University

Breakthroughs in Type 1 Diabetes at Emory University When the level of blood glucose, also called blood sugar, rises after a meal, the pancreas responds by releasing insulin into the bloodstream. Insulin helps cells throughout the body absorb glucose from the bloodstream and use it for energy. Diabetes develops when the pancreas does not make enough insulin, the body's cells do not use insulin effectively, or both. As a result, glucose builds up in the blood instead of being absorbed by cells in the body. In type 1 diabetes , the beta cells of the pancreas no longer make insulin because the body's immune system has attacked and destroyed them. The immune system protects people from infection by identifying and destroying bacteria, viruses, and other potentially harmful foreign substances. A person who has type 1 diabetes must take insulin daily to live. Diabetes and Pancreatic Islet transplantation: Type 1 diabetes affects one in every 400 children and adolescents in the US. Pancreatic islets, also called islets of Langerhans, are tiny clusters of cells scattered throughout the pancreas. Pancreatic islets contain several types of cells, including beta cells, that produce the hormone insulin. Due to the limitations of exogenous insulin therapy and whole pancreas transplantation, pancreatic islet transplantation has emerged as a promising therapy for Type 1 Diabetes. Unsuccessful transplants can be attributed to several factors, researchers say. The current technique of injecting islets directly into the blood vessels in the liver causes approximately half of the cells to die due to exposure to blood clotting reactions. Also, the isletsmetabolically active cells that require significant blood flowhave problems hooking up to blood vessels once in the body and die off over Continue reading >>

Clinical Research - North Atlanta Endocrinology And Diabetes, Duluth And Lawrenceville

Clinical Research - North Atlanta Endocrinology And Diabetes, Duluth And Lawrenceville

in the office of North Atlanta Endocrinology & Diabetes, PC We have been performing studies, assisting in the testing and development of new diabetes medications for over 20 years. Some of the major advancements in diabetes therapy have been offered to and experienced by our patients, over the years. Physicians Research Associates, LLC, located in the NAED Lawrenceville office, is owned and operated by Dr. David Arkin , Dr. Ola Odugbesan , Dr. David Shore , Dr. Aparna Mahakala , Dr. Peter Lu and Dr. Ketan Goswami . They are assisted by two Research Coordinators Karla Wardell CRC, Research Manager and Carolyn Paulus CRC, CMA. All studies are conducted under the guidelines of Good Clinical Practices (GCPs), under Institutional Review Board (IRB) oversight, and according to the rules and regulations of the FDA. We are a dedicated multi-therapeutic research facility established to provide our patients cutting-edge therapies and access to leading research studies, while ensuring compassionate care for our volunteers. Clinical pharmacology research is the process whereby medications are tested and approved for use in the treatment of various medical conditions. All medications must pass through prolonged, rigorous testing prior to their approval for prescription use in the U.S. population by the Food and Drug Administration (FDA). In order to obtain such approval, pharmaceutical companies ask physicians to recruit willing patients with medical conditions that are expected to respond to new medications. Hence, clinical pharmacology research offers patients the opportunity to experience the effects of new drugs prior to their release to the general public. The trials conducted at Physicians Research Associates are Phase III trials, meaning, the medications have already been te Continue reading >>

Tuberculosis Vaccine May Reduce Type 1 Diabetes Risk, Type 2 Risk

Tuberculosis Vaccine May Reduce Type 1 Diabetes Risk, Type 2 Risk

3 Coroner: Head injury, cardiac arrest killed Pike Co. football player Those participating in the clinical trials (average disease duration of 19 years) were given the vaccine twice four weeks apart and then studied for about eight years following treatment. Regular monitoring throughout the eight-year study found that HbA1c levels of individuals receiving the vaccine dropped by more than 10 percent at the three-year mark and by more than 18 percent after four years of treatment. These levels reached near-normal figures five years after treatment. RELATED: Scientists may have found a way to reverse type 2 diabetes HbA1c refers to glycated hemoglobin, which develops when hemoglobin, the red blood cell protein that carries oxygen throughout the body, is combined with glucose in the blood. Participants treated with BCG were found to have an average HbA1c of 6.65 four years later. The threshold for diabetes diagnosis is close to an HbA1c of 6.5. "If they get vaccinated twice, there's a delay. But then, after about 3.5 years, their blood sugars come down, not to the total normal range, but near normal range," Faustman told ABC affiliate WCVB . RELATED:Loneliness increases your risk of Type 2 diabetes, study suggests Individuals in that near normal range have dramatically reduced risk of associated complications, such as renal disease, heart disease and blindness. The vaccine, according to the researchers, helps the body boost production of tumor necrosis factor, a hormone especially beneficial to Type 1 diabetics. In 2001, Faustman's team first reported that inducing TNF production may cure Type 1 diabetes in mice, but since TNF dosing is toxic in humans, clinical trials have utilized BCG for its ability to elevate TNF levels safely, Medical Xpress reported. RELATED: Men wi Continue reading >>

A Research Trial Of Aralast In New Onset Diabetes (retain) - Part I

A Research Trial Of Aralast In New Onset Diabetes (retain) - Part I

A Research Trial of Aralast in New Onset Diabetes (RETAIN) - Part I Gordon Weir | Joslin Diabetes Center | Boston, MA Terry Strom | Beth Israel Deconess | Boston, MA Atlanta Diabetes Association | Atlanta, GA Childrens Hospital of Atlanta | Atlanta, GA Childrens Mercy Hospital | Kansas City, MO Naomi Berrie Diabetes Center | New York, NY Nationwide Childrens Hospital | Columbus, OH Childrens Hospital of Pennsylvania | Philadelphia, PA Pacific Northwest Research Institute | Seattle, WA Control of the immune destruction of pancreatic cells is a critically important challenge for type 1 diabetes research. Strategies to control autoimmunity have focused on reducing or inhibiting autoreactive T cells, but it seems likely that control of inflammation will also be necessary for an optimal result. Alpha-1 antitrypsin (AAT) is a serine proteinase inhibitor found in high concentrations in serum, which has been found to inhibit a variety of proteolytic enzymes and also has anti-inflammatory properties that result from inhibition of cytokine production, complement activation, and immune cell infiltration.It has been used as a remarkably safe treatment for more than 20 years in patients with deficiency of AAT who have chronic obstructive pulmonary disease. AAT has been found to reverse new-onset diabetes in nonobese diabetes (NOD) mice and to induce a state of self-tolerance. It has also been found to inhibit the rejection of transplanted islets in mice. Because of its efficacy in preventing immune destruction of islets in rodent models of diabetes and its impressive safety record, we propose that AAT be used in a clinical trial for new-onset T1DM. Primary Objective: Determine whether Aralast NP (AAT) will slow the progression of the autoimmune destruction of cells and lead to the Continue reading >>

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