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DRC

U.S. FDA approves Medtronic’s ‘artificial pancreas’ for diabetes

Original article published by Yahoo! Finance. Click here to read the original article.

Medtronic Plc won U.S. approval on Wednesday for an “artificial pancreas” that is the first device to automatically deliver the right dose of insulin to patients with type 1 diabetes, freeing them from continually monitoring insulin levels throughout each day.

The U.S. Food and Drug Administration, in its approval of the device, the MiniMed 670G, hailed it as a breakthrough.

The device offers type 1 diabetics “greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin,” Dr. Jeffrey Shuren, director of the FDA’s medical device division, said in a statement.

Analysts said the FDA approved the device six months sooner than expected. However, it will not be available until the spring of 2017.

The MiniMed 670G is the first device that allows a glucose sensor to communicate with an insulin pump and automatically regulate the insulin flow. The device is approved for those aged 14 and older.

The device measures glucose levels every five minutes and automatically administers insulin as needed. Patients will still need to instruct the device to deliver extra insulin for meals and notify the device when they exercise – which lowers glucose levels.

About 1.25 million American children and adults have type 1 diabetes, a condition in which the pancreas produces little or no insulin – a hormone needed to obtain energy from food.

Patients take insulin injections at various times of the day. But blood sugar can drop to dangerously low levels if too much insulin circulates in the bloodstream, requiring patients to frequently or continually monitor their insulin levels throughout the entire day.

“This device will mean peace of mind, in knowing a person will be in normal blood sugar range a great majority of the time,” said Derek Rapp, chief executive officer of the Juvenile Diabetes Research Foundation, which has spent $116 million on research in the artificial pancreas field.

Rapp, who has a college-age son with type 1 diabetes, said his son as a child had to be awakened many times each evening so his finger could be pricked for a blood sample, to ensure his blood sugar level was in an acceptable range. If too low, his son would be given fruit juice or a snack. If too high, he would be given insulin.

“It is a major news event that a system of this kind has been approved – the first time a pump will administer insulin as a result of information it receives from a sensor,” Rapp said.

The Medtronic device includes a coin-size sensor with a protruding needle that is slipped under the skin and continually monitors glucose levels. It is held in place with a sticky backing. The other main component is an insulin pump, often worn on the side of the abdomen, which has tubes that lead to a catheter that delivers the insulin.

Insulin pumps are currently used by more than a third of U.S. patients with type 1 diabetes, but they require manual adjustment to administer the needed insulin dose. Many patients also wear sensors that continually monitor their glucose levels.

Several insulin pump makers, including Johnson & Johnson , Tandem Diabetes Care Inc and Insulet Corp , are teaming up with sensor maker Dexcom Inc to develop devices like Medtronic’s but are several years behind, according to Jefferies analyst Raj Denhoy.

He said the Medtronic system is a big step for patients, but the Holy Grail would be a completely automatic artificial pancreas that does not need any intervention, including for meals or exercise. Such a product is probably at least five years away from development, he said.

Although Medtronic has not announced a price for the MiniMed 670G, Denhoy estimated it may cost $5,000 to $8,000, with the annual cost of disposable sensors another few thousand dollars.

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Gladitood

Support a Cure for Type 1 Diabetes on Gladitood

Millions of children and adults struggle with type 1 diabetes (T1D). Throughout the month of October, we’ll be raising money to help find a cure on Gladitood, a crowdfunding platform that helps nonprofits raise funds for important causes. This is an exciting opportunity but we need your help

Consider Autumn, a woman in her mid-20s who was diagnosed at the age of nine. Every day she is carefully balancing her blood sugar through painfully pricking her fingers to manage her blood sugar. She’s been hospitalized for diabetic ketoacidosis, a condition where they body produces excess blood acid, which can quickly become fatal if not treated. Diabetes doesn’t just affect her, it affects her family, friends and co-workers too.

We need to raise $5,000 by the end of October.

How Can You Help?

Donate to Diabetes Research Connection on Gladitood. Donating to DRC through Gladitood is easy. Simply visit our campaign page, choose a donation level to the right that you’d like to contribute to, then follow the prompts to donate through Gladitood’s secure platform. In exchange for donating, you’ll be able to choose from a variety of “rewards,” ranging from a Facebook shout-out, to tickets to our Brews and Blood Sugar event, to a Q&A session with a T1D researcher. There is no minimum or maximum donation; donors can contribute as little or as much as they want, and all donations are tax-deductible as DRC is a 501(c)(3) nonprofit organization.

Spread the word about our Gladitood campaign! Whether you post about it on Facebook, email it to your contacts or share the link with your co-workers, we’re grateful for everyone who shares our project and helps us raise $5,000 through Gladitood. For those that want to be more involved, Gladitood allows volunteers to create a fundraising page, set a personal fundraising goal, and share their unique URL link with their network in order to raise money on behalf of DRC.

Why Is DRC Raising Money on Gladitood?

Gladitood offers the ability for donors to fundraise on DRC’s behalf by creating and sharing a custom fundraising page with your network of family and friends. Running a project on Gladitood helps spread the word about our mission, just by taking our organization to donors looking for a place to give. The more visibility, the more likely we are to meet our goal and continue to fund innovative, peer-reviewed T1D research.

How Will the Money Raised Through Gladitood be Used?

Donations to the General Fund collected through Gladitood will help early-career scientists get their ideas off the ground by providing funds to conduct peer-reviewed research designed to prevent, cure and treat T1D. The General Fund, after reasonable reserves, may be used to complete funding for research projects that are short of their goal. DRC’s operating costs are kept as low as possible and are targeted to be less than 10% of gross revenue.

Unfortunately, scientific research is expensive. Just consumable supplies needed for a research project can cost $20,000 or more. By raising money that goes directly to the scientists researching T1D, we’re able to ease the financial burden of research and fight for a cure for T1D.

Visit our Gladitood campaign page today to support our T1D research and help us reach our $5,000 goal by the end of October.

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DRC

An Important Talk About The Importance Of Diabetes Awareness

Original article published by The Huffington Post. Click here to read the original article.

National Diabetes Awareness Month is right around the corner, and it brings up the concern regarding how huge of an issue diabetes really is. A spokesperson from Diabetes Research Connection has agreed to answer some questions regarding Type 1 diabetes and the research that is being conducted to understand this autoimmune disease more.

1. Can you tell us a little more about type 1 diabetes; how is it different from type 2?

Type 1 diabetes (T1D) is a chronic autoimmune disease, like multiple sclerosis and muscular dystrophy. T1D is the result of the human immune system mistaking the body’s beta cells, which produce insulin, for foreign cells and destroys them. These beta cells produce insulin in response to elevated blood sugar levels. A person with T1D must constantly test his or her blood sugar and inject insulin or use an insulin pump to normalize blood glucose levels. Currently, there is no known cure for T1D.

Type 2 diabetes (T2D) is much more common than T1D. While the causes for T2D aren’t fully understood, excess weight, inactivity, age and genetics contribute to the development of this disease. Patients with T2D make insulin, but their cells can’t respond to it adequately. In some cases, T2D can be controlled by exercise, diet and weight loss.

Diabetes is the leading cause of adult blindness, kidney failure, cardiovascular disease, amputations, nerve damage and other complications. This is why the Diabetes Research Connection (DRC) supports research designed to prevent, cure and better the disease.

2. Explain to us what you do to research Type 1 Diabetes.

DRC is a nonprofit organization headquartered in San Diego, California. Established in 2012, DRC’s mission is to connect donors with early-career scientists enabling them to perform peer-reviewed, novel research designed to prevent and cure T1D, minimize its complications and improve the quality of life for those with the disease.

Researchers from across the country submit a grant application to members of DRC’s Scientific Review Committee, which is comprised of over 80 of the leading U.S. diabetes experts. Each research proposal is carefully scrutinized for innovation, value and feasibility.

Approved projects receive up to $50,000 in as few as 12 weeks. 100% of funds go directly to each scientist’s lab. To ensure transparency, each investigator provides updates to donors on their project. Final outcomes are posted on DRC’s website. This openness informs the research community of credible, new science. Research redundancy is less likely to occur, resulting in donated and government funds being used more efficiently.

3. There is no cure for Type 1 Diabetes, but do you think that could change anytime soon?

The discovery that insulin injections could treat T1D almost 100 years ago is the seminal finding and access to insulin is a daily necessity for people with this disease. There are a number of current research efforts to improve how external insulin is given in order to most closely control blood glucose levels, andthat is perhaps the most exciting area of medical research in our future. There are also many scientists working on preventing the onset of T1D or curing it after is has developed. Cells that can replace those lost in T1D and T2D are now a reality in several laboratories worldwide. It may be possible to create a new type of beta cell supply derived from stem cells. By using gene splicing, engineered beta cells may avoid rejection by the immune system. This futuristic approach has tremendous potential providing that the protein responsible for the immune attack to beta cells is identified, successfully targeted and silenced. Lastly, these designer cells should perform as intended without adverse side effects. A clinical trial has begun using human beta cells derived from embryonic stem cells and implanted under the skin in protective capsules to avoid their immune rejection.”

4. What are some of the greatest breakthroughs your scientists have had on a project?

Todd Brusko, Ph.D., from the University of Florida, completed his project, “Engineering Immune Cells To Stop Autoimmune Attacks” in December of 2015. The goal of his DRC supported project was to create a technology platform that would enable an optimized Treg cell (a specialized set of white cells that appear to interfere with the immune damage to beta cells) therapy for the treatment of type 1 diabetes. Therefore, Dr. Brusko set out to manufacture biodegradable nanoparticles that would release a Treg growth and survival factor binding to Treg cell surfaces. In animal experiments, his initial data supports the notion of improved engraftment and function. These findings offer critical proof-of-principle data that is closely watched by those with T1D because it addresses an important hurdle that must be overcome for a cure. If successful, this method will increase the number of protective cells which can help prevent further destruction of remaining beta cells.

Kristin Mussar, Ph.D. Candidate, from the University of Washington, completed her project, “Creating New Insulin-Producing Cells To Repair Damaged Pancreas” in August of 2016. In her project, Mussar identified a population of white cells called macrophages residing in the pancreas of newborns that is necessary for islet cells to expand in number as well as to mature into functional insulin-producing cells. Mussar found that a functionally similar population capable of boosting islet proliferation exists in the bone marrow of adult individuals, which suggests that there might be potential for islet repair in adults. The lab Mussar conducts her research in is currently investigating whether this bone marrow population can be used as a cell therapy to enhance the repair process of islet cells in adult mouse models of injury. This project is important because it has identified a different set of white blood cells that may allow the proliferation of insulin producing cells in the pancreas of diabetic patients, offering hope for a cure.

5. November is National Diabetes Awareness Month, how will your organization be promoting the Cause?

We’re launching a 30-day matching gift campaign to promote our General Fund. The fund covers program costs that support our research projects, as well as operating expenses. During the Double Your Dollars for Diabetes campaign, DRC will match donations made to the fund (up to $25,000 in matching), and on Giving Tuesday, DRC will quadruple its matching contribution. In addition, we are encourage holiday shoppers to purchase gifts through the AmazonSmile Program and select DRC as their nonprofit of choice to receive a small donation from the online retailer. More information will be available on our website prior to our November 1st launch.

6. Where can people learn more about your research projects?

People can learn more about DRC and our projects by visiting our website at drcsite.wpengine.com. We encourage visitors to join the DRC family by signing up for our monthly newsletter or becoming a donor.

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t1d research

Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes

Original article published by The Journal of the American Medical Association. Click here to read the original article.

Closed-loop artificial pancreas technology uses a control algorithm to automatically adjust insulin delivery based on subcutaneous sensor data to improve diabetes management. Currently available systems stop insulin in response to existing or predicted low sensor glucose values, whereas hybrid closed-loop systems combine user-delivered premeal boluses with automatic interprandial insulin delivery. This study investigated the safety of a hybrid closed-loop system in patients with type 1 diabetes.

Methods

Patients aged 14 to 75 years with type 1 diabetes for at least 2 years, glycated hemoglobin (HbA1c) less than 10%, and more than 6 months of insulin pump use were recruited from 10 centers (9 in the United States, 1 in Israel) between June 2, 2015, and November 11, 2015. This before and after study had a 2-week run-in period (baseline) for patients to learn the devices without the automated features followed by a 3-month study period with the initial 6 days used to collect insulin and sensor glucose data for the hybrid closed-loop algorithm. In the study period, there was a 6-day hotel stay during which 1 day was used for frequent sampling of venous blood glucose to verify the accuracy of the system. The last patient visit was March 7, 2016. Two central and 4 local institutional review boards approved the study. Written informed consent was obtained from adults and parents, and written assent from minors.

The system included investigational continuous glucose monitoring sensors with transmitters, insulin pumps displaying real-time glucose data, a proprietary algorithm, and blood glucose meters. Patients were required to periodically calibrate sensors and enter carbohydrate estimates for meal boluses. Every midnight, multiple parameters were automatically adjusted by the algorithm.

Safety end points obtained during the run-in and study periods (including the hotel stay) were the incidence of severe hypoglycemia and diabetic ketoacidosis, serious adverse events, and device-related serious and unanticipated adverse events. Prespecified descriptive end points included time in open vs closed-loop systems; the percentage of sensor glucose values below, within, and above target range (71-180 mg/dL), including at night time; changes in HbA1c, insulin requirements and body weight; and measures of glycemic variability. End points were collected during both periods and analyzed with SAS(SAS Institute), version 9.4.

Results

Of the 124 participants (mean age, 37.8 years [SD, 16.5]; men, 44.4%), mean diabetes duration was 21.7 years, mean total daily insulin dose was 47.5 U/d (SD, 22.7), and mean HbA1c was 7.4% (SD, 0.9). Over 12 389 patient-days, no episodes of severe hypoglycemia or ketoacidosis were observed. There were 28 device-related adverse events that were resolved at home. There were 4 serious adverse events (appendicitis, bacterial arthritis, worsening rheumatoid arthritis, Clostridium difficile diarrhea) and 117 adverse events not related to the system, including 7 episodes of severe hyperglycemia due to intercurrent illness or other nonsystem causes.

The system was in closed-loop mode for a median of 87.2% of the study period (interquartile range, 75.0%-91.7%). Glycated hemoglobin levels changed from 7.4% (SD, 0.9) at baseline to 6.9% (SD, 0.6) at study end . From baseline to the end of the study, daily dose of insulin changed from 47.5 U/d to 50.9 U/d, and weight changed from 76.9 kg to 77.6 kg. The percentage of sensor glucose values within the target range changed from 66.7% at baseline to 72.2% at study end. Sensor and reference glucose values collected during the hotel stays were in good agreement, with an overall mean absolute relative difference of 10.3% (SD, 9.0).

Discussion

To our knowledge, this is the largest outpatient study to date and it demonstrated that hybrid closed-loop automated insulin delivery was associated with few serious or device-related adverse events in patients with type 1 diabetes. Limitations include lack of a control group, restriction to relatively healthy and well-controlled patients, the relatively short duration, and an imbalance between the length of the study periods. Differences in HbA1c levels may be attributable to participation in the study. A similar study in children is under way. Longer-term registry data and randomized studies are needed to further characterize the safety and efficacy of the hybrid closed-loop system.

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continuous glucose monitoring

Does CGM Benefit Injection Users? Yes! Results from Dexcom’s DIaMonD Study

Original article published by diaTribe. Click here to read the original article.

Continuous glucose monitoring (CGM) is often considered a technology for insulin pump users – not those on injections. New results from Dexcom’s DIaMonD study, presented at the ADA Scientific Sessions, will hopefully change that.

DIaMonD examined if the addition of CGM in those on multiple daily injections (MDI) could help improve blood sugar control. In this six-month study, participants with an average starting A1c of 8.6% were given either “usual care” (fingersticks alone) or the use of CGM for 24 weeks, measuring changes in A1c, time-in-range, and other outcomes. MDI users that added CGM saw a meaningful reduction in A1c of 0.9%, compared to a 0.4% improvement in the fingersticks (control) group. CGM also cut hypoglycemia by 30% (23 fewer minutes per day) and reduced time spent over 180 mg/dl by 83 minutes per day, far exceeding results in the control group.

Dr. Howard Wolpert (Joslin Diabetes Center) summarized the implications of the DIaMonD study, asserting that healthcare providers should consider recommending CGM to ALL patients with type 1 diabetes who have not attained their glucose goals – not just those on insulin pumps. This would be a major change from current trends, where only ~7% of MDI users with type 1 diabetes use CGM in the T1D Exchange registry.

DIaMonD adds to the evidence that CGM improves time-in-range, reduces highs and lows, and improves A1c. This does not come as a surprise since glucose value and trend can be observed every five minutes and alarms sound for lows and highs, allowing people to recognize patterns, tighten the feedback loop, and take action to improve. We expect this technology to only improve as apps and software make CGM data more useful – particularly for those not on pumps.

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diabetic dog

Type 1 Diabetes and Diabetic Alert Dogs

Dogs are often called a man’s best friend – but for some, this common phrase has a much deeper meaning.

Groups like Canine Hope for Diabetics and Diabetic Alert Dogs of America help type 1 diabetics safely gain independence through training and providing working service dogs. These Diabetic Alert Dogs are trained to pick up on low (hypoglycemia) or high (hyperglycemia) blood sugar events and alert their owners before it becomes dangerous. These dogs are able to detect the chemical change produced by blood sugar high and lows and alert their owners so they can take steps to return their blood sugar to normal levels and avoid a diabetic emergency.

How Diabetic Alert Dogs Make Life Easier for Those With T1D

To get a glimpse of just how much of a difference these dogs make for adults and children with T1D, consider Luke’s story. Luke was diagnosed with T1D at just two years old. His mom took him to the doctor after noticing he was tired, thirsty and irritable, and a fingerprick confirmed that he had T1D. The doctor sent Luke straight to the hospital, where his mom began to learn how to take care of him with the new diagnosis: how to prick his finger, how to check his blood sugar and how to administer insulin.

So why did Luke need a Diabetic Alert Dog? He is hypoglycemic unaware, which means that he can’t tell when his blood sugar is getting too low. Diabetic Alert Dogs are trained to notice when blood sugar gets too low and notify their owners. Getting a dog would give Luke more independence; he’d be able to play sports, go to friends’ houses and be a “normal” kid again.

Luke received Jedi, a Diabetic Alert Dog who has saved his life many, many times. Jedi knows when Luke’s blood sugar gets too low, and alerts him and his mom so that they can take the necessary steps to correct his blood sugar. Just recently, at a Friends for Life conference, Jedi alerted Luke’s mom twice while he was playing with other children with type 1 diabetes. Luke was too low the first time and too high the second time.

It’s not just Luke benefitting from from having a Diabetic Alert Dog, either. Many children and adults with T1D have dogs that warn them of extreme blood sugar fluctuations, often saving their lives.

If you have T1D and are interested in learning more about Diabetic Alert Dogs, we encourage you to contact Canine Hope for Diabetics, Diabetic Alert Dogs of America or a similar group that trains alert dogs for diabetics.

For more information, news updates and resources for type 1 diabetics, sign up for our newsletter.

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diabetes infographic preview

What Are The Types of Diabetes? [INFOGRAPHIC]

The term “diabetes” refers to a group of diseases that result in problems with blood sugar levels. Each type of diabetes has a different root cause.

View the infographic below to learn more about the different types of diabetes, including who they affect, their cause and typical treatment.

For more information about type 1 diabetes, check out our resource center.

DRC-Infographic

Note: T1D is diagnosed in children, young adults and adults.

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OUR PROJECTS

See our approved research projects and campaigns.

Role of the integrated stress response in type 1 diabetes pathogenesis
In individuals with type 1 diabetes (T1D), the insulin-producing beta cells are spontaneously destroyed by their own immune system. The trigger that provokes the immune system to destroy the beta cells is unknown. However, accumulating evidence suggest that signals are perhaps first sent out by the stressed beta cells that eventually attracts the immune cells. Stressed cells adapt different stress mitigation systems as an adaptive response. However, when these adaptive responses go awry, it results in cell death. One of the stress response mechanisms, namely the integrated stress response (ISR) is activated under a variety of stressful stimuli to promote cell survival. However, when ISR is chronically activated, it can be damaging to the cells and can lead to cell death. The role of the ISR in the context of T1D is unknown. Therefore, in this DRC funded study, we propose to study the ISR in the beta cells to determine its role in propagating T1D.
Wearable Skin Fluorescence Imaging Patch for the Detection of Blood Glucose Level on an Engineered Skin Platform
zhang
A Potential Second Cure for T1D by Re-Educating the Patient’s Immune System
L Ferreira
Validating the Hypothesis to Cure T1D by Eliminating the Rejection of Cells From Another Person by Farming Beta Cells From a Patient’s Own Stem Cells
Han Zhu
Taming a Particularly Lethal Category of Cells May Reduce/Eliminate the Onset of T1D
JRDwyer 2022 Lab 1
Can the Inhibition of One Specific Body Gene Prevent Type 1 Diabetes?
Melanie
Is Cholesterol Exacerbating T1D by Reducing the Functionality and Regeneration Ability of Residual Beta Cells?
Regeneration Ability of Residual Beta Cells
A Call to Question… Is T1D Caused by Dysfunctionality of Two Pancreatic Cells (β and α)?
Xin Tong
Novel therapy initiative with potential path to preventing T1D by targeting TWO components of T1D development (autoimmune response and beta-cell survival)
flavia pecanha