March 31, 2014 ~ Medtronic Insulin Pump Therapy and CGM with Dr. Francine R. Kaufman

Photo_FrancineKaufman

 

FRANCINE R. KAUFMAN, M.D.

Chief Medical Officer and Vice President, Global Medical,

Clinical & Health Affairs, Medtronic Diabetes

Emeritus Professor of Pediatrics and Communications at USC

The Center for Diabetes, Endocrinology & Metabolism

Francine Ratner Kaufman, M.D. has had a 30 year distinguished careerin diabetes care, research and advocacy.  In 2009, she stepped down as director of the Comprehensive Childhood Diabetes Center, and head of the Center for Endocrinology, Diabetes and Metabolism at Childrens Hospital Los Angeles to become Chief Medical Officer and VP of Global Clinical, Medical and Health affairs at Medtronic Diabetes (Northridge, CA).

 

Dr. Kaufman is also a Distinguished Professor Emerita of Pediatrics and Communications at the Keck School of Medicine and the Annenberg School of Communications of the University of Southern California, and an attending physician at Childrens Hospital Los Angeles.

Dr. Kaufman has published more than 200 peer-reviewed and invited publications. She is the author of more than 30 books or book chapters. In 2008, she edited the 5th edition of the ADA’s the Medical Management of Type 1 Diabetes.  In 2005 her book, Diabesity, was published by Bantam. Diabesity explores the ravages of the obesity and diabetes epidemics as they spread across the globe. Dr. Kaufman was chair of the National Institutes of Health funded Studies to Treat (the TODAY Trial) and Prevent (the HEALTHY Trial) Type 2 Diabetes in Youth (STOPP-T2). She was a principal investigator of TrialNet, a multinational consortium evaluating ways to prevent type 1 diabetes, funded by the National Institutes of Health (NIH).  She has received many awards and honors, including the LA City Council for promoting youth physical fitness (2004), from the State of California for her role in banning sodas from Los Angeles Unified School District (2003), and from the American Diabetes Association (ADA), Juvenile Diabetes Research Foundation (JDRF), European Association for the Study of Diabetes (EASD), Partners in Care, Starbright Foundation, amongst others.

In 2009, Dr. Kaufman was elected to membership in the Advisory Council of the Diabetes Branch of the NIH. In 2007, she filmed a documentary for Discovery Health on the global diabetes epidemic which was aired around the world on World Diabetes Day, November 14, 2007. Also in 2007, Dr. Kaufman was Co-Chair of the Diabetes Work Group for the Department of Health Services of the State of California to recommend diabetes treatment and prevention strategies for the Medicaid population.  In 2005, she was elected Membership in the Institute of Medicine.  Dr. Kaufman was national president of the American Diabetes Association in 2002-03.  She was elected to AOA Medical Honorary Society. She was also president of Shaping America’s Health, chair of the National Diabetes Education Program, and served as chair of the Youth Consultative Section of the International Diabetes Federation.

Listen to the latest broadcast of Diabetes Living Today®:  March 21, 2014 ~ Medtronic Insulin Pump Therapy and CGM with Dr. Francine R. Kaufman

FDA: Diabetes device plan may help patients faster

Reuters) – The U.S. Food and Drug Administration issued new guidelines on Thursday for the development of a potentially revolutionary device to treat type 1 diabetes that will give manufacturers ‘maximum flexibility’ in getting it to U.S. patients.

The guidelines reflect months of behind-the-scenes negotiations with patient advocates, medical device makers and researchers working to develop an artificial pancreas — a complex system of pumps and sensors aimed at automating the care and treatment of type 1 diabetes.

It is not yet clear if they will appease concerns that the FDA would set the bar too high, making regulations so cumbersome that it would delay access of these potentially revolutionary devices to diabetics in the United States.

“This guidance was developed in a way to account for innovation,” Charles “Chip” Zimliki, who heads an FDA initiative to speed up availability of an artificial pancreas, told Reuters in a telephone interview.

Zimliki said the new draft guidance gives researchers and medical device makers clear guidelines for approving clinical trials that can prove these devices are safe in real-world outpatient settings.

“I think we’re doing a really good job at getting these clinical studies going and we’re showing them a path that I think can get them to a safe and effective product in the U.S.,” he said.

Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement the new guidance will “provide maximum flexibility to manufacturers seeking to bring this device to U.S. patients.”

“We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works,” Shuren said.

Zimliki says the guidelines take into account concerns raised over guidelines for a very early version of an artificial pancreas device, known as a low glucose suspend device.

Those devices involve a safety feature built into an insulin pump that shuts off the pump when a diabetic’s blood sugar falls to dangerously low levels.

OUTSIDE OF BODY

The new guidelines are focused on more complex artificial pancreas devices that would automate many of the tasks a diabetic must do to manage their disease.

These systems are made up of medical devices worn outside of the body to take over for insulin-making cells in the pancreas, which become destroyed in people with type 1 diabetes.

The systems combine two medical devices, an insulin pump and a continuous glucose monitor or CGM that receives information on glucose levels from a sensor placed under the patient’s skin.

The pump and CGM work together, monitoring the body’s glucose levels and automatically pumping appropriate doses of insulin as determined by a computer algorithm.

These systems are meant to manage dangerous spikes and valleys in blood sugar that occur as diabetics try to manage the disease by checking their blood sugar and injecting themselves with insulin.

The FDA guidance document recommends a three-phase clinical trial progression leading to outpatient clinical trials.

And it suggests ways researchers can use existing safety and effectiveness data for various components that make up the system, including data gathered from clinical studies conducted outside of the U.S.

When final, the guidance will help manufacturers and investigators assemble submissions for clinical trials as well as product approval submissions.

The devices are aimed at treating the 3 million Americans with type 1 diabetes, an autoimmune disease in which the immune system destroys cells in the pancreas that make insulin.

Formerly called juvenile diabetes, type 1 diabetes is less common than type 2 diabetes, the form of the disease linked to obesity and lack of exercise that affects 26 million people in the United States.

People with type 1 diabetes currently must monitor their blood sugar and take insulin several times a day to regulate it and prevent diabetic complications, which include heart and kidney disease.

 

Going wireless with diabetes treatment

By James Kendrick | November 30, 2011, 6:54am PST

Summary: Diabetes is running rampant in the U. S., and treatment for the disease is evolving. Glucose meters and insulin pumps are now wireless, allowing hands-free operation 24/7.

Diabetes is a horrible disease with long-term ramifications for those afflicted. The affects on the human body of glucose levels that remain out of control for extended periods can be devastating. Those with diabetes can (and should) go to great lengths to fight the disease with every tool at their disposal. This now includes using insulin pumps that can wirelessly connect to glucose level monitors, allowing for on-the-fly doses of insulin that mimics the operation of the human body.

I was first diagnosed with Type 2 diabetes a decade ago. Type 2 diabetes now afflicts over 20 million Americans, and treatment can vary from simple diet control to multiple injections of insulin daily. I have been in the insulin injection club for years, and after discussions with my healthcare provider I am considering entering the world of the “pumpers.” These are the diabetics using an insulin pump 24/7 to keep total control over their glucose level, the best way to minimize long-term complications caused by diabetes.

What does this have to to with covering mobile technology? Plenty, as my research into insulin pump technology demonstrates. Insulin pump treatment consists of two parts: the pump itself, a highly calibrated device the size of the pager of old, and glucose monitors which keep an eye on the internal blood levels at all times. These two work together through wireless communications, in a totally mobile configuration. You probably interact with folks using insulin pump technology every day, and just don’t know it.

While the insulin pump itself can be (and usually is) worn under clothing to hide it, there are glucose meters that can pair up to the pump wirelessly. These can be simple, like the meters used with the finger prick method for measuring glucose in the blood, that send the metered results to the insulin pump. Insulin dosage is adjusted appropriately based on the measured results in real-time, resulting in insulin treatment much like that of the human body. Some pumps can constantly monitor the glucose blood level in real-time and make adjustments automatically, much like the human body.

Some of these glucose meters can serve as remote controls over the insulin pump. The user can leave the pump wherever it is situated and do everything needed via the remote meter. These use Bluetooth to provide two-way communications between the two gadgets. That shows how far this mobile healthcare technology has come, when we realize they are just gadgets. Highly specialized gadgets to be sure.

Just about all modern glucose meters and insulin pumps can connect to a laptop or computer via USB to upload recorded information. This provides detailed tracking by the user, useful for determining what is happening with the diabetic’s all-important glucose level. Some of these software solutions can be remotely accessed by the healthcare provider to make proper adjustments to the treatment from afar.

I am close to determining what equipment I will be using to treat my diabetes, but nothing is finalized yet. I can use all of the advice I can get with the complicated decision process concerning the gear, so please leave a comment in the TalkBack section if you can. I am particularly eager to hear what pumps and meters others might be using, and how well that is working out.

iPro2 Continuous Glucose Monitoring Device Receives FDA Approval

Medtronic, Inc. has announced FDA approval for company’s iPro2, Professional Continuous Glucose Monitoring (CGM) system. The iPro2 has been previously covered on Medgadget . The system comprises a wearable continuous glucose monitoring sensor/data logger and docking station for uploading the recorded data. The technology is tailored for healthcare providers looking to monitor and retrospectively review their patients’ glucose management. The assessments are carried out over a three day period and can help the clinician identify excursions from optimal glucose levels and adjust the patient’s glucose management plan accordingly.

The press release explains the operation of the system:

Setup can be completed in a few minutes and includes inserting a glucose sensor into the patient’s skin, educating the patient, and connecting the iPro2 to the sensor.  The patient then conducts normal daily activities while the iPro2 records and stores as many as 288 glucose readings over each 24-hour period.

iPro2 is adaptable to almost any patient’s lifestyle because of its small, light and water-tight profile, and the patient is not required to interact with the device. After three days of wear, the patient returns iPro2 for upload to new web-based CareLink™ iPro software, which provides a summary of glucose data in easy-to-read reports.

The system has been available in Europe for over a year and it will be great to see the impact of this technology stateside.

Press release…

iPro2 product page…

Flashback: Medtronic Unveils iPro 2 Professional CGM

September 6, 2011 ~ Diabetes Living Today® ~ No Sugar Added® Open Forum

Diabetes Living Today® radio program, provides listeners with education, inspiration and motivation to live healthy and well with diabetes. Whether you have diabetes or know someone who does Diabetes Living Today® radio program offers experience, insight, education and tips to manage life with diabetes. Through interviews, including “World Class” Research Scientist, physicians and people living with diabetes, living well tips and questions from the listening audience, host Kitty Castellini and Endocrinologist Dr. Joseph J. Fallon, Jr. are there every step of the way to offer guidance, advice, and most of all, support.

This week Kitty and Dr. Fallon will host their No Sugar Added®  “Open Forum.”

Photo Above:  Kitty Castellini & Dr. Joseph J. Fallon, Jr.

Listen to Diabetes Living Today®

September 6, 2011 ~ Diabetes Living Today® ~ No Sugar Added® Open Forum