Continuous Glucose Monitors (recent reports)


		Continuous Glucose Monitors (recent reports) (Top Posts - Science - 060509, updated 071409) - - - Summary of posts I made from April 30, 2009 -to- June 5, 2009, pertaining to Continuous Glucose Monitors and how a recent (April 26, 2009) event + the accumulation of almost 50 years of treatment for type 1 diabetes have impacted yours truly: - - - Some optimistic views, along with a skeptical view, on where this technology currently stands and where it may be going regarding reducing A1c levels -and- reducing incidents of hypo- glycemia: - - - - - - - - - - - - - - - First, a skeptical view: - - - Continuous Glucose Monitoring Technology: Promising New Tool For Maintaining Optimal Glucose Control ScienceDaily (June 2, 2009) http://www.sciencedaily.com/releases/2009/05/090529112532.htm - - - Excerpt: ... "Do We Really Need Continuous Glucose Monitoring?" Anne Peters, MD, from the University of Southern California Keck School of Medicine (Los Angeles), points out some of the drawbacks of current CGM technology: for example, the devices are "finicky and require care and calibration leading patients to use them infrequently"; "few physicians know how to interpret the data"; and "CGM devices have not been shown to reduce rates of severe hypoglycemia." [that statement is in contradiction with the following report that offered a much more optimistic view on the current positive impact of Continuous Glucose Monitors] http://www.sciencedaily.com/releases/2009/05/090527151140.htm ... - - - end excerpt - - - - - - - - - - - - - - - - - - An upbeat view: - - - DIABETES TECHNOLOGY & THERAPEUTICS Volume 11, Supplement 1, 2009 Mary Ann Liebert, Inc. DOI: 10.1089=dia.2008.0105 Editorial The Future of Continuous Glucose Monitoring http://www.liebertonline.com/doi/pdfplus/10.1089/dia.2008.0105 - - - Excerpt: ... Many subjects with diabetes are likely to benefit from this technological advance. Patients with higher A1c levels will likely see a drop in A1c values because of altered behavior in response to constant information of higher glucose values. However, subjects with lower A1c levels will notice value in decreasing time spent in hypoglycemia by using CGM. Of course, not all patients will benefit from early adoption of this technology, which is still clearly in its early phases. However, as CGM matures it is hoped to have greater penetration into the world of type 1 diabetes. ... - - - end excerpt - - - - - - - - - - - - - - - - - - An exciting optimistic view: A comprehensive history on the development of Continuous Glucose Monitors which ends with an exiting optimistic view of where all this will (in the near future?) eventually end up: - - - DIABETES TECHNOLOGY & THERAPEUTICS Volume 11, Supplement 1, 2009 Mary Ann Liebert, Inc. DOI: 10.1089=dia.2009.0045 Editorial Continuous Glucose Monitoring: An Overview of Its Development http://www.liebertonline.com/doi/pdfplus/10.1089/dia.2009.0045 - - - Ending excerpt: ... Even though today all CGM devices are approved as adjunctive (must cross-check with fingerstick glucose values), it is my hope and sincere belief that these devices will become available as stand-alone in the near future. It is a non-stop evolution that eventually will result in a cure for this disease. - - - end excerpt - - - - - - Continuous Glucose Monitoring Devices Benefit People With Type 1 Diabetes http://www.sciencedaily.com/releases/2009/05/090527151140.htm - - - Complete article: ScienceDaily (May 27, 2009) - People with type 1 diabetes who have already been successful in achieving recommended blood sugar goals can further benefit from using continuous glucose monitoring (CGM) devices, according to results of a major multi-center clinical trial by the Juvenile Diabetes Research Foundation. According to the JDRF study, using CGM devices enables people who have achieved excellent control (with HbA1c levels below 7 percent) to continue to tightly manage their diabetes while cutting down on the frequency of low blood sugars, called hypoglycemia. Research has shown that good blood sugar control is a key factor in reducing the risk of the devastating long-term com- plications of the disease, such as blindness and kidney disease -- but that the fear of low blood sugar emergencies often pre- vents many people from achieving tight control, and remains a constant concern for those who manage their diabetes well. The landmark Diabetes Control and Complications Trial (DCCT) showed that with intensive insulin therapy, excellent blood glu- cose control was obtained, but at the expense of a considerable increase in hypoglycemia. Today, the JDRF study has shown that, with CGM, hypoglycemia can be reduced while maintaining excellent blood sugar control. ... Participants all had good diabetes control when they enrolled in the trial, and were randomly assigned to either a group that used CGM devices or one using standard finger-stick glucose testing for 26 weeks. Findings of the study were published online by the journal Diabetes Care. "The research suggests that CGM devices helped people who were already doing an excellent job of managing their diabetes continue to do so, while lowering the risk of pushing their blood sugar so low it causes hypoglycemia, which can be life threatening," said Dr. Bruce Bode, Atlanta Diabetes Associates and one of the lead authors of the Diabetes Care paper. "These trials are showing that CGM not only helps people get into control, which can have a significant positive impact on lowering the risk of complications, but it enables them to stay in control without increasing the near-term risk of hypoglycemia. That's ter- rific news for people with diabetes and their families." (People with diabetes try to maintain their blood sugar levels be- tween 70 mg/dL and 180 mg/dL. When blood sugar becomes very low, people can become confused, lethargic, and even slip into a coma or die. Very high blood sugars can also be dangerous. And long term, lack of control increases the risk of developing devastating complications, including eye, kidney, nerve, and heart disease. HbA1c is a measure of long term blood sugar control; standards of good control are generally below 7% for adults, and below 7.5% to 8% for children, depending on age. According to the DCCT findings, every one point reduction in HbA1c reduces the risk of long-term complications by approximately 40%.) According to the study, for the people using CGM devices the time the blood sugar level was below 70 mg/dL decreased by 37 minutes a day. This compared with a decrease in the control group of only 5 minutes a day. In other words, people in the CGM group spent almost two hours more time per day in the target blood sugar range of 71 to 180 mg/dL compared with the control group, and about half an hour less time per day with glucose values in the potentially dangerous hypoglycemia range. ... Encouragingly, similar beneficial results were seen in children, adolescents, and adults spanning the ages of 8 to 69 years. ... The study is the second major publication resulting from JDRF's groundbreaking CGM trials, established to clinically document the benefits of CGM devices in helping people with type 1 diabetes manage their disease more effectively. In results published last fall in The New England Journal of Medicine, the JDRF Continuous Glucose Monitoring Study Group reported that CGM substantially improved blood sugar levels without increasing the frequency of hypoglycemia in adults over 25 years of age in a ran- domized trial of 322 adults and children with type 1 diabetes and HbA1c levels above 7 percent. (Like virtually every other study of a new drug or device in the treat- ment of type 1 diabetes, because lowering of HbA1c was the primary outcome of interest, that study excluded individuals already reaching target HbA1c levels lower than 7 percent. As a result, the study group also conducted a separate, concurrent randomized trial to evaluate the efficacy and safety of CGM in adults and children with type 1 diabetes who already had successfully achieved HbA1c levels less than 7 per- cent with intensive insulin therapy.) Dr. Kowalski noted that over the past 15 years, the use of rapid and long-acting insulin analogs, improvements in insulin pumps, and more frequent home blood glucose monitoring have had a positive impact on the ability of people with type 1 diabetes to achieve blood sugar control targets. However, the rates of severe hypoglycemia remain too high and the occurrence of such events is often followed by a decline in glycemic control due to fears of further hypoglycemic epi- sodes. Hypoglycemia remains the major limiting factor for people with type 1 diabetes in trying to achieve and maintain good blood sugar control. These study results are extremely encouraging in showing that hypo- glycemia can be reduced without sacrificing glycemic control. About Type 1 Diabetes Type 1 diabetes is an autoimmune disease that affects children, adoles- cents, and adults, in which the immune system attacks cells in the pan- creas that produce insulin, a hormone that enables people to convert food into energy. People with type 1 diabetes are dependent on insulin for the rest of their life. But insulin is not a cure, and people with diabetes are at significant risk for a wide range of serious complications, including heart disease, blind- ness and kidney disease. As many as 3 million people in the U.S. have type 1 diabetes. About CGM Devices CGM devices, manufactured by several companies and approved by the FDA as an adjunctive therapeutic for diabetes, provide both a real- time snapshot of the glucose levels of a person with diabetes, as well as trend information on whether glucose is moving upwards or down- wards, and how fast. Devices also provide warnings when the glucose is becoming too high or too low. - - - end of article - - - - - - - - - - - - - - - - - - - - - - - - Post I made on May 6, 2009: Continuous Glucose Monitor / Hypoglycemia / Insulin / Glucagon Update 2 -- Continuous Glucose Monitor (CGM) / Hypoglycemic Status After a visit to a doctor, major changes to my insulin therapy are going to be embarked on, with the goal being 100% avoidance of hypoglycemia, while main- taining or reducing my excellent HbA1C levels. This is the first time I'd gotten an HbA1C level since 1995 or so, and then, the doctor was surprised my level was so good being that I didn't fit the normal model of how to manage the disease. I don't recall what that level was, but yesterday, it was 6.7, indicat- ing good diabetic control (at least as pertains to HbA1C) over a long period of time (also explains why I've had no complications after almost 50 years of having type 1 diabetes, since the age of 5). I'm switching to new insulins (I've been using NPH and Regular since 1960) to both attempt better con- trol and to maintain or reduce HbA1C while at the same time avoiding hypoglycemia. That's the goal, anyway, and in that regard, it appears that a Contin- uous Glucose Monitor is well-advised. Here's an interesting article on a type 1 diabetic race car driver who's using Levemir & Novolog flex pens in a manner similar to what I'm about to embark on: http://sev.prnewswire.com/null/20090414/NY9837314042009-1.html Here's a quick run-down on 4 continuous glucose monitors. The DexCom Seven is now the DexCom Seven Plus, with more features than those that are listed. http://www.diabetesnet.com/diabetes_technology/continuous_monitoring.php - - - Interesting 29 minute video on Continuous Glucose Monitors: http://www.youtube.com/watch?v=q_mZPpCKKH0 Taking Control of Your Diabetes Continuous Glucose Monitoring - - - For "All You Ever Wanted to Know About Continuous Glucose Monitors, but Were Afraid to Ask", the follow- ing 1 hour video tells the tale. A thorough discussion of the JDRF study which recommends Continuous Glucose Monitors for type 1 diabetics to both lower HbA1C levels and reduce incidents of hypoglycemia, as well as some helpful insight into how to use the CGM device (of note, acetiminophen is verboten): http://www.researchchannel.org/mov/uw_lab_glumon_1300k_qt.mov - - - Update (071409) The next step in type 1 diabetes management, the artificial pancreas, currently in test trials: Artificial Pancreas May Free Diabetics From Constant Glucose Monitoring - - - The JDRF Artificial Pancreas Project > Continuous Glucose Monitor (CGM) http://tinyurl.com/JDRF-ContinuousGlucoseMonitors Continuous Glucose Monitor (CGM) Continuous glucose monitor (CGM) is a device for people with diabetes that provides continuous "real-time" readings and data about trends in glucose levels. This can allow people with diabetes to understand the level of their glucose and whether it is rising or falling, and to intervene by eating food or taking insulin to prevent it from going too high or too low. To date, continuous glucose monitors from three companies have been approved by the FDA, and a major clinical trial funded by JDRF has found that people with type 1 diabetes who use CGM experience significant improvements in blood sugar control. Additional information: * Results of JDRF's CGM Human Clinical Trial http://tinyurl.com/JDRF-CGMsHumanClinicalTrial * Join JDRF's CGM Coverage Campaign http://www.jdrf.org/cgmcoverage * Read JDRF's Position Statement on CGM Coverage by Health Insurers http://www.jdrf.org/index.cfm?page_id=111283 * Read an article about CGM in the American Association of Clinical Endocrinology publication, First Messenger. http://www.aace.com/pub/fm/JanFeb09fm.pdf * JDRF CGM Trial Named One of Top Medical Break- throughs of 2008 http://www.jdrf.org/index.cfm?page_id=111318 For more information about specific continuous glucose moni- toring (CGM) devices, click on the links below: * Abbott FreeStyle Navigator® Continuous Glucose Monitoring System http://www.freestylenavigator.com/en_US/application/html/freestyle-navigator.htm * DexCom SEVEN® Plus http://www.dexcom.com/ * Medtronic MiniMed Paradigm® REAL-Time Insulin Pump and Continuous Glucose Monitoring System http://www.minimed.com/products/insulinpumps/index.html - - - Brief Explanation of Hypoglycemic Unawareness Causality Caused by the liver shutting down its administration of glucagon, which raises blood sugar, if it experiences too much in the way of highs and lows. I've already found that this may be a result of having the disease for a long time, but in any case, with this new intensive therapy, 4 shots per day + either manual testing every two hours or automatic testing all day, verifying that blood sugars are within acceptable ranges, if it is reducable, the hypo- glycemic unawareness, we'll see if that improves. Needless to say, a Continuous Glucose Monitor would be ex- tremely well-advised, medically speaking, in my case, having had at least 7 instances of emergency care caused by hypoglycemia in the past four years. That, of course, doesn't include the multiple night-time hypos when emergency care wasn't solicited, one in which a scar on my forehead was the noticable result, or the daytime hypos when co-workers interceded without requiring intervention from emer- gency care. - - - Study Pinpoints Role of Insulin on Glucagon Levels An interesting article I was working on back on April 7, 2009, which addresses why my type 1 diabetes, having it for so long, has lowered my ability to sense low blood sugar: - - - April 7, 2009 Summary of research results: Insulin -- blood sugar reducer. Glucagon -- blood sugar increaser. Type 1 diabetes -- impact of insulin injec- tions over many years suppresses the re- lease of glucagon, thereby increasing the chances of hypoglycemia. So, a side impact of long-term type 1 diabetes (a condition I've had for over 48 years) is that my risk of hypoglycemia has increased, and the following article explains why that has occurred: - - - Study Pinpoints Role of Insulin on Glucagon Levels http://www.newswise.com/articles/view/550742/ - - - Excerpt: Researchers at the Joslin Diabetes Center have shown for the first time that insulin plays a key role in suppressing levels of glucagon, a hormone involved in carbo- hydrate metabolism and regulating blood glucose levels. The study helps in the understanding of why those with diabetes have high blood glucose levels and could lead to develop- ment of a drug aimed at targeting glucagon levels. Produced by the alpha cells in the pancreas, glucagon acts on the liver to help raise blood glucose when it becomes low. It has the opposite effect on the liver as insulin, which is released from pancreatic beta cells to lower blood glucose when it is high. In a healthy individual, the two counter each other to keep blood glucose levels balanced. ... In addition, the research may also help in the understanding of why patients with type 1 diabetes in particular, who are required to inject insulin on a regular basis, are at risk for hypoglycemia. It was thought that this increased risk was linked in some way to insulin receptors in the alpha cells, an idea that today's study suggests is in fact the case, Dr. Kulkarni explained. "This gives us some insight into the cause of hypoglycemia, the most common com- plication in patients with type 1 diabetes," he said. "Injecting insulin leads to a decrease in blood glucose. If it starts to go too low, glucagon normally kicks in to prevent hypo- glycemia. But, what happens in diabetes is the alpha cells become desensitized by repeated insulin injections over many years and they start to behave abnormally. We believe this is linked to insulin receptor function." - - - - - - - - - - - - - - - - - - - - - Excerpt from post I made on May 2, 2009: Update -- Continuous Glucose Monitor (CGM) / Hypoglycemic Status Still in the early stages of ascertaining how to go about getting a CGM. Don't know if or how much of it would be covered under my health care plan. For my European friends, in America, health care for most isn't covered by national health insurance, so for those who have health care, it's a matter of satisfying individual health care providers require- ments to ascertain what is/is not covered and how much (if any) is provided for any health care treat- ment. Any way, the biking thing, my stamina is beginning to build up, and no hypoglycemia since the one that caused the cop to dissuade me from driving (i.e., saying my drivers license was revoked, though I have yet to receive a letter confirming that, but I suspect it's on the way). If the CGM is the answer, in my case, it would be- hoove society to facilitate getting one of those, but it is America I live in, after all, and I'm doubtful that much, if any, of that will be covered under the health plan. In any case, unless someone has testimony that they experienced disappointment with a CGM, I'm optimistic that that (along with a change in my insulin treatment, along with any medication or treatment that I'm unaware of that might increase my hypo- glycemic awareness to levels I used to have, and it doesn't appear there is any that would work in my case, being that I've had the disease for almost 50 years) is the ideal solution. I suppose, I'm discovering something about the long- term consequences of having type 1 diabetes since age 5 that I didn't expect, that being the decrease in hypoglycemic awareness, and the fact that society reacts with a stick rather than a helping hand regarding such matters, but whatever, since I'm before forced to deal with the stick, I'll do so by trying to submit to their will (although, there is that option of dropping out, and I'm unsure, right now, if I even have it in me, the submission thing, but I'm trying to do it), and looking for any helping hands that may be extended. As for the despair I mentioned recently, I think that's lifting, but it is a very stressful time, and I admit I'm at risk until these major league life-impacting events are resolved in some positive way. I did have a spark of optimism this morning, so that's welcome, even if it's unjustified based on my present status. Once again, anyone having any helpful suggestions, please share. Thanks in advance. ... - - - - - - - - - - - - - - - - - - - - - Excerpts from two posts I made on April 30, 2009: How many blood sugar tests do you do per day? For those who 'depend' on blood sugar testing for so- called control, some information from a video I recently viewed might give you pause to reconsider your reliance or confidence in that. A blood sugar test is a photograph of an instance in time. An instance. Your blood sugar varies over a 1,440 minute day, from minute to minute. For 'normal' non-diabetic people, every second of every minute of every hour of every day, their pancreas is mon- itoring and responding to blood sugar levels. For diabetics who supposedly depend on blood sugar tests for so-called control, your information reflects photographs of blood sugar which may deviate, dramatically, from what your blood sugar is doing in all the moments you're not testing. In essence, if you blood sugar test 3 times per day, you're getting a blood sugar picture that equates to 3/1440 (or 2/10ths of one percent) of what your blood sugar is up to during that day. For further details, see the following for details on the futility of relying on a few photographs for so-called 'control', and also, for an understanding of why many type 1 diabetics look at blood sugar testing as a farcical joke, providing naught but the pretense of the appearance of 'control', nothing more: www.drblumervideo.com As for a better way, can't know 'til I've tried it, and as such, I hesitate to recommend it, so I'll leave it at that, for now, and will get back to you on such matters after I've gone through the process of getting a doctor to 'prescribe' a continuous glucose monitor, and actually used it to assess how much it really helps to 'control' this damnable disease we, who are type 1, are forced to deal with for every moment of every day until a cure is found. - - - (another post on April 30, 2009) ... I wrote to a doctor who is type 1, and here's some helpful advice he had to offer regarding my current situation: "We have similar medical histories. The severe hypoglycemia is the most disconcerting aspect of my long term diabetes (there are others but they are less likely to acutely impact me). That said, I would strongly suggest you consider a continuous glucose monitor (CGM). Dexcom makes a good one. They are well worth the cost and can literally save your life. I use a Navigator. My severe lows have gone away and I have advanced warning if they are coming, even if I'm asleep. ..." - - - - - - - - - - - - - - - - - - - - - For a reference on what caused my switch in insulin regimen and my switch to active blood glucose testing, refer to the following posts I made on from April 28 to 30, 2009: Personal Note -- Drivers License Revocation http://prohuman.net/social_legal/drivers_license_revocation.htm - - - - - - - - - - - - - - - - - - - - -