As last month we have products to review for you. The first you can find out about at www.diabetesresponse.com. This is a service for those of us with diabetes that have concerns about living alone and the possible repercussions of having a severe hypoglycemic event or seizure when there is no one to care for us. It is based on phone calls at a routine time to check in on a client’s health. If no one answers then back up people are called to check in and emergency personnel are sent if none of these people are available or if deemed necessary. For those of us with brittle type 1 diabetes this may be something to look into if we can’t afford to have professional help to monitor us when we live alone. Just a thought! This second is called SummerSoles. These woolen inner soles are available in colors and patterns for women’s shoes in the ultra absorbent material as well as in a polyester material. We all know that some of us have problems with sweaty feet so if your special socks are not doing the job, first, I’d see my doctor for suggestions and then maybe get a referral to a podiatrist. By the way, there is an article in Diabetes Care about a study with thick special socks that will help impede diabetic foot complications of ulcers. Ask your health care if you are prone to ulcers. Finally, you may want to look into this product. Which does not come cheaply, costing $7.95 for one set. I did wear a provided sample in my cross-trainers to the gym and they are comfortable but since I have few problems with my feet except all of those reminders of dancing on point from the age of 5. They were more difficult to use in my new flat shoes as they tightened them up a bit too much for comfort. It’s up to you. You can find them at www.summersoles.com.
Well let’s get started with December’s articles. The first part of this issue will be about Continuous Glucose Monitors (CGM). I currently use one and am enthusiastic about its impact on my life and thought that maybe you would be interested in looking into this new technology that along with my insulin pump bring me just a little closer to that “artificial pancreas" that we have been waiting for. Please read and find out the pros and cons. As of the writing of this article there is only one insurance company in my state that will pay for the either the monitor or supplies. I use 3-4 sensors a month depending on how long I can reboot up the sensor. None of this is cheap, but just knowing the direction my blood glucose is moving and the alarms that sound when my blood glucose levels are low or high, make having the monitor in my pocket make me feel better. Let’s begin. The first article I found to share with you comes from the American Academy of Pediatric Section on Endocrinology Newsletter, Volume 16, Summer/Fall 2007 written by Lori M.B. Laffel, M.D., MPH from Joslin Diabetes Center and Aaron J. Kowaski, PhD from the JDRF Artificial Pancreas Project Juvenile Diabetes Research Foundation. The writers acknowledge that helping children and adolescents with diabetes and their caregivers must take into account many variables which make control difficult. Ordinary blood glucose monitors provide only episodic data and gives no information on the rate and direction in the blood glucose concentration. According to the authors CGM provides information in three areas. First, it sounds alarms for high and low levels. Having a CGM, I can share that these alarms will continue to sound even as you treat the problem although I can forestall the alarm to some extent. Second, it allows for real time insulin adjustments based not only upon the glucose level but also if it is falling or rising at that moment. Third, it allows for retrospective review of glycemic excursions based upon time of day, activity level, and food intake that can be used to refine insulin adjustments. As an aside, yesterday I had one of my quarterly endocrinology appointments. I had been looking at my charts that the computer program that comes with my CGM can print out. My physician also printed off a chart and we decided to fiddle once again with the basal rates on my insulin pump because of reactions to exercise and late afternoon low blood glucose levels. Yesterday afternoon was better.
There are currently two FDA-approved manufactures manufacturers of real-time continuous glucose sensors to use in adults 18 years of age and older and one awaiting approval, one devise is FDA-approved for use in children ages 7-17. The DexCom STS Continuous Glucose Monitoring System was approved in March 2006. The wireless sensor determines glucose levels in subcutaneous tissue and radio transmits glucose data to the receiver every 5 minutes for up to a week. There 7-day sensor was recently approved. For reasons of honesty, this is the monitor I use. It was available in my state; I tried it out, and bought it. The 3-day sensors that were available were not, in my opinion, reliable and I was looking into leaving my state to buy the other brand elsewhere when I tried the 7-day sensor. They work and the monitor is reliable. What else can I ask for? MiniMed offers the only CGM device currently approved for children, one is a stand alone devise and one is coupled to an insulin pump although the information is not used to dose insulin doses. Both of theses systems provide data for up to 72 hours. The alarm will sound when it predicts low or high blood glucose levels and also when is sensed a rapid change. Finally, the Freestyle Navigator is a 5-day real time CGM awaiting FDA approval. It displays blood glucose every minute with the direction and rate of change displayed. It uses vector technology to alarm up to 30 minutes before it predicts the occurrence of low or high blood glucose levels. Now for the big problem, with all of these monitors. You are told from the get-go that none of them are approved as a replacement for traditional glucose monitoring. That is you are asked not to treat low or high levels until you prick your finger. My CGM is right almost all of the time, but it has been wrong especially when I first insert a new sensor. It calms down quickly and is reliable. Recently the JDRF launched a large multi-centered randomized controlled trial to test the effectiveness of CGM use. The study is powered to detect the reduction in A1c after 6 months use in patients who initially had A1c levels above 7.0%. Additionally, a second cohort with A1c levels below 7.0% will be monitored for hypoglycemia reduction. It is hoped that one outcome of this research will the development of implementation and dissemination tools and algorithms for optimized use of CGM. The end goal is to develop the “holy grail" of diabetes treatment, a closed loop insulin delivery system of that artificial pancreas which would act like the beat cells that type 1 diabetes are lacking. The limitation for this in the past has been a robust continuous glucose monitor and a mature control algorithm that would drive the insulin delivery system. Using systems that currently available a group form Yale led by Dr. Stuart Weinzimer at Yale has shown excellent feasibility data of a fully closed system in teens with type 1 diabetes. The authors concluded that the next 10 years will hopefully bring additional technological advances that will close that loop for an artificial pancreas and approach a cure for type 1 diabetes.
One study of note which might help you in making a decision came out of the June ADA 67th Scientific Meetings held in June. In a 6-month randomized multi-centered trail 138 experienced pump users with an initial A1c above 7.5% or lower were randomized to a conventional finger prick method of testing blood glucose levels or CGM. At 6 months groups both groups decreased from a mean of 8.5% to 7.8%. Iri B. Hirsch, M.D. medical director of the University of Washington Diabetes Care Center in Seattle reported the results. They found a linear relationship between CGM and lower A1c levels. Those with 100% or more (defined as using the sensor at least 6 days per week) saw the A1c levels fall from 8.56% to 7.69%. Those with less than 60% adherence saw their baseline A1c levels rise from 9.45% to 9.63%. “These people with higher HbA1c levels were not taking care of their diabetes before the trial, and if they are not interested or focused, this won’t help them," Hirsch stated. He hopes that future studies will enroll motivated patients. “We used the wrong the population because diabetes is lifestyle-patients have to be interactive with their sugars, and if they’re not involved, we can’t help them”. To that end the JDRF is sponsoring the research that is discussed above.
Time to share abstracts. Diabetes Care 30:2822-2826,2007 has an article that is important for all of us with diabetes to read. It fits beautifully with the review of continuous glucose monitors. If the alarm is blaring I sure would not get in the car without checking my blood glucose levels and treating it if necessary. Many of us have had a hypoglycemic event while driving and we must make adjustments in our lives to protect ourselves and others. I sure want my children to not fear me driving my grandchildren to the movies or out for a treat. Please talk to your physician or health care team about what you need to do to make sure you, your passengers, and all on the roads are safe. The answer can be as simple as taking your blood glucose reading before getting behind the wheel. The title of the article is The Decision Not to Drive During Hypoglycemia in Patients with Type 1 and Type 2 Diabetes According to Hypoglycemia Awareness by Alexander D.M. Stork, M.D. et al. In recent years there has been an ongoing discussion on the relationship between diabetes and driving. In many states rules for yearly physician reports to retain driving privileges have been dropped. As driving performance will inevitably decline at lower levels of glycemia, patients’ decisions concerning driving or taking corrective action when hypoglycemia occurs immediately before or during driving is paramount to understand. Twenty-four type 1 diabetic patients with normal awareness of hypoglycemia( TI Norm group) , 21 type 1 patients with impaired awareness of hypoglycemia (TI Imp group), and 20 type 2 diabetic patients with normal awareness of hypoglycemia (T2 group) were studied. They were asked whether they felt hypoglycemic and whether they would currently drive during experimental euglycemia and hypoglycemia. In the T1 Norm group, 1 patient (4.2%) decided to drive during hypoglycemia. In the T1 Imp group, 9 patients (\42.9%) said they would drive in the hypoglycemic condition. In the T2 group, 5 patients (25%) would drive. This was more frequently the case for patients on oral hypoglycemic agents. No effect of sex was noted.
The researchers concluded that patients with type 1 diabetes and impaired awareness of hypoglycemia frequently decided to drive while hypoglycemic, whereas patients with type 1 diabetes and normal awareness of hypoglycemia appeared to make safe decisions concerning hypoglycemia and driving. Strikingly, patients with type 2 diabetes and normal hypoglycemia awareness frequently made potentially dangerous decisions as well, particularly when using hypoglycemic agents. Therefore, early, clear, and consistent education is imperative.
Finally, as of November 14, 2007, GlaxoSmithKline’s Medication Avandia will carry the warning label it “may, or may not increase risk of heart arracks”. Because of current research it could not state that the medication did cause a risk of heart attack. Talk to your physician for more information.
BSP
