September 20, 2013

No True Government Support for Test Strip Safety

This is a take off on Ann Bartlett's blog of July 17. I have held this too long, but with what has happened with the Society of General Internal Medicine (SGIM) and their list for Choosing Wisely, I feel that this needs exposure again. Ann is very confident that our medical insurance needs to stay out of the way when it comes to our medical supplies.

Unfortunately, they will be hitting type 2 patients on oral medication very hard probably around the first of the year. When Dr. Robert Ratner, chief scientific and medical officer for the ADA that says, “Many people with type 2 diabetes who are on medications don't need to do home glucose monitoring at all." This is followed by the SGIM putting this statement at the top of their “Choosing Wisely” list, "Don't recommend daily home finger glucose testing in patients with Type 2 diabetes mellitus not using insulin,” patients with type 2 diabetes on oral medication will be in the dark about the management of diabetes. Yes, bold is my emphasis, but apparently is having little in the way of getting people upset.

Our local support groups have had a meeting about this including a support group from a neighboring community. I appreciate the action of the support group I belong to for their actions, but for other emails, I have only had one from a doctor that I have had discussions with and worked with on setting up shared medical appointments. See my blog here.

David Klonoff, MD, from the University of California, San Francisco had the only positive comments at the meeting held the week of September 9. He also said, "Our organization is very interested in this public-health issue, which is to see that safe blood glucose monitoring systems are available for patients." Yes, some of the representatives from the online diabetes community were positive, but only about the desire to promote test strip safety and reliance.

Even the FDA was dragging their feet to delay action. Yes, you can claim that it takes time for them to act, but without funds to back up the request for action, the FDA will continue to side step on the issue time after time.

Courtney H. Lias, PhD, director of the division of chemistry and toxicology devices at the FDA, said, “Some advantages of a surveillance system include its potential ability to identify sources of error for further investigation and to deter/discourage detrimental manufacturing or design issues.” She continued, “However, some of the downsides are that such a system won't identify the source of the error — additional investigation would be required; it might be expensive and difficult to oversee; and small sample sizes might not detect outliers among the billions of glucose tests conducted every year.”

Translation, It isn't going to happen. This is confirmed by her statement, “And to make such a program mandatory, either Congress would have to pass a new law or the FDA would have to engage the rule making process, which is typically incredibly lengthy and, at best, takes 5 to 6 years. "This is not an overnight scenario."”

So between the FDA and CMS, we can forget about increased accuracy or correcting problems in the supply of faulty test strips. Yes, the FDA will support a voluntary program that requires no funds from them. However, the program must be a credible surveillance program and if it is, it can be a very powerful tool. (If the FDA chooses to back it.) Surprisingly the members of most manufacturers in attendance endorsed to proposal.

CMS does not agree.

September 19, 2013

More You Need to Know About Insulin

In the previous blog, I left out several discussion points that I will cover in this blog. The first item is what to do if you are having a medical procedure. First, you must talk this over with your doctor and follow their directions. I have been through enough medical procedures that I know what has to be done and I just do them. In one case for a procedure, my blood glucose level was at 86 mg/dl and the surgeon had a bag of glucose hung and added to the IV. After my blood glucose tested 120 mg/dl, the glucose IV was halted. This delayed the procedure for 30 minutes and I was given a tongue lashing.

Then when the procedure was finished, and I was in the recovery room, my wife brought me my testing supplies. A reading of 305 mg/dl caused me to issue a call for the surgeon and ask why he had not countered with insulin therapy once I went over 180 mg/dl per hospital directives. He did not answer, but turned and left. Filing a complaint did not result in any discussions.

In general, when you are scheduled for a day procedure such as a colonoscopy or outpatient surgery, you will be required to fast for at least 12 hours before the procedure. I know with a colonoscopy that it is useless to eat for about 20 hours before the surgery as you start taking medications to clean your intestines. This means that if you are on oral medications, generally you will stop these at least 24 hours prior to the procedure. Even though this applies to metformin, I try to stop at least 48 hours before and don't restart for at least 72 hours after. It is still best to talk this over with your doctor for best advice.

If you are taking insulin, definitely talk this over with your doctor. Also, test your blood glucose several times and just before the procedure to stay current with your goal of blood glucose management. If you are using one of the incretins: Byetta, Bydureon, Victoza, or Symlin, you can skip taking these if you aren’t eating solid food. Always talk to your doctor about surgery procedures if you are set up with an IV as generally, it will contain glucose and this can wreck havoc with your diabetes management. Some surgeries do have a procedure in place to balance blood glucose with insulin at a certain level; however, most surgeons will ignore procedures.

On the day of your procedure is where changes in your usual routine normally occur. Oral medications are withheld until after the procedure and you have restarted your normal food intake. This is because many oral medications will cause hypoglycemia on an empty stomach. Even though I have been advised only to take half my normal injection of Lantus, many procedures prefer Lantus or Levemir be given at their normal dosage. Most intermediate-acting (NPH) and mixed dose insulins are usually reduced or skipped to avoid hypoglycemia when given without food. It is always wise to consult your doctor for the correct action.

Because I do not use or like insulin pens, I can only advise you to read this short blog by Joslin, or carefully read the instructions that come with your pens. I prefer syringes and have used them since starting insulin.

I will conclude this blog with some information about syringes. Everyone advises only using a syringe one time and they using a new syringe. In general, this is sound advice. The medical community is concerned about infections and other diseases being transferred by reused syringes.

The one factor often overlooked is this as shown in the following image:

Because today's needles are much smaller, damage as shown above can happen after two uses. Although the risk isn't excessive for infections and insulin preparations contain antibacterial additives to inhibit the growth of bacteria, the reuse of needles can still increase the possibility of a skin infection. If you practice good hygiene and do not have pre-existing skin infections or a compromised immune system, you should have few problems. I have reused syringes and after two times, the third time can be more painful as shown in the above image. Never should needles or syringes be shared with others.