Did You Participate in the FDA Conference?

I had wanted to, but a doctor appointment was more important. I was on the road minutes after the start of the conference and did not return home until an hour after it was supposed to end.

The appointment was not what I had hoped for on A1c, but the rest was all in the ranges for each test. Finally, a doctor that felt my A1c should be lower and was not asking me to let it rise. At least this time I know I will need to work more diligently to bring it down – means no more snacks.

At least one website now has something posted about the conference and how the FDA could not handle the numbers of people participating and the site crashed. Rather than regurgitate what has already be stated, please read the blog at Diabetes Mine.

Thank you.

A Patient That Knows He Needs Help

Two days later, Karen sent me their phone number and asked me to call later at about 3:00 PM when Andy would be there. Then she started asking questions about lifestyle changes that could help her husband. I answered her question by asking her to read my blog on components of lifestyle change. I also told her that some might not apply, but that both needed to learn about eating to his meter. I gave her this blog and said both needed to read it. I suggested that if at first he had postprandial readings of 140 mg/dl, not to be overly concerned as it would take some time and experience to bring diabetes management into good focus.

I also suggested that they do some experimenting, as this was also a good way to learn. I teased her about making him her lab rat while learning about how the different foods affected his diabetes. I said that eating low carb and medium to high fat would take some effort on her part and I suggested that they convert in the following two weeks and then allow this to take over for the month following. I said it may take some effort and they needed to be careful when he had trouble with some foods and the amount of fat. Everyone reacts differently and it takes patience.

I said that starting on insulin should make it easier because metformin might possibly have created stomach problems and diarrhea, especially converting to a low carb and high fat diet. I assured her that communications with the new doctor were important and not to be afraid to ask questions if needed. I also told her that his request about insulin dosage questions was important and showed that he was concerned. I did suggest that she talk to the doctor about a prescription for glucagon and learn how to use it, if and when needed. I told her that glucagon was for severe hypoglycemia and she could need it if her husband had a severe low. I said the doctor would know this and would ask her questions, but it was better to ask than not ask and have problems. I urged them to talk with the doctor first. Then if it was prescribed, hopefully they would never need it, but it would be a cost that may not be needed.

I also suggested that she or her husband have a good talk with their pharmacist and see what he had for glucose tablets and that her husband carry a meter and test strips at all times plus the glucose tablets. Once the six months have passed, and things have settled down, then they could relax some. I asked if her husband wore leather gloves or cloth gloves most of the time. I said once I knew that, I would make more suggestions.

Then it was time to time to call. Andy was there and both were on the phone. I asked if they had reliable internet and used Facebook or Skype. Andy said the internet was decent, but not for Skype and they hadn't tried Facebook. Karen said they would talk to their son and see what he thought as that could be a good idea for the three children that were spread out in the West.

We talked for an hour and they asked many questions. I sent my email and this raised many more questions. I told them I would send more URLs that they could explore and read. Andy said he was reading many of my blogs and he would be asking more questions. He did say that he was glad to see my blog on washing hands and not using alcohol pads. He did admit that he wore both types of gloves for protecting his hands, wore the cloth over the leather during the winter, and even had some thick mittens during the coldest weather. He said he had two meters and the doctor had sent a letter for extra test strips for six months, but the pharmacist would not have heard yet. I told him that when he was out away from home and needed to test and it was too cold to wash his hands, he should use the alcohol pads if he needed to, but he felt that wearing the gloves he would not need them.

He said the pharmacist had made sure that he had glucose tablets and told him when to use them. He said they would talk to the doctor about glucagon, but Andy was concerned about the fact that he was often out away from the buildings and sometimes a few miles from his wife. His wife then said, but we have more than one horse and two all-terrain vehicles and maybe until things settled down, she should go with him. I said that was entirely up to them and should depend on what the doctor might advise. We agreed to email as things progressed. Karen asked about my cost of using the phone and I told her to call and have me call them back. We had talked over two hours which surprised them.

We agreed to stay in touch. use emails, and phone calls to ask and answer questions.  He agreed to let me continue blogging about his experiences if it will help others. I thanked him for that, as I do feel that real life experiences will help others in their battle with diabetes.

Metformin Not First-Line Treatment

Even though this is interesting, it still does not tell us why many doctors are not using metformin as the first-line treatment for type 2 diabetes. The results of a new US study show that only 58% of individuals with type 2 diabetes were started on metformin as their first oral glucose-lowering medication. This is despite the fact that this drug is widely recommended as the initial therapy of choice in numerous diabetes guidelines.

I can say that insulin can be an excellent choice when the doctors have waited too long to diagnose type 2 diabetes, but this isn't even mentioned in the people receiving other medications. All were other oral medications - sulfonylureas, thiazolidinediones, and dipeptidyl peptidase 4 (DPP-4) inhibitors. The Study period was from July 2009 to end of June 2013 and who filled a second prescription for a medication in the same class within 90 days of the first.

Senior author Dr Niteesh K Choudhry, from the division of pharmacoepidemiology at Harvard Medical School, Boston, MA explained it this way, "These findings have significant implications for quality of life and medication costs."

In an accompanying commentary, Drs Jodi B Segal and Nisa M Maruther (Johns Hopkins University School of Medicine, Baltimore, Maryland) agree with these conclusions. "This meticulously conducted study… adds modestly to what is already known on this topic. First-line therapy should be metformin in patients without contraindications."

“Without contraindications” is the key and this, along with quality of life and medication costs are the reasons for metformin being considered in first-line therapy. Occasionally some doctors are persuaded by drug representatives to use other medications and money may be the reason these doctors start with the more expensive drugs.

Dr. Choudhry stated, “Although the study did not examine the specific prescribers involved, with this type of national insurer the "vast majority" of physicians would have been primary-care providers (general internists) seeing patients in routine care settings.”

A total of 15 516 patients were said to have met the inclusion criteria, of whom 8964 (57.8%) started therapy with metformin. Sulfonylurea treatment was the first drug in 23% of cases, 6.1% began treatment with thiazolidinediones, and 13.1% with DPP-4 inhibitors.

“Patients prescribed metformin were less likely to require treatment intensification compared with those who used the other medications: 24.5% who started on metformin required a second oral medication, compared with 37.1% of patients prescribed a sulfonylurea, 39.6% who began with a thiazolidinedione, and 36.2% given a DPP-4 inhibitor first. Sulfonylureas, in particular, were associated with more adverse cardiovascular events and hypoglycemia.”

I am aware of many patients that are started on metformin, extended release (ER), that have been doing well because they followed directions and consumed it with food or at meal time and had few of the gastrointestinal problems. Others have started on regular metformin and have encountered the gastrointestinal discomfort. Most are okay in a few weeks and a few have been unable to tolerate this. I don't know anyone using the liquid metformin, but it is available.

In addition to the above link, this topic has received wide press. One more link if you are interested is this by Healio Endocrine Today.

An Understanding Doctor

Continued from the prior blog. The day Andy had been to the new doctor, his wife did send me an email. It was not a short email either. She said her husband had a blood draw upon arrival and another A1c test. When the doctor saw them, he said I think you know what the diagnosis is. He said you have type 2 diabetes and I don't need any more tests. Your plasma glucose is 189 mg/dl and your A1c is 11.9. With the test from yesterday of 11.8, this would indicate that they are rather accurate.

The doctor then asked both to keep a food log and asked if they had a food scale. Since they did not, he urged them to purchase one from the pharmacist and had a coupon for them. The doctor asked what the wife's occupation was and was surprised when she said that she was a nutritionist. I was surprised as well, but she said she had not practiced for the last five years. Karen (not her real name) said that the doctor said then you will understand when I suggest a low carb, medium to high fat and medium protein food plan for your husband. Karen said I asked if he did not mean low fat and high carb and was told that he knew he didn't stutter and if she could not accept low carb, medium to high fat, then he would send both of them to the university for further education.

Karen said that she understood, but was surprised that a doctor would recommend this. She then said that he recommended avoidance of certain saturated fats, and of course, all trans fats, but most of the rest were on the table. She asked the doctor if he would do some more tests to determine renal problems and other tests for kidney and other weaknesses. She said the doctor now was asking questions and said he would do the tests and he could understand why. He said that he was not prescribing metformin, but would be starting him on insulin for at least 6 months to a year. He said he would be checking his A1c and wanted him to send his meter readings monthly, plus the food logs. For that, he gave them the secure email address.

The wife said she was quite impressed with his knowledge of insulin and the doctor wanted him or her to call if he was having problems adjusting the insulin. She said at anytime was his emphasis. She continued that this was totally different from the doctor they had been seeing. In addition, they were handed a copy of the tests and told to keep a record of them. Included with the reports was a sheet of websites about type 2 diabetes.

In two weeks he will have another battery of tests and the doctor said they would pull another plasma glucose test. Karen said even with the added travel distance, she was changing doctors as well. The doctor they had been seeing was about to retire and the new doctor would not say anything against their doctor, but did admit that there were doctors that had not moved past 1998 changes for diabetes.

The last of the email was from Andy and he said that he was going to have to get used different lifestyles. He said he would need his wife for the nutrition and meal plans. He felt that exercise was one and walking more instead of riding a horse or an all-terrain vehicle. He is happy they have chickens and their own animals for butchering. Karen added that now she will need to learn to make their own sausage and she will not trim as much fat and they will save the fat they do trim for use later. Andy said that the ducks and geese would be good eating too. Then he said maybe not the pet ones. Andy added that one duck is always around when he saddles the horse and raises a fuss if he is not lifted up so he can ride as well. Their wings are clipped to prevent them from flying away.

Andy concluded that he was glad that I had him use the home A1c test the pharmacist had and he would be using the second test in 30 days. He then asked my thoughts on purchasing more of them. For that, I suggested that he read this by David Mendosa and if he felt the cost was reasonable, then he could decide for himself. I also suggested that he read and understand this by David.

Why Will Doctors Not Diagnose Diabetes?

I have heard of this, but I was not looking forward to the day I received an email with these circumstances. I answered the email, but felt I had to force the issue. The person felt he had diabetes because of his symptoms, especially his blurry vision, but his doctor would not diagnose him. All he was told was to watch what he ate as his blood sugar was becoming elevated.

I asked if he had copies of his lab reports and he answered no. He said that he had asked the doctor for a copy, but the doctor had just ignored him. I then advised him to put the request in writing with a date of request and the dates of the lab reports if possible. I told him that he might be required to wait 30 days, and if he did not receive them, there would be more work on his part.

He had said that his doctor was about 35 miles away and the next doctor was about 135 miles away from him. I had asked if he had a good relationship with a pharmacist and he said he had and in the same town as his doctor. I suggested that he talk to the pharmacist and see if he could get diabetes testing supplies, a lancet, lances, test strips, and a meter. Andy (not his real name) does not have access to other sources within 135 miles. I suggested checking Amazon and he said that would be a second choice for him.

An hour later, I received an email with a telephone number and a request to call him at the pharmacy. The pharmacist had told him he was out of supplies and would not have any for about a week. He asked what my position was and I said a type 2 diabetes patient. The pharmacist said that he had been shown my blog and wondered if there was anything more. I assured him that I had other problems, high cholesterol, high blood pressure, and sleep apnea. He asked if I knew about the A1c testing kit that used to be manufactured by Bayer and I said yes. He said he had two remaining that he would gladly sell as the expiration date was coming in 40 days.

I asked if he would use one to show Andy how to use the second one. The pharmacist agreed and asked if I could remain on the line. I agreed and I could hear them talking. Then the pharmacist came back on the phone and said he was shocked and would be recommending that he travel the extra distance to another doctor, as he firmly believed he had diabetes. I could hear Andy tell him to tell me and the pharmacist said the A1c showed 11.8. The pharmacist said he would call the doctor in a town 100 miles distant from there and get him an appointment as soon as possible. Then he would have my friend go to Amazon and look over the meters and supplies available and have him order for quicker delivery.

When the Andy arrived home he sent me another email saying that he would be seeing the new doctor the next day and would pick up testing supplies there as the pharmacist had called another pharmacist to see if he had the supplies and had set back some for him to purchase the next day. Then Andy was asking all types of questions about foods and testing. I had been pulling together blogs of mine and blogs by others for him to read and I sent them to him; telling him that we could communicate after he returned from the doctor. I did ask for his phone number and gave him mine. He said he would have his wife email me when they arrived home, as he would be busy with chores that could not wait. He said his wife is aware of what has happened and will be with him the next day.

This will be continued when I have more information.

Use Insulins – Don't Make This Mistake!

I have make mistakes with insulin and I am not proud of the way I made them. As a result, I have set up checks to make sure they don't happen again. This mistake reported in Diabetes in Control is not one I have made, but I can understand this happening. At least the pharmacist gave the pharmacy intern credit for discovering how the mistake was made. This makes this more meaningful and shows that the pharmacist takes pride in her staff and wants them to succeed.

Four days after the prescription was filled (actually refilled as the patient had been on the insulin for several years), the patient called. She complained that she was having unexplained lows at bedtime and highs during the morning and during the day. She had been questioned about food activity and how she was drawing the insulin into the

syringe and injecting the dose and nothing seemed to have changed.

All seemed to have been covered until the intern suggested that the patient might have let the insulin get too warm or too cold. It was suggested that she bring the bottles into the pharmacy to let them be examined.

After she brought them in, everything seemed okay, but the intern noticed that the bottles were in the wrong boxes. When the patient was asked about this, she said it was easier for her to hold onto the bottles for dosing if she left them in the box. She said that she must have switched them when she had taken them out to pop off the safety tops. She was instructed to place the bottles in the correct box. She was advised to make sure they were always in the proper box. There have not been any more problems for the patient.

Yes, there are a lot of things to remember with insulin, but it can be managed. Two of the three times I have had hypoglycemia, I knew that I had injected too close to the other insulin when I took the syringe out after the injection. Easy fix – just wait 30 minutes and test, going down, but still not below 90 mg/dl. Wait 15 minutes and test again. Time to chew on a glucose tablet. Wait another 15 minutes, and eat another glucose tablet. Repeat three more times and then I was back over 70 mg/dl. Wait a final 15 minutes and test for hopefully the last time and at 81 mg/dl.

The last low I am not certain what happened, the only thing I can guess, it that my finger that I used for the test was not clean and I injected too much insulin as a result. This has taught me to be extra careful and always wash my hands before testing and dry carefully. I don't use paper towels, but I use regular towels and if I need to, I change them two or three times per week.

AACE Urges Congress to Act

When I first read about this a couple of weeks ago, I was not happy with the American Association of Clinical Endocrinologists. My first thoughts were that the AACE would undo some of the good that the group Strip Safety had accomplished. But the more I thought about it, I soon realized that Alan J. Garber, M.D. of nefarious fame of the AACE was not calling the shots. I also realized that the more help for diabetes and the tools for diabetes, the better off we all could be.

The letter, signed by AACE president Mack Harrell, MD, and president-elect George Grunberger, MD, called for the passage of two bills: the Medicare CGM Access Act (HR5644/S2689), and the National Diabetes Clinical Care Commission Act (HR1074/S539). The latter would establish a public/private commission to coordinate activities that currently span 35 federal departments, agencies, and offices, according to the statement.

The letter also asks Congress to conduct follow-up hearings to examine FDA's pre- and postmarketing surveillance and enforcement activities for medical devices, along with a call for a review of Medicare's competitive bidding practices. With regard to the FDA, the AACE is asking for more rigorous pre- and postmarket surveillance of glucose testing supplies and the prohibition of devices that don't meet current quality standards.

The above are all needed and if accomplished, could be a big help for all people with diabetes. The Medicare CGM Access Act promotes Medicare coverage of continuous glucose monitors. Currently, Medicare does not reimburse for CGM, which means that well-controlled patients with type 1 diabetes lose an important means of monitoring once they hit the eligibility age of 65. Grunburger said it is unclear why Medicare does not cover the devices, despite the evidence of benefit and cost savings. The device has been associated with a reduction in hospitalizations for hypoglycemia.