Wednesday, November 07, 2007

Type 1 diabetes, gadgets, and evidence based medicine

A recent keynote speech by Richard Kahn, Chief Scientific Officer of the American Diabetes Association (ADA), seems to have raised the ire of Amy and numerous commenters over at Diabetes Mine. Kahn spoke about where we’ve been and where we’re going with technological advances in diabetes care. So what’s controversial about that, you ask?

The post and comments that followed covered several related issues---inappropriate lumping of type 1 and type 2 diabetes, failure to advocate for patients, not enough emphasis on a cure---but I will focus on one. It seems Dr. Kahn is being accused of “dissing” diabetes technology:

It is frightening that someone like Kahn, who in his position with the ADA is arguably the most visible spokesperson for diabetes in this country, would deliver a speech essentially dissing the value of new diabetes technologies -- and at the country's top gathering of D-tech experts, no less!

OK, so did Kahn really dis new technology? Here’s an excerpt from the speech:

The ‘90s also gave birth to many other advances in technology without which we would have made little progress in controlling the ravages of the disease. Laser photocoagulation, insulin pumps, angioplasty and by-pass procedures, mono filaments for foot exams, sophisticated glucose meters, and many more technological advances, have given people with diabetes a far better life than was imagined even a decade or two earlier. They have certainly saved lives, improved many more lives, and made diabetes manageable for millions of people.

Kahn suggests a healthy skepticism towards new technology. He raises questions of evidence. But he’s not dismissive, at least in my reading. He’s not even suggesting technologies be subjected to the same scrutiny we apply to new drugs. I can think of many gadgets, bells and whistles, both in and outside the field of diabetes, which have survived such scrutiny despite a lack of proof of improvement in clinical outcomes. The proliferation in the 1980s of programmable functions in cardiac pacemakers and new modes in mechanical ventilators are just two examples. Many of these advances, while never passing the rigorous tests of evidence based medicine, remain available today to the benefit of individual patients.

Amy goes on:

Think of the ramifications. If the ADA comes out with an official position that there's no value in using an insulin pump, or a CGM system, or even a fingerstick meter if you're a Type 2 not on insulin, the Powers That Be will listen.

The ADA should follow the evidence. Although insulin pumps have no proven superiority over newer insulins they represent an alternative which should be available to patients with type 1 diabetes. I can understand patients’ concerns. I hope we never see the day when the patient has to wait a year after the doctor fills out a ream of paper in order to get a pump. That may happen if we go to a single payer system---not as a result of any influence of Richard Kahn or the ADA.

H/T to Kevin MD.

1 comment:

Anonymous said...

The Pumpers: Better compliance for Insulin-dependent diabetic patients?

With some diabetic patients, the hormone insulin may be absent, yet necessary for their survival. As I recall, a man named Pauescu developed the concept of insulin replacement, and discovered a method of using insulin secreted from pigs as a replacement method for humans, which was effective at that time. Legend has it that this concept originated in a dream this man had on a night soon before his idea became reality several decades ago. Yet presently, this hormone which is naturally produced by the pancreas normally has advanced as far as treatment goes for the diabetic patient through synthetic engineering, as they are dependent on insulin for their treatment, and those are type 1 diabetic patients.

Recently, the Denver Bronco’s quarterback, Jay Cutler, was recently diagnosed with diabetes, a disease that affects over 20 million people. As I recall, part of his treatment regimen involves what is called an insulin pump. They are approximately the size of a cell phone, and the users of such pumps are called, in the diabetic community, ‘pumpers’. Developed primarily for type 1, or insulin-dependent diabetic patients, the pumps can be used by some type 2 diabetic patients if they have some dependence on insulin replacement, which has steadily increased over the years. The importance of the device is improved management of the disease, which can cause life-threatening consequences if the disease of diabetes is not controlled properly.

The three elements The Pumpers:

A New Paradigm in diabetes management of an insulin pump include the pump itself and its components, such as the insulin tube for delivery of insulin, and a catheter that delivers basal and bolus doses, which are dependent on preset calculations. The amount of insulin is fast or rapid acting to ensure maximal pharmacokinetics to create intensive insulinotherapy for required diabetes management. These insulin amounts are ultimately determined by the patient’s doctor, who is usually an Endocrinologist, including bolus doses determined by the patients glucose level calculated with their carbohydrate intake, also known as the meal- time dose. Furthermore, the amount of insulin delivered by these methods is quite small due to the nature of the medication being rapid acting.

The makers of such pumps tend to partner with associations relevant to the disease of diabetes, as well as local chapters of such organizations as the ADA and Endocrinology societies that may exist, along with contacting diabetes educators frequently at different locations throughout the country. Unfortunately, there are few Endocrinologists in the United States, as it is not one of the more lucrative specialties of a doctor, so treatment of diabetes is dependent on many others who are not doctors, but patient care specialists regarding this disease.

Competing companies are few, as there are approximately 5 insulin pumps in the market, with Medtronic having the largest share of 30 percent, as I understand. In addition, some pumps avoid the possibility of metabolic action therapy due to their dosing precision, in addition, there is at least one pump that has long acting lithium battery that averages about a 6 week lifespan, yet a pump user should have a battery replacement with them at all times. The personalized insulin and carbohydrate ratio provided by insulin pumps greatly reduces any incidence of such complications as hypoglycemia. Also, in addition to storing and recording glucose and carbohydrate values with a back up mechanisms, some insulin pumps have a low basal rate, which I understand is an advantage as well. Regardless, and in my opinion, the ultimate advantages of insulin pumps exist with all that are available to patients presently.

The cartridges of the insulin pumps hold a large number of units of insulin, which is an additional benefit. Further benefits include the fact that the pumps are convenient and reliable- especially if damage is avoided to the pump. Most importantly, the personal service provided to the patients by the caregivers of existing diabetic teams in health care facilities from hospitals to health care centers dedicated to the disease of diabetes ensures proper management of their disease, much to the benefit of those who have diabetes.

The market growth of insulin pumps is anticipated at over 10 percent a year, as only 20 percent of type 1 diabetic patients have utilized these pumps out of over a million type 1 diabetics in the United States. The market is speculated to be greater than one billion dollars and is expected to increase due to speculated growth of the Insulin pump market. Many believe this therapy is superior in comparison with previous treatment options available to diabetic patients, along with being less cumbersome for these patients. Because of this, there is decreased mortality along with increased quality of life for diabetics, as they are assured of better control of their disease in this rather convenient way. This has been proven by better A1C blood tests and glycemic control of diabetic patients.

The steady dosing maintains the patient’s metabolic requirements and decreases long term consequences associated with diabetics. It has also been proven that insulin pumps result in fewer hospitalizations, ER visits, and episodes of hypoglycemia due to the excellent control provided by the insulin pumps while providing the necessary intensive therapy for their disease state. The fast acting insulin used in these pumps is created through genetic engineering, I believe. In addition, patients are encouraged to check their blood sugar greater than three times a day while on the insulin pump. So this system is both friendly to the user and is clearly a very convenient form of treatment for them. The A1C test, by the way, is a blood test that reflects the diabetic patient’s average blood sugar over a period of a few months.

Those who may be interested in insulin pumps will include those described already, along with hospitals, long term care facilities, home health care agencies, pediatricians, and possibly dialysis clinics, to name a few. Most likely, those considered for insulin pumps will be diabetic patients that are unable to achieve compliance with their current treatment regimen, along with other benefits of insulin pumps stated so far.
The diabetes team for a diabetic patient may include an Endocrinologist, a diabetes educator, a dietician, along with the insulin pump representative. Follow ups with this team may include review the progress of the insulin pump for the patient and how the patient is tolerating the treatment. Often, classes can be scheduled through an institution or center regarding insulin pump training a few times a month.

Education and training about the insulin pump may include the following:

1. Glycemic control importance and how to prevent and treat as needed
2. Basal and bolus concepts and how they contribute to the treatment
3. Pump basics and strategies. Negative effects stressed to pt. if their pump is not used properly.
4. Importance of knowing blood sugar and why. Definitions of terms like A1C
5. How to deliver a bolus dose after checking carbohydrate intake
6. How to check the pump’s memory
7. Troubleshooting, phone number access, and how to replace battery
8. Emphasize the safety of the insulin pump if operated correctly
9. Keeping a glucagon injection and spare battery with you

Ultimately after training others, it is important that the patient acknowledges understanding of how the device works, as well as the consequences that may occur if directions are not followed that are ultimately determined by the patients doctor. And fortunately, doctors and others who treat diabetes now have a new tool or device to assure compliance and longevity of these patients.

Innovation is a wonderful thing, such as what has been described. Control of such a large and devastating disease is of great importance, so there seems to be a much desired need for pumpers now and likely in the future. Especially for those patients who slack on following their prescribed treatment regimen. And this will have to do until relevant transplants to reverse diabetes become more frequent and less complicated.

Dan Abshear

Author’ note: What has been annotated is based upon information and belief