Once again we have collected new research to share with you. Diabetes is a life-long disease, whether type 1 or 2 and understanding how you may effected by it and by new products and research can only help you make informed decisions about your care. At this point each month we ask for your ideas about what interests you. We'll look for it. We also applaud you for reading these abstracts. As I've stated before, hiding from the scarier results of research, and the truths about diabetes, is easy, but it certainly doesn't help much and, in fact, it may hurt you. So, please read on. This month we are pleased to bring you two abstracts about new insulin products. As a new insulin pumper, I was interested in an implanted pump article, so we share that. We then look at the headlines about the misperceptions of many type 2 diabetics about heart disease and the discovery of a gene for insulin resistance syndrome which may be linked to heart disease. Next, we look at depression and diabetes. We end on a positive note with the race to produce better diabetes tests. So lets begin:
First let's look at those two articles on insulins. The first reports on a 2-year study presented at the American Thoracic Society's 97th International Conference which found that an inhaled form of insulin appears to control blood glucose levels without harming lung function. The lead researcher William T. Cefalu, MD at the University of Vermont College of Medicine examined this inhaled insulin which was designed to deliver insulin deep into the lung. It is hoped that it will allow some people with type 1 diabetes to reduce the number of insulin injections they must give themselves daily. It may also help some people with type 2 diabetes who normally take only oral agents to control their diabetes without having to take insulin injections. The study included 140 patients who had completed one of three 3-month studies of inhaled insulin's safety and efficacy. The 2 year study looked at blood sugar levels and found that the inhaled insulin initially controlled this and continued to do so over the two years. "Patients with type 1 or type 2 diabetes have preferred inhaled insulin over injections and this observation has been previously reported. In addition, patients with type 2 diabetes may be reluctant to start insulin injection therapy even though two or more of the oral therapies may not be controlling blood sugar levels." The researchers will continue to look at inhaled insulin's relative effectiveness as the study continues.
Our second article discusses a once-daily insulin product which has been launched in the US. Aventis Pharmaceuticals announced that it has begun a launch of Lantus (insulin glargine) in the US. This new insulin was approved by the US Food and Drug Administration in April 2000. Lantus is an insulin analog with a relatively constant concentration time of 24 hours, as opposed to the shorter duration of other insulins that require frequent daily injections. This therapy is indicated for both adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes who require long-acting insulin to control high blood glucose levels. Lantus was originally expected to be available in the US in September 2000, but it was marketed in Germany first where it quickly captured 30% of the market. Spokesperson for the company stated that the delayed launch was due to a new manufacturing process that required an FDA review. Once that was completed, the company began to build a supply for the current launch in the US. "...we have enough Lantus to be available to any patient who wants access to it."
A new implanted insulin pump may be in your future. It will deliver insulin into the abdominal cavity. The reservoir will hold a three month supply of insulin that is refilled by injection, and the pump can be controlled externally with a device much like a TV remote. The pump, like the external pumps, can be programmed to deliver insulin at various rates so that larger doses can be given before meals. It is hoped that in the future an implantable pump will be able to make decisions about how much insulin is needed. This will rely on a glucose monitor, but so far this piece of the puzzle remains elusive. We'll keep our eyes and ears open for you.
Next we go to those abstracts about heart disease. Our What's Hot article this month is on reducing the risk of cardiovascular disease in diabetes, so it's important that we all keep up with information about this subject. We all know that as a diabetic we are four times as likely to develop cardiovascular disease than the nondiabetic population. The first abstract describes how most type 2 diabetics do not realize the significance of heart disease. This information came from a survey released May 22 by the American Heart Association. The statistics are of concern. While 2/3 of type 2 diabetics have some form of cardiovascular disease, only one third consider it a serious complication of diabetes. The study, conducted by Roper/Starch Worldwide in December 2000 for Partners Against Insulin Resistance. It included 532 people with type 2 diabetes. The findings of this survey were are follows:
- 53% of the participants ate recommended numbers of fruits and vegetables and 33% exercised regularly.
- 28% had high levels of cholesterol
- 83% did not know a correct definition of insulin resistance
- 43% of diabetics using glitazone class drugs did not know if this medication treated insulin resistance and 33% never heard the term.
- 33% of diabetics were overweight with nearly half being obese or morbidly obese, based on BMI.
The study shows that more diabetics need to know that heart disease is an ultimate problem for them. They also need a better idea of what insulin resistance is. Dr. Sidney C. Smith of the American Heart Association suggest that newly diagnosed diabetics should not only learn to control metabolic issues, but also we made aware of cardiovascular complications and its contributions to morbidity and mortality in diabetics. The AHA is launching a 2-prong attack to combat cardiovascular disease in diabetics which will address these issues.
Our second article on heart disease comes form Circulation: Journal of the American Heart Association by Robert A. Hegele, M.D. A rare genetic condition called Dunnigan-type familial partial lipodystrophy (FPLD) may speed the development of heart disease. This condition bears a sticking similarity with the more common insulin resistance syndrome or metabolic syndrome X. The gene mutation responsible for FPLD causes weight gain in the abdomen, chest and face. Affected persons also have high insulin levels, high blood pressure, high triglycerides and low levels of high-density lipoprotein (HDL - the good cholesterol). Likewise, syndrome X is characterized by central obesity, high levels of insulin circulating in the blood, high triglycerides, low HDL and high blood pressure. Syndrome X is known to speed the development of heart disease. This study confirms that people with this FPLD trait also have a speed up of the development of heart disease.
The researchers examined 23 FPLD carriers and 17 controls. All carriers had insulin resistance as well as significantly more type 2 diabetes, hypertension and lipid abnormalities than the control group. The researchers concluded that FPLD is an appropriate human single-gene model for insulin resistance syndrome. It is hoped that studying this rare genetic condition can lead to a better understanding of more common forms. An example of this would be the studying of a rare form of high cholesterol which led to the creation of statin class cholesterol-lowering drugs, now one of the world's most prescribed medications.
Diabetes Care 24:1069-1078, 2001 has an article by Ryan J. Anderson, BA et al titled The prevalence of comorbid depression in adults with diabetes. The researchers looked at the odds and prevalence of clinically relevant depression in adults with both type 1 and type 2 diabetes. It is known that depression is associated with hyperglycemia and a increased risk for diabetic complications. A more accurate estimate of depression prevalence than that which is now available is needed to gauge the impact of depression management in diabetes.
A total of 42 eligible studies for MEDLINE and PsycINFO databases and published references were used; 20 (48%) included a nondiabetic comparison group. In the controlled studies, the odds of depression in the diabetic group were twice that of the nondiabetic group and did not differ by sex, type of diabetes, subject source, or assessment method. The prevalence of comorbid depression was significantly higher in diabetic women (28%) than in diabetic men (18%), in uncontrolled (30%) than in controlled studies (21%), in clinical (32%) than in community (20%) samples, and when assessed by self report questionnaires (31%) than by standardized diagnostic interviews(11%). They concluded that diabetes doubles the odds of comorbid depression. Prevalence estimates are affected by several clinical and methodological variables that do not affect the stability of the odds ratio.
We end with the news that many companies are looking for new and better ways of monitoring blood glucose levels because diabetes is one of the fastest growing diseases in this country. Johnson and Johnson is offering $1.3 billion for the glucose monitoring business of a company called Inverness Medical Technologies. This company has marketed a blood-monitoring device that takes only five seconds. New devices are being made that are less painful and can be used more simply. Most of the new monitoring devices are from Inverness/Johnson and Johnson, MediSense/Abbott, Roche Diagnostics, Bayer, and TheraSense Inc, which developed a diabetes tester called FreStyle for drawing blood from the upper arm, thigh, calf and anywhere on the hand. MediSense's Soft-Tact does not use chem strips and takes 20 seconds to read blood sugar levels. It stores up to 450 readings and provides average readings for the last 7,14 and 28 days. All data can be downloaded to a computer for further analysis.
Is this a good business? Roche Diagnostics is the leader in the $4 billion a year blood monitoring business - a business which has a 15% annual growth rate. Look for more development here.
BSP
