When will it sink in!

December 15, 2010

“Priority should be given to programs with intensive and proactive follow-up that target patients at high risk of diabetes complications rather than to programs with low frequency of contact that target the overall population of patients with diabetes.” These words came from the authors of a study entitled “Effectiveness of disease-management programs for improving diabetes care: a meta-analysis” which was published online yesterday by the Canadian Medical Association Journal. Although Diabetic Investor is not overly fond of meta-analysis, at least this meta-analysis does not involve a diabetes drug or device, therefore making the analysis conclusions less subjective than what we have seen with other meta-analysis.

According to this study which reviewed forty-four studies, disease-management programs have a favorable impact improving glycemic control with the additional benefit of reducing a patient’s HbA1c. Just in case anyone has forgotten why it’s so important to help patients lower their HbA1c, consider that according to the United Kingdom Prospective Diabetes Study found that for each 1% reduction in HbA1c was associated with a 37% DECREASE in the risk of macrovascular complications and a 21% DECREASE in the risk of death related to diabetes.

The study, not surprisingly, found that disease-management programs are more effective for patients with poor glycemic and thus are prone to higher risk of complications. This may seem obvious but it does bring up a fundamental flaw with many of these programs that believe there is a one size fits all approach to diabetes management. In the real world the diabetes patient population can be divided into three basic groups, intensive managers, part-time mangers and non-managers.

Patients in the intensive manager group, the smallest percentage of patients, take their diabetes management seriously. While the majority in this group is on some type of insulin therapy, this is not always the case. The key element here is not what therapy option they chose to follow rather their level of engagement with their diabetes. Simply put, they have taken it upon themselves to make diabetes management part of their everyday life.

At the other end of the spectrum, the non-managers are almost the exact opposite of intensive managers. Non-managers basically see their diabetes a minor annoyance and hassle. They don’t take their diabetes seriously and see no need to become engaged with their disease. The unfortunate reality is there really isn’t much anyone or any program can do to engage these patients. For reasons many just don’t understand they are happy ignoring their diabetes, living their lives almost as if they don’t believe they even have diabetes. Unfortunately, too many patients fall into this group.

In the middle, and by far the largest group of patients, fall into the part-time manager category. These patients understand they have diabetes and also understand they need to manage their diabetes. The problem comes in with how intense this management should be and how it fits into their lives. Unlike intensive managers who monitor their glucose regularly, check their HbA1c quarterly, have annual eye exams, etc. Part-time managers are frustrated by the labor intensive nature of diabetes management and are looking for an easier way to manage their diabetes. A management system that does not control their lives rather a system that fits into their lifestyle. They are receptive to disease management and education provided it fits into their lifestyle and they see a personal benefit from the education. As the authors correctly note; “Patient education is the cornerstone of diabetes care.”

For some time Diabetic Investor has been watching the diabetes industry move from just being a provider of drugs or devices, to more of a patient coach. Just yesterday we noted how Medtronic (NYSE:MDT) with their new version of CareLink, can become a patient coach helping the patient manage their diabetes more effectively. Medtronic has no desire to take the physician out of the loop, rather using tools like CareLink they can enhance the physician’s ability to assist their patients and do so cost-effectively.

We have also followed the progress being made by Sanofi-Aventis (NYSE:SNY) who seeks to become the first company to provide a completely integrated and connected diabetes company. Sanofi wants to go beyond selling patients the drugs and devices they use and looks to expand into helping the patient more effectively manage their diabetes. As we have noted many times before the day is quickly approaching when patients will no longer buy their drugs from one company and devices from another, rather they will be prescribed a diabetes management system. This diabetes management system will include everything the patient needs with built in connectivity.

Although the study does not state specifically that different types respond to different disease management approaches, this conclusion can be inferred by their statement that these programs are more effective with patients with poorly controlled diabetes. The reality is just as treating diabetes is not a one size fits all approach neither should disease management be a one size fits all approach. An intensive manager will respond to a very different approach than a part-time manager. For example, an intensive manager is more likely to be interested in the latest drugs and devices. The intensive manager also embraces the available technology using the information to more effectively manage their diabetes. An intensive manager does not need to be reminded to monitor their glucose levels as they already understand the value of this information and how they can use it to more effectively manage their diabetes.

On the flip side, a part-time manager needs some coaxing to monitor their glucose levels on a regular basis. Frankly their not quite sure what this information means but they understand basically it needs to be done. An effective disease management approach would recognize the differences between the intensive manager and part-time manager and design approaches that align with the different needs of each group.

The authors concluded their study by stating; “Effective components of the programs were a high frequency of patient contact and the ability for disease managers to adjust treatment with or without the prior physician approval.” (Bold added by Diabetic Investor.) This conclusion is critical and also reveals another fundamental flaw in the majority of programs, the lack of patient contact. In the real world where physicians use guilt or fear to motive patients, patients prefer positive reinforcement and concern. This is one reason so many patients are turned off by programs, instead rewarding them for positive behavior, better outcomes and performing many of the daily tasks they must do to more effectively manage their diabetes, they treat the patient as if they are a child who should be scolded when they do something wrong or punished for not doing something they should be doing.

In the real world managing diabetes is tough enough as it is and for part-time managers especially they don’t need a disease manager calling them every five minutes to remind them to take their medications, visit their physician or check their glucose levels. However, part-time managers are very responsive to positive interactions and friendly reminders. For example, studies have shown that far too often physicians don’t even bother to look at a patient’s glucose log. Here the patient has gone to all the time and trouble to not only monitor their glucose but to track it as well. Rather than reinforcing this good behavior, the message delivered by the physician is all this work really doesn’t matter. Or worse, they look at the log focus on the higher than normal readings and scold the patient.

Common sense and human behavior tells us that a more effective approach would be to congratulate a patient for their hard work and provide tips on how they can avoid the higher than normal readings. Perhaps the best non-diabetes example comes from the many patients who try and lose weight. Anyone who’s ever been on diet knows they are more likely to remain engaged as they see the pounds dropping. This change in behavior is also reinforced when a friend, family member or co-worker notes how good they look. The simple reality is, whether it’s losing weight or managing diabetes patients respond much better to positive stimuli rather than negative stimuli.

Diabetic Investor also agrees that disease management can be enhanced when it is not necessary to consult with the physician before a change is made, however this may be somewhat impractical in the real world as the physician for numerous reasons does not want to be out of the loop. This issue can be overcome easily with technology like CareLink, where the physician can be kept informed and participates in the patient’s disease management. For example, using technology the disease manger can consult with the patient’s physician prior to a patient interaction. The physician approves what the manager plans on discussing with the patient and the manager can relay this approval to the patient. In the real world programs are more successful when the patient’s physician endorses and encourages participation rather than running interference.

Diabetic Investor also sees technology being used as a cost effective method for constant patient interaction and reinforcement. Besides email and text messages, diabetes devices themselves can add feedback features that reinforce positive patient behaviors. While this may sound somewhat hooky, a simple device like a glucose monitor can deliver more than just a number. This is not unlike what AgaMatrix has done with their monitors which deliver a smiley face after a good reading. Would it be that difficult to add in message that says thank you or good job? As we noted earlier hooky or not patients respond better to positive stimuli or no stimuli at all.

What concerns Diabetic Investor most isn’t what this study says or the conclusions it made. What is truly concerning here is how many times it needs to be said before everyone wakes up and realizes two critical points: