#1: REIMBURSEMENT IS A BARRIER TO CONTINUOUS GLUCOSE MONITORING. We spoke to Medtronic, Dexcom, and Abbott about reimbursement, but none of them were willing to discuss specifics. Dexcom said that they filed for codes right after getting FDA approval in March and they are hoping for reimbursement as soon as possible. However, they could not give a specific time estimate on reimbursement because it is up to the insurance companies, not Dexcom. They did mention that individuals have gotten reimbursed on a case-by-case basis. As far as indications, Dexcom wants to cast a wide net in terms of its customer base. Even though their FDA approval is for insulin users only, they want to attract everyone, including Type 2 patients on orals or diet and exercise. This is in contrast to Medtronic’s focus on pump users. Dexcom is pushing CGM for real-time patient analysis for instantaneous adjustments more than retrospective analysis by healthcare providers since glucose profiles are so variable from day to day. However, the Dexcom rep was also in favor of physicians buying CGM devices and loaning them to patients for short periods of time, especially for Type 2 patients.
Gary Schenider gave a talk on interpreting CGM data where he said that he thinks CGM has been over-promoted as a panacea. However, he conceded that all of his 300+ CGM patients have learned something from CGM because there is always room for fine-tuning their regimens. During Gary Schneider’s talk, a lot of CDEs bemoaned the lack of training in interpreting CGM data. Marcia Draheim commented that it surprised her that some health care providers do not like CGM because it provides them with more information than they are ready to handle because from her perspective, the beauty of CGM is that you can get as much data as you prefer.
#2: THERE IS A GROWING EPIDEMIC OF TYPE 2 DIABETES IN CHILDREN AND YOUTH. In Dr. Francine Kaufman’s session on type 2 diabetes in children, she described “hybrid diabetes,” or beta cell failure with impaired fasting glucose tolerance. This is due to the increasing number of patients with type 1 diabetes who are also overweight. Dr. Kaufman emphasized that the prevention of type 2 diabetes is as much about social and environmental factors as it is about diet and genetics. She suggested a tax on products that cause obesity.
#3: THE RENIN-ANGIOTENSIN SYSTEM MAY HOLD PROMISE FOR DIABETES PREVENTION. ACE-1 and ARB inhibitors may reduce the appearance of type 2 diabetes by preserving beta cell function, enhancing insulin sensitivity and changing microcirculation and potassium and magnesium status, which increases islet insulin secretion and cellular insulin action. In the ALLHAT study, the largest hypertension trial ever conducted, an ACE-inhibitor was shown to be more effective in reducing the percentage of new onset diabetes than a diuretic or a calcium channel blocker. Subjects on ACE-inhibitor lisinopril showed a 5.8% incidence of new onset diabetes after two years and an 8.1% incidence at a four-year followup, as compared to subjects on the thiazide diuretic chlorthalidone (9.6% incidence at two years and 11.6% incidence at four years) or the calcium channel blocker amlodipine (7.4% incidence at two years and 9.8% incidence at four years). In the DPP study, metformin with diet and exercise reduced diabetes incidence by 39% while just diet and exercise alone reduced diabetes incidence by 31%.
#4: THERE IS A BRAND NEW LANDSCAPE OF TREATMENT OPTIONS FOR TYPE 2 DIABETES. Nathan Painter presented a very thorough overview of the treatment options for type 2 diabetes. When he asked the audience whether they thought inhaled insulin would replace injected insulin, most people shook their heads no. Dr. William Cafalu thinks that the patients who might benefit most from inhaled insulin are the subset of Type 2 patients who are trying to control their diabetes with diet and exercise alone. Painter mentioned that Byetta might confer beta cell protection and/or regeneration. As for Levemir, he does not consider it a me-too drug, but he doesn’t like it because of the wide variability of duration indicated on the label (12-24 hours). In contrast, he does consider Apidra a me-too drug, though he did not mention tumors. Dr. Cefalu also talked about metformin, saying that, “probably every person in the country should go on metformin.” Metformin and glitazones work in conjunction with insulin to increase its efficacy. However, despite all of these new treatment options, few patients achieve their target A1C. Dr. Cefalu attributes this problem to “clinical inertia,” or the lack of understanding of efficacy/time activity profiles of currently available agents.
#5: INPATIENT MANAGEMENT OF HYPERGLYCEMIA IS STILL A STRETCH GOAL. Of the 300+ people who attended Dr. Etie Moghissi’s talk on the subject, none felt that they were where they needed to be in terms of inpatient hyperglycemia management. However, about half have started putting protocols in place and started discussing the issue in their hospitals. Moghissi discussed the ADA/AACE consensus statement on inpatient hyperglycemia management in great detail. She was very adamant that the sliding scale should be abandoned, and the audience clapped in response. As for the cardiothoracic ICU in particular, Norbert Knack found that the most effective insulin protocol was the one created by Dr. Bruce Bode and refined by Dr. William Biggs; it uses the Glucomander formula (see www.adaendo.com for Dr. Bode’s work and www.amirillomed.com for Dr. Biggs’ work).
#6: INFORMATION TECHNOLOGY WILL PLAY AN INCREASING ROLE IN DIABETES MANAGEMENT AND EDUCATION. Bonnie Pepon and Caille Wendekier presented the findings from a study that compared effects of online diabetes education for patients who had private internet access with those who had public internet access. In the study, public internet access consisted of kiosks with privacy screens at Uniontown Hospital. All study participants used MyCareTeam, an interactive website developed by Georgetown University that included a program that compiled uploaded glucose meter information and a program that allowed the CDE and patients to send messages to each other. The differences in A1c change, quality of life change, and problem areas score change between the two groups were insignificant, and these areas improved for both groups. While there was more deviation among those with public internet access, a public kiosk proved to be an effective medium for online diabetes education.
In her talk on the use of technology in diabetes education, Marcia Draheim predicted that the approaching shift in customer base to the new baby boomer seniors will change the way diabetes education is done. These patients are going to be busier and more technologically savvy, and health informatics will help diabetes education adjust. Health informatics will allow information to be sent rapidly from hospital to hospital. Furthermore, databases will be created to store data that has become too complex for paper-based methods. Finally, Draheim predicts that reimbursement will shift to meet the upcoming needs of patients. She hopes that educators will soon be able to bill for reviewing e-mails and doing other work on line. Welcome to the 21st century!
#7: IN ANOTHER ALARMING TREND, GESTATIONAL DIABETES IS INCREASING AMONG YOUNGER WOMEN, MANY OF WHOM ARE UNDER TWENTY. The HAPO study is currently underway to develop outcomes-based criteria for the diagnosis and classification of gestational diabetes mellitus. The MiG study is being conducted to compare the safety and effectiveness of insulin versus metformin in gestational diabetes mellitus. Both are slated to end in 2007. Women with gestational diabetes mellitus who used various intervention therapies to prevent complications in their babies and themselves showed the highest decreases in serious complications and macrosomia-and postpartum depression.
#8: DIABETIC NEUROPATHY IS CURRENTLY UNDER MANAGED. In her talk on diabetic neuropathy, Virginia Valentine estimated that the annual cost of diabetic neuropathy is $13 billion. Valentine recommended that CDEs use the Michigan Neuropathy Screening Instrument (MNSI) (which can be found at https://med.umich.edu/mdrtc/survey/survey_svi.html) to assess whether a patient has peripheral neuropathy. About 30% of diabetes patients are referred to neurologists for neuropathy, but the experience is rarely rewarding. Not only does it often take up to 6 months to get a [very expensive] appointment with a neurologist, but neurologists often do not have any solutions. As far as pain treatment options, Valentine thinks that neurontin is no more effective than TCAs, though neurontin causes fewer side effects. In addition, generic neurontin is now available, so it should no longer cost more. In addition, aldose reductase inhibitors are almost here - Fidarestat is in trials, and Epalrestat is now being marketed in Japan. Finally, ruboxistaurin has been fast-tracked by the FDA for retinopathy because the clinical data were so good. While ruboxistaurin was less convincing on the neuropathy front, it will hopefully be the first effective drug to treat the pathology underlying diabetic neuropathy and not just the pain.