February 2016 Issue
February 2016 Issue
Diabetes Tech Talk:
An Interview with Dr. George Grunberger
Want to know about the latest scoop on diabetes technology? What might be coming down the pike to help patients better manage their diabetes? There's no better person to ask than George Grunberger, MD, FACP, FACE.
In 2002, Dr. Grunberger started the Grunberger Diabetes Institute in Bloomfield Hills, Michigan, to better serve his patients with diabetes. As Dr. Grunberger told us, diabetes technology is his passion. Since 2010, Dr. Grunberger has chaired multiple consensus groups organized by the American Association of Clinical Endocrinologists (AACE) to develop recommendations for the use of insulin pumps and continuous glucose monitors (CGM).
Q: You have spearheaded the development of several position statements and consensus meetings on both insulin pumps and continuous glucose monitors. What's the source of your passion for diabetes technology?
Dr. Grunberger: My passion is to speed up translational research so diabetes technology gets in the hands of the patients. In my practice, I see not only the toll diabetes takes but also the toll hypoglycemia takes on patients. I see their fear and the real impact of hypoglycemia. It's amazing what patients will do once they experience a hypoglycemia episode to make sure it doesn't happen again. It's frustrating for me to have technology available that can alleviate that fear and hopefully even prevent hypoglycemia, and to see it not getting into the hands of patients. So I'm trying to do everything possible, at least for my patients, to see they get a taste of the technology and get to use it. I cannot cure diabetes, so my job is to make sure patients can live life as long possible with the disease.
Q: Will the advent of sensor-augmented insulin pumps revolutionize diabetes care? Why or why not?
Dr. Grunberger: Theoretically, we can fix everyone's blood sugar with insulin. Why aren't we doing it? Because hypoglycemia is the barrier. If we do things to avoid, minimize, or mitigate hypoglycemia, we can help people better control their glucose. And hopefully with the artificial pancreas project, which the FDA has mapped out, we're going to get there. These systems already exist, although none of them are on the market yet. Nevertheless, hundreds of people already have an artificial pancreas because they have or are participating in clinical trials. These patients have less to worry about, because the system will automatically adjust insulin delivery to provide glucose control. When the artificial pancreas is officially on the market, it has the potential to revolutionize the healthcare of people with diabetes who depend on insulin.
Q: What sort of technological advances would help make pumps and CGM accessible to a broader range of patients?
Dr. Grunberger: Diabetes management is up to the patient. Healthcare professionals can assist, can cheerlead, can educate, but in the end, only the patient can decide what's important for them. Technology can help, but it can't replace the input of the patient. People make choices; technology can't replace that because technology can't read brain waves and translate necessary insulin action based on what the patient is about to do. For example, if a patient with diabetes decides to exercise, he or she should decrease the insulin delivery 1 to 2 hours before the activity because it will take a couple of hours before it will affect the cells. Technology cannot anticipate those needs.
If patients use CGM and the pump together, it's amazing how much more flexibility they have. If somebody takes one injection of basal insulin, it's going to be with them for the next 24 hours. No matter what they decide to do, if they try to change something, they have to think "oh, I have this basal insulin sitting there for the next 24 hours." If they're on the pump, there's no basal insulin, so patients can be more flexible. If patients want to go for a run, they can suspend the delivery of insulin. The pump does a lot to improve quality of life. It's not instant, but it does give patients more flexibility. As an endocrinologist, the main reason I recommend the pumps is because of better quality of life, not necessarily better blood sugar control.
Q: What do you think the next diabetes technology innovation will look like?
Dr. Grunberger: The ideal approach would be islet cells transplants, but done in a such a way that you don't need immunosuppression—this would be a cure for diabetes. The main reason transplants haven't been adopted is that patients must be on immunosuppression for life, which is risky because of the side effects of those drugs.
The ideal artificial pancreas would be implanted so you don't have to wear all the stuff. Currently people on the integrated CGM and pump need two insertion sites: one for CGM sampling of the interstitial fluid and another site to infuse insulin. Some people, such as thin people and children, don't have that much real estate, or that much space on their bodies, yet they still have to change the insertion sites for the pump about every three days and the CGM once a week. Anything that will make it mechanically easier, such as a single catheter that can deliver insulin and sample glucose, will be an advance.
Ultimately what's needed is a either a cure or at least something that can be implanted so that the patient doesn't have to wear a device at all.
ENRICHING DIABETES EDUCATION VIA CULTURAL SENSITIVITY & AWARENESS
BY BRANDI WALKER, RPA-C, CDE
As a diabetes clinical supervisor (DCS) in Brooklyn, New York, I have learned the importance of being able to relate to my patients' cultural backgrounds. After all, there are approximately 1.1 million ethnically diverse people living here.
It's important to keep in mind that diabetes disproportionately affects people with specific cultural/racial heritages, including African-Americans, Latinos, Asian and Pacific Islanders, American Indians, and Alaskan natives [Narayan et al]. In addition, more and more patients today have access to health insurance, including patients with various ethnic backgrounds, because of the Affordable Care Act.
As these factors converge, diabetes educators (DEs) will be responsible for educating more culturally diverse patients with different perceptions about diabetes when it comes to lifestyle changes, medications, and how they can continue to live a healthy life with diabetes.
IDENTIFYING CULTURAL BARRIERS
It's important to understand how cultural perceptions can affect the way patients approach and manage their diabetes.
- Some Latino patients may believe that having diabetes is a punishment from God for something they did, and they may not think they can control the outcome of their disease.
- Eastern Asian patients may feel that diabetes can be prevented and controlled by balancing their internal energy. They may believe in using traditional herbal medicines and home remedies.
- African-American patients sometimes believe they simply have a "touch of sugar" because they feel okay and still manage their daily activities. They may think that bitter foods and herbs, along with a strong faith, will eradicate their disease.
A common barrier among many of these patients is their perception of insulin. They may believe that insulin is a sign of failure, that it will cause more harm than good, and that they ultimately will die on it.
GREATER UNDERSTANDING=BETTER CARE
Identifying cultural barriers will help you ask appropriate questions about how your patients feel and why. You can delve deeper into any home remedies they may be taking or issues that could affect adherence. Involving family members can help patients realize they aren't alone and can help them overcome feelings of shame or punishment. It's also important to provide them with nutritional advice that takes into consideration the foods commonly eaten within their culture.
It's our responsibility as educators to uncover and understand these cultural considerations so that we can educate our patients to the best of our ability. A Position Statement issued by the American Association of Diabetes Educators (AADE) gets to the heart of the issue: "Embracing and practicing cultural humility is vital to developing a mutually respectful relationship among patients and healthcare providers [that] will help patients achieve desired outcomes to improve their quality of life."
A number of online resources and calendars are available to help you build your cultural calendar of ethnic and religious observances. A great place to start is this calendar published by Missouri State's Division of Diversity and Inclusion, which specifies holidays that require fasting or other practices that may affect patients' glucose control. You can use this information to start a dialogue with your culturally diverse patients about their upcoming holiday plans and how their diabetes therapy may need to be adjusted.
- Narayan KMV, Williams D, Cowie CC, Gregg EW. Diabetes public health: From data to policy. New York, NY: Oxford University Press; 2011.
- Cultural sensitivity and diabetes education: American Association of Diabetes Educators (AADE) Position Statement. American Association of Diabetes Educators. Accessed June 4, 2015.
- Cultural and religious observances. Missouri State Division of Diversity and Inclusion. Accessed June 4, 2015.
WHEN THE DE'S ROLE EXPANDS, PATIENT OUTCOMES IMPROVE
Diabetes educators formally trained and overseen by endocrinologists can successfully instruct and guide patients' treatment at the primary care level—even without the patients being seen by an endocrinologist. In a recent study [Al-Atrash et al] presented at the American Association of Clinical Endocrinologists' (AACE's) 24th Annual Scientific and Clinical Congress, researchers reported that these specially trained certified diabetes educators (called CDE-Ambassadors, or CDE-As) induced significant improvements in patient outcomes, including:
- Glycemic control (as measured by A1C);
- Body weight/body mass index (BMI);
- Blood pressure (BP); and
- Lipid concentrations
ABOUT THE STUDY
The retrospective review included 100 patients with type 2 diabetes (T2D) who were referred by their primary care physician (PCP) to consult with a CDE-A at an endocrinology practice. None of the patients was seen directly by an endocrinologist. The CDE-As received training from endocrinologists for 3 months prior to the study start.
The patients' clinical outcomes were compared to 45 patients with T2D from the same practice who were not referred to a CDE-A. Researchers tracked glycemic control, cardiovascular risk factors, and other clinical measures during an average study period of 4.6 months, starting with the first CDE-A visit and ending with each patient's regularly scheduled follow-up appointment with his or her PCP. During that time, most patients met with the CDE-A 2 times.
Overall, the patients who were under the care of a CDE-A saw the following improvements:
- Glycemic control: A1C dropped from 8.4% ± 2%, to 6.8% ± 1%
- Weight/BMI: Weight decreased by 2.8 kg, and BMI by 0.96 (P <0.0001 for all).
- BP: Systolic BP decreased from 134 ± 17 mm Hg to 128 ± 13 mm Hg, and diastolic BP dropped from 80 ± 10 mm Hg to 77 ± 9 mm Hg (P <0.005 for both).
- Lipid concentrations: Low-density lipoprotein-cholesterol (LDL-C) fell from 108 ± 36 mg/dL to 96 ± 36 mg/dL, and triglycerides decreased from 189 ± 121 to 162 ± 90 mg/dL (P <0.005 for both).
- Albuminuria: The urine microalbumin/creatinine ratio dropped from 64 ± 536 to 27 ± 153 mg/g (however, that number was not statistically significant at P = 0.33).
"These changes were dependent on changes in dietary habits and drug therapy, including the addition or optimization in the doses of anti-diabetic drugs and insulin doses," the authors wrote. They noted that the improvements in lipid concentrations occurred without any changes in statin therapy, theorizing that enhanced adherence may have been a factor.
In contrast, the 45 comparator patients who were not under the care of a CDE-A during a similar follow-up period did not see any significant changes in any of these indices.
FUTURE RESEARCH & FOLLOW-UP
The researchers stated that they are considering conducting prospectively randomized studies to compare centers that are supported with CDE-As and those that are not, with a focus on measuring the durability of these effects as well as cost considerations—including possible cost savings.
"The changes in glycemia, blood pressure, lipids, and body weight would potentially result in a significant reduction in microvascular and macrovascular complications and improvement in the quality of life of these patients," the authors stated. "In addition, it will reduce the magnitude of expenditure which currently occurs in the management of these complications."
DIABETES EDUCATOR TAKE-HOME POINT FROM LAUREL MESSER, RN, MPH, CDE: The improvement in health metrics that patients in this study experienced is good news for both patients and DEs. There is no question that when healthcare professionals spend time with their patients, patient education, understanding, and outcomes improve. This study demonstrates exactly that, with an exciting applicability to DEs and the important role we can play in improving patient outcomes.
Here are some thoughts on how the CDE-Ambassador model can be translated and replicated for wider use:
- More PCPs could employ professionals in a CDE-Ambassador type role to work in conjunction with local endocrinologists for ongoing training. With a shortage of practicing endocrinologists in this country, this is a creative way to ensure that patients with diabetes receive comprehensive care in a primary care setting.
- Perhaps a DE in your practice (such as yourself!) could initiate a conversation about how to expand the DE role to make a version of the CDE-Ambassador a local reality. Opportunities abound, and clinical research such as this study backs up the life-changing difference that DEs can make.
In a healthcare environment that discourages providers from spending adequate time with patients, maximizing the role of DEs to deliver first-rate healthcare is inspired. As DEs, we consistently strive to utilize our advanced knowledge to achieve better patient outcomes—so it's a perfect fit.
- Al-Atrash F, Mersereau M, Bierbrauer M, et al. The CDE-Ambassador: A novel approach to control diabetes at the primary care level leads to significant improvement in glycemic control and cardiovascular risk factors [Abstract]. Presented at: American Association of Clinical Endocrinologists' 24th Annual Scientific and Clinical Congress; May 13-17, 2015; Nashville, TN. http://journals.aace.com/doi/pdf/10.4158/1530-891X-21.s2.1. Accessed May 20, 2015.
- 24th Annual Clinical & Scientific Congress. American Association of Clinical Endocrinologists. http://am.aace.com/. Accessed May 20, 2015.
LET'S GET PHYSICAL:
BEST PRACTICES IN FITNESS & EXERCISE EDUCATION
Let's talk about exercise and fitness.
While everyone knows physical activity is a critical component of optimal diabetes control, it's important to use fresh, creative approaches when discussing this topic with patients so that you can keep them engaged and motivated.
We've brought together 4 diabetes educator (DE) thought leaders to share the best of their best practices in this area. Their focus, like yours, is on helping patients connect the dots when it comes to the key role that exercise plays in helping them achieve optimal diabetes control. Two of these experts have the added perspective of personal experience, since they are on sensor-augmented pump (SAP) therapy themselves.
Q: What are some of your best practices to encourage patients to exercise?
GETTING OFF TO A GOOD START
"We encourage exercise through a 'Keys to Control Diabetes Program' offered through the local wellness center. The program is a free 1-month membership with an individualized exercise program from an exercise physiologist. Once the month is completed, ongoing membership at the wellness center is encouraged. Some patients are not able to maintain their membership due to the cost, in which case we recommend walking/biking on local trails, a home regimen, and/or joining a fitness center with a lower cost."
KNOWLEDGE IS POWER
"The Plans and Recommendations template in our practice's electronic medical record allows us to enter take-home exercise instructions for patients. I encourage adult patients to get at least 150 minutes of exercise weekly.
In Maine, the winter weather can be severe, and it is imperative that patients have access to indoor exercise that they enjoy. I frequently show patients short clips of YouTube exercise videos such as Leslie Sansone's 'Walk at Home' series or Paul Eugene's 'Chair Fitness Workouts.' They can see for themselves that these routines are fun and do-able by the average person."
CARROTS INSTEAD OF STICKS
"I like to remind patients that diabetes doesn't own them—they own their diabetes. Therefore, I encourage them to integrate exercise into their lives, while explaining that everyone should take part in regular physical activity to better their overall health—whether they have diabetes or not. Patients need to buy in to the fact that exercise is something good they are doing for themselves, and not some type of punishment or burden to bear."
Q: What are some specific challenges patients on pump therapy face when it comes to exercise, and how do you overcome those challenges?
SENSE & SENSOR-BILITY
"The biggest challenge that insulin-using patients experience when exercising is hypoglycemia. One helpful feature of SAP therapy is the ability to use a temporary (temp) basal rate. When necessary, a patient can program a lower basal rate for a specified period of time. Intense exercise of long duration can have a prolonged BG-lowering effect, and a reduced temp basal rate can help prevent low BG hours later.
I am on SAP therapy myself, and have found this approach to be very helpful when I am getting core exercise such as weeding the garden. Knowing that core exercise makes my BG drop significantly, I have my low alert set on 70. When I reach a sensor glucose (SG) of 70, I am alerted. When I am using my elliptical machine, I watch my SG while exercising and afterwards. I have found that my elliptical exercise does not result in the same intense drop in BG as core exercises. How do I know this? From data provided by my sensor, of course!"
EMPOWERING PATIENTS WITH TEMP BASALS
"There is so much flexibility in how you can use a temp basal, and I try to empower patients to just TRY IT! There is no magic formula for duration and percent. I may suggest an initial setting (example: 2 hours post-exercise at 50%), while emphasizing to patients that this is just a starting point and probably not optimal—but that they can experiment from this point forward. I find temp basal usage empowers patients to feel more in control of their diabetes regimen."
Q: What are some considerations for patients on pump therapy when it comes to active vacations or exercise in specific weather conditions?
PACK 2 OF EVERYTHING!
"I have developed a Vacation Information Card to clearly guide patients when they prepare and pack for vacations. I always tell them to assume they will not be able to obtain supplies at their destination, so it is in their best interest to pack 2 of everything."
HOPE FOR THE BEST, PREPARE FOR... INEVITABILITIES
"Patients who live in Maine frequently go to the Caribbean or Florida during the winter. We get many questions about how to deal with the sand, salt water, and hot weather while on IPT.
Some patients purchase waterproof cases for their pump. We also recommend that they take a cooler with them to the beach. They can put their pump into a container and in the cooler for brief amounts of time while they go in the water for a swim. It's important to remind patients that swimming tends to cause BG to drop significantly. I always remind patients to take juice and snacks to the beach, to stay well hydrated, and to pack more supplies than they think they will need.
Winter sports can pose different challenges. It is important that the infusion site is placed in a location on the body where there won't be a lot of jarring. Patients need to wear the clip that goes with the pump and ensure that it's securely attached when skiing or snowboarding. It's also important to keep insulin close to their warm body. I have heard of few if any problems with insulin freezing during winter sports while following these guidelines.
Skiing and snowboarding, both core exercises, can cause significant drops in BG. Patients need to be reminded that they always, always must carry glucose tablets or another form of fast-acting carbohydrate with them in case of hypoglycemia."
Q: What are some considerations for intensive exercise regimens when on pump therapy?
LEARNING FROM OBSERVATION
"We have some patients who are elite athletes. I recall one young woman who participated in national track and field events who would have higher BG levels during competitions. Intense exercise or exciting athletic events actually can cause BG to rise temporarily.
We have some patients who find that they do not need to consume extra carbohydrates during an intense or exciting event—but they need to consume extra carbs afterwards, when the stress hormones subside and BG tends to drop.
Patients who are successful in managing their BG levels during exercise have watched their levels during and after exercise and have learned from those observations. We advise patients to take the time upfront to learn how their glucose levels react to various types of exercise. Sensor data is extremely important in monitoring how factors such as exercise affect glucose levels."
FINDING THOSE SWEET SPOTS
"When patients plan to start new exercise regimens while on IPT, I advise them to check their BG before, during, and after exercise. If BG is < 100 mg/dL prior to exercising, I suggest they eat 15 grams of carbohydrates with a protein, without coverage, prior to exercising. If the patient has a BG >250 mg/dL prior to exercising and ketones are present, I advise them not to work out until the BG is <250mg/dL and no ketones are present.
Once the exercise effect on glucose control is known, education is provided on temp basal use. If the patient is experiencing hypoglycemia during exercise, usually 20% to 90% temporary basal is started 1 hour before and during exercise. The temp basal is then stopped after close monitoring of BG.
Hypoglycemia can occur 24 to 36 hours after intense exercise, so small frequent meals are encouraged. The patient is advised to continue to monitor their BG before, during, and after exercise, and changes are made accordingly to their exercise needs. Temp basal also can be used to manage hyperglycemia during exercise."
- Leslie Sansone's Walk at Home [YouTube channel]. Leslie Sansone's Walk at Home.. Accessed June 2, 2015.
- Paul Eugene: Born to inspire the world to fitness [YouTube channel]. Paul Eugene. Accessed June 2, 2015.
- Messer L. In the Know: We want to hear from you! Medtronic Diabetes. Accessed June 2, 2015.
NEWS YOU CAN USE
METER TO METER
It's important to remind patients to use the meter that comes with the pump for accuracy. The CONTOUR®NEXT LINK meter is the only blood glucose meter approved by the FDA as part of the MiniMed® 530G with Enlite® system. This meter should be used consistently, especially for boluses and calibration. For more information on sensor calibration techniques, refer to "Help Has Arrived: Mastering Advanced Calibration Techniques."
In previous issues of In the Know, Dr. Timothy Gilbert shared his valuable insights about insulin pump therapy and secrets to their success. In this issue, Dr. Gilbert shares his tips on setting up practice management goals and performing practice efficiency as a team. Check out this video to uncover the scenes behind his practice!
Time will "spring forward" on March 13, 2016 when Daylight Savings Time begins. The time on your insulin pump and meter determines your personal settings (including basal and bolus rates), so remind your patients to update insulin pump and meter settings to ensure that it is up-to-date!
- Gilbert, T. Implementing MiniMed® 530G with Enlite Best Practices and Training. Medtronic Diabetes. Accessed January 21, 2015.
- Gilbert, T. T2D and pump therapy: It's time to redefine the "ideal" patient. In the Know [Medtronic Diabetes and Bayer HealthCare]. Accessed January 21, 2015.
- Gilbert, T. Insulin pump therapy/CGM: There is no "one-size-fits-all." In the Know [Medtronic Diabetes and Bayer HealthCare]. Accessed January 21, 2015.
- Spring Forward. Loop Blog. Accessed January 21, 2015.
- CONTOUR® NEXT LINK User Guide. Medtronic Diabetes. Accessed January 21, 2015.
- Updating Your Time & Date. Medtronic Diabetes. Accessed January 21, 2015.
- ALICIA DEVORE, RN, CPT, has been an independent Certified Product Trainer for Medtronic for 2 years. Most of her work is based in endocrinologist offices In Wheeling, West Virginia. She works with both pediatric and adult patients. Alicia was diagnosed 7 years ago with type 1 diabetes (T1D) and currently manages it with the MIniMed® 530G with Enlite® system.
- GENEVA KENNEDY, CPT, is a Certified Product Trainer (CPT) for Medtronic, based in Kentucky. For the past 11 years, she has worked collaboratively with the medical team at a large endocrinology practice. Her work for Medtronic includes helping to identify patients with T1D and type 2 diabetes (T2D) who are candidates for pump therapy, and providing support for insurance processes, pre-pump training, pump therapy Initiation, and ongoing training.
- HEATHER LECLERC, MS, RD, CDE, is a clinical supervisor of The Diabetes and Endocrine Specialists of Maine, an outpatient practice of Eastern Maine Medical Center where she has worked for the past 28 years. Along with the office's 5 other certified diabetes educators (CDEs), Heather provides education for patients with diabetes of all ages and assists the 5 providers in the office with day-to-day medical management. Approximately 8 years ago, she developed latent autoimmune diabetes in adults (LADA) and is treating it with the MiniMed 530G with Enlite.
- LAUREL MESSER, RN, MPH, CDE, is a proud diabetes educator and clinical research nurse who has specialized for the past 10 years in T1D, insulin pump, continuous glucose monitoring (CGM), and artificial pancreas device system studies. She works with pediatric and adult patients at the Barbara Davis Center for Childhood Diabetes in Aurora, Colorado. Laurel helped author the Pump and CGM Pink Panther book and has contributed to others in the series.
- ELIZABETH (BETH) NARDACCI, MS, FNP-BC, CDE, guest editor of this issue of In the Know, is a family nurse practitioner at Capital Region Diabetes and Endocrine Care in Albany, New York. Her special interests include diabetes technologies, including professional and personal CGM and insulin pump therapy, chronic kidney disease, and renal transplantation. She is a principal investigator in the OpT2mise international pivotal trial for use of insulin pump therapy in type 2 diabetes (T2D). Beth serves as an advisor to the American Association of Clinical Endocrinologists Task Force on Continuous Glucose Monitoring. She was a recipient of the Juvenile Diabetes Research Foundation's Inspiration Award and has made numerous presentations and published clinical papers on diabetes technologies. Please send your feedback about the issue to IntheKnow@medtronic.com.
- BRANDI WALKER, RPA-C, CDE, is a Clinical Supervisor and has been with Medtronic Diabetes for almost 9 years. She has been educating patients with diabetes for 13 years. Her extensive experience with interventional radiology and treating vascular complications from diabetes, and having family members with type 2 diabetes makes her passionate about diabetes.