	Chronic conditions, such as type 2 diabetes mellitus (T2DM) and heart disease, continue to increase in prevalence and cost. The American Diabetes Association estimates that 29.1 million Americans had diabetes in 2012.

 The healthcare cost of the 21.1 million who were actually diagnosed totalled $245 billion, which is more than 2 times higher than nondiabetics.

 The World Health Organization estimates that by 2030, 330 million people worldwide

will have diabetes. These sobering statistics only begin to tell the human story. Diabetes is the major cause of both end-stage renal disease leading to dialysis or kidney transplant and noncongenital blindness. End-stage organ failure significantly reduces the quality of life of people with diabetes and takes a major emotional toll on patients and their families.

	T2DM and many other chronic conditions can be prevented, controlled, even reversed with a combination of medical treatment and lifestyle changes. Unfortunately, many people are unable to start or maintain these needed steps. A better healthcare system that treats the whole person—not only the condition&mdash;can help.

THE CRITICAL ROLE OF MEDICATIONS IN TREATMENT

	No doubt, medications play a critical role in the management of chronic disease and in preventing or delaying additional more serious conditions. For example, controlling blood glucose with and without insulin, is an important goal for diabetics and helps to prevent a number of vascular and neurologic complications and related disabilities. Effective adherence to medication regimens will improve both outcomes and quality of life for patients, and reduce both direct and indirect costs.

	Reminder programs, timers, electronic pill boxes, and other devices can be great tools for helping patients who are forgetful or are on complex medication schedules. Additionally, plan designs, such as Aetna RX Healthy Outcomes, remove or lower the co-payment for targeted drugs to help address financial barriers. However, even a $0 co-pay does not always result in perfect adherence.

	Most medication nonadherence stems from patients choosing not to take their medications based on beliefs about their treatment, diagnosis, and prognosis. They may choose not to fill their prescriptions, take the medication infrequently, or stop taking medication altogether due to side effects or other concerns. Studies that examine intentional and unintentional nonadherence show that 80% of medication nonadherence is deliberate. Further, despite much attention, health literacy accounts for only 20% of nonadherence.

	Patients are not pill-taking machines, and medication adherence alone is not the answer to improving health. Healthy diet and exercise can also deliver significant health benefits. Still, the  disease is only one part of a person’s life. Medication, diet, and exercise must be incorporated into a person’s existing routine in a way that is both realistic and sustainable—and that requires motivation.

	Health plans, both insured and employer-sponsored, often feature incentives and reward programs for healthy actions. These external motivators may include a reduction in premiums for completing an activity, such as answering a health risk—assessment questionnaire or reaching a health goal (target cholesterol levels, healthy weight, steps walked, etc).

	Taken a step further, programs like Aetna’s Metabolic Syndrome Program assess a person’s current risk for metabolic syndrome. This group of 5 closely related conditions—increased blood pressure, elevated blood sugar, excess body fat around the waist, low HDL, and high triglyceride cholesterol levels&mdash;can increase a person’s risk of heart disease, stroke, and diabetes. The more conditions a person has at one time, the greater the risk. However, metabolic syndrome can be reversed by making changes to diet, losing weight, and exercising. Aetna’s program provides a detailed, personalized health report with suggested steps that help prompt the member to take action to better health. While both incentives and actionable information can provide a great start, continuing the journey to better health requires development beyond external motivators to internal motivation.

	Suppose a person takes up jogging to lose weight and increases the amount of aerobic activity that he can log in his employer-sponsored health challenge, he may be rewarded for meeting a new health goal. But, over time, those rewards begin to matter less. To keep running, he needs to want to run. Running—not the external reward&mdash;becomes the goal. The satisfaction that he feels when he completes a run, logs miles for the week, or enjoys the camaraderie of being with like-minded individuals at a local 5K race are all rewards in themselves. The popularity of Team-In-Training and the high participation rates in marathons and races of all lengths demonstrate the power of internal motivation.

	Recognizing the importance of internal motivation, Aetna’s care management programs have integrated motivational interviewing (MI) techniques to help people identify and develop internal motivators. Instead of telling people why they need to follow a treatment or just rewarding them for doing so, nurses and health coaches help each individual develop a unique set of internal motivators. MI focuses on mutual, personal guidance and has been proved in clinical studies to decrease resistance and enhance motivation to change. Building from this evidence, Aetna health coaches can better empower members in their care.

	Practicing the principles of MI, Aetna’s disease management nurses have an enhanced ability to create a safe place for members to focus on their health. Nurses elicit, rather than impose, motivation to change. They help members explore and reinforce their own arguments for change, and then guide fully informed and autonomous choices. Creating a highly personalized member experience with real conversations, not scripted interactions, encourages members to take greater responsibility for their actions and health.

	Studies also demonstrate that adherence improves in patients who report a good relationship with their physician, with effective communication being an important factor in those relationships. A patient-centered approach to care promotes a partnership in making decisions about medication, considers cultural beliefs and attitudes, and actively encourages input and feedback from the patient.

	Mobile technology is transforming the world, and health care is no different. Patients have a growing selection of phone apps and Web-based tools to help inform, connect, motivate, and track their health goals. Several adherence apps are free and have companion websites that allow physicians to enter their patients’ prescriptions. Many have privacy-compliant cloud data storage that can be accessed from the doctor’s office, updated, and delivered to the patients’ mobile devices. Customized reminders also can be set up, and information on doses taken or missed can be exported to the doctor’s office for review. Still, technology alone has limited benefits. Many of the apps rightly have disclaimers advising that patients should not rely on an app alone to remember to take medications.

	Addressing the problem of chronic disease management requires approaching people as an entire being, not as a machine fuelled by pills. Rather than focusing on medication adherence alone, patients need access to a combination of external and internal motivators that can help them start and maintain a routine that successfully integrates medication, healthy diet, and exercise. When health plans, plan sponsors, healthcare providers, and patients can work more closely to ensure all of the elements are considered and supported, better health outcomes will follow.

	Ed Pezalla, MD, is vice president, national medical director for Aetna Pharmacy Policy and Strategy; Mark Friedlander, MD, is chief medical officer for Aetna Behavioral Health; and Mary Von, RN, is senior project manager, Aetna Behavioral Health.

	1. National Diabetes Statistics Report. CDC website. http://www.cdc.gov/diabetes/library/reports/surveillance.html. Published June 10, 2014. Accessed December 30, 2014.

	2. American Diabetes Association. Economic costs of diabetes in the United States in 2012.Diabetes Care. 2013;36:1033-1046.

	3. Country and regional data on diabetes. World Health Organization website. http://www.who.int/diabetes/facts/world_figures/en/. Accessed December 30, 2014.

Articles

Evidence-Based Diabetes Management

Optimal Health Requires More Than Medication

	The treatment landscape for type 2 diabetes mellitus (T2DM) has broadened greatly over the past decade with innovative therapies now targeting several distinct pathways involved in the metabolic regulation of blood glucose levels. The advent of these treatments has sparked a new race in the pharmaceutical industry to demonstrate clinical and cost-effectiveness benefits compared with standard-of-care therapies.

	One noticeable trend in the development of new oral anti-diabetic products is the increase in fixed-dose combination therapy (FDCT) products, which aim to increase efficacy in lowering glycated hemoglobin (A1C) and blood glucose while reducing the side effects of the individual agents used. Several FDCT products combining metformin with a sulfonylurea, thiazolidinedione, or dipeptidyl peptidase-4 (DPP-4) inhibitor are already on the market. Other products that combine these medications with newer agents, such as the sodium-glucose co-transporter 2 (SGLT-2) inhibitors, are either in late-stage clinical trials or under FDA review. While the goal of preserving or increasing market share for a product is common among developers of these combination therapies, the benefits of these products to patients will no doubt come under increasing scrutiny from payers.

	One rationale for developing FDCT products is the benefit of increasing patient adherence to prescribed medication regimens. By reducing a patient’s pill burden, especially for those with additional comorbidities requiring dual or triple therapy, an FDCT product may offer a more convenient administration option compared with loose-dose combination therapy (LDCT) with individual products.

	Several studies have evaluated the impact on adherence rates of switching patients from dual therapy to FDCT. One retrospective cohort analysis of 7570 FDCT users and 14,762 LDCT users in the Texas Medicaid prescription claims database showed a 12.4% increase in patient adherence.

 A separate study focusing on patients treated with pioglitazone and metformin found an 8.9% increase in adherence when switching from LDCT to FDCT,

and analyses of 17 different studies conducted between 1998 and 2009 yielded similar results, with improvements in adherence ranging from 10% to 13% with FDCT compared with LDCT.

	The increased adherence seen with FDCT products translated into improved clinical outcomes and cost-effectiveness for patients. Several studies analyzing the effect of nonadherence to prescribed oral anti-diabetic regimens on glycemic control found increased risks of all-cause hospitalization and mortality due to complications from poorly treated diabetes.

The subsequent economic burden of these complications was also evaluated, and a retrospective analysis of 100,000 patients with T2DM found annual increased healthcare costs of $336 and $1509 for  nonadherent metformin and sulfonylurea users, respectively, compared with adherent users.

 These figures were obtained even after accounting for the increased cost of medication that comes with improved adherence, showing that the medication cost was more than offset by the cost savings from averted hospitalizations.

 The cost of an FDCT product (Actoplus Met, pioglitazone/ metformin) compared with its analogous LDCT products was also studied, and the FDCT product was found to be $0.26 less per tablet compared with the LDCT products, leading to a cost savings of approximately $8 per patient per month with FDCT therapy.

CMS REIMBURSEMENT POLICIES FOR FDCT PRODUCTS

	Despite these findings, which support the clinical efficacy and economic benefits of FDCT therapy, a cost-cutting battle continues over the formulary inclusion status of these products in Medicare Prescription Drug Benefit Program (Part D) plans. CMS proposed a change for 2015, struck down in June 2014, that would have made FDCT products exempt from being required on the formularies of Part D plans. The rationale given for this change was that because all individual medications in a given therapeutic class would be included on the formulary as single-entity products, requiring the inclusion of FDCT products would be redundant and unnecessary.

	The proposed change would also have both encompassed protected therapeutic classes such as anticonvulsants and antineoplastics, which traditionally include all medications in the class on formulary without restrictive prior authorization requirements,

 and removed the protected designation for immunosuppressants, antidepressants, and antipsychotics, which would reduce the number of medications on formulary for these classes in a bid to lower drug costs. CMS proposed that antiretroviral medications be excluded from this exception, under the rationale that nonadherence to treatment in this therapeutic class presented far more serious clinical consequences than in other cases. As such, CMS concluded that the benefit of increased adherence with antiretroviral FDCT products would warrant formulary inclusion in addition to the single-entity products.

 For now, there are no active proposals to exempt FDCT therapies in protected drug classes from required formulary inclusion. However, it remains to be seen what future guidance CMS will issue regarding FDCT medications, as the agency continues to pursue costcutting strategies while considering the potential clinical and economic benefits of these products.

	The proposed changes to Medicare Part D regarding FDCT products come even as the FDA has reconsidered exclusivity rules for such therapies. In recognition of the clinical and cost-effective benefits provided by FDCT products, the FDA finalized an industry guidance in October 2014 that extended exclusivity to 5 years for newly approved FDCT products that combine a New Chemical Entity (NCE) with previously approved components. This benefit, however, will not apply retroactively; any FDCT products approved prior to finalization of the guidance will still have the former 3-year period of exclusivity. In making this change, the FDA noted the benefits of FDCT products, such as improved patient adherence and clinical outcomes, as well as advantages in certain therapeutic areas, such as anti-infectives in combating drug resistance. As such, the FDA considered the change in exclusivity rules an incentive to encourage the development of novel FDCT products.

	David Yao is a PharmD candidate at the Ernest Mario School of Pharmacy, Rutgers, the State University of New Jersey.

	1. Cheong C, Barner JC, Lawson KA, et al. Patient adherence and reimbursement amount for antidiabetic fixed-dose combination products compared with dual therapy among Texas Medicaid recipients. Clinical Therapeutics. 2008;30(10):1893-1907.

	2. Barner JC. Adherence to oral antidiabetic agents with pioglitazone and metformin: comparison of fixed-dose combination therapy with monotherapy and loose-dose combination therapy. Clinical Therapeutics. 2011;33(9):1281-1288.

	3. Garcia-Perez LE, Alvarez M, Dilla T et al. Adherence to therapies in patients with type 2 diabetes. Diabetes Ther. 2013;4:175-194.

	4. CMS. Contract year 2015 policy and technical changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs. https://www.federalregister.gov/articles/2014/01/10/2013-31497/medicareprogram-contract-year-2015-policy-and-technicalchanges-to-the-medicare-advantage-and-the#h-41 Published January 10, 2014.

	5. Food and Drug Administration. New chemical entity exclusivity determinations for certain fixed-combination drug products: guidance for industry. https://www.federalregister.gov/articles/2014/10/16/2014-24597/new-chemicalentity-exclusivity-determinations-for-certain-fixedcombination-drug-products-guidance Published October 2014.

Patient Adherence and CMS Reimbursement Policies for Combination Oral Anti-Diabetic Therapies

	Each year, diabetes complications send more than 10 million Americans to the emergency department,

 cause nearly 50,000 cases of kidney failure, necessitate nearly 75,000 amputations, contribute to millions of heart attacks and strokes,

	The good news is that existing treatments control the disease well enough to prevent most of those problems and eliminate most of those costs. The bad news is that the majority of patients

	fail to follow treatment plans with the precise diligence that would keep them healthier and the healthcare system solvent. In theory, a system that automatically gives patients just the right amount

	of medication at just the right time could revolutionize diabetes treatment, and that’s why some researchers are so excited about an experimental product for type 2 diabetes mellitus (T2DM), ITCA 650. ITCA 650 can pack a full year’s worth of a medication called exenatide into a matchstick-sized tube, which sits under the skin and dispenses a continuous trickle of treatment.

	Implantation takes only a few minutes and hurts little more than a single shot. Operation is automatic. Trial results are impressive. “I have been doing diabetes research for 47 years now, and this ranks among the most exciting things I’ve ever seen,” said Jay S. Skyler, MD, MACP, deputy director of the Diabetes Research Institute at the University of Miami’s Miller School of Medicine. “It has shown itself to be truly powerful in trials to date, reducing A1C (glycated hemoglobin) levels to a remarkable degree without any effort from patients."

		The only way to consolidate a year’s worth of medication into an implantable device is to start with an incredibly potent medication, and it would be hard to find one more potent than exenatide. In

		2005, the FDA approved the drug for use in T2DM patients at 2 tiny doses: 10 or 20 micrograms per day.5 Those doses equate to 3.65 or 7.3 mg per year. A single tablet of extra-strength acetaminophen, by comparison, contains 500 mg of medication. Of course, the medicine inside an implantable device must also be stable enough to remain at body temperature for months

		on end without degrading. Exenatide, in its original formulation, failed miserably on this front. It was a synthetic hormone that degraded almost immediately under anything short of optimal

		conditions. The notion of using it inside an implantable device only became possible when researchers at Intarcia Therapeutics, a Boston-based company, discovered a technique for stabilizing

		proteins, peptides, and antibodies at very high temperatures. Intarcia’s executives quickly realized that this stabilization process would allow medications to remain potent for long periods inside the human body.

		The only real obstacle was distribution. However, as they soon discovered, another company had already designed osmotic mini-pumps that could release a steady stream of medication into the body for years on end. Intarcia bought the rights to that technology and, shortly thereafter, began testing its lead product. The most recent information about ITCA 650’s performance came out in October, when Intarcia announced top-line results of 2 phase 3 trials of the formulation. The first of those trials randomized 460 patients with A1C levels between 7.5% and 10% evenly among placebo and 2 doses of ITCA 650, 40 mcg per day and 60 mcg per day. (Doses of Intarcia’s formulation are higher than approved doses of exenatide because earlier trials demonstrated 40 mcg and 60 mcg to be more effective than lower doses of the form of the drug and delivery system.)

		Patients in the active arms started with 3-month devices that delivered an initial dose of 20 mcg per day, and then received 6 months of treatment at one of the 2 trial doses. Those who eventually received the lower trial dosage of 40 mcg saw their A1C levels drop an average of 1.4 percentage points, and those who received the higher dosage of 60 mcg saw their A1C levels drop an average of 1.7 percentage points. Both of those reductions significantly bested results for patients in the control arm of the trial.

		Intarcia announced these results, of  the FREEDOM-1 and FREEDOM-1 high baseline phase 3 trials, in an October press release. The company said it was submitting full findings for presentation

		at the 75th Annual Meeting of the American Diabetes Association, scheduled for June 2015 in Boston.

The second set of results involved patients with A1C levels between 10% and 12%, and gave them 20 mcg per day for 3 months and 60 mcg per day for an additional 6 months. Patients in this second trial started with average A1C levels of 10.8% and ended, on average, 3.4 percentage points lower at 7.4%. These results, which were considered preliminary, were presented at the 50th meeting of the European Association for the Study of Diabetes in Vienna, Austria,

		which took place September 15-19, 2014.

		Many of the patients in both of the trials were already using 1 or more oral treatments when their trial started. Such patients continued using those medications throughout the trial and, thus, used

		ITCA 650 as part of a combination therapy. Some patients, however, particularly in the first trial, were not using medications when they enrolled and, thus, used ITCA 650 as monotherapy. The medication provided significant benefits in both cases. “I think this device has the potential to be a true game changer,” said Robert Henry, MD, a professor of medicine at the University of California at San Diego and the director of the Center for Metabolic Research at the VA Medical Center in San Diego. Henry, like Skyler, does consulting work for Intarcia, among other pharmaceutical companies, and he has participated in ITCA 650 trials. 

		“The medication reduces A1C levels in virtually everyone. Only 2 of 60 patients in a recent trial I led did not experience reductions of at least 0.5%. It also produces significant weight loss—3% of

		body weight, on average—in most people. And it requires no effort from patients. The pump, to my knowledge, has never failed. It just works.”

		Intarcia is currently undertaking 2 more phase 3 trials, and if they meet their goals, the company expects to submit ITCA 650 for FDA approval in early 2016. Doctors who have used the treatment

		in trials are counting the days. “With continued success in the remaining phase 3 trials, we should have a real game-changing therapy available soon to help physicians to better manage this

		serious disease,” Henry said. If ITCA 650 does win FDA approval, it will constitute a significant step on the road toward easier treatments for T2DM. Patients who had the disease in the early part of the last century had no option other than insulin injections. That changed in 1955 when drug makers introduced the first oral medications that stimulate the pancreas to make more insulin.

 In the early days, these oral medications were often used in addition to injections, rather than as a replacement, but as oral therapies have improved, more patients have stopped using any kind of injection. Nearly 57% of all Americans with diabetes now solely use oral medications to treat their condition.

		Still, many patients fail to follow the treatment plans prescribed by their doctors. According to a recent review of research on patient compliance, more than one-third of all patients eat things they should avoid, and more than 80% of them exercise too little. In fact, electronic monitoring of pill consumption found that adherence rates for oral medication ranged from 53% to 67%.

 Specialists say that even fewer patients with T2DM religiously follow instructions for using injectable medication. These failures trigger many of the complications that exact such a physical toll on people with

		diabetes and such a financial toll on the American medical system. That toll has ballooned in recent years as America has grown older, fatter, and more racially diverse. The number of people diagnosed with T2DM grew from about 6 million in 1980 to more than 21 million in 2011,

		Another 86 million Americans 20 years and older had prediabetes as of 2012, and experts estimate that one-third of all Americans will eventually develop the condition.

Unless people with diabetes begin controlling their condition better than they have to date, such an increase in patient  numbers will threaten the solvency of the healthcare system and ruin millions of lives.

		Countless initiatives are already under way in nearly every corner of the healthcare system to help patients get a better handle on their disease: local governments are making restaurants put

		calorie counts on menus, employers are subsidizing gym memberships, insurers are adjusting co-pays, doctors are joining accountable care organizations, and drug makers are spending billions on research. 

		Intarcia joined this widespread fight against diabetes in the mid-2000s, shortly after one of its experimental medications failed in phase 3 trials. The privately held company had focused on cancer

		medications since it opened its doors in 1997, but its owners were considering all their options, including liquidation, when several Intarcia researchers discovered the technique for stabilizing proteins, peptides, and antibodies at high temperatures. “Their announcement came as a total surprise. No one else in the company even knew they’d been working on the project, but the importance of their discovery was immediately obvious,” said Intarcia CEO Kurt Graves. “These biological compounds are some of the best treatments we have for a wide range of diseases, but they’re totally unstable at room temperature, let alone body temperature. That makes them hard to manufacture and hard to store and hard to use, and that, in turn, limits their usage and makes them expensive. Finding a way to keep these medicines stable at body temperature for years on end was like finding the Holy Grail.”

		Intarcia patented the technique, of course, but Graves still declines to explain it in anything but the broadest terms: Intarcia imbeds unstable medications in a suspension formula that keeps them fixed indefinitely. Company researchers have yet to determine how long its process can keep fragile medications in working order. They have kept some bottled samples at 105 degrees for more than 3 years now, and those samples show no sign of deterioration.

		Still, it was quickly apparent that the process worked well enough to create something unprecedented in the treatment of chronic illnesses: once-a-year implants that delivered continuous edication. Intarcia, therefore, began looking for approved medications that were suitable candidates for its stabilization technique and the micro-pump technology that it acquired for product delivery. Many biological medications appeared insufficiently potent for long-term delivery. A year’s supply of a medication with a therapeutic dose of 500 mg per day would require an implant the size of a bread box, which, presumably, would not be very comfortable. Exenatide, however, looked about as promising as a candidate could look: a very effective treatment for a very common disease that was used by relatively few people because its fragile formulation could only be taken by injection. Despite the existing approval for exenatide, Intarcia put ITCA 650 through a full trial process and submitted a new drug application to the FDA in an attempt to prove that its stabilization process did not increase side effects or, conversely, stabilize the drug so much that it

	Trial results to date indicate that the stabilization process and continuous delivery affect both the medication’s efficacy and its side effect profile. Fortunately, they seem to increase the former and

	decrease the latter. It is unclear whether the increased efficacy stems entirely from eliminating the dosing errors that took place when exenatide was tested as an injection or whether other factors,

	such as continuous delivery, play a role. As for the reduction in side effects—especially the nausea that is common with exenatide injections&mdash;Intarcia’s scientists and some of the researchers who have worked on ITCA 650 trials generally credit the transition from concentrated injections to a small but steady stream of medication. Whatever the reason, Intarcia executives believe that the combination of effortless administration and negligible side effects might allow them, eventually, to get expanded approval for ITCA 650, approval that would allow them to use the product both as a treatment for T2DM and as a tool for preventing people with prediabetes from developing the disease.

	“We haven’t announced pricing yet,” Graves said. “But the stability of our formulation of this medication greatly reduces manufacturing and handling costs, so we could price ITCA 650 far

	closer to an oral therapy than a typical biologic injection….At that sort of price, it could certainly make sense to use it for prevention as well as treatment.”

	1. Washington RE, Andrews RM, Mutter R. Emergency department visits for adults with diabetes, 2010 [statistical brief #167]. Rockville, MD: Healthcare Cost and Utilization Project (HCUP), Agency for Healthcare Research and Quality; November 2013. www.hcup-us.ahrq.gov/reports/statbriefs/sb167.jsp. Accessed December 30, 2014.

	2. Centers for Disease Control and Prevention. National Diabetes Statistics Report: estimates of diabetes and its burden in the United States, 2014. Atlanta, GA: HHS; 2014.

	3. National Association of Chronic Disease Directors. Addressing a major complication of diabetes to reduce health care costs. Society for Public Health Education website.http://www.sophe.org/

	Sophe/PDF/NACDDDiabeteWhitePaper.pdf. Published February 2012. Accessed December 2014.

	4. Li R, Bilik D, Brown MB, et al. Medical costs associated with type 2 diabetes complications and comorbidities. 2013;19(5):421-430.

	5. FDA approval history for Byetta. Drugs.com website. www.drugs.com/history/byetta.html. Accessed December 30, 2014.

	6. Intarcia announces two positive phase 3 trials for ITCA 650 in type 2 diabetes: FREEDOM-1 and FREEDOM-1 high baseline (HBL) study results [press release]. http://intarcia.com/media/pressreleases/2014-oct-1-phase-3.html. Boston, MA: Intarcia Therapeutics; October 1, 2014.

	7. Henry RR, Rosenstock J, Baron MA. Efficacy and tolerability of ITCA 650 (continuous subcutaneous exenatide) in poorly controlled type 2 diabetes with base A1C >10%. Presented at: 50th Meeting of the European Association for the Study of Diabetes; September 19, 2014; Vienna, Austria. Abstract 242.

	8. History of diabetes. American Diabetes Association website. http://www.diabetes.org/research-and-practice/student-resources/historyof-diabetes.html. Updated May 9, 2014. Accessed

	9. Delamater A. Improving patient adherence. 2006;24(2):71-77.

	10. Katz MJ, Laughton F. Diabetes type 2 continuing education for health professionals. A-Train Education website. https://www.atrainceu.com/course-all/diabetes-type-2-090. Accessed December 30, 2014.

	11. American Diabetes Association. Infographic: a snapshot of diabetes in America. http://www.diabetes.org/diabetes-basics/statistics/cdc-infographic.

	html. Updated June 11, 2014. Accessed December 30, 2014.

On the Horizon in Diabetes Therapy: A Delivery System That Doesn't Rely on the Patient

	Here at the Joslin Diabetes Center, we are committed to making the lives of those with diabetes better through world-class research, patient care, and education. We are engaged in activities across the spectrum of diabetes innovation, leveraging our strengths in clinical care, research, and education to address this global epidemic. We continue to export the models for care and education developed here in Boston to share them with others around the world.

	Over our 116-year history, we have introduced new care models, from the role of the diabetes educator to team-based care to population health to new treatment for complications, such as the discovery of laser photocoagulation for diabetic retinopathy. It is this commitment to sharing what we know and to engaging others who can aid us in our mission of preventing and treating diabetes and its complications that makes us especially excited to join with 

 to present Patient-Centered Diabetes Care 2015. This year, the third that 

has presented the conference, it will be held April 16-17, 2015, at the Renaissance Boston Waterfront Hotel.

	Past attendees of this meeting or Joslin’s Diabetes Innovations conference know why this partnership works so well. A shared goal of these meetings has been to convene stakeholders from across the healthcare spectrum: payers, policy makers, leaders in clinical care and research, diabetes educators, and, of course, patients and their advocates. Patient-Centered Diabetes Care 2015 will continue this tradition, as we will bring together esteemed faculty, both as presenters and participants in panel discussions. The topics will cover the diversity of issues that affect diabetes care. Over 2 days, we will share new findings in clinical research, gain insights into the behavioral issues that affect diabetes treatment, and learn about new technology that could transform care.

	Bringing the conference to Boston has allowed us to tap the vast expertise of our faculty at Joslin, and more broadly, at Harvard’s programs in public health. We will also be joined by leading payers, educators, and patient advocates. I would like to highlight just a few of the participants who are coming to Boston:

 is senior physician and medical director of the Lipid Clinic and chairman of the Clinical Oversight Committee at Joslin. Dr Ganda, who is an associate clinical professor of medicine at Harvard Medical School, will be speaking about new developments in lipid management.

is the director of the Joslin Institute for Technology Translation (JITT) and director of Insulin Pump and Continuous Glucose Monitoring programs. Dr Wolpert, who is an associate professor of medicine at Harvard Medical School, will share insights from his award-winning research on how technology can change the landscape of diabetes management.

 is a professor of epidemiology and nutrition at the Harvard School of Public Health and is completing service as a member of the 2015 Dietary Guidelines Advisory Committee. Dr Hu, who is director of the epidemiology and genetics core of the Boston Obesity Nutrition Research Center, will discuss the impact of national nutrition policy.

 the founder and editor of DiabetesMine™, is one of the nation’s most important diabetes patient advocates. She returns to Patient-Centered Diabetes Care this year to discuss the role of social media in the treatment and education of persons with diabetes. Clinicians who are not using social media need to hear from Ms Tenderich and her fellow panelists.

is the owner of Hope Warshaw Associates, LLC, a diabetes and nutrition consultantcy, and an important force in the use of social media to educate persons with diabetes.

vice president and national medical director, Pharmacy Policy and Strategy, Aetna Inc, and 

corporate chronic condition medical director for Humana, Inc, are among the representatives from national commercial payers who are taking part in panel discussions. They’ll contribute to discussions on the role of integrated delivery networks in promoting adherence and a debate on whether combination therapies are worth the cost.

	Of course, this is just the beginning. For clinicians especially, Patient-Centered Diabetes Care 2015 will offer a unique opportunity to interact with key leaders across the healthcare continuum to share innovative approaches to improve the lives of those with diabetes. This meeting will also offer a chance for decision makers in the payer community, for leading patient advocates, and for those who influence healthcare policy to interchange ideas and address the opportunities and challenges of Patient Centered Diabetes Care. I encourage you to join us in Boston.

Dr Gabbay is chief medical officer and senior 

vice president at the Joslin Diabetes Center, 

Join Us in Boston for Patient-Centered Diabetes Care 2015

	It was clear to Kate Lorig, DrPH, immediately that she was dealing with a special case in her type 1 (T1DM) and type 2 diabetes mellitus (T2DM) self-management workshop at the Stanford Patient Education Research Center, where she serves as director. Lorig had asked a female diabetic what sort of a commitment she could make to reduce her sugar intake.

	The woman replied that she would eat no more than 2 candy bars a day. While that’s not an ideal goal for a diabetic, Lorig didn’t bat an eye. “I said ‘How certain are you that you’ll eat no more than 2 candy bars a day?’ ”

	The woman started to cry. “You understand,” she said. “I’m eating 8 candy bars a day. During break, I went out to my car and ate 2 candy bars.”

	For this particular diabetes patient, Lorig knew no formulaic management plan was going to succeed. The patient needed a solution adapted to her own situation, which a face-to-face encounter was able to uncover.

	“She’s made a huge commitment,” Lorig said. “If I’d given her the lecture on carbohydrates at that point, I’d never have seen her again. It’s going for the real, not the ideal.”

	In battling chronic diseases like T1DM and T2DM outside the hospital, researchers and doctors who spoke with 

agreed that intense involvement with patients is the key to success, though it often comes at a high price that cannot be sustained given the current structure of the healthcare reimbursement system.

	Despite calls for value-based care, limitations in the reimbursement system still obstruct successful patient management, said Harold D. Miller, president and CEO of the Center for Healthcare Quality and Payment Reform. Miller served as strategic initiatives consultant for the Pittsburgh regional health initiative from 2006 to 2010, where nurses were sent to the homes of people discharged from the hospital and were empowered to do what they, as nurses, thought was necessary to help the patients adhere to a recovery plan.

	The chronic disease management program was a success, though it had to be funded through foundation grants as there was no established payment system under Medicare, Medicaid, or commercial insurance. There were no other standard medical servic-es revenue that could be tapped, Miller said.

	“Nurses are trained to be able to help their patients, and the idea was let the nurse figure out what the problems were and what needed to be done about them, rather than being limited to do a specific kind of thing,” Miller said. The nurses encountered the same sorts of problems that Lorig sees in the Stanford self-management classes—problems that aren’t easily anticipated by a doctor sending a patient home from a hospital or divined by a nurse making a follow-up telephone call.

	“One nurse who went to a home found that a patient had been using a nebulizer, and he was dutifully washing it every day according to instructions, but he was putting it wet into a plastic bag, which was a perfect breeding ground for bacteria,” Miller said. He added that he was aware of examples from similar programs in other parts of the country, such as a diabetes patient who couldn’t see properly to put the needle into his insulin bottle. “It’s hard to imagine all of the unique kinds of circumstances like that,” he said. “Many patients can’t read, can’t see, or can’t understand, and educational material alone may not solve the problem. They didn’t see it or they didn’t realize what it meant.”

	The Pittsburgh project generated more savings in avoidable hospitalizations than the nurse intervention cost, Miller said, but the program only continues today because a local hospital was willing to pay for 1 nurse to continue making house calls. Other studies have shown that well-designed patient education and self-management programs can more than pay for themselves by improving patient outcomes, he said.

	Diabetes, as a chronic disease, ranked third in 2011 for the number of Medicaid readmissions (23,700) behind schizophrenia (35,800) and mood disorders (41,600), according to the Healthcare Cost and Utilization Project.

CMS has not yet implemented formal readmission reduction targets, though some medical professionals wonder if that isn’t imminent, based on the direct medical cost of T1DM and T2DM expenditures, which amounted to $176 billion in 2012, according to a recent study by the American Diabetes Association.

Such targets could add more urgency to the quest to have patients take on more responsibility for managing their own health.

	“Diabetes is infrequently the primary cause of readmission,” said Mary Korytkowski, MD, professor of medicine and interim chief of the Division of Endocrinology at the University of Pittsburgh. “It may eventually be recognized as a contributor to need for readmission, but is not currently a focus of many readmission prevention strategies.” Diabetes is often an underlying problem for many hospital admissions and readmissions, such as pneumonia, congestive heart failure, and vascular disease, Korytkowksi said. For this reason, whenever a patient comes into the hospital for what may or may not be a diabetes-related ailment, doctors and nurses need to know about this to allow analysis of the current level of glycemic control, as well as a patient’s ability to participate in recommended self-management.

	In a T1DM and T2DM patient education program conducted in Pittsburgh, with results published in late 2013, Korytkowski and her fellow researchers concluded that a course of inpatient education could have positive effects on both short- and long-term patient health outcomes in this patient population. “The ability of patients with diabetes to achieve desired metabolic goals while reducing risk for long-term complications requires education in self-management practices with periodic reinforcement of these principles. For this reason, a program of diabetes self-management education (DSME) is recommended as standard of care for all patients with diabetes,” the report stated.

The same report estimated that fewer than 50% of patients receive DSME, which puts them at increased risk for complications and hospitalization. Even so, the growing emphasis on self-management education today is a vast improvement from before, Korytkowski said.

	Years ago, Korytkowski said, diabetes classes were held for hospitalized patients once or twice a week. These classes required patient attendance, which was not always realistic in those with acute medical problems. This resulted in poor attendance, she said. But patient education is one of the things competing for health workers’ attention and, as a result, it suffers the fate of many other prioritized needs, Korytkowski said.

	“There’s so much attention now on limiting length of stay and just taking care of the issue that brought them into the hospital. So, say they have pneumonia: you treat the pneumonia, but the fact

	that their blood sugar is off just doesn’t rise to the surface. The pace of things just doesn’t allow for all of these things that brought them to the hospital to be addressed.”

	A multi-year study on an Australian population of chronic heart disease and T1DM and T2DM patients published in April 20134 weighed the value of repeated phone contact through the My Health Guardian (MHG) health maintenance program, which included followup with patients after discharge. “MHG proved to be an effective means to reduce the likelihood and duration of hospitalizations for individuals with diabetes and heart disease,” authors of the study wrote. “In this study, the MHG program demonstrated a consistent effect; treatment group members had reduced admissions, readmissions, and ALOS (average length of stay) relative to comparison group members....Furthermore, the magnitude of effect increased over time, demonstrating the importance of a sustained program for maximizing impact.”

	While other researchers contend that face-to-face contact with patients outside the hospital is often essential to tailor diabetes management to individual situations, study coauthor Elizabeth Rula, PhD, said, telephonic management has a place in managed healthcare. “Diabetes is one of the conditions that is known to be very susceptible to improvement as a result of these programs,” said Rula, who is executive director and principal investigator at the Healthways Center for Health Research in Tennessee. Healthways is the provider of the MHG program that was studied. “We identified people who had recently been discharged or hospitalized, and tried to reach out to them,” Rula said. “That is a really critical point in time—you might call it a teachable moment&mdash;in terms of when someone is acutely aware their health is not optimally managed. So at that point, they can be amenable to the program and changes in how they are managing.”

	In a prior study of telephonic followup for admitted patients with chronic conditions, nurse-delivered calls occurring within 14 days after discharge were associated with a 23% decrease in readmissions. From her work on this study, Rula saw the importance of timely follow-up, “because most readmissions occurred within 2 weeks of discharge, and a third within 1 week. Delays in identifying or reaching patients once they return home create missed opportunities to prevent a return to the hospital.”

	One of the barriers to the Australian program, however, was the limited amount of patient medical history information available, contrary to what US medical personnel generally have at their disposal, Rula said. Knowing more about patients’ medical history enables a more targeted approach in the telephonic program, she said.

	“Typically we are able to model who is at highest risk for readmission, and reaching out to them is not a one-way push for information,” Rula said. “Here in the States, we often have access to a more robust picture of that person’s prior claims. When we’re working with health systems, we can actually get in up front and do an assessment of patients while they are in the hospital and start working with them at that point in time to allow early identification of that person’s needs and barriers that could result in a readmission.”

	She said the potential of working with a patient before and after their care transition “is shown in our recent evaluation of the full model where we were able to initiate needs assessment and discharge planning in the hospital, which is then supported by telephonic follow-up.”

	The success of the multiple phone call approach in the MHG study was not replicated in a study published this fall in 

, where researchers found that a single scripted phone call to T2DM patients was not successful in getting them to adhere to the use of a new medication.

A stated goal was to test whether this relatively inexpensive form of intervention would increase medication adherence, but the authors concluded: “This low-intensity intervention did not significantly improve medication adherence or control of glucose, blood pressure, or low-density lipoprotein cholesterol. Wide use of this strategy does not appear to be warranted; alternative approaches to identify and improve medication adherence and persistence are needed.”

	Some believe the money spent on telephonic management is not wisely invested and actually diverts funds from more productive patient management and education initiatives. In Camden, New Jersey, the Camden Coalition of Healthcare Providers’ (CCHP) Care Management Program, Link2Care, has claimed a significant reduction in patient readmissions and nonemergent use of hospital emergency departments via the use of health teams who track patients from the hospital setting back into the community and provide support services that ensure that even patients’ housing needs are addressed. Targeting high-volume users of the health system, “A team of nurses, social workers, community health workers and health coaches, supported by data of healthcare utilization, perform home visits, accompany patients to doctor visits, and help patients enroll in social-service programs,” according to program literature.

	In Camden, where per capita income is significantly lower than in the rest of New Jersey, researchers were finding patients who not only didn’t have insulin, “They didn’t have food, their electricity was getting turned off, and they were significantly depressed,” all factors that contributed to their inability to manage their health conditions more successfully, said Jason Turi, associate clinical director of the CCHP. Such patients were among a population of 20% of hospital users who accounted for 90% of costs at 3 Camden hospital systems from 2002-2007. The team approach to care management was “found to improve health outcomes [and] decrease utilization of emergency and inpatient services and costs for a cohort of 36 ‘high utilizers’ from $1.2 million monthly to $534,000 monthly, a saving of 56% over 5 years.”

	“Part of the sustainability strategy for operations like ours and around the country is to reroute money away from telephonic management and into community-based operations,” because the belief is that community-based programs work better, Turi said. That is accomplished by working at the policy level, “actually getting to where care management dollars are going for publicly insured folks, especially Medicaid, to working here in New Jersey with our funders and with the Medicaid office to start rethinking what it means to do case management for complex patients.”

	The program is currently the focus of a Massachusetts Institute of Technology proof-of-concept study that Turi believes will confirm what he considers the legitimacy of the approach and make funding easier to obtain. The program has already won a pay-for-performance contract from UnitedHealthcare, which administers Medicaid payments in New Jersey. “This is actually not a grant,” Turi said, “which is great. They pay us to service some of their more complex patients in Camden.”

	1. Hines AL, Barrett ML, Jiang J, Steiner CA. Conditions with the largest number of adult hospital readmissions by payer, 2011. Rockville, MD: Healthcare Cost and Utilization Project, Statistical Brief Number 172. Agency for Healthcare Research and Quality; April 2014.

	2. American Diabetes Association. Economic costs of diabetes in the United States in 2012. Diabetes Care. 2013;36:1033-1046.

	3. Korytkowski MT, Koerbel GL, Kotagal L, Donihi A, DiNardo MM. Pilot trial of diabetes self-management education in the hospital setting. Primary Care Diabetes. 2014;8(3):187-194.

	4. Hamar GB, Rula EY, Wells A, Coberley C, Pope JE, Larkin S. Impact of a chronic disease management program on hospital admissions and readmissions in an Australian population with heart disease or diabetes. Popul Health Manag. 2013;16(2):125-131.

	5. Harrison PL, Hara PA, Pope JE, Young MC, Rula EY. The impact of postdischarge telephonic followup on hospital readmissions. Popul Health Manag. 2011:14(1):27-32.

	6. O’Connor P, Schmittdiel JA, Pathak RD, et al. Randomized trial of telephone outreach to improve medication adherence and metabolic control in adults with diabetes. Diabetes Care. 2014;37(12):3317-3324.

	7. Healthcare Hotspotting in the United States. Poverty Action Lab website. http://www.povertyactionlab.org/evaluation/health-care-hotspotting-unitedstates. Accessed December 3, 2014.

For Staying Power, Diabetes Interventions May Need a Hands-on Element

	The American Heart Association (AHA) and American Stroke Association (ASA) released an updated guideline last fall recommending the Mediterranean or DASH-style diet (Dietary Approaches to Stop Hypertension) as a way to lower the risk of first-time stroke.

 The guideline update, appearing in the journal 

, is just the latest endorsement for consuming a diet rich in fruits, vegetables, whole grains, and nuts, as well as increasing physical activity and not smoking to improve cardiovascular health, control weight, and prevent or reduce the effects of diabetes.

	Recent studies continue to affirm the positive effects of the Mediterranean diet on cardiometabolic and overall health. Among the results:

	• Lau, Wong, et al published a study the same day as the new guideline in the 

, which tracked a group of patients who already had coronary artery disease. Those who more closely followed the Mediterranean diet were less likely to experience spikes in blood pressure or suffer strokes than those who did not follow the diet closely.

	• A novel study published in December 2014 in the 

found that in a randomized controlled trial, patients with reduced sodium intake were less likely to have headaches than those with a normal diet.

	The AHA/ASA guideline update was based on a study led by James Meschia, MD, professor and chairman of neurology at the Mayo Clinic, Jacksonville, Florida. “We have a huge opportunity to improve how we prevent new strokes, because risk factors that can be changed or controlled—especially high blood pressure&mdash;account for 90% of strokes,” he said.

	The update included the following specific recommendations:

	• Eat a Mediterranean or DASH-style diet, supplemented with nuts.

	• Monitor high blood pressure at home with a cuff device.

	• Keep prehypertension from becoming high blood pressure by making lifestyle changes such as getting more physical activity, eating a healthy diet, and managing weight.

	• Reduce the amount of sodium intake; sodium is found mostly in salt.

	• Visit your healthcare provider annually for blood pressure evaluation

	The update also specifically addressed the issue of medication adherence, which is a significant problem in treating diabetes and high blood pressure.

	Patients whose medication isn’t working or is causing intolerable side effects shouldn’t stop taking it—they should ask their doctor for something else, the guideline states.

	The AHA/ASA guideline describes the Mediterranean-style or DASH-style diet as emphasizing vegetables, whole grains, legumes, nuts, seeds, poultry, and fish. Both are limited in red meat and foods containing saturated fats, which are mostly found in animal-based products such as meat, butter, cheese, and full-fat dairy. According to a statement from the AHA, Mediterranean-style diets are generally low in dairy products and DASH-style diets emphasize low-fat dairy products.

	Finally, the AHA statement warns against smoking, especially among womentaking oral contraceptives, and states that avoiding secondhand smoke lowers stroke and heart attack risks.

	1. Meschia JF, Bushnell C, Boden-Albala B, et al. Guidelines for the primary prevention of stroke: a statement for healthcare professionals from the American Heart Association / American Stroke Association. Stroke. 2014;45(12):3754-3832.

	2. Dangi-Garimella S. New studies affirm Mediterranean diet’s potential for patient self-management, prevention of T2DM. Am J Manag Care. 2014;20(SP4):SP113-SP114.

	3. Lau KK, Wong YK, Chan YH, et al. Mediterranean-style diet is associated with reduced blood pressure variability and subsequent stroke risk in patients with coronary artery disease [published online October 28, 2014]. Am J Hypertens. 2014. doi:10.1093/ajh/hpu195

	4. Amer M, Woodward M, Appel LJ. Effects of dietary sodium and the DASH diet on the occurrence of headaches: results from randomised multicentre DASH-Sodium clinical trial [published online December 11, 2014]. BMJ Open. doi:10.1136/bmjopen-2014-006671.

	5. Diets high in fruit, vegetables, whole grains, and nuts among factors to lower first-time stroke risk [press release]. Dallas, TX: American Heart Association; October 29, 2014. http://newsroom.heart.org/news/diets-high-in-fruit-vegetableswhole-grains-and-nuts-among-factors-to-lower-firsttime-stroke-risk.

Updated Guideline, Research Favor Mediterranean Diet to Control Blood Pressure, Prevent First-Time Stroke

	While diabetes continues to be a major global health concern, disease management, not cure, remains the steadfast goal. According to the 2014 National Diabetes Statistics Report from the CDC, a steady increase in the number of diabetic patients has been observed since 2010: 29.1 million Americans were estimated to have diabetes in 2012, up from 25.8 million in 2010, including more than 8 million who were undiagnosed. Hyperglycemia, however, is not a health condition managed in isolation; in addition to serious complications associated with disease progression (eg, microvascular disease, blindness, and lack of wound healing), diabetes also increases one’s susceptibility to cardiovascular disease, dyslipidemia, stroke, and kidney disease. A tremendous influence on the overall health of an individual, diabetes associated healthcare costs amount in the billions. The cost in the United States alone was estimated at $245 billion in 2012, and 30% of the expenses were calculated as being indirect, such as those due to loss of productivity.

	Type 1 diabetes mellitus (T1DM), previously known as juvenile diabetes, is diagnosed in only 5% of people with hyperglycemia.

 An autoimmune disorder that results in the immune-mediated destruction of the pancreatic β cells that produce insulin, T1DM can affect both children and young adults, resulting in a lifetime of insulin therapy.

	Several out-of-the-box approaches are being evaluated in T1DM patients to save them the misery of everyday insulin treatment. One such approach is transplanting these patients with functional insulinproducing β cells that have been differentiated from human pluripotent stem cells (hPSCs). A collaborative study between the Harvard Stem Cell Institute and the Diabetes Center of Excellence at the University of Massachusetts generated functional human β cells from hPSCs in vitro without any genetic alterations of the cells. The β cells, which were generated following sequential differentiation resulting from high-glucose challenges, were structurally and functionally similar to pancreatic β cells. Mice transplanted with these cells could secrete insulin and reduce hyperglycemia.

	Another approach has been to regulate a person’s immune system to suppress the autoimmune response generated in individuals with T1DM, the hypothesis being that a personalized approach to modulating the immune system could cure patients. While generalized immune suppression is not a feasible option—considering the associated adverse effects&mdash;procedures such as autologous hematopoietic stem cell therapy could prove useful. Clinical immune interventions have been conducted, but immune-modulators such as rituximab and otelixizumab showed functional variability based on age and ethnicity.

	Vaccination with HLA-binding peptide epitopes is another option, though several challenges remain, including a person’s HLA haplotype, defining the route of administration, and the dose and frequency of administration. Trials examining the efficacy of cell therapy with FOXP3+ TREG cells to halt T1DM progression are presenting encouraging results in preliminary studies. However, the specificity of the FOXP3+ TREG cells to selectively suppress islet autoimmunity, as well as stability of their cells, remains questionable.

REPURPOSING THE CALCIUM CHANNEL BLOCKER VERAPAMIL

	In their attempt to find a cure for T1DM and to help rid patients of their daily insulin dose, investigators at the University of Alabama at Birmingham (UAB) have designed a clinical trial to evaluate the blood pressure medication verapamil for use in T1DM.

 To be initiated early this year, the trial, funded by a multi-million dollar grant from the Juvenile Diabetes Research Foundation, is based on preliminary evidence from a mouse model, which showed that the commonly used blood pressure medication could completely reverse diabetes in mice.

	Research conducted in the laboratory of Anath Shalev, MD, director of UAB’s Comprehensive Diabetes Center, found that administering oral verapamil could prevent β-cell death in mice with T1DM. How? The authors found that verapamil repressed the expression of thioredoxin-interacting protein (TXNIP), a gene whose glucose-regulated expression is induced in the islets of diabetic individuals, resulting in β-cell death.

 TXNIP also induces the expression of IL-1β, a cytokine that promotes T1DM. Following their discovery that verapamil can inhibit the expression of TXNIP,

 Shalev’s research team evaluated the drug in vitro in pancreatic β cells, and in vivo in mice, and found that verapamil-mediated downregulation of TXNIP prevented β-cell apoptosis, improved β-cell survival and function, and rescued mice from diabetes. Importantly, verapamil could regulate TXNIP expression only in the presence of elevated glucose levels, which offsets any unwanted side effects due to excessive reduction of TXNIP below physiological levels.

	The trial aims to enroll 52 people, 19 to 45 years of age, within 3 months of being diagnosed with T1DM. These patients will be initiated on a placebo or verapamil while on their insulin pump therapy, and blood glucose will be monitored using a continuous glucose monitoring system.

 that the trial, which has already been initiated will continue to enroll adults within 3 months of being newly diagnosed with T1DM, until spring 2016. 

January 2015

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Join Us in Boston for Patient-Centered Diabetes Care 2015

For Staying Power, Diabetes Interventions May Need a Hands-on Element

Updated Guideline, Research Favor Mediterranean Diet to Control Blood Pressure, Prevent First-Time Stroke

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A Look Beyond Findings on Telephone Intervention Reveals Why Having Data Matters

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