A Toast to Our History.

EDITOR'S NOTE: This article is adapted from the address Ms. Kruger delivered as the recipient of the American Diabetes Association's Outstanding Educator in Diabetes Award for 2017. She delivered the address in June 2017 at the Association's 77th Annual Meeting and Scientific Sessions in San Diego, Calif. A webcast of the speech can be viewed on ADA's DiabetesPro website at https://professional.diabetes.org/webcasts-ss2017.

It is a great honor to receive the 2017 Outstanding Educator in Diabetes award. I have had the privilege of working as both a clinician sharing in the lives of children and adults with diabetes and as a clinical researcher. Along the way, I have had the support and friendship of hundreds of people. I thank you all now and hope that you will know that you all have been part of my truly amazing journey. I have been losing sleep about how best to convey what I have been doing for the past 35 years. I never really thought about having a career; I thought I would work for a while and just see where that took me. Well, here I am!

For this discussion, I will focus on three areas:

My role in clinical research through the Diabetes Control and Complications Trial (DCCT)

The role of the nurse practitioner (NP) in diabetes, and

My role as a volunteer within the American Diabetes Association (ADA)

The Start of Something Big

Heading to Detroit

An East Coast girl born and raised, I attended Boston College School of Nursing in Massachusetts, where I received an amazing education that continues to serve me well. The day I graduated, we packed the car and headed to Detroit, Mich. I honestly had no idea where Detroit was and had to look it up on a map. I had agreed to go but had been promised I would only be living in Detroit for the summer, then heading back to Boston. More than 40 years later, I am still working in Detroit and no longer that naïve, and the Midwest turned out to be a wonderful place to raise three amazing daughters.

The Detroit Visiting Nurses Association (VNA) had taken me on as a brand-new graduate for a position that was to be for one summer only, but which then extended to become the true start of my nursing career. I knew I could not work as a floor nurse in a hospital, because even as late as 1976, nurses were expected to stand when a physician entered the room, and anyone who knows me will understand that that was never going to happen.

The Detroit VNA gave me the opportunity to begin thinking about the team approach to medical care. Although I was out in the field by myself, I always had the opportunity to get assistance when needed from a variety of team members, including dietitians, a physical therapist, social workers, and a team of NPs to provide care. Being in the field by myself taught me to recognize what I did not know and when to ask for help. It taught me to be a strong advocate for my patients. All of these were skills I would need to become an NP.

The Personal in the Professional

The roles each of us play within the diabetes world have personal, as well as professional, meaning. In my case, I was 11 years old when my mother was diagnosed with diabetes at the age of 30 years. She already knew what the devastation of living with diabetes could be; her mother also had diabetes.

My mother died in 1982 at the age of 47 years, just as the DCCT began. This was before blood glucose meters were available. Patients were rarely, if ever, included in the development of their care plans. My mother did not receive any diabetes education or medical nutrition therapy. Our knowledge of diabetes and appropriate diabetes care was just emerging. Of course, my mother did not have “the serious kind” of diabetes. I often think of how much higher her quality of life would have been with all that we now know about diabetes.

By the time I graduated nursing school, my grandmother and her two brothers and each of their children were all living with type 2 diabetes. Thus, it was no surprise that, after graduate school, I wanted to work in the area of diabetes.

The Diabetes Control and Complications Trial

I entered the diabetes health care force in 1982 as an NP, having just graduated from Wayne State University in Detroit. The role of the NP was, at the time, still a revolutionary one, but Henry Ford Hospital had been employing NPs for 10 years by the time I arrived. Today, it employs more than 500 NPs.

I was hired by Dr. Fred Whitehouse to help bring human insulin to market and to be Henry Ford Hospital’s trial coordinator for the DCCT, for which he was a principal investigator (PI). At the time, I truly had no idea what that meant, how my role would develop, or what the outcome of that landmark trial would mean for so many people.

Type 1 Diabetes Management: An Abbreviated History

The treatment of type 1 diabetes has come a long way since the day in 1922 when the first injection of insulin was given. The discovery of insulin was the single most important breakthrough in diabetes therapy. It changed the course of diabetes treatment and saved countless lives. However, by the late 1930s, it was clear that diabetes could be treated with insulin to prevent death, but living with diabetes was accompanied by long-term complications of the disease. There was a great deal of debate and controversy regarding the extent to which elevated blood glucose caused or contributed to these complications.

In 1964, Miles Laboratories produced the Dextrostrip, a strip for testing fingerstick glucose levels. It took 5 more years for a portable glucose meter to be available. In the mid- to late 1970s, standard care for type 1 diabetes consisted of 1–2 insulin injections per day and urine glucose testing. In the late 1970s, early insulin pumps were under investigation, and in 1979, the A1C blood test was introduced. Thus, by the end of the 1970s, the necessary tools were available to conduct a study to objectively test the hypothesis that maintaining near-normal blood glucose levels would delay or prevent diabetes complications and to assess the impact of intensive insulin regimens.

Exploring the Glucose Hypothesis

The DCCT was a complex, multicenter trial designed to study the effects of two different diabetes treatment regimens on the early vascular complications of type 1 diabetes. The trial examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of microvascular and neurological complications compared to standard care. A total of 1,441 participants were followed for a mean of 6.5 years.

By now, everyone in the diabetes care community knows the outcome of the DCCT: a 60% reduction in eye, kidney, and nerve disease with intensive therapy (1). Countless articles have been published from the DCCT and its long-term follow-up, the Epidemiology of Diabetes Interventions and Complications (EDIC) study, over the past 35 years, defining best practices for the management of type 1 diabetes. But that is not the whole story.

The Story Behind the Results

Figure 1 shows the PIs for the DCCT. With one exception, they were all men. The diabetes community may have thought these guys ran the study, but, as Margaret Thatcher once said, “If you want something said, ask a man. If you want something done, ask a woman.” Figure 2 is a picture of the DCCT trial coordinators—100% women. These are the folks who really ran the show. There was one trial coordinator per site, and that person was given the enormous responsibility of implementing the study protocol. Many, like me, had just entered the world of diabetes. We had a protocol for the DCCT, but there was a lot the protocol did not cover. It did not define the role of the trial coordinators or provide them with training on how to recruit and retain volunteers. It did not provide technology or therapy management education, either. Importantly, it did not encourage support across clinics and among coordinators, nor did it understand or anticipate the crucial need for the team approach.

FIGURE 1.

DCCT investigators.

FIGURE 2.

DCCT trial coordinators.

Learning Together

There was much to learn, and it all had to be done without losing sight of the main study questions. The trial was designed to use insulin pump therapy, a fairly new technology for 1983. Insulin pumps then were the size of a brick. It was difficult to refine the basal rates or the bolus doses. Metal cannulas were used, and site infections occurred frequently. Most concerning to me, though, was the fact that I had absolutely no idea what an insulin pump was. So, while trying to figure out how to do research, how to recruit patients, and how to implement the protocol, I needed to learn diabetes care, how to adjust insulin, and, of course, what an insulin pump was.

Dr. Whitehouse sent me to St. Louis, Mo., to get a crash course in insulin pump therapy from Drs. Julio Santiago and Neil White and Lucy Levandowski, their site’s trial coordinator. When I returned to Detroit, I was expected to be the new pump expert and to start and manage all of the insulin pumps in the DCCT at Henry Ford Hospital. And that is exactly what I did, and what the other trial coordinators did at their own sites. Luckily, the patients did not know any more than I did and were willing to let me learn with them.

The trial coordinators made their voices heard that the protocol as it stood would not allow us to achieve the study goals. Elliott Joslin once said, “All too often in recent years it has been felt that if the urine were rendered sugar-free by fasting, the treatment of the diabetes ended; in reality it has hardly begun.” As a study team, we learned very quickly that our job had just begun and that, as Dr. Joslin knew back in 1919, there was much more to diabetes care than just freeing the urine of glucose. Although we had some amazing diabetes experts among us in 1982, there were not a lot of available therapies or devices about which to be an expert. Much of today’s diabetes expertise (and many of our current diabetes experts) grew out of the work of the DCCT.

Defining Intensive Therapy

As DCCT chairman Dr. Oscar Crofford of the Vanderbilt University center in Nashville, Tenn., commented, “Intensive diabetes treatment is not just ‘more insulin.’” We all learned together what it meant to implement intensive insulin therapy. We expected a lot from the volunteer participants in our intensive treatment group. They had weekly phone contact and monthly visits with the clinic team. They took three to four insulin injections daily or wore an insulin pump. They performed four to seven blood glucose checks daily, including once a week at 3:00 a.m. They were asked to keep a blood glucose diary.

There were other challenges and frustrations, as well. We had mixed beef-pork insulin, large blood glucose meters that required a great deal of blood, and those bulky insulin pumps. These were all new to our patients and at times overwhelming. Our patients also faced personal challenges, including life transitions such as going to college, getting married or divorced, having and raising children, and changing jobs, not to mention just dealing with the hassles of everyday life. After several years in the study, one young man who had been randomized at age 17 and was then in law school informed me that he was going away for the summer because he needed a break from me. He said he would see me in September and that I should not try to find him. True to his word, that young man returned and is now a successful attorney with three children and a continuing participant in the EDIC.

Defining the Trial Coordinator Role

In the beginning, there was limited staffing, and the trial coordinators were responsible for overseeing everything, including:

Recruiting, including reviewing the study with potential participants and obtaining consent

Eligibility testing, including drawing, processing, and shipping blood samples

Completing copious amounts of paperwork, making copies, and sending them to the coordinating center

Arranging patient visits for ophthalmology, neurology, psychology, and nutrition services

Educating patients within their treatment group, including training on insulin pumps and blood glucose meters

Obtaining and reviewing patients’ blood glucose diaries, and sharing responsibility for adjusting insulin regimens

Keeping patients engaged in the study to help ensure that they would return for all of their follow-up clinic visits

In the early days of the DCCT, there was one trial coordinator per site, and there were no study nurses. Each trial coordinator had to be certified to do anything and everything. One personal story provides an example. Participants received autonomic nervous system testing before being randomized. As part of this test, a patient was required to breathe very deeply and then exhale for 20 seconds into a mouthpiece connected to a blood pressure gauge. The trial coordinator watched the needle on the gauge to be sure the patient was breathing hard enough. This could be a labor-intensive process, and I was the only one in my center certified to perform this function. On 7 December 1984, I had several such tests scheduled, and, I was very pregnant. As the patients did their breathing, I found myself breathing with them and realized that I was in labor 3 weeks early. Much to the chagrin of Dr. Whitehouse and my obstetrician, I stayed to complete the testing. I had my daughter 45 minutes later, but the tests had gotten done! We had a newborn sleeping in a file cabinet drawer for 3 months at our clinic so we could meet the pace of recruitment. Successful recruitment required innovation, and we needed to have a sense of whether a potential volunteer could handle the rigors of the study over time. Being a mother of young children while serving as a DCCT trial coordinator also required innovation and the hope that I could handle the rigors of the study over time.

Trial coordinators led the diabetes management teams. At 27 of the 29 DCCT sites, nurses filled the role of trial coordinator. Initially, the input of the trial coordinators was not proportional to the importance of their role. Although we attended steering committee meetings, we were asked to sit at the back of the room to be seen, but not heard. However, over time, the PIs were looking more and more often to the back of the room for answers that only the trial coordinators could provide. Our seats were moved up to the table.

Early on, the trial coordinators worked alone. But we soon realized that we needed to come together to make our role and the trial successful. We developed and shared a variety of best practices and success stories among ourselves. Monthly phone calls among sites helped us get patients to treatment goals, and visits to other sites helped teams grow.

Figure 3 is an organizational chart that developed over time as the trial coordinators’ role became equal to that of the PIs and other team members were added. A Trial Coordinators Committee was established that met the day before each steering committee meeting. In 1984, I was asked to chair it, which also allowed me to represent the trial coordinators as a member of the trial Planning Committee. This enabled me to provide input from the trial coordinators into the ongoing development of the DCCT and its protocol. I chaired that committee until 1991, when Gayle Lorenzi and Meg Bayless took over as co-chairs as the DCCT was wrapping up and EDIC was beginning. Two years ago, Cathy Martin replaced Meg Bayless when she retired. Together, Gayle and Cathy ensure that the needs of the patients are always put first and that the role of the trial coordinator has the support it needs to continue to grow.

FIGURE 3.

Organizational structure of a typical DCCT clinical center.

Clinic-to-Clinic Collaboration

Each DCCT center was paired with another center to assist in getting patients to their treatment goal. Ours was paired with the team at Yale, and the two teams held a monthly call to review the therapy regimens of patients whose A1C was not at treatment goal. We learned a great deal from Drs. Bill Tamborlane and Bob Sherwin, Jo Ann Ahern, and, later, Patty Gatcomb about diabetes care and management and about insulin pumps. They brought a fresh view to our patients and helped us move them to the treatment goal. These inter-team calls helped us develop the team approach in the DCCT and helped us understand even more acutely why a team was needed to manage diabetes and why our patients were the most important members of the team.

There were other forms of inter-team collaboration as well. Hypoglycemia events were well defined and documented in the DCCT, and to minimize these events, each clinic was paired with a PI from a different clinic to review each event in detail. Henry Ford Hospital was paired with Orville Kolterman from the University of California, San Diego, for hypoglycemia review.

After any assisted hypoglycemic event, we would have a conference call to review the case and ensure that we had done everything possible to prevent another event. Over time, the study group learned from our patients and from each other best practices to assist our patients in preventing and treating low blood glucose.

Orville and I were also asked to team up and visit sites across the country for a variety of reasons, but mostly to ensure that the clinics were working as a team, patients’ needs were being met, and the protocol was being followed so we would have a definitive answer about intensive therapy at the end of our trial. As I traveled to other DCCT sites, I was always impressed by the work being done, the quality of the care being provided, the understanding of the importance of what we were doing, and the appreciation of how much this trial was adding, not only in terms of testing our hypothesis, but also in developing the role of the trial coordinator and the team approach to diabetes care.

A Successful Study

Throughout the decade-long DCCT, only 11 patients failed to complete the study. Follow-up data were collected at a rate of 97% (without computers). Patients in the intensive treatment group were able to achieve a mean A1C of 7.2% with minimal technology. Over time, the role of trial coordinator grew and gained the respect of all involved in the study. To quote DCCT PI and EDIC chairman David Nathan, “The study was successful because the nurses in the study (trial coordinators) provided the care.”

At long last, the DCCT Research Group provided evidence in support of intensive treatment and glycemic control (1), and in so doing, gained an appreciation for and reaffirmed the work of members of many disciplines who helped to make the trial a success. Key DCCT team members, representing both nutrition and nursing, published reports on their expanded roles in the DCCT, thereby helping to expand the roles of their disciplines in clinical practice after the trial’s end (2–6). In this regard, the DCCT was certainly a bright light along the road for diabetes team members of all disciplines.

Role of the Diabetes NP

As Shakespeare wrote, “What’s in a name? That which we call a rose by any other name would still smell as sweet.” So, what is the correct name for an NP? Clinical specialist? Advanced practice nurse? Advanced practice provider? Physician extender? Mid-level provider? I can assure you there is nothing mid-level about the care we provide. So, although I have answered to many of these names, I prefer simply to be called what I am: an NP.

The role of NP emerged in 1965, with the founding of the first NP program in the United States, at the University of Colorado. The literature indicates that NPs can manage 80–90% of routine office visits without the need for consultation or referral (7). NPs are also particularly adept at knowing when to seek input, when to refer patients, and when to ask for assistance.

Filling the Gap in Diabetes Care

When I began my career, there were 5.7 million Americans with diabetes (8). By 2017, that number had grown to 30.3 million (9), and it is expected that, by 2025, more than 53 million Americans will have diabetes (10). How will we provide care for all of these people? There are so many things we need, but most importantly, we need enough health care providers to provide diabetes care. There is currently a shortage of about 1,500 adult and 100 pediatric full-time equivalent endocrinologists in the United States (11). The increase in the prevalence of diabetes will increase demand for adult endocrinologists such that the shortfall will increase to 2,700 by 2025 without an increase in the number of fellows trained (11).

However, while the number of endocrinologists continues to decline, the number of NPs continues to grow (Figure 4) (12). We have the knowledge and desire to take care of patients with diabetes and are more than able to fill the gap that exists in the care of people with diabetes. For almost 10 years, there has been a Board Certified–Advanced Diabetes Management diabetes specialty certification for NPs (13). As my friend Dr. Steven Edelman once wrote, “The only caregivers who should be taking care of people with diabetes are the interested ones, regardless of whether their title is diabetes nurse specialist, primary care physician, or endocrinologist” (14). NPs are interested and available to fill the gap.

FIGURE 4.

Number of NPs in the United States, 1999–2017 (12). The NP role emerged in the mid-1960s.

NP as Diabetologist

Numerous studies since the inception of the NP role have compared the independent judgment of NPs to that of physicians. They have found that physicians and NPs make equally accurate diagnoses. However, NPs are more likely to:

Provide disease prevention and counseling

Provide health education

Provide health promotion

Adapt the medical regimen to the patient’s preferences

Order fewer costly drugs

Prescribe fewer drugs

And listen more to the patient (7)

A prospective study (15) performed at Henry Ford Hospital was designed to evaluate whether the intervention of an NP would improve outcomes for patients with poorly controlled diabetes (n = 193) in a primary care practice. As shown in Figure 5, NP care resulted in a decrease in A1C from 9.64 to 7.75% in 6 months. Furthermore, 148 patients experienced A1C lowering of >3%, and annual eye exams increased from 40 to 68%. A study from the Veterans Health Administration (VHA) (16) looking at >88,000 patients in 198 primary care programs also demonstrated a lowering of A1C with the intervention of an NP. These data suggested that NP staffing would reduce diabetes complications and deaths by 7% among VHA patients with diabetes. Clearly, NPs have the knowledge and desire to take care of patients with diabetes and are more than able to fill the gap that exists in the care of people with diabetes.

FIGURE 5.

Reduction in mean A1C and increase in annual eye exams after 6 months of NP diabetes intervention (16).

Labors of Love: Volunteering for the ADA

Pushing the Envelope on the Executive Committee

I was fortunate to have served on the ADA board of directors from 1990 to 1993 and on the executive committee with Dr. Frank Vinicor and David McClure from 1993 to 1996. From day one, they supported my everyday need to push the envelope, and through the 3 years we served, there were many challenges and changes to the diabetes world and to the ADA as an organization.

When I began my stint on the executive committee, the term of the senior vice president was for fewer years than that of our physician counterparts’ presidential term, and that was just not right. Changing that was an uphill battle started by Pat Stenger and completed by Linda Siminerio and me, but the outcome was worth it, and by the time the change happened, most in the association supported it. To paraphrase Sen. Mitch McConnell of Kentucky, we were warned, we were given an explanation, and, nevertheless, we persisted. As a result, Belinda Childs became the first official President, Health Care & Education.

But the work at ADA during our tenure on the executive committee had just begun. Still ahead was laying the groundwork for the formation of the ADA Research Foundation, which was established in 1994, and working on the merger of 50 separate state-level organizations into one national entity, among other important initiatives.

Facilitating Donations for the Research Foundation

Fundraising is at the heart of everything ADA does and is what allows ADA to be the strong organization it is. Without fundraising, we do not have the ability to support research, offer programs, or support advocacy. Over the years, I had many volunteer roles at ADA, including 10 years on the Research Foundation board of directors and 3 years as its chair. It was an unusual role for a health care provider, perhaps, but who better to understand and articulate to our donors the devastation diabetes causes daily?

The Research Foundation was established to provide a unified focus to research efforts and to give passionate donors a forum to express their interests. We established the Healthcare Professional Gift Program after a conversation with my colleague Sam Abbate. The vision was to set up a program for diabetes professionals to donate their honoraria over time to become members of the Pinnacle Society, the elite group of individuals who have given $10,000 or more to the Research Foundation. Within the first 2 years, 65 diabetes professionals had joined, and the number continued to grow.

Through my volunteer service to the Research Foundation, I uncovered fundraising skills I did not know I had, netting about $2 million annually in major gifts for most of the years of my tenure. I discovered that people give because we support outstanding peer-reviewed research, yes, but also because we ask. I learned from this experience that we had no idea what individuals were willing or able to donate unless we asked. Our requests were never met with just “No,” but we sometimes got, “Not now.” Thus, making it comfortable for individuals to turn down our requests was also important and left the door open for possible future donations.

Life Lessons

I have had the privilege of being involved in both the ADA and the diabetes world on many levels during the past 35 years. It was not always easy. Health care has changed, and the demands and needs of people with diabetes continue to evolve. The team needed to adequately care for people with diabetes will also continue to evolve. We must remain open to all team members and always remember that patients must be at the head of the team. Most of all, I have learned over the years that we must never accept “No” as the answer when we are seeking change that is both necessary and right.

* * *

I wish to thank my Henry Ford colleagues who are also my friends and family. They support me, humor me, and most importantly work as a team to deliver excellence in health care.

I also thank Dr. Fred Whitehouse, who has supported me and believed in me in every way for the past 35 years. He has been my mentor, my friend, and my guiding light. I truly believe I fell into the right hands, as not many could have handled me on a daily basis. In 2006, he wrote an editorial for Diabetes Spectrum called “The Color Blue: Musing After 68 Years in the Diabetes Wars” (17). In it, he said:

“Sixty-eight years ago, the color blue meant a normal or near-normal blood sugar level. We now know that what the color blue promised is what we seek. Although it may take several generations, we know the goal. We run a relay race; we pass the torch from generation to generation. We do our best when we carry the torch, but we are not disappointed that the goal is not reached during our turn. It would be arrogant to think that the end of the race might happen on our watch. The joy is in the run and the help we can offer to our diabetic friends. Through it all, we seek what the color blue had implied.”

I am privileged to have run this race by his side.

I also thank my three daughters: Brianne, who received her first masters degree while sleeping under my desk while I was attending graduate school; Andrea, who for the first 3 months of her life slept in a file cabinet drawer in my office while I recruited for phase 3 of the DCCT; and Leah, who at 10 days old attended her first ADA annual meeting. Their support of what I have done all these years and our love for each other know no limits.

And so, I close with a toast to our history and thanks to all. I have been so fortunate to have the support, friendship, and guidance of so many.