T2D AND PUMP THERAPY

FROM THE EXPERT

T2D AND PUMP THERAPY:

IT’S TIME TO REDEFINE THE ‘IDEAL’ PATIENT

BY LAUREL MESSER, RN, MPH, CDE

BUILDING BRIDGES: SECRETS TO FOSTERING STRONG PROVIDER RELATIONSHIPS FOR OPTIMAL OUTCOMES

Many patients with type 2 diabetes (T2D) who have suboptimal control on multiple daily injections (MDI) can benefit from insulin pump therapy.

Learn how 2 experts have turned the idea of the “ideal” T2D pump patient on its head—with incredible results:

  • Timothy R. Gilbert, MD, shares how he and his team put patients in the driver’s seat, resulting in A1C-lowering in 90% of patients who had poor glycemic control on MDI, as well as a 95% pump retention rate; and
  • Elizabeth Nardacci, MS, FNP-BC, CDE, explains how viewing patients as individuals, with individualized needs, expands their therapeutic options—along with their potential to achieve optimal control.


EMPOWERING PATIENTS, PROVIDING FLEXIBILITY, IMPROVING OUTCOMES

BY TIMOTHY R. GILBERT, MD

Patients who have poor glucose control despite MDI therapy present a number of challenges. Whether it’s poor compliance or inconsistent documentation, the underlying challenges are often related to the burden of therapy combined with low motivation.

In our endocrine-focused practice, we often find that these patients are doing fewer than 3 fingersticks per day, or if they are doing more, they aren’t documenting them. We also have found that appointment times for patients on MDI are 30% to 40% longer than average—due in part to the fact that having limited data about these patients inhibits our ability to make decisive, impactful therapy decisions.

FINDING A BETTER WAY
Not long after starting my practice in 2006 with just myself, 1 nurse/certified product trainer (CPT), and a medical assistant who doubled as a receptionist, I came to a realization: There had to be a better way.

For our practice, the sea change came when we changed our approach to identifying potential candidates for insulin pump therapy. Instead of asking, “Why should I put this patient on a pump?”—we started asking, “Why shouldn’t I put this patient on a pump?”

This shift occurred because in appropriately selected patients [see below], including those with T2D, we continue to see the positive effects of insulin pump therapy—particularly with continuous glucose monitoring (CGM). Time and time again, patients feel more empowered and their adherence and self-management improve; outcomes also improve, with lower A1Cs and reduced glucose variability; and patients benefit from a more flexible lifestyle. Importantly, I have no preconceived notions about who might benefit from pump therapy when it comes to how long someone has had diabetes (especially true of T2D patients) or how long they have been on MDI.

When patients move from MDI to pump therapy, we find that we spend less time clinically in evaluation mode and more time actually treating these patients and providing care. Not only do the patients benefit, the entire care team does.

IMPROVED CLINICAL OUTCOMES
Since opening our practice in 2006, our patient volume with diabetes has increased at least 3- to 4-fold. The patient mix is 50% diabetes, with 70% T2D and 30% type 1 diabetes (T1D). Our practice has grown to include a new physician partner, 2 nurse practitioners, 2 registered dietitians, 2 LPNs, 2 medical assistants, and 4 staff in the front office.

Our experience with insulin pump therapy also has grown significantly during that time. We currently have more than 600 active patients on pump therapy, and we do about 450 professional CGM (iPro®) studies per year.

Our practice’s data on file show that 90% of our patients who did not achieve good glycemic control on MDI have seen significant decreases in A1C on insulin pump therapy. In the last 2 years, with pump therapy alone, we have seen a 1.2% reduction in A1C; with insulin pump/CGM therapy, A1C reductions have averaged 1.8% to 1.9%. These reductions are variable, in keeping with the adage of “the bigger they [A1Cs] are, the harder they fall.”

MORE INFORMED THERAPY DECISIONS
We utilize CareLink® Pro therapy management software, part of the MiniMed® 530G with Enlite® system, with all of our patients on insulin pump and CGM therapy. This means that we can see every move patients are making by downloading the data recorded into the insulin pump by the Bayer CONTOUR®NEXT LINK meter.

No longer do we need to worry about patients saying they forgot their glucose book or meter. We can make informed therapy decisions based on real-time data and the detailed graphs and reports in CareLink. In fact, we have 3 PCs at our practice dedicated solely to CareLink downloads, and patients don’t move from the waiting room to the exam room until their data are downloaded.

PUMP THERAPY IN T2D
In their 2014 Consensus Statement [Grunberger et al], the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) expanded the criteria for ideal insulin pump candidates to include intensively managed insulin-dependent T2D patients. This change is reflective of a movement by physicians and payers, especially during the past few years, to recognize the clinical value of insulin pump therapy for patients beyond just T1D.

It is gratifying to see widespread acceptance of this therapeutic option for T2D patients, especially given the positive results we have seen in our practice for nearly a decade now in aggressively placing these patients on pump therapy when clinically appropriate.

As a referral-only practice, we are seeing more and more T2D patients who need intensive treatment regimens. In 2013, 43% of our new pump starts were T2D, and last year, 46% were.

The Medtronic Pumping Protocol book [Bode et al], the 2014 AACE/ACE Consensus Statement [Grunberger et al], and the American Diabetes Association (ADA) Standards of Medical Care in Diabetes-2014 are very similar as related to patient selection for pump therapy.

We follow those guidelines, with indications that include:

  • Elevated A1C
  • Glycemic variability
  • Recurrent hypoglycemia
    • Nocturnal
    • Activity-induced
  • Hypoglycemia unawareness
  • Recurrent diabetic ketoacidosis
  • Dawn phenomenon
  • Gastroparesis
  • Pregnancy
  • Patient Quality of Life
    • Meal flexibility
    • Busy lifestyle
    • Athletes
    • Tighter control

Patient preference is an extremely important factor in making the decision to move to pump therapy. We have found that about 90% of patients for whom we recommend pump therapy accept the recommendation. The vast majority say they wish they would have done it sooner and are happy with their improved glucose control and newfound freedom—for example, they can exercise without loading up on carbohydrates ahead of time, and they can eat with a bit more flexibility.

Our pump retention rate is over 95%, and we believe that’s no accident. This high retention rate is due to specific processes we have in place to assess patients, to obtain their buy-in, and to support them in their journey. Some of our best practices follow.

POSITIONING PATIENTS FOR SUCCESS
It’s important to recognize when patients are motivated—whether by the desire to get better or by fear (of long-term health risks, etc.)—and to capture that motivation.

While some providers may have the tendency to use pump therapy as a carrot and make patients jump through multiple hoops to “earn” the pump, our approach is different. We would rather put patients in the driver’s seat and give them an opportunity to succeed. Once they are empowered with integrated insulin pump/CGM therapy, these patients rarely disappoint .

With that said, we do take specific steps to position patients for success:

  • Although most patients do better on pump therapy, it’s important to assess them to ensure some key criteria can be met:
    • Willingness to monitor their blood sugars on a regular basis (4 to 6 times/day);
    • Ability to quantify food intake (simplified forms of carbohydrate counting can be used if needed);
    • Adherence with medical follow-up appointments—critical to gain the full benefits of therapy;
    • Must be responsible and psychologically stable—at least to some degree.
  • It’s important to set expectations upfront—what therapy is and what it’s not. We explain to patients that pump therapy doesn’t cure diabetes.
  • The goal of our practice is to allow patients to live with diabetes and not for diabetes. The lifestyle and flexibility that pump therapy provides can help accomplish that.
  • All patients sign a contract, which outlines their training and follow-up schedule, before initiating pump therapy. It’s not a legally binding contract, but it outlines what we expect of them. For example, they agree to check their glucose levels at least 4 times per day and to quantify and enter their carbohydrate intake. We have found that this process creates a greater commitment from patients in achieving their treatment objectives.
  • We have standardized our training and education processes so that patients are consistently taught appropriate skills to allow them to become good pump patients. We pre-plan, so as soon as patients are prescribed pump therapy, they are put on the schedule for either 3 (insulin pump therapy) or 5 (insulin pump/CGM therapy) appointments with a diabetes educator (DE) at established intervals. They know how important the appointments are to their success and are aware that if they miss 1 appointment, everything will be delayed. The DEs provide the training and education, along with the documentation of patients’ progress. Retraining is provided as needed—for example, training on advanced features of the MiniMed 530G with Enlite system as patients progress in their therapy.

    Our training protocol for insulin pump/CGM therapy includes:

    • Pre-Pump Training: 60 to 90 minutes
      • Carbohydrate counting (mandatory regardless of carb-counting education in the past) and utilization of the pump
      • Meter linked to pump and date and time set (if pump is in-hand)
      • Usually a 1-time visit, unless more carb-counting instruction is needed
    • Pump Start (1 to 2 weeks later): 2 hours
      • Review and discuss menus, program settings, and insulin pump initiation
      • Insulin and prescription are provided at visit
      • Patient brings pump and all pump supplies to this visit
    • Pump Follow-Up (1 week later): 1 hour
      • Download pump and review data using CareLink therapy management software
      • Address questions and discuss advanced features
      • Assist patient to personalize pump settings
    • Sensor/CGM Start (1 to 2 weeks later): 1 hour
      • Sensor initiation, settings programmed into pump, transmitter linked
      • CareLink education—patient instructed to download at home
    • System Follow-Up (1 to 2 weeks later): 1 hour (or longer, as needed)
      • Download pump and CGM report, make adjustments, and educate on advanced pump features
      • Collect CareLink report and review with patient

The process is based on doing all of our training in-house with the assistance of Medtronic’s clinical team or CPTs. It can be adjusted as needed for practices that have different set-ups.

The Medtronic clinical team has been integral in streamlining our processes and taking some of the burden off of our staff. Every new pump patient must have contact with a Medtronic representative. The Medtronic representative assists in introducing pump and CGM therapy and also with insurance approvals. They see prospective patients once or twice a week on a set schedule, and the vast majority of patient contacts are face-to-face (a few patients who have to travel 2 to 3 hours to the practice have phone appointments).

GOOD FOR PATIENTS, GOOD FOR THE PRACTICE
The clinical and lifestyle benefits of insulin pump/CGM therapy for T2D patients are clear. Another benefit that perhaps is not discussed as often is that patients with T2D who are on insulin pump therapy are actually easier to manage. There’s great satisfaction in delivering higher quality care and therapeutic recommendations based on detailed data and reports, and doing so 20% to 30% more efficiently.

Inevitably, when I’ve talked to doctors and other members of care teams at high-volume pump practices, they say: “I wish I would have pumped my T2D patients sooner—it’s easier, for them and for us—and there’s much less glycemic variation.”

Hear, hear.

SOURCES
Grunberger G, Abelseth JM, Bailey TS, et al. Consensus Statement by the American Association of Clinical Endocrinologists/American College of Endocrinology Insulin Pump Management Task Force. Endocr Pract. 2014;20(5):463─489. Available at: https://www.aace.com/files/insulin-pump-management-cs.pdf. Accessed April 22, 2015.

Bode BW, Kyllo J, Kaufman FR. Pumping protocol: A guide to insulin pump therapy initiation. Northridge, CA: Medtronic Diabetes Medical Education. 2012. https://s3.amazonaws.com/medtronic-hcp/Pumping%20Protocol%20-%20a%20Guide%20to%20Insulin%20Pump%20Therapy%20Initiation.pdf. Accessed April 24, 2015.

American Diabetes Association. Standards of Medical Care in Diabetes—2014. Diabetes Care. 2014;37 (Suppl 1):S14–S80. Available at: http://care.diabetesjournals.org/content/37/Supplement_1/S14.extract. Accessed April 24, 2015.

Timothy R. Gilbert, MD, is founder and medical director of the Endocrinology Center of Southwest Louisiana in Lake Charles, Louisiana. The practice is a division of Imperial Health, the region’s largest physician-owned multi-specialty group. Dr. Gilbert has served as a primary investigator and sub-investigator for several diabetes studies. He is a member of the AACE, ADA-Professional Section, the Endocrine Society, and the Louisiana State Medical Society, where he currently serves as a parish delegate on the state level. Dr. Gilbert speaks nationally on multiple diabetes-related issues, including utilization and management of insulin pump/CGM therapy.

DON’T THINK OUTSIDE THE BOX—FORGET THERE EVEN IS A BOX

BY ELIZABETH NARDACCI, MS, FNP-BC, CDE

Having worked in the field of diabetes for the past 30 years, I’ve learned an important lesson when it comes to insulin pump therapy: Many patients with T2D who have suboptimal control on MDI can benefit from pump therapy—and the best candidates aren’t always the most obvious ones.

This mindset has taught me to not only think outside of the box when it comes to identifying T2D patients who could benefit from pump therapy—but to forget there even is a box. By focusing on my patients as individuals, with individualized needs, their therapeutic options are expanded, along with their potential to achieve optimal control.

I’ve also learned that there is no “perfect” candidate—T2D or otherwise—for pump therapy. It’s important for both providers and diabetes educators (DEs) to use our professional judgment to identify T2D patients who have the potential to benefit from this therapy, and to provide them with the education, training, and support they need to be successful.

WHAT OPT2MISE HAS TAUGHT US
My experience as both a nurse practitioner and a trained DE is further supplemented by my work as a principal investigator for OpT2mise, the largest randomized, controlled study on insulin pump therapy for T2D. The international trial compared the efficacy and safety of insulin pump therapy and MDI in 331 adult patients (aged 30 to 75 years) with T2D who had failed to respond to a basal-bolus regimen after active insulin titration [Reznik et al; Aronson et al].

To download a copy of the OpT2mise clinical summary in PDF form and/or a copy of the full study from The Lancet, Click Here, and scroll to the bottom of the page, click, and enter your email address. Please send your ideas for future From the Expert topics to IntheKnow@medtronic.com.
While I had been recommending and prescribing pump therapy to T2D patients for many years with positive results prior to my involvement with OpT2mise, the study results reported last year in The Lancet [Reznik et al] confirmed the benefits*:

  • A 1.1% A1C drop with MiniMed® insulin pump therapy versus 0.4% in the group on MDI (all patients included in the study had a baseline A1C between 8% and 12%);
  • 0.7% between groups difference in A1C in favor of MiniMed insulin pump therapy;
  • Almost twice as many patients achieved an A1C <8% with MiniMed insulin pump therapy versus MDI (55% versus 28%).

Safety and other key results [Reznik et al] included:

  • No severe hypoglycemia events with MiniMed insulin pump therapy and no significant increase in the time spent in hypoglycemia;
  • No ketoacidosis events with MiniMed insulin pump therapy;
  • 20% total daily insulin dose reduction with MiniMed insulin pump therapy when compared with MDI;
  • 8% increase of HDL cholesterol concentration with MiniMed insulin pump therapy and 7% decrease in the MDI group;
  • No significant difference in body weight change with MiniMed insulin pump therapy.

The OpT2mise outcomes have squarely countered past concerns by those who had said there wasn’t enough medical evidence, or that there was conflicting evidence, about the use of pump therapy in patients with T2D.

While this growing body of clinical evidence is extremely important from a scientific standpoint, what’s just as rewarding for me is seeing first-hand the success of pump therapy in my T2D patients on a near-daily basis. Let me tell you more about that.

‘NO ONE EVER TOLD ME IT WAS AN OPTION’
While all patients are different and their clinical needs vary, patterns can begin to emerge when identifying patients with T2D who have failed MDI and who could potentially benefit from pump therapy.

You probably recognize this scenario:

You walk into the room and look at the patient, who is on MDI with suboptimal control of her T2D. Even in combination with metformin and other oral agents or injectables, the regimen is not meeting her therapeutic needs. She may be near-hopeless, with little confidence, and feeling guilty about her high numbers.

She is frustrated and near the end of her rope because no matter what she does, her A1C has remained high. As a result, the patient may have decreased self-care over time, with less testing or no testing. Or maybe she is testing and wants to do better, but she doesn’t even know about pump therapy or thinks it’s only an option for patients with T1D.

Typically, this patient has received treat-to-target advice common for those on long-acting insulin, and since this strategy has appeared to help her fasting numbers, she may be surprised to learn that her A1C is quite elevated at 9% to 10%.

When I identify T2D patients in this situation who are likely to meet the Medicare or private insurance criteria for pump therapy** (or who can private pay) and I suggest it to them, the most common response I receive is: “No one ever told me it was an option.”

Often, once insurance coverage is obtained, these patients go on to receive pump therapy—and typically, they never look back.

WHY WE SHOULDN’T ‘LABEL’ PATIENTS
In considering patients with T2D for pump therapy, it’s important to remove blame and guilt from the equation. These patients almost always want to do better—but their current therapy isn’t meeting their needs, and they just don’t know where or how to start. So they look to their care team—including the DE—for guidance.

Because of the progressive nature of T2D, one critical factor that is often overlooked is that the therapy that may have worked for a patient 5 years ago—or even 2 years ago—eventually may be rendered ineffective.

While these patients may hold some responsibility for their lack of diabetes control (no patient is 100% adherent!), it’s important not to label them. Removing the “blame factor” from the caregiver-patient dialogue opens a whole new conversation. Pump therapy can be a start-over for patients, both therapeutically and psychologically.

EXPANDING THERAPY OPTIONS—AND SUPPORT
In the past, the only T2D patients who were considered for pump therapy were those who were already extremely adherent, but in recent years we have expanded the patients we will consider—with great success.

Instead of expecting patients with T2D to be perfect and using pump therapy as a “reward,” we have come to realize that not only is the technology a critical tool in improving diabetes control, there are additional benefits we never even predicted. These patients, who have struggled to achieve therapeutic goals on MDI, commonly view the transition to pump therapy as a “clean slate”—and they ultimately become more adherent with necessary self-management such as carb counting, regular pre-meal blood glucose (BG) testing, etc.

Of course, patients do have to demonstrate that they are willing to do the “homework” needed to transition to pump therapy—including quantifying food, regular BG testing, and adjusting insulin as needed.

If patients have challenges such as issues with health or technology literacy, we work with them to try to overcome these hurdles. OpT2mise found that even patients with minimal cognitive impairment can do well on pump therapy [Reznik et al], so we know the evidence supports transitioning these patients if they are given the proper support. If patients aren’t able to count carbohydrates effectively, we provide simplified methods of doing so. We reinforce the necessity of regular BG testing if they want to be successful. If patients are worried that they “might make a mistake” while on therapy, we let them know we will be there guiding them every step of the way.

Once these patients initiate pump therapy, they feel empowered by their second chance, and their renewed commitment really shows. Their diligence—and the critical support of their care team—often pays off.

Some of my favorite moments as a provider are being able to tell these patients: “Guess what, your A1C is down at last!”

I have literally had patients tell me that this was the best news they have ever received in a decade or more of having diabetes. Now that’s what I call rewarding—for both the patient and the care team.

SHIFTING THE PARADIGM
In my opinion, pump therapy is an underutilized and underprescribed option for T2D patients on MDI with suboptimal control. Often, when these patients aren’t meeting their therapeutic goals, providers send them to dietitians/educators to lose weight. They are given the appropriate education and training, but these patients still don’t lose the weight, their numbers don’t improve, and before we know it, months—and then years—go by.

The entire caregiving team has not only the ability—but a responsibility—to inform patients of all the potential options available to attain optimal control on their lifelong diabetes journey. If current therapy such as MDI (often with oral medications and/or injectables) is not working, we need to change what we are doing—and pump therapy could be a much-needed solution.

As a whole, diabetes caregivers could help more patients by thinking differently about who might be a candidate for pump therapy and giving them a chance. Sometimes, all you need is someone to believe in you and support you—and DEs are really, really good at that.

*Results achieved do not guarantee results in all prospective new patients; variability as between patients is possible.

**Medicare and private insurance guidelines vary and are subject to change as related to the coverage of insulin pump therapy and/or CGM. For example, guidelines may require suboptimal control on a maximal program of basal/bolus injections over a specified period of time in C peptide-deficient patients, and test results often must be submitted, such as fasting BG, A1C, and C peptide levels. Be sure to consult the Centers for Medicare & Medicaid Services (CMS) and your patients’ private insurance criteria for the most current information. Medtronic’s clinical support team can provide assistance upon request.

SOURCES
Reznik Y, Cohen O, Aronson R, et al. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): A randomized open-label controlled trial. Lancet. 2014; 384:1265-1272.

Aronson R, Cohen O, Conget I, et al. OpT2mise: A randomized controlled trial to compare insulin pump therapy with multiple daily injections in the treatment of type 2 diabetes—Research and methods. Diabetes Technol Ther. 2014;16:414-420.

OpT2mise: The largest randomized, controlled study on insulin pump therapy for type 2 diabetes. Medtronic Diabetes. http://professional.medtronicdiabetes.com/opt2mise. Accessed April 24, 2015.

Elizabeth (Beth) Nardacci, MS, FNP-BC, CDE, is a family nurse practitioner at Capital Region Diabetes and Endocrine Care in Albany, NY. 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 T2D. Beth serves as an advisor to the American Association of Clinical Endocrinologists Task Force on Continuous Glucose Monitoring. She has made numerous presentations and published clinical papers on diabetes technologies and was a recipient of the Juvenile Diabetes Research Foundation’s Inspiration Award.