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Working as a Team forImproved Patient Outcomesin Type 2 Diabetes CME/CE/ABIM MOC

Supported by an independent educational grant from Sanofi


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Working as a Team for Improved Patient Outcomes in Type 2 Diabetes CME/CE/ABIM MOC

Target AudienceThis activity is intended for primary care physicians, diabetologists & endocrinologists, cardiologists, diabetes educators, nurses, and pharmacists.

GoalThe goal of this activity is to increase awareness of new therapeutic options using fixed-dose insulin combination injectable therapies and of how an interprofessional team can collaborate to improve management of type 2 diabetes (T2D).

Learning ObjectivesUpon completion of this activity, participants will:

• Have greater competence related to

– Describing new therapeutic options using fixed-dose insulin combination injectable therapy

– Discussing collaboration as an interdisciplinary team to improve T2D management

• Demonstrate improved performance associated with

– Describing collaborating effectively for improved medication use, glycemic control, and reduction of risk for hypoglycemic events

Accreditation Statements

In support of improving patient care, Medscape, LLC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

ACCME: 0.50 AMA PRA Category 1™ Credit:

For Physicians Medscape, LLC designates this enduring material for a maximum of 0.50 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

ANCC: 0.50 contact hours 0.50 contact hours are in the area of pharmacology

The American Association of Diabetes Educators is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. This program provides .5 contact hours of continuing education credit.

The AADE is also accredited by the California Board of Registered Nursing (CEP#10977).

This article is a CME/CE/ABIM MOC certified activity.To earn credit for this activity visit:


CME/CE/ABIM MOC Released: 08/31/2017; Valid for credit through: 08/31/2018


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ABIM MOC: Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.50 MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Aggregate participant data will be shared with commercial supporters of this activity.

ACPE: The American Association of Diabetes Educators is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This program provides 0.5 contact hours (.05 CEUs) of continuing education credit.

ACPE Universal Activity Number: 0069-9999-17-277-H01-P

The American Association of Diabetes Educators (AM001) is a Continuing Professional Education (CPE) Accredited Provider with the Commission on Dietetic Registration (CDR). CDR Credentialed Practitioners will receive .5 Continuing Professional Education units (CPEUs) for completion of this activities/materials. Continuing Professional Education Provider Accreditation does not constitute endorsement by CDR of a provider, program, or materials.

Certified Diabetes Educators: To satisfy the requirements for renewal of certification for the National Certification Board of Diabetes Educators (NCBDE), continuing education activities must be diabetes related and approved by a provider on the NCBDE list of Approved Providers (www.ncbde.org). NCBDE does not approve continuing education. The American Association of Diabetes Educators (AADE) is on the NCBDE list of Approved Providers.

Medscape, LLC staff have disclosed that they have no relevant financial relationships.

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This activity is designed to be completed within the time designated on page 2; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on page 2. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 75% on the post-test.

Follow these steps to earn CME/CE credit*: 1. Read the target audience, learning objectives, and author disclosures. 2. Study the educational content online or printed out. 3. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. We encourage you to complete the Activity Evaluation to provide feedback for future programming.

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Disclosures

Moderator

John E. Anderson, MD The Frist Clinic, Nashville, Tennessee

Disclosure: John E. Anderson, MD, has disclosed the following relevant financial relationships:

Served as an advisor or consultant for: Abbott Laboratories; AstraZeneca Pharmaceuticals LP; Boehringer Ingelheim Pharmaceuticals, Inc.; Janssen Pharmaceuticals, Inc.; Lilly; Merck & Co., Inc.; Sanofi

Served as a speaker or a member of a speakers bureau for: AstraZeneca Pharmaceuticals LP; Boehringer Ingelheim Pharmaceuticals, Inc.; Janssen Pharmaceuticals, Inc.; Lilly; Sanofi

Dr Anderson does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr Anderson does intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Panelist

Davida F. Kruger, MSN, APR-RC, BC ADM Nurse Practitioner, Henry Ford Health System, Detroit, Michigan

Disclosure: Davida F Kruger, MSN, APR-RC, BC ADM, has disclosed the following relevant financial relationships:

Served as an advisor or consultant for: Abbott Laboratories; Dexcom, Inc.; Intarcia Therapeutics, Inc.; Janssen Pharmaceuticals, Inc.; Lilly; Novo Nordisk

Served as a speaker or a member of a speakers bureau for: Abbott Laboratories; AstraZeneca Pharmaceuticals LP; Boehringer Ingelheim Pharmaceuticals, Inc.; Dexcom, Inc.; Janssen Pharmaceuticals, Inc.; Lilly; Novo Nordisk; Valeritas

Received grants for clinical research from: AstraZeneca Pharmaceuticals LP; Dexcom, Inc.; Lexicon Pharmaceuticals, Inc; Lilly; Novo Nordisk

Owns stock, stock options, or bonds from: Dexcom, Inc.

Ms Kruger does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Ms Kruger does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.


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Susan Cornell, PharmD, CDE Associated Professor of Pharmacy Practice; Associate Director of Experiential Education, Midwestern University Chicago College of Pharmacy, Downers Grove, Illinois

Disclosure: Susan Cornell, PharmD, CDE, has disclosed the following relevant financial relationships:

Served as an advisor or consultant for: Novo Nordisk; Sanofi

Served as a speaker or a member of a speakers bureau for: Novo Nordisk; Sanofi

Dr Cornell does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr Cornell does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Carol H. Wysham, MD Clinical Professor of Medicine, University of Washington, Spokane, Washington

Disclosure: Carol H Wysham, MD, has disclosed the following relevant financial relationships:

Served as an advisor or consultant for: AstraZeneca Pharmaceuticals LP; Boehringer Ingelheim Pharmaceuticals, Inc.; Janssen Pharmaceuticals, Inc.; Lilly; Novo Nordisk; Sanofi

Served as a speaker or a member of a speakers bureau for: AstraZeneca Pharmaceuticals LP; Boehringer Ingelheim Pharmaceuticals, Inc.; Insulet Corporation; Janssen Pharmaceuticals, Inc.; Lilly; Novo Nordisk; Sanofi

Dr Wysham does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr Wysham does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

EditorsAnne G. Le, PharmD, RPh Senior Scientific Director, Medscape, LLC

Disclosure: Anne G. Le, PharmD, RPh, has disclosed no relevant financial relationships.

CME/Content ReviewerAmy Bernard, MS, BSN, RN-BCLead Nurse Planner, Medscape, LLC

Disclosure: Amy Bernard, MS, BSN, RN-BC, has disclosed no relevant financial

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Introduction

Working as a Team for Improved Patient Outcomes in Type 2 Diabetes

John E. Anderson, MD: Hello, I am Dr John Anderson, an internal medicine physician at the Frist Clinic in Nashville. Welcome to this program titled, “Working as a Team for Improved Patient Outcomes in Type 2 Diabetes.”


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Panelists

Joining me today are Davida Kruger; I must mention, Davida -- congratulations on your Outstanding Educator in Diabetes Award that you received.

Davida F. Kruger, MSN, APN-BC, BC ADM: Thank you.

Dr Anderson: We are really, really proud of you.

Ms Kruger: Thank you.

Dr Anderson: Davida is a nurse practitioner at the Henry Ford Health System in Detroit. Welcome.

Ms Kruger: Thank you.

Dr Anderson: Susan Cornell; Susan is an associate professor at Midwestern University Chicago College of Pharmacy. Susan, thanks for joining us.

Susan Cornell, PharmD, CDE: Thank you.

Dr Anderson: Last but not least, Dr Carol Wysham. Carol is clinical professor of medicine at the University of Washington. It is a pleasure to have you with us, Carol.

Carol H. Wysham, MD: Thanks, John.

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Pathophysiological Approach to T2D

T2D Characterized by β-Cell Failure

Dr Anderson: Carol, let’s start with you. Let’s talk about type 2 diabetes (T2D) and the progressive nature of this disease.[1,2] It is never going to be static, is it?

Dr Wysham: We know that what defines hyperglycemia in patients with diabetes is β cell failure. That progresses over time. That is going to require that we follow diet and exercise. Medication is going to be necessary generally from the beginning. Progressively, we will need to add medications. Throughout the course of the disease, patients need to understand that injectable therapy is eventually going to be needed[3,4]; often, that therapy is going to include insulin.[5,6]

Successfully Starting an Injectable Medication


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Dr Anderson: Talk about that. Do you find that you are able to get your patients started on injectable therapy fairly easily? What are your strategies?

Dr Wysham: I start from the first time I see the patient and introduce that concept.[7] I use our diabetes educators very frequently in the course of the treatment of the patients[7] and encourage the educators to demonstrate what an insulin injection feels like; often, they teach a finger stick at the same time, so that the patients can detect the difference in the pain.[8,9]

When I am presenting patients with different options, obviously sometimes one option is going to be better than the other. I try to give them the options of what they think will better fit into their lifestyle. Often, we are starting the first injectable with a glucagon-like peptide-1 (GLP-1) receptor agonist (RA) because it does give the benefits of weight loss and no hypoglycemia.

Finding the Right Insulin Dose for Your Patient

Dr Anderson: We also know that we start insulin, we have to titrate it. Comment if you would about insulin titration and when it is time to intensify therapy?

Dr Wysham: I often see patients after the primary care provider has started insulin and titrated it up. Most of the time, the patients come in taking more insulin than necessary. There are 2 important rules that one can follow to consider intensifying the dose. For the first rule, determine if the dose reaches 0.5 unit/kg or, when using pounds, divide the patient’s weight by 4. If the insulin dose is greater than either of those 2 values, studies show that continuing to increase insulin is really not going to buy any significant reduction in glycated hemoglobin (HbA1c).

[10]

The other rule is very helpful if the patient reaches a fasting glucose of less than 130 mg/dL on average but the HbA1c is still above 7%. More basal insulin is not the answer. The patient really needs something to address postprandial glucose levels.[11,12]

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Intensifying Basal Insulin Therapy With a GLP-1 RA: 2017 ADA Guidelines

Dr Anderson: In primary care, this is a real point of clinical inertia and that is intensifying insulin, particularly basal insulin therapy. Can you make a quick comment about some of the new fixed-dose combinations and what those really mean?

Dr Wysham: We at the American Diabetes Association (ADA) and, I believe, most of us as endocrinologists really appreciate the concept now that we can use GLP-1 RAs to intensify our patient’s insulin therapy when he or she fails to reach glycemic control.[5] The GLP-1 RAs are every bit as efficacious as 3 shots of rapid-acting insulin in the studies that have been done.

Combination of Basal Insulin With a GLP-1 RA In the Same Syringe

There are 2 new products that combine basal insulin with a GLP-1 RA in the same syringe. These new products are fixed-dose combinations of the 2 injectable products. What a great thing to offer our patients who are already taking 1 injectable, and not quite getting to goal. We can offer patients something that does not change the number of injections and does not change how they have to check their blood glucose. The new products are titrated very similarly to the way that we have been titrating insulin.[13-15]


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Ms Kruger: The other nice thing about them is that they do not increase the risk of hypoglycemia, which is such a big concern for our patients. They do not increase weight. If we had add a rapid-acting insulin, both the risk of hypoglycemia and the patient’s weight increase.

Dr Wysham: That is correct.

Fixed Combination Injectable GLP-1 RA/Basal Insulin Combinations

Dr Anderson: Lixisenatide and insulin glargine are combined, as are degludec and liraglutide. I will let you weigh in, everyone. What are the unique challenges in terms of education for these fixed-dose combinations?

Ms Kruger: It is kind of hard for people to wrap their head around these combinations because, if you use the lixisenatide/glargine combination, it goes up to only 60 units.[16] If you use the liraglutide/degludec combination, it goes up to only 50 units.[17] You have to focus on the insulin dosing. The way I think about it is that you dose based on the insulin, and the GLP-1 RA comes along. You get smidgens of the GLP-1 RA based on the dosing of the insulin. When you are looking at the pen, the dose in there is the insulin dose, and you do not have to worry about the GLP-1 RA.

You have to know the maximal dose of each of them. You have to know what dosing the patient has been taking previously and understand the whole concept of GLP-1 RAs. It can be a little tricky, but once you get the hang of it, it makes it that much easier, and easier for the patient as well.

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Starting a GLP-1 RA/Basal Insulin Combination

Dr Anderson: Susan, with the pen, you treat this like insulin, right?

Ms Cornell: Correct.

Dr Anderson: In terms of priming and insulin pen needles, can you comment about that?

Ms Cornell: Right. Patients will be receptive to this combination product because it is in essence 2 doses in 1. Often, however, providers prescribe the pen but forget to prescribe the pen needles, which opens up a Pandora’s box for errors and patient mistakes. It is very important for all prescribers, if they take nothing else away from today, to take away this advice. When you write prescriptions for these pens, make sure you write prescriptions for pen needles as well. It is important for patients to understand that, too.

Another thing to remember, as Davida pointed out, we are dosing on the insulin but we are also priming on the insulin.[16,17] Patients who may have been taking a GLP-1 RA only had primed the pen the first time. Now they are going to have to prime the pen every time. From an educational standpoint, that is very important. That missed step, once again, can lead to errors.

Dr Wysham: I would love to get back to the needle issue. One of the major issues that disgruntles patients when we do send in the prescription for the needles is when somebody has checked the 29-gauge half-inch needle option. Clinicians need to know that there are many different options available. Studies have shown that a 4- or 5-mm needle length is all the patients need, and 31- or 32-gauge needles -- they are painless. Make sure that your staff knows which of the options to choose.

Ms Cornell: The smallest needle you can get is what is appropriate for just about every patient.

Dr Wysham: That is correct.


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AEs of GLP-1 RA/Basal Insulin Combinations[18]

Dr Anderson: Please make a comment about what we know about the gastrointestinal (GI) adverse event (AE) rates in the clinical trials with these fixed-dose combinations. Carol, what do we know about this?

Dr Wysham: Throughout the development of all of the GLP-1 RAs, nausea and vomiting, are the most common AEs. It is the rate at which the GLP-1 RA reaches the therapeutic dose that determines the rate of GI AEs.[15] One of the nice things about these fixed-dose combinations is you are starting at very low doses of the GLP-1 RA, and you are titrating slowly, so that the time it takes to reach the therapeutic dose of the GLP-1 is slowed. The rates of nausea and vomiting are, in a lot of cases, one-fourth of what they are with the individual component.

Dr Anderson: Susan and Davida, if you have had a patient for whom a previous GLP-1 RA failed due to AEs, would this information be a reason to perhaps reconsider?

Ms Kruger: Absolutely. I would still talk about nutrition with the patients, though. We know the GLP-1 RAs delay gastric emptying, which means the patient gets a sense of fullness, a sense of satiety, but the patients need to pay attention to that. Overeating is a reason for some of the nausea to occur. Even though the rates of nausea and vomiting are so much lower, it is still important to talk about whole nutrition and eating less. I agree with you; there is no reason not to go back and try it with these individuals as well.

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Administering the GLP-1 RA/Basal Insulin Combinations

Ms Cornell: The other point to bring up regarding what Davida is saying is that how you dose these products is slightly different. The lixisenatide/glargine combination (iGlarLixi) needs to be dosed before a meal.[16] Meal timing is very important for lixisenatide/glargine, whereas with degludec/liraglutide (iDegLira), we do not have to worry about that.[17] This is important for patients because they need to remember to take the medication before they eat. How does that fit into their schedule?

Dr Wysham, you brought up patient involvement in personalized medicine. How does this work for this patient? If you have a patient who skips breakfast, and that is normally when they would dose it, this might be something to talk about.

Dr Anderson: It brings up the role of the educator in this team approach, which we have all known. Nobody can do everything. This seems to me that this is a new change in therapy.


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DSME/S

Dr Anderson: We have talked about this before that diabetes self-management education (DSME) would be appropriate in this circumstance, correct?

Ms Kruger: DSME is always important, when you diagnose a person and when you are making major changes in their therapies or other changes in their lives. There are definitely marked periods when we should be using diabetes educators and diabetes education.[19,20] We sometimes forget to use medical nutritional therapy. Every patient deserves the opportunity to receive DSME.

Sometimes patients come to my office, and they have either never had diabetes education or it has been 10 years since they received it. Life has changed. Therapies have changed. When we are giving a therapy like this, we really want patients to understand and be successful with their therapy. Those are times and periods that we should send them back for education.

Dr Wysham: Most people have coverage for medical nutrition therapy annually. We should take advantage of that. They can help support the recommendations that the provider is making in the office.

Ms Kruger: Another reason we want to send back these patients to a dietitian is because we know our patients are hungry. We know they do not have that sense of fullness. Now we are going to give them therapies that provide that that sense of fullness. Therefore, patients may be able to do something really good for themselves with nutrition that they were not able to do before because of that lack of sense of satiety. Let them go back to the dietitian and learn more . We really do need to send them back for it.

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GLP-1 RAs “Fix” 6 of the 8 Defects

Ms Cornell: You bring up a good point, because we have all heard from our patients they never feel full. They are always hungry. That is the lack of satiety.

Ms Kruger: I hear that, too.

Ms Cornell: It is the lack of satiety. So the nice part of the GLP-1 RAs is they do provide that satiety.[5,6,21] If the patient is not expecting it, it can come as a shock. I believe in education any time we are starting a new drug. The other thing to think about as healthcare providers is that we spend very little time in our patient’s overall life. We have a small window of opportunity to provide the tools they need to manage their lives successfully on their own without us to control their diabetes. That is the important role of the diabetes education -- to make sure patients are living that quality, healthy life and doing well.


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Utilize a Team Approach to Care

Who Is on the “Team” and What Is Their Role?[22]

Ms Kruger: You should not be deterred from using diabetes education and medical nutritional therapy if you do not have a provider in your office. Most offices are not that fortunate to have someone in their office who can just at the drop of a hat provide patients with education and/or have them see a dietitian. But the community is rich with those people. If you cannot do it in your office or you do not have the people, know where the resources are so the patients can be referred.

It is important that we follow up to make sure that the patient understood the importance of receiving education. They may think they know something that they do not know; helping them understand that this is an opportunity, just as you just said, to live a better life, a more full life, if they understand how to manage their diabetes.

Dr Wysham: In addition, referral communication is important. This is what you identify as the problem, and then the feedback. You might have thought it was this, but we discovered that this was what was going on in the patient. Back and forth communication is so valuable.

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The Endocrinologist’s Role in Optimizing Diabetes Care[23]

Dr Anderson: You come from different backgrounds, different institutions. Things work a little differently. I am in a primary care world. Carol, tell us a little bit about how your team works. What does that team look like at your institution?

Dr Wysham: It is different for our endocrinology clinic. Our educators are embedded in our clinic. We encourage the patients’ primary care providers to refer to the diabetes educators. All of our patients see an educator before they see the endocrinologist; often, I do not need to see those patients. If an educator assesses that, for example, a patient was not taking his or her insulin correctly and now the educator has taught him or her how to take the insulin correctly, then the patient can return to primary care. The diabetes educators serve as patient advocates.

The other thing that is also true that patients when they see an HbA1c of 14% and they are being started on 10 units of basal insu-lin, the educators refer the patient to us, and say can you give me permission to call in a prescription for rapid-acting insulin. They are so important in our system. I do not know what to do with this. Why don’t you make an appointment with the educator? They are experts at that.

We have 4 educators. They each spend 1 day a week at our primary care satellites so that everyone has access to at least 1 of the educators once a week; the primary care providers can bring in their patients on those days and have the education done on the same day.


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The Pharmacist’s Role in Optimizing Diabetes Care[24]

Dr Anderson: I think that is great that you bring the educators to where those patients are going to feel comfortable. In the pharmacist world, would you talk a little bit about team care and how you approach this?

Ms Cornell: I am fortunate that I work with a fabulous team. I work with nurse practitioners, physician assistants, physicians, primary care endocrinology nurses, dietitians, dentists, and optometrists. We really have a good team. This referral, as you have talked about -- it is very important to realize that it takes a team to manage the patient with diabetes. The old saying of it takes a village to raise a child; that is the same when it comes to the patient with diabetes. It is important is to have the team members communicating to each other, talking to each other, and knowing when to hand off.

Often, historically, everybody thought it was their responsibility to manage this particular patient. It is not. It is a team approach. I work side by side with my prescribers. We determine with the patient what is the best therapy based on that patient’s needs.

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The Nurse’s Role in Optimizing Diabetes Care[25]

Dr Anderson: Davida, talk about your institution.

Ms Kruger: I am in an endocrinology practice. We have 6 nurse practitioners and 8 endocrinologists. Our endocrinologists all practice general endocrinology. They see patients with thyroid problems, and they do all kinds of other things as well, bone and mineral. They like the nurse practitioners to manage most of the patients with diabetes.

The endocrinologists may see a person the first time he or she comes in as a new patient. Then the patient will be sent to the nurse practitioner for diabetes education. We know about all of the devices and are very comfortable with all of the medications. In addition, we have a dietitian in our group, and we have some diabetes educators. If the use of a glucose meter or continuous glucose monitoring or a drug is new to a patient, we can have the patient sit with the diabetes educator in addition to the time he or she would spend with the nurse practitioner. We are fortunate.

Outside of our office, we have an educator at each of our satellite locations to work with the primary care physician and the nurse practitioners. They can also refer to them. They would do management. They would titrate the insulin for them. They would say it is time to move on. Then we have a connection back to us where they might call and say can you look at this? Is it time for an endo consult? Tell me what the next step is and I will do it. It is a really nice handoff in terms of how we manage the patients.


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The Primary Care Provider’s Role in Optimizing Diabetes Care[23]

Dr Anderson: I am in a primary care institution. Even though we are a 39-member group, we do not have clinical diabetes educators (CDEs). We have nurse practitioners, but we do not have CDEs embedded. Most of the education has to be referred out. Our medical nutrition therapy is right around the corner at the hospital. It is convenient.

One of the things I have always talked about is the members of the team need to be able to communicate. That is not just print out your form and send it and get it filed into the electronic medical records. Sometimes you need to pick up the phone. Isn’t that right?

Dr Wysham: That is right.

Ms Kruger: It really is.

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In Whom to Use the GLP-1 RA/Basal Insulin Combinations?

Dr Anderson: As a panel, let’s talk about these fixed-combination coformulations. It is remarkable -- consider just the mechanical engineering involved -- to be able to deliver fixed-dose combinations of a basal insulin and GLP-1. What are the FDA indications? Who are the right patients for this?

Dr Wysham: The FDA in their analysis of the clinical data came up with the recommendation. It is now the indication that these coformulations be used in patients for whom either basal insulin or a GLP-1 RA fails[16,17]; as such, these agents are not designed to be used immediately after oral therapy, although that is a very attractive use in my mind. At this point, it is to follow the failure of one or the other injectable.

Ms Kruger: That accounts for the dosing, because the dosing is based on prior dosing of insulin or other medications. That makes a whole lot of sense that that is the indication.


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Insulin “Fixes” 5 of the 8 Defects

Ms Cornell: What I like best about these products goes back to fixing all the defects in diabetes.[5,6,21] When we talk about type 2 diabetes, we talk about the 8 defects. When you put these 2 together, you are getting 5 or 6 of those defects taken care of with the benefits of weight loss and low hypoglycemic risk in 1 injection. It is a win-win situation for the providers and the patients.

A Closer Look at iGlarLixi[16]

Dr Anderson: So let’s talk specifically about iGlarLixi. Carol, just tell us a little bit about the pen, initial dosing, and maximal dose. Walk us through that.

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Dr Wysham: iGlarLixi is a combination in a ratio of 100 units of glargine insulin with 33 µg of lixisenatide, a short-acting prandial GLP-1 RA. With that ratio, depending on the dose of the basal insulin, if the patient is taking less than 30 units a day, he or she would start taking 15 units of the combination. If a patient is taking less than 15 units, it is not indicated to switch over.

If the patient is taking 30 units or more of basal insulin, then the starting dose is generally 30 units. Once you determine the starting dose, the titration in the study was to increase by 2 or 4 units weekly, depending on the fasting glucose value.

The maximal dose that can be delivered with the iGlarLixi is 60 units of the glargine because that gets to the maximal approved dose of lixisenatide, which is 20 µg.

Ms Kruger: It is important for the provider to understand that if your patient is taking 40 or 45 units of insulin, you still only want to start with 30 units. You have to remember that this is a combination. The reason we are taking the patient down to 30 units is allow the patient to slowly adjust to the use of a GLP-1 RA combination.

Tell the patient, “We hope your blood sugars are going to look better. Initially, they may not look as good because we are taking you down so that you do not have issues with nausea, but we can quickly titrate.” What you were talking about is 1 unit every other day. For the patient who is taking a higher dose of insulin that we are taking him down, that really might work. If you have a patient who is taking only a small dose, let’s say 30 units, and you want to eventually take the patient higher to get better control, you may then do a weekly titration.

Dr Wysham: I think it depends on the tolerability.

Ms Kruger: Absolutely. No question.

Ms Cornell: It is important to realize, too, with these products, especially iGlarLixi, that once you open the pen, it is good for only 14 days. Many of my patients do not want to throw anything away -- they paid for it and want to get every little drop. Make sure they understand that after 14 days, it is no longer good. I always tell my patients it is like milk; it spoils.

Dr Wysham: At 22 units a day, a patient would go through the pen in 2 weeks.

Ms Cornell: True, provided the patient is adherent and taking it correctly.

Dr Anderson: And titrating like they are supposed to be. Let’s talk just a little bit about patients who need a lot more than 60 units of basal insulin. You start doing the math at 0.5 unit/kg, and the vast majority of patients with type 2 diabetes will be able to tolerate this medication.

Dr Wysham: And be able to be controlled.


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A Closer Look at iDegLira[17]

Dr Anderson: Susan, please talk a little bit about iDegLira. What does the pen look like? What does that fixed ratio look like?

Ms Cornell: iDegLira is great because, just as Dr Wysham pointed out, where iGlarLixi is a basal insulin with a short-acting GLP-1 RA, iDegLira is a basal insulin with a long-acting GLP-1 RA. It is important for folks to realize the difference between short- and long-acting GLP-1 RAs. Short-acting medication definitely covers that postprandial glucose. The long-acting medication tends to cover both fasting and postprandial glucose. We tend to see a little greater fasting level drop -- we tend to see a little greater HbA1c drop because of that fasting component.

That is part of the reason why this particular drug can be dosed any time of the day. It is not tied to a meal. We do not have to worry so much about making sure the patient is taking it 1 hour before eating a meal. That way we get a little longer action out of it. The dosing is very similar; you need to titrate this up. You start it at 16 units of insulin. We always focus on the insulin. The nice thing here is that regardless of the dose of basal insulin the patient has been taking or if the patient is basal insulin naive and is taking a GLP-1 RA, we start at 16 units and titrate up.

With iDegLira, we always focus on the insulin dose. We are starting them at 16 units, then we slowly titrate them up. It could be 2 units every 2 to 4 days. As we have talked about, it is patient specific.

Dr Wysham: This one you would probably want to titrate slower because the long duration of action of degludec defines the need to be a little slower.

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How to Effectively Use CDEs for Patient Education[26]

Ms Cornell: Not all patients can manage this on their own. Or they are a little hesitant. They are unsure. They do not have that confidence. Often, when we start these titrations for patients, we have them call back in a week and read their blood glucose values to one of our nurses, dietitians, or educators. I am fortunate I have students with me. We will work with the patients to help them to understand their glucose values. That helps build their confidence so the patients are then better capable of managing titration on their own.

Dr Wysham: We do something similar. I flag the educator of the day. We have an educator who is in charge of phone calls every day to call the patient in a week. If the educator senses that the patient is not doing well with titration, it is an indication for him or her to come in for education.

Dr Anderson: It is important to select the proper agent – there is a long-acting and there is a short-acting agent. It is about knowing your patient and individualizing care. Just as you said, some patients really need to be held by the hand a lot more than do others. Others may be able to do this flawlessly and have no problem. Talk about how you include the patient in this decision-making process.


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What to Educate Patients on Regarding the GLP-1 RA/Basal Insulin Combinations[15]

Ms Kruger: You always have to educate or you are not going to be successful. I am talking about the patient’s lifestyle and when do they eat, when do they not eat? Asking, Can you remember to take this within 1 hour of the meal; those kinds of things. Are you comfortable with titration? How do we get you comfortable with the titration? They need to understand that and make a choice.

Ms Cornell: It is important to include the family. Many times our patients come in and they bring their family because one person says one thing. They go home and tell the family members, and the family members, who live with them day in and day out, will tell them something different than their provider told them. Now you have a little discrepancy going. It is very helpful to bring the family in so that everybody hears and everybody is on the same page. That way you can say, What does this mean to you? What are your thoughts about starting this injection? What concerns do you have about doing this? That way sometimes the family member will defer or add in to the conversation.

Dr Anderson: Any last thoughts, Davida, as we talk about team-based care?

Ms Kruger: First, this is an exciting opportunity for our patients to improve their therapy, getting much more from the therapy with the same number of injections. It is very clear that multiple people need to touch the patient for the patient to be successful. Education is still the cornerstone for our patients. They deserve the opportunity throughout the course of their diabetes to see a diabetes educator and a nutrition advisor.

Dr Anderson: Susan?

Ms Cornell: We have come a long way in the past several decades. I remember back in the day when we had 2 choices: sulfonylureas and insulin. That was it. Today, we have 12 classes of drugs. Yet with all this great technology and science, we still have this battle of diabetes.

We can have everything, the best drugs, the best people, but if the patient is not taking the drug and is not taking it correctly, then we are losing the battle. These frequent check-ups, I like to always call them medication checkups, checking with the patient and saying how are you doing? How are you taking your medication? Especially with devices; show me how you are using this device.

Dr Anderson: Teach back.

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Ms Cornell: Teach back, exactly. Doing those periodic checkups, not only the first time, but 2, 3, 6 months later, a year later. It does not have to be just 1 person. It can be any member of the team to do this.

Dr Anderson: Carol?

Dr Wysham: As Susan stated, it is the team, and the provider should not feel like he or she has to do it all. They are not trained. They do not have the skills of pulling out the patient’s underlying concerns. We are not very good at saying, Will you take this? Of course they are going to say yes to us, but they will be truthful to the educators. It is freeing to realize that there are other people on the team, that we can help divide up responsibilities and not to feel like it all has to happen on our shoulders in a 10- or 15-minute office visit.

Dr Anderson: As a primary care physician, I welcome the opportunity for anyone who has a chance to touch my patient and influence him or her during those 3 to 4 months before I see them come back.

Closing

Thank You

Davida, Susan, Carol, thank you for joining me in this valuable discussion.

Thank you for joining in this activity. Please continue on to answer the questions that follow and complete the evaluation.

This transcript has been edited for style and clarity


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AbbreviationsADA = American Diabetes AssociationAE = adverse eventDSME/S = diabetes self-management education and supportFDA = US Food and Drug AdministrationFDC = fixed-dose combinationFPG = fasting plasma glucoseGI = gastrointestinalGLP-1 = glucagon-like peptide-1HbA1c = glycated hemoglobinHGP = hepatic glucose productionNPH = neutral protamine HagedornPPG = postprandial glucoseRA = receptor agonist

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