Barriers to Intensifying Insulin in T2D Management: An Interview on Clinical Inertia

Treatment intensification for patients with type 2 diabetes (T2D) already on a regimen of daily basal insulin is a difficult transition – for both the patient and the clinician rendering care, observed Brian Levy, MD, in a recent conversation with Patient Care Online.

The transition to basal plus mealtime insulin increases daily injections from 1 to 4 for the patient and adds complexity and risk to patient management for the clinician—one barrier for each party to gaining better control of hyperglycemia.

But that’s just 1 barrier among many for both patient and clinician, Levy, an endocrinologist and clinical assistant professor of medicine at NYU Grossman School of Medicine, told Patient Care. So-called clinical inertia is multifactorial and can delay T2D treatment intensification by more than 4 years.

In the interview that follows Levy sketches a clinical profile of the patient with T2D who now needs to add mealtime insulin. He talks candidly about the psychosocial and logistical factors that slow clinical progress and cites evidence of how some patients struggle.

Brian L. Levy, MD, is an endocrinologist and clincial assistant professor of medicine at New York University Grossman School of Medicine in New York, NY.

The following transcript has been lightly edited for clarity and style.

Patient Care Online. I’d like to ask you to sketch a profile of a patient with type 2 diabetes being seen in primary care who's considered an ideal candidate for bolus mealtime insulin. How long have they had diabetes? What's their medication history, their age, etc? What does the patient look like?

Brian Levy, MD. These patients who need to advance from basal insulin to mealtime insulin do tend to have a longer history of diabetes—on average greater than 10 or 15 years. These patients tend to be overweight, or medically obese. Type 2 diabetes is both a disease of resistance to insulin based on obesity, but also a progressive loss of insulin over time, less insulin produced by the pancreas. So the duration of diabetes at the time when they need insulin is many years longer than for a patient who might be well controlled on a noninsulin therapy. That also presumes that a patient has been over the years on the right treatment paradigm for their type 2 diabetes starting with 1, 2, or 3 oral antihyperglycemic agents and/or injectable noninsulins like the GLP-1 receptor agonist class. These are all great treatments but over time, they may become less effective. The first hurdle is for the patient to be started on a once-a-day basal insulin. Then, after the physician has titrated the basal insulin upwards over time, but patients are still not achieving their glycemic goals (as measured by the hemoglobin A1c test), that is when further intensification, beginning mealtime insulin, is required. These patients might tend to be older because they've had diabetes longer. By older I mean in their 50s and up. But that's not necessarily going to be true in the future because people are developing type 2 diabetes at younger and younger ages, sadly, sometimes as pediatric or adolescent patients. So, the need for insulin may start at a younger age than what we're seeing now.

PCO. Clinical inertia is not a new phenomenon, and it happens across disease states. What tends to be the resistance on the physician side? The physician knows that this is the next right step, but what potentially holds him back?

Levy. There are several physician barriers, especially in the primary care office, where they may not have the same staff, such as diabetes educators, that an endocrinologist might have. And yet, the majority of people with type 2 diabetes are treated in the primary care office simply because type 2 diabetes is so common. One thought that goes through the clinician’s head, though we don’t want it to, is, “If only you (the patient) followed your diet, lost weight, and exercised, you wouldn't need advancement to insulin therapy.” That’s not entirely true. At every step of the way, we want patients to focus on weight control and eating the right foods. So, that’s one barrier that clinicians have. The other well, there are many, but another is it's a lot more work. And it's a lot more time consuming to first initiate insulin. I mentioned that's the first barrier—basal insulin. Even more so, the next barrier is intensification of insulin, from 1 shot a day to let's say, 4 shots a day—3 mealtime shots, plus a basal shot. There is fear on the clinician’s part of new issues such as hypoglycemia and how to manage it, how to teach patients how to manage hypoglycemia. There is the fear of not feeling comfortable with up- titrating insulin doses once the regimen becomes complex. And the list goes on. It’s stressful for the healthcare professional and has a lot to do with lack of time. Dealing with the patient’s other problems, like high blood pressure, heart disease, arthritis.It’s hard in a busy office practice with all their patients having multiple medical issues that they deal with on a daily basis.

PCO. I would think that for the patient there are equally as many barriers. Maybe one of the primary ones being the fear that this means their diabetes is getting worse. They may also be putting out negative energy that meets the clinician’s energy and together it pushes the discussion away from the elephant in the room.

Levy. You’re totally right, it's negative energy on both sides. And we have to break those barriers. Patients are afraid that if their insulin is intensified, that means they're sicker. And that's not necessarily true. It means the disease has progressed and requires a different way to manage it to successfully prevent diabetes complications by controlling the blood glucose.

But multiple injections mean many things too many patients. They usually take their basal insulin as 1 injection per day, usually in the evening, in the privacy of their own home. Multiple injections mean something quite different; it means taking shots during the daytime, which can interfere with daily activities. Whether that’s being at work at a meeting, or social activities, being in a restaurant, where you have to separate from the crowd to take your insulin, which makes you feel different from the crowd. There are feelings of embarrassment. People with type 2 diabetes are already somewhat embarrassed because the disease has a negative connotation. It usually means, “You're overweight and you don't want to eat healthy.” Also, not necessarily true. And then last, but certainly not least, and I don't want to underestimate it, is injection pain. We teach that insulin shots are painless. They are relatively painless, but they're not painless. And to go from 1 shot-a-day to 4 shots-a-day for mealtime-plus-basal insulin is a pain issue as well.

I’d like to bring up a study. This was a survey of a large number of people with type2 diabetes, and it astounded me as a clinician in that 72% of the patients reported that they do not take their insulin outside of the home. That is a significant number. And the other important number here is that more than half of the patients reported missing injections they knew they should take, or they simply forgot to dose, perhaps at a social event or at a work meeting.

There is another study which has shown that if patients who need a shot at each meal miss 4 of those shots in a week, that’s 4 out of 21 injections a week of mealtime insulin, the result is an increase in their hemoglobin A1c of up to 1%. That's significant.

We spend a large part of our day in a postprandial state, really about 12 hours a day. So, patients with type 2 diabetes need insulin to control how high their sugars go after meals, and they're not taking their shots because of a variety of psychosocial barriers. Glycemic control is going to worsen which puts them at increased risk of developing complications over time.