Unstuck: Battling Clinical Inertia in Diabetes Management with Technology and Innovation

Health care professionals often care for patients with diabetes who cannot, or will not, meet therapeutic goals. These patients seem to be “stuck” with elevated glycated hemoglobin (A1C) levels and, even worse, unmotivated to adopt lifestyle changes to treat the disease, despite compliance with their medicines.

This complacency may not be solely the fault of the patient, but of the clinician as well, the latter of whom may be reluctant to change the regime, a term called “clinical inertia.” When clinical inertia is present, the prudent clinician should reach out for more innovative options to reignite diabetes management.

The Diabetes Quality Improvement Project, founded in 1997 by the Centers for Medicare & Medicaid Services, the National Committee for Quality Assurance, and the American Diabetes Association (ADA), measured and evaluated diabetes management in the United States. Although clinicians are now held accountable for improvement in diabetes care, they have unfortunately shown little improvement in managing the disease and its comorbidities.¹

Between 2000 and 2050, the number of diagnosed diabetes cases is expected to increase 225%, based on rates from the 1984 to 2000 National Health Interview Survey and census projections. The largest expected increase is in the elderly population, specifically those 75 years and older, where there is an expected increase of 460%.²

The huge economic impact of diabetes can be attributed, in part, to its chronic complications. In 2002, direct medical expenses for diabetes totaled nearly $92 billion. This included $23.2 billion for diabetes care and $24.6 billion for chronic complications attributed to the disease. (The remaining amount was for excess prevalence of other medical conditions.)³This is a heavy burden, but also an opportunity and a call to motivate and empower our patients to better achieve goals.

Chronic complications of diabetes were unheard of prior to the discovery of insulin in 1921. At the end of 1923, Eli Lilly and Company was able to produce large quantities of highly refined insulin and offer it for sale, helping to widely distribute the drug to patients with diabetes, most of whom would otherwise have died within a few years of diagnosis.⁴Insulin, no doubt one of medicine’s most profound and notable medical advancements, was the first of many diabetes management breakthroughs. Nowadays, with advances in technology and new medicines, there is an even wider range of diabetes treatment options available.

Needle Avoidance Solutions

Intensifying treatment in diabetes often involves needles, not only with insulin, but with the glucagon-like peptide (GLP-1) agonists, as detailed below. The extent of needle avoidance in patients who have type 1 or type 2 diabetes (T1D and T2D) is difficult to precisely assess, yet the health care provider knows that needle avoidance is a common reason why some patients are reluctant to use insulin.

In 2006, there was excitement over the first commercially available inhaled insulin, Exubera. It was unfortunately hampered by a bulky inhaler and high price, and with a lack of coverage by insurance companies, the medicine was withdrawn from the market in 2007.⁵Afrezza, a dry powder formulation of recombinant human regular insulin for inhalation released by MannKind, was approved by the FDA in 2014 for both T1D and T2D. For patients with T2D, Afrezza is suggested as a second or third-line choice when metformin and other oral hypoglycemics are not achieving patient goals. This rapid-acting insulin is absorbed in the lungs and typically given to patients already taking a long-acting insulin. It is administered in 4-unit and 8-unit increments. Because it is administered via inhalation, it is faster-acting than its counterpart subcutaneous rapid-acting insulins. It also boasts a smaller inhaler than its predecessor.⁶

A recently published study in the journalDiabetes Careshowed that for an individual with T2D whose disease is not adequately controlled with oral drugs, adding Afrezza can significantly improve blood glucose control. The average A1C level of the 177 study subjects who took the inhaled insulin dropped to 7.5% from 8.3% compared with a placebo, with which it dropped to 7.9%.⁷More patients in the Afrezza group also saw a drop in A1C to 7% or less, which is the recommended ADA target.⁷

The most common adverse effect of inhaled insulin is a persistent dry cough. Afrezza carries a black box warning of acute bronchospasm risk and is contraindicated in those with chronic pulmonary disease, such as asthma or chronic obstructive pulmonary disease and cautioned in lung cancer and smokers.⁶

Diabetes Drug Advancements

GLP-1 Agonists

New drugs in the GLP-1 receptor agonist class, also called incretin mimetics, include Tanzeum (albiglutide), Saxenda (liraglutide), and Trulicity (dulaglutide). As an adjunct to diet and exercise, these injectables activate the GLP-1 receptor in the brain to regulate appetite and caloric intake, increase insulin secretion, decrease glucagon secretion, and delay gastric emptying. Older drugs in this category include Bydureon and Byetta (exenatide) and Victoza (liraglutide).

This class is associated with nausea which, in effect, can induce weight loss. Drugs in this class have a black box warning for an increased risk of thyroid tumors and, thus, patients, especially those with family history of thyroid cancer, need to be aware of this potential problem.

SGLT2 Inhibitors

Sodium-glucose co-transporter 2 (SGLT2) inhibitors are an oral class of T2D medications that are effective in lowering blood glucose by blocking its reabsorption at the kidney, allowing it to be excreted in the urine. Farxiga (dapagliflozin), Jardiance (empaglifozin), and Invokana (cananigliflozin) are in this class. Renal impairment renders these drugs less effective; therefore, there are renal dosing adjustments. Genital mycotic infections may be seen in patients using these drugs.

DPP-4 Inhibitors

Tradjenta (linagliptin), Januvia (sitagliptin), Onglyza (saxagliptin), and Nesina (alogliptin) are dipeptidyl peptidase- 4 (DPP-4) inhibitors. These oral medications have a similar mechanism of action as the GLP-1 agonists, slowing incretin metabolism, increasing insulin synthesis, and decreasing glucagon levels.

Innovative Technology in Diabetes Management

Insulin Pumps

Technological advances in the treatment of diabetes are vast and very dynamic, and a full discussion of such is beyond the scope of this article, however, a discussion of the generalities of insulin pumps and continuous glucose monitoring is warranted.

The insulin pump is an excellent tool in intensive insulin therapy. It is physiologic, affording a steady basal rate and easily administering boluses as needed. When combating clinical inertia, however, it is best to first have stronger patient and provider engagement before switching from multiple daily injections to pump therapy. Popular pumps include the Insulet OmniPod, Medtronic Paradigm Revel, Animas Ping, and Accu-Chek Spirit Combo.

V-Go (insulin delivery system)

Providers are often faced with patients with T2D who are wrought with anxiety over starting insulin. Other patients who are on insulin may skip their doses for reasons including injection pain, inconvenience, and embarrassment. In this population, intensifying therapy proves difficult and the busy clinician is met with resistance from his reluctant patient. The V-Go insulin delivery system is a relatively new mechanical device that could benefit the patient with uncontrolled T2D. Requiring no batteries, infusion sets, or programming, it can be a simpler method to reengage the disengaged patient with persistently elevated fasting and postprandial numbers. This waterproof system is disposable after a 24-hour application. It is available in a preset basal rate of 20, 30, or 40 units a day with on-demand bolus capabilities in 2-unit increments, provided with a click of the device. The V-Go has risks similar to any insulin delivery device, with hypoglycemia being the most prominent.⁸

Continuous Glucose Monitoring

Continuous glucose monitoring (CGM) devices afford excellent capabilities for close monitoring of blood glucose in both T1D and T2D. These devices are especially applicable when more data are needed for the patient to provide feedback on self-monitoring, as well as for the provider to make optimal treatment decisions, helping to battle clinical inertia.

A continuous glucose monitor not only provides a constant blood glucose level, but elicits a broader roadmap in its exhibit of glucose trajectory. Thus, it provides the patient with diabetes a continual feedback upon which to draw after food, exercise, or other activities of daily life (ADL).

CGM is very engaging. Without it, it is nearly impossible, as well as impractical, to perform enough daily fingerstick glucose tests to fully grasp a glucose excursion. The monitor allows a basis for more accurate and directed disease self-management.

One of the most common reasons patients with diabetes keep their blood glucose high is fear of hitting a low. CGM combats the frustration associated with glucose lability with a constant reading and trajectory, and reveals trends to identify to avoid hypo- and hyperglycemic events. In a study of 120 children and adults with T1D, the time spent per day in hypoglycemia was significantly shorter with those randomized to the CGM group than to the control group. Furthermore, time spent in normoglycemia (defined as 70 to 180 mg/dL) was significantly lower in the CGM arm compared with the control group.⁹

The continuous glucose monitors utilize a sensor which is placed under the skin and changed every few days. Unlike fingerstick glucose readings which read blood, CGM entails interstitial fluid monitoring. Because of this, the monitor requires calibration with a blood glucose check, as well as occasional updates with fi ngersticks.10 It is important to note that interstitial glucose levels may lag behind blood glucose levels by about 5 minutes.^10,11

The Dexcom G4, MiniMed, and Freestyle are popular CGM systems. Newer receivers also boast “share” capabilities with connections via Bluetooth to a smartphone. Providers are able to download data from the monitors during office visits, affording a thorough exploration of a patient’s glucose trends.

Conclusion

It is prudent that providers and patients alike reengage by seeking treatment options newly available to patients with diabetes. Diabetes treatment is no longer limited to a paltry list of options; it has been enhanced by modern advances and technology. New insulin analogs have made the regulation of blood sugar much easier with quicker-acting onsets. Inhaled insulin is a new and effective option for patients with diabetes. For our patients with T2D, we can also rely on newer medicines such as GLP-1 agonists, SGLT2-inhibitors, and DPP-4 inhibitors.

Technological advancements have brought forth a variety of insulin pumps and continuous glucose monitors which are less cumbersome than their predecessors. Candid discussion with our patients on the stress their diabetes takes on their ADL (see“Diabetes Burnout and Patient Wellness”) will often reignite their volition to push forward and achieve clinical goals.

Diabetes Burnout and Patient Wellness

Effective disease management is not complete without a full assessment of diabetes-related stress. In the busy practice setting, it is extremely difficult for the clinician to find the time to fully assess and address each patient’s stress.

Combating a patient’s disengagement from his or her own health care can be facilitated with an inquiry into the patient’s stress level as associated with the chronic illness. There are several diabetes-related stress screen tools, such as the Problem Areas in Diabetes, a 20-item questionnaire; the Diabetes Distress Scale, a 17-question test that measures various aspects of living with diabetes; and a Questionnaire on Stress in Diabetes.^12-14

The implementation of stress management strategies is an often overlooked key to overcoming barriers to glucose control. It is beneficial for the patient to understand how to collaborate with providers on a plan for management of high-stress days.

Fostering an environment of hope and optimism and enlisting the help and support of family and friends is necessary to help fight diabetes stress. In the current day and age of pay-for-performance health care and the emphasis laid upon goal-reaching for a better glycated hemoglobin level, the underlying stress of diabetes is a topic that falls by the wayside.

Diabetes burnout is not readily addressed in today’s busy practice. When diabetes burnout is suspected, abiding by a brief period of less intense or modified self-management may be suggested by the provider. Parameters of this period need to be detailed so as to render it safe.¹⁵Reaching out to diabetes support groups, participating in diabetes-related events or fairs, or joining the local chapter of the American Diabetes Association (ADA) is beneficial and affords the patient an outlet. There are also camps available for children and adolescents.¹⁵

Journalist and author Daniel Brannan, who penned the ADA-endorsed book,Life to the Fullest: Stories of People Coping with Diabetes; Diabetes Doesn’t Have to be a Death Sentence, was recently interviewed forContemporary Clinicabout his experience with the daily stresses of diabetes. A patient with type 1 diabetes, Mr. Brannan was asked how frequently he experiences diabetes burnout and he responded, “All the time.”

With regard to diabetes, he relates, “It is a constant stressor, one which there is no escape [from]. It’s with you every minute of every day.” He adds that it is tiring to plan every aspect of one’s life. “I can’t just walk out the door. I have to think ahead about food, drink, insulin, and know my blood sugar. Every step that I take is not without forethought.”

Mr. Brannan wears a continuous glucose monitor which has helped him immensely in the control of his sugars and in preventing hyper- and hypoglycemic events, yet it has its drawbacks as well. “The [continuous glucose monitor] is another reminder that I have this chronic illness.” To fight diabetes burnout, Mr. Brannan says that he takes one day at a time. “If I had to think about how many shots I’ll need to live another 20 years, it would be overwhelming. So for me, it’s one shot at a time... Each day my eyes open is a gift.”

.

For a resource center for diabetes news, research, and media content, please see the, “Diabetes Compendium”http://www.ajmc.com/compendium/diabetes

For Diabetes Wellness Resources, go to:›www.mayoclinic.com›www.diabetes.org

Michele D. Brannan, MPAS, PA-C,graduated magna cum laude with a bachelor’s degree in health science and graduated with distinction with her master of physician assistant studies degree, each from Gannon University. She started her career at St. Louis University, working in cardiology before joining Alton Internal Medicine, where she has practiced for 10 years.

References

1. Grant RW, Buse JB, Miegs JB;University Health System Consortium (UHC) Diabetes Bench-marking Project Team. Quality of diabetes care in U.S. academic medical centers: low rates of medical regimen change.Diabetes Care.2005;28(2);337-442.
2. Engelau MM, Geiss LS, Saaddine JB, et al. The evolving diabetes burden in the United States.Ann Int Med. 2004;140(11):945-950.
3. Hogan P, Dall T, Nikolov P; American Diabetes Association. Economic costs of diabetes in the US in 2002.Diabetes Care.2003;26(3):917-932.
4. History of diabetes. American Diabetes Association website. www.diabetes.org/research-and-practice/student-resources/history-of-diabetes.html?referrer=https://www.google.com/. Updated May 9, 2014. Accessed September 17, 2015.
5. Simons J. How the Exubera debacle hurts Pfizer.Fortunemagazine website. http://archive.fortune.com/2007/10/19/magazines/fortune/simons_pfizer_erbitux.fortune/index.htm?postversion=2007101916. Published October 19, 2007. Accessed September 17, 2015.
6. Afrezza [prescribing information]. Danbury, CT: MannKind Corporation; 2015. www.afrezzapro.com/afrezza-action-profile. Accessed September 17, 2015.
7. Rosenstock J, Franco D, Korpachev V, et al. Inhaled Technosphere insulin versus inhaled Technosphere placebo in insulin-naïve subjects with type 2 diabetes inadequately controlled on oral antidiabetes agents. American Diabetes Association Diabetes Care website. http://care.diabetesjournals.org/content/early/2015/08/07/dc15-0629.abstract. Published 2015. Accessed September 4, 2015.
8. V-Go [prescribing information]. Bridgewater, NJ: Valeritas, Inc; 2015.www.go-vgo.com/sites/default/files/upload/hcp_dosing-titration.pdf. Accessed September 17, 2015.
9. Battelino T, Phillip M, Bratina N, Nimri R, Oskarsson P, Bolinder J. Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. American Diabetes Association Diabetes Care website. http://care.diabetesjournals.org/content/34/4/795.short. Published 2011. Accessed September 5, 2015.
10. Steil GM, Rebrin K, Mastrototaro J, Bernaba B, Saad MF. Determination of plasma glucose during rapid glucose excursions with a subcutaneous glucose sensor.Diabet Technol Ther.2003;5(1):27-31.
11. Kulcu E, Tamada JA, Reach G, Potts RO, Lesho MJ. Physiological differences between interstitial glucose and blood glucose measured in human subjects.Diabetes Care.2003;26(8):2405-2409.
12. Polonsky WH, Anderson BJ, Lohrer PA, et al. Assessment of diabetes-related distress.Diabetes Care.1995;18(6):754-760.
13. Polonsky WH, Fisher L, Earles J, et al. Assessing psychosocial distress in diabetes: development of the diabetes distress scale.Diabetes Care.2005;28(3):626-631.
14. Herschbach P, Duran G, Waadt S, Zettler A, Amm C, Marten-Mittag B. Psychometric properties of the Questionnaire on Stress in Patients with Diabetes--Revised (QSD-R).HealthPsychol. 1997;16(2):171-174.
15. Ruggiero L, Wagner J, deGroot M. Chapter 4. In: Mensing C, ed.The Art and Science of Diabetes Self-Management Education. Chicago, IL: American Association of Diabetes Educators; 2006.