Managing a diabetic patient is a delicate balance; finding that balance in an older patient is even trickier. Many older adults suffer from multiple comorbidities, which further complicates disease management. One very common problem encountered with the rigorous control of glycated hemoglobin (A1C) is hypoglycemia (blood sugar below 70 mg/dL). As examined in a previous issue of Evidence-Based Diabetes Management,1 frequent episodes of hypoglycemia can lead to hypoglycemia unawareness—a condition where the body fails to generate the usual warning signs of an overcompensated blood sugar drop.
A recent study, published in JAMA Internal Medicine, highlighted the significance of this problem in the elderly population by conducting an exhaustive analysis of more than half a million patients enrolled within the Veterans Health Administration (VA) in 2009.2 The patients evaluated were at least 75 years old, received insulin and/or a sulfonylurea, and had intensive glycemic control (in categories of less than 6%, less than 6.5%, and less than 7%). The conclusion: 11.3% of the patients had A1C less than 6%, 28.6% had A1C less than 6.5%, and 50% had A1C less than 7%, with a wide variation observed across the VA facilities. The study concluded that because patients treated with antidiabetic agents are highly susceptible to episodes of hypoglycemia, their glycemic management should be reevaluated, especially with respect to intensive therapy.2
A commentary exploring the study findings was published in The Journal of the American Medical Association. Its authors, while calling for a change in approach when treating the older population, elegantly highlighted some of the current barriers:
• The need to reconcile evidencebased data and patient-centered medicine
• Clinical inertia, which prevents therapy reduction
• Conflicting information and multiple guidelines, combined with commercial marketing, which can confuse both the patient and the physician
• The difficulty, for physician and patient alike, of discussing treatment de-escalation.3
The authors of the commentary also alluded to an important issue that has confronted the primary care realm for some time: the 20 minutes that the primary care physician can allocate per patient is not sufficient for a discussion of scaling back treatment.
James Sabin, MD, clinical professor of population medicine and psychiatry at Harvard Medical School and director of the Harvard Pilgrim Health Care Ethics Program, concurred with 2 of these arguments. On his blog entry for The Hastings Center, Sabin pointed out that acknowledging and accepting new practices that might contradict old ones meets with an immense amount of resistance from the physician. A contributing factor, he adds, is skepticism in the provider’s mind about pharmaceutical industry—sponsored research. Sabin points out that reducing treatment would be an acknowledgment of vulnerability and mortality. Age increases sensitivity to insulin and oral diabetes medications, which puts the patients at an increased risk of hypoglycemia.4
How Do You Confront This Challenge?
Choosing Wisely for geriatric patients
Early last year, the American Geriatric Society issued guidelines, as a part of the Choosing Wisely initiative, which included recommendations for physicians on medication use and A1C control in older diabetic patients. The guideline clearly states that moderate glycemic control is better than tighter control: “Tight control has been consistently shown to produce higher rates of hypoglycemia in older adults. Given the long time frame to achieve theorized microvascular benefits of tight control, glycemic targets should reflect patient goals, health status, and life expectancy. Reasonable glycemic targets would be 7% to 7.5% in healthy older adults with long life expectancy, 7.5% to 8% in those with moderate comorbidity and a life expectancy of less than 10 years, and 8% to 9% in those with multiple morbidities and shorter life expectancy.”5
Clinical trials designed for the elderly
Despite a high incidence of diabetes among individuals over 65 years of age, clinical trials usually exclude older persons and even those who have multiple comorbidities. Data from the National Diabetes Statistics Report, released this year, show that 25.9% of seniors (over 65 years of age) suffer from diagnosed and undiagnosed diabetes mellitus.6 The heterogeneity of their health status, combined with the lack of evidence from clinical trials, has resulted in a lack of standardization of intervention strategies for these older adults.7
Although retrospective studies have evaluated glycemic control, comorbidities, and hypoglycemic events in the elderly, very few prospective studies have been conducted in that population.
One such study, completed last year, compared the efficacy and safety of 2 different insulin regimens in the management of nursing home patients with type 2 diabetes mellitus.8
Organized efforts to raise awareness The American Diabetes Association convened a Consensus Development Conference on Diabetes and Older Adults in 2012, which addressed the heterogeneity of health status of older adults and the lack of clinical trial—based evidence to determine standard intervention strategies for older adults.
By creating an overarching view of the disease epidemiology in older adults, including comorbidities, the conference aimed at developing guidelines to fill in evidence gaps. The experts who participated in the conference arrived at a consensus—following a review of all the available data and literature—that A1C goals should be individualized per each patient’s needs and health status, rather than set down as rigid goals to meet (see the Table).7
To fill the existing gaps in the knowledge base on older adults with diabetes, the expert participants in the conference recommended that studies and trials should specifically include older adults who have dependent living situations and who might suffer from multiple comorbidities. Additionally, the recommendations called for using evidence from “real-world” settings to help develop treatment guidelines.7
Lack of Elderly in Trials: A Managed Care Burden?
Consider the following statistics:
• About 10.9 million adults 65 years or older (about 26.9% of that age group) were estimated to have diabetes in 2010
• Of the 65-years-or-older diabetic population, heart disease is noted on 68% of diabetes-related death certificates9
• Seniors use a sizable portion of services compared with individuals under 65 years of age, especially:
º hospital inpatient days
º nursing/residential facility days
A diabetes model generated by the Institute for Alternative Futures predicts that by the year 2025, the total population of seniors with diagnosed and undiagnosed diabetes will present a 59% upsurge: from 10,821,600 in 2010 (estimated by CDC) to 17,191,000 in 2025.
The expected medical and societal costs of this dramatic increase are estimated at $168 billion—up from $105.7 billion in 2010.11 These costs are preventable. What is lacking is a solid evidence base and data, which can be accrued by including more seniors in clinical trials or by designing trials to specifically address diabetes complications in that population.
Gaining a better understanding of prediabetes is another approach. Biomarkers that could identify the formative years of the disease—when symptoms are lacking—could help prevent or regulate the condition before disease complications set in.References
1. Dangi-Garimella S. The persistent complication of hypoglycemia in diabetics. Am J Manag Care. 2014;20(SP8):SP251-SP252.
2. Tseng CL, Soroka O, Maney M, Aron DC, Pogach LM. Assessing potential glycemic overtreatment in persons at hypoglycemic risk. JAMA Intern Med. 2014;174(2):259-268.
3. Andrews MA, O’Malley PG. Diabetes overtreatment in elderly individuals: risky business in need of better management. JAMA. 2014;311(22):2326-2327.
4. Sabin J. Overtreatment of elderly diabetics. Over 65 blog: The Hastings Center. http://www.over65.thehastingscenter.org/overtreatmentof-elderly-diabetics/. Published July 7, 2014. Accessed August 28, 2014.
5. American Geriatrics Society: ten things physicians and patients should question. Choosing Wisely website. http://www.choosingwisely.org/doctor-patient-lists/american-geriatricssociety/.
Released February 21, 2013. Accessed August 28, 2014.
6. Statistics about diabetes. American Diabetes Association website. http://www.diabetes.org/diabetes-basics/statistics/. Updated August 20, 2014. Accessed August 29, 2014.
7. Kirkman MS, Briscoe VJ, Clark N, et al. Diabetes in older adults. Diabetes Care. 2012;35(12):2650-2664.
8. Diabetes in the elderly: prospective study (DMElderly). ClinicalTrials.gov website. http://clinicaltrials.gov/show/NCT01131052.
9. Fast facts: data and statistics about diabetes. American Diabetes Association website. http://professional.diabetes.org/admin/User-Files/0%20-%20Sean/FastFacts%20March%20
2013.pdf. Accessed September 3, 2014.
10. American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013;36(4):1033-1046.
11. United States’ diabetes crisis among seniors: today and future trends. http://www.altfutures.org/pubs/diabetes2025/US_Diabetes2025_Seniors_BriefingPaper_2011.pdf. Institute
for Alternative Futures website. Published 2011. Accessed September 3, 2014.