Professional Documents
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ANALYSIS
12 3
Rene Rodriguez-Gutierrez postdoctoral researcher , Kasia J Lipska assistant professor of medicine ,
4 5 1
Rozalina G McCoy assistant professor of medicine , Naykky Singh Ospina endocrinology fellow ,
6 1
Henry H Ting senior vice president , Victor M Montori, professor of medicine , Hypoglycemia as a
Quality Measure in Diabetes Study Group
1
Knowledge and Evaluation Research Unit, Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Medicine, Mayo Clinic,
Rochester, MN 55905, USA; 2Division of Endocrinology, University Hospital Dr Jose E Gonzalez, Autonomous University of Nuevo Leon, Monterrey,
Mexico; 3Section of Endocrinology, Yale School of Medicine, New Haven, CT, USA; 4Division of Primary Care Internal Medicine, Mayo Clinic,
Rochester, MN, USA; 5Division of Health Care Policy and Research, Mayo Clinic, Rochester, MN, USA; 6New York-Presbyterian Hospital, New
York, USA
The goals of diabetes care are to reduce the risk of short and hypoglycemia.2 22 We propose that hypoglycemia be included
long term complications, increase longevity, and improve health as a counterbalance measure of quality as an effort to fully
related quality of life. Tight glycemic control—aiming for a optimize and individualize glycemic control and thereby
hemoglobin A1c (HbA1c) concentration below 6.5-7.0%—has improve the care of patients with diabetes.
been the cornerstone of diabetes care based on the results of
Current quality measures in diabetes care
early randomized clinical trials that suggested a reduction in
microvascular and macrovascular complications.1 2 These trials A key effort to standardize measurement and reporting of the
also found a twofold to threefold increase in the risk of severe quality of care in diabetes came with the Diabetes Quality
hypoglycemia among patients randomized to intensive glycemic Improvement Project (DQIP) in the early 2000s. The DQIP
control.3 4 However, given the long term benefits of intensive proposed HbA1c <9.5% (80 mmol/mol); low density lipoprotein
glycemic control, this risk seemed justified and some have (LDL) cholesterol ≤3.36 mmol/l (130 mg/dL); blood pressure
suggested a target for HbA1c “as close to normal as possible control (<140/90 mm Hg); annual foot, eye, and nephropathy
(<6%).”5 6 For many patients, hypoglycemia is the limiting factor examination; smoking cessation counseling; annual HbA1c
to achieving stringent glycemic goals.5 7 It is also often perceived testing; and biennial lipid profiles. These measures were later
an unavoidable burden that needs to be accepted in order to used in the US Healthcare Effectiveness Data and Information
accrue the potential long term benefits of glycemic control. Set and have been widely adopted worldwide,23 including by
But this model of care is now changing, particularly in type 2 the National Committee for Quality Assurance and National
diabetes. The effect of tight glycemic control on microvascular Quality Forum in the United States, and the National Institute
and macrovascular outcomes that are important to patients (end for Health and Care Excellence (NICE) in the United
stage renal disease, dialysis, blindness, clinical neuropathy, Kingdom.24-26 The guidelines give little attention to
stroke, and death) remains uncertain,8-11 making it increasingly hypoglycemia. The International Diabetes Federation (IDF), an
difficult for many patients and clinicians to accept the risk of umbrella organization of 230 national diabetes associations,
severe hypoglycemia. Furthermore, even mild episodes of proposes more than 20 potential quality indicators, but none
hypoglycemia (those that are self treated) impose a burden, targets hypoglycemia.27 NICE simply adds that patients who
cause distress, and disrupt the ability of patients to perform have experienced severe hypoglycemia should be referred to a
everyday activities.12 In addition, severe hypoglycemia is specialist diabetes team.26 Only the Department of Veterans
associated with adverse outcomes such as death, cardiovascular Affairs has specifically focused on hypoglycemia with its recent
events, cognitive impairment, dementia, impaired autonomic initiative promoting the formulation of a personal plan for
function, fall related fractures, poor quality of life, and increased managing blood glucose.28
cost (table).12-21 Recent clinical diabetes guidelines advocate
assessment and prevention of hypoglycemia, including reducing
stringency of glycemic targets among patients at risk of severe
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BMJ 2016;352:i1084 doi: 10.1136/bmj.i1084 (Published 7 March 2016) Page 2 of 4
ANALYSIS
hypoglycemia at every visit, change in the diabetes treatment comprehensive type 2 diabetes management algorithm—2016 executive summary. Endocr
Pract 2016;22:84-113. doi:10.4158/EP151126.CS. 26731084.
program in response to a hypoglycemic episode, education for 2 National Institute for Health and Care Excellence. Type 2 diabetes in adults: management:
patients to prevent hypoglycemia, and prompt detection and NICE, 2015. www.nice.org.uk/guidance/ng28
3 Diabetes Control and Complications Trial Research Group. The effect of intensive
treatment of events. Actions could also include education of treatment of diabetes on the development and progression of long-term complications in
patients on how to respond to hypoglycemia, use of a medical insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-86. doi:10.1056/
NEJM199309303291401. 8366922.
alert bracelet or similar identification, and prescription of 4 UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with
glucose tablets or glucagon. Arguably, current quality measures sulphonylureas or insulin compared with conventional treatment and risk of complications
do not promote improvements in the implementation of these in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837-53. doi:10.1016/
S0140-6736(98)07019-6. 9742976.
measures. While not all of these measures are pertinent to every 5 American Diabetes Association. Standards of medical care in diabetes. Diabetes Care
patient with type 1 and type 2 diabetes, some should be focused 6
2005;28(suppl 1):S4-36. doi:10.2337/diacare.28.suppl_1.S4. 15618112.
Jellinger PS, Smith DA, Mehta AE, et al. American Association of Clinical Endocrinologists’
on the care of people at high risk of hypoglycemia—that is, guidelines for management of dyslipidemia and prevention of atherosclerosis. Endocr
patients who have experienced hypoglycemia. Pract 2012;18(suppl 1):1-78doi:10.4158/EP.18.S1.1. .
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BMJ 2016;352:i1084 doi: 10.1136/bmj.i1084 (Published 7 March 2016) Page 3 of 4
ANALYSIS
Key messages
Quality measures for diabetes have focused on hyperglycemia at the expense of hypoglycemia
Hypoglycemia disrupts patients’ lives and is associated with adverse health outcomes
Measures designed to detect, prevent, and promptly treat hypoglycemia are needed
7 Cryer PE. Hypoglycaemia: the limiting factor in the glycaemic management of type I and 24 National Committee for Quality Assurance. Diabetes recognition program (DRP), 2015.
type II diabetes. Diabetologia 2002;45:937-48. doi:10.1007/s00125-002-0822-9. 12136392. http://www.ncqa.org/Programs/Recognition/ChangestoDRP.aspx
8 Yudkin JS, Richter B, Gale EA. Intensified glucose lowering in type 2 diabetes: time for 25 National Quality Forum. Endocrine Measures, 2014. http://www.qualityforum.org/projects/
a reappraisal. Diabetologia 2010;53:2079-85. doi:10.1007/s00125-010-1864-z. 20686748. endocrine/?section=CandidateConsensusStandardsReview2013-12-092014-04-02
9 Montori VM, Fernández-Balsells M. Glycemic control in type 2 diabetes: time for an 26 National Institute for Health and Care Excellence. Diabetes in adults. Quality standard.
evidence-based about-face?Ann Intern Med 2009;150:803-8. doi:10.7326/0003-4819- 2011. https://www.nice.org.uk/guidance/qs6/chapter/List-of-statements-
150-11-200906020-00008. 19380837. 27 International Diabetes Federation, Clinical Guidelines Task Force. Global guideline for
10 Hemmingsen B, Lund SS, Gluud C, et al. Targeting intensive glycaemic control versus type 2 diabetes. IDF, 2012.
targeting conventional glycaemic control for type 2 diabetes mellitus. Cochrane Database 28 US Department Veterans Affairs. Hypoglycemia safety initiative (HSI), 2015. http://www.
Syst Rev 2013;11:CD008143.24214280. qualityandsafety.va.gov/ChoosingWiselyHealthSafetyInitiative/HypoglycemiaSite/
11 Coca SG, Ismail-Beigi F, Haq N, Krumholz HM, Parikh CR. Role of intensive glucose Hypoglycemia.asp
control in development of renal end points in type 2 diabetes mellitus: systematic review 29 National Quality Forum. Consensus task force. 2011. https://www.qualityforum.org/
and meta-analysis intensive glucose control in type 2 diabetes. Arch Intern Med Measuring_Performance/Improving_NQF_Process/Consensus_Task_Force.aspx
2012;172:761-9. doi:10.1001/archinternmed.2011.2230. 22636820. 30 Frier BM. Hypoglycaemia in diabetes mellitus: epidemiology and clinical implications. Nat
12 Green AJ, Fox KM, Grandy S. SHIELD Study Group. Self-reported hypoglycemia and Rev Endocrinol 2014;10:711-22. doi:10.1038/nrendo.2014.170. 25287289.
impact on quality of life and depression among adults with type 2 diabetes mellitus. 31 UK Hypoglycaemia Study Group. Risk of hypoglycaemia in types 1 and 2 diabetes: effects
Diabetes Res Clin Pract 2012;96:313-8. doi:10.1016/j.diabres.2012.01.002. 22296853. of treatment modalities and their duration. Diabetologia 2007;50:1140-7. doi:10.1007/
13 Bonds DE, Miller ME, Bergenstal RM, et al. The association between symptomatic, severe s00125-007-0599-y. 17415551.
hypoglycaemia and mortality in type 2 diabetes: retrospective epidemiological analysis 32 Diabetes Control and Complications Trial Research Group. Hypoglycemia in the Diabetes
of the ACCORD study. BMJ 2010;340:b4909. doi:10.1136/bmj.b4909. 20061358. Control and Complications Trial. Diabetes 1997;46:271-86. doi:10.2337/diab.46.2.
14 Zoungas S, Patel A, Chalmers J, et al. ADVANCE Collaborative Group. Severe 271. 9000705.
hypoglycemia and risks of vascular events and death. N Engl J Med 2010;363:1410-8. 33 Gregg EW, Li Y, Wang J, et al. Changes in diabetes-related complications in the United
doi:10.1056/NEJMoa1003795. 20925543. States, 1990-2010. N Engl J Med 2014;370:1514-23. doi:10.1056/
15 McCoy RG, Van Houten HK, Ziegenfuss JY, Shah ND, Wermers RA, Smith SA. Increased NEJMoa1310799. 24738668.
mortality of patients with diabetes reporting severe hypoglycemia. Diabetes Care 34 Crasto W, Jarvis J, Khunti K, et al. Multifactorial intervention in individuals with type 2
2012;35:1897-901. doi:10.2337/dc11-2054. 22699297. diabetes and microalbuminuria: the Microalbuminuria Education and Medication
16 Goto A, Arah OA, Goto M, Terauchi Y, Noda M. Severe hypoglycaemia and cardiovascular Optimisation (MEMO) study. Diabetes Res Clin Pract 2011;93:328-36. doi:10.1016/j.
disease: systematic review and meta-analysis with bias analysis. BMJ 2013;347:f4533. diabres.2011.05.008. 21640424.
doi:10.1136/bmj.f4533. 23900314. 35 Miller ME, Bonds DE, Gerstein HC, et al. ACCORD Investigators. The effects of baseline
17 Whitmer RA, Karter AJ, Yaffe K, Quesenberry CP Jr, , Selby JV. Hypoglycemic episodes characteristics, glycaemia treatment approach, and glycated haemoglobin concentration
and risk of dementia in older patients with type 2 diabetes mellitus. JAMA on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD
2009;301:1565-72. doi:10.1001/jama.2009.460. 19366776. study. BMJ 2010;340:b5444. doi:10.1136/bmj.b5444. 20061360.
18 Geller AI, Shehab N, Lovegrove MC, et al. National estimates of insulin-related 36 Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and diabetes: a report of a
hypoglycemia and errors leading to emergency department visits and hospitalizations. workgroup of the American Diabetes Association and the Endocrine Society. Diabetes
JAMA Intern Med 2014;174:678-86. doi:10.1001/jamainternmed.2014.136. 24615164. Care 2013;36:1384-95. doi:10.2337/dc12-2480. 23589542.
19 McCoy RG, Van Houten HK, Ziegenfuss JY, Shah ND, Wermers RA, Smith SA. Self-report 37 Pedersen-Bjergaard U, Færch L, Allingbjerg ML, Agesen R, Thorsteinsson B. The influence
of hypoglycemia and health-related quality of life in patients with type 1 and type 2 diabetes. of new European Union driver’s license legislation on reporting of severe hypoglycemia
Endocr Pract 2013;19:792-9. doi:10.4158/EP12382.OR. 23757608. by patients with type 1 diabetes. Diabetes Care 2015;38:29-33. doi:10.2337/dc14-
20 Johnston SS, Conner C, Aagren M, Ruiz K, Bouchard J. Association between 1417. 25288675.
hypoglycaemic events and fall-related fractures in Medicare-covered patients with type 38 Geelhoed-Duijvestijn PH, Pedersen-Bjergaard U, Weitgasser R, Lahtela J, Jensen MM, Östenson CG.
2 diabetes. Diabetes Obes Metab 2012;14:634-43. doi:10.1111/j.1463-1326.2012.01583. Effects of patient-reported non-severe hypoglycemia on healthcare resource use, work-time
x. 22335246. loss, and wellbeing in insulin-treated patients with diabetes in seven European countries.
21 Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for J Med Econ 2013;16:1453-61. doi:10.3111/13696998.2013.852098. 24144009.
adverse drug events in older Americans. N Engl J Med 2011;365:2002-12. doi:10.1056/ 39 Zhang Y, McCoy RG, Mason JE, Smith SA, Shah ND, Denton BT. Second-line agents
NEJMsa1103053. 22111719. for glycemic control for type 2 diabetes: are newer agents better?Diabetes Care
22 American Diabetes Association. 5. Glycemic targets. Diabetes Care 2016;39(suppl 2014;37:1338-45. doi:10.2337/dc13-1901. 24574345.
1):S39-46. doi:10.2337/dc16-S008. 26696679.
23 Fleming BB, Greenfield S, Engelgau MM, Pogach LM, Clauser SB, Parrott MA. The Accepted: 05 02 2016
diabetes quality improvement project: moving science into health policy to gain an edge Published by the BMJ Publishing Group Limited. For permission to use (where not already
on the diabetes epidemic. Diabetes Care 2001;24:1815-20. doi:10.2337/diacare.24.10.
granted under a licence) please go to http://group.bmj.com/group/rights-licensing/
1815. 11574448.
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BMJ 2016;352:i1084 doi: 10.1136/bmj.i1084 (Published 7 March 2016) Page 4 of 4
ANALYSIS
Table
ACCORD, Action to Control Cardiovascular Risk in Diabetes; ADVANCE, Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled
Evaluation; HR, hazard ratio; CI, confidence interval; RR, relative risk; SF-12, short form-12; PhQ-9, patient health questionnaire-9; HRQoL, health related quality
of life.
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