Amir Qaseem, MD, PhD, MHA; Linda L. Humphrey, MD, MPH; Roger Chou, MD; Vincenza Snow, MD; Paul Shekelle, MD, PhD; for the Clinical Guidelines Committee of the American College of Physicians
Qaseem A, Humphrey LL, Chou R, Snow V, Shekelle P, for the Clinical Guidelines Committee of the American College of Physicians. Use of Intensive Insulin Therapy for the Management of Glycemic Control in Hospitalized Patients: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2011;154:260-267. doi: 10.7326/0003-4819-154-4-201102150-00007
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Published: Ann Intern Med. 2011;154(4):260-267.
The American College of Physicians (ACP) developed this guideline to present the evidence for the link between the use of intensive insulin therapy to achieve different glycemic targets and health outcomes in hospitalized patients with or without diabetes mellitus.
Published literature on this topic was identified by using MEDLINE and the Cochrane Library. Additional articles were obtained from systematic reviews and the reference lists of pertinent studies, reviews, and editorials, as well as by consulting experts; unpublished studies on ClinicalTrials.gov were also identified. The literature search included studies published from 1950 through March 2009. Searches were limited to English-language publications. The primary outcomes of interest were short-term mortality and hypoglycemia. This guideline grades the evidence and recommendations by using the ACP clinical practice guidelines grading system.
ACP recommends not using intensive insulin therapy to strictly control blood glucose in non–surgical intensive care unit (SICU)/medical intensive care unit (MICU) patients with or without diabetes mellitus (Grade: strong recommendation, moderate-quality evidence).
ACP recommends not using intensive insulin therapy to normalize blood glucose in SICU/MICU patients with or without diabetes mellitus (Grade: strong recommendation, high-quality evidence).
ACP recommends a target blood glucose level of 7.8 to 11.1 mmol/L (140 to 200 mg/dL) if insulin therapy is used in SICU/MICU patients (Grade: weak recommendation, moderate-quality evidence).
Does the use of IIT to achieve tight glycemic control compared with less tight glycemic control improve important health outcomes in the following settings or patient populations: surgical intensive care unit (SICU), medical intensive care unit (MICU), general surgical ward, general medicine ward, patients with myocardial infarction or acute stroke, and patients in the perioperative setting?
What are the harms of strict glycemic control in the above subpopulations?
IIT = intensive insulin therapy; MICU = medical intensive care unit; SICU = surgical intensive care unit.
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Harvard Medical School
February 16, 2011
Comment on the ACP Guidelines for the Management of Glycemic Control in Hospitalized Patients
The American College of Physicians' clinical practice guidelines for the management of hyperglycemia in hospitalized patients are confusing and may do more harm than good. The guidelines recommend against use of intensive insulin therapy (IIT) in the intensive care unit (ICU) as well in the non-ICU setting irrespective of the diabetes status. The IIT is defined as the use of intravenous insulin infusion. If intravenous insulin infusion should not be used in the ICU, what should be used to keep blood glucose levels in 140-200 mg/dL range? Should it be the oral agents, multiple subcutaneous insulin injections or a sliding scale insulin regimen? Many physicians consider multiple subcutaneous insulin injections also an IIT. This is especially true in the non-ICU setting where intravenous insulin is rarely used. Therefore, if following these guidelines, many hospitalized patients will be given only sliding scale insulin. This is potentially dangerous for all type 1 diabetic patients and many type 2 diabetic patients. Moreover, no upper limit for blood glucose levels has been set for the non-ICU patients. I think ACP guidelines should be more explicit and explain what should be done and not just what should not be done.
Rajesh Garg, M.D. Assistant Professor of Medicine Division of Endocrinology, Diabetes and Hypertension Brigham and Women's Hospital, Harvard Medical School 221 Longwood Ave, RF 393 Boston, MA 02115 email@example.com
Gauranga C. Dhar
Bangladesh Institute of Family Medicine And Research, USTC
February 17, 2011
Intensive Insulin Therapy in hospitalized patients.
In diabetics, sudden fall of blood glucose causes sympathetic and adrenergic activation. Direct effects of catecholamine and sympathetic system activation as well as catecholamine induced hypokalemia through Na+K+ATPase system leads to long QTc and QTd; ventricular tachy-arrhythmia (Torsade de pointes) and death. Patients either in SICU or MICU may present with hyperglycemia where blood glucose equal or >180mg/dl (10mmol/L) frequently indicates previously undiagnosed of existing diabetes. On the other hand non-diabetics with moderate hyperglycemia (<180mg/dl) in ICU may be found as a result of altered carbohydrate metabolism, glycogenolysis, gluconeogenesis and lipolysis associated with stress with the involvement of corticotrophin releasing hormone-arginine-vasopressin-catecholamine system. It has long been known that poorly controlled hyperglycemia among hospitalized patients is associated with increased morbidity and mortality but stringent glycemic control with intensive insulin therapy (IIT) leading to normoglycemia (4.4mmol/L to 6.1mmol/L) is associated with increased mortality due to hypoglycemia. Although to reduce such adverse outcomes, altered target of IIT; 7.8mmol/L to 11.1mmol/L in such contingent of patients also associated with similar mortality. Currently we do not have enough evidence that more relaxed target; 10mmol/L to 11.1mmol/L provides with better outcomes. As defined by American Diabetes Association, hypoglycemia, at blood glucose level <3.9mmol/L (<4.0mmol/L according to Canadian Diabetes Association), counter regulatory sympatho-adrenal activation starts to take place where catecholamine play one of the crucial roles. Same pathophysiological factor applies to any person with hyperglycemia experiencing "any sudden fall" of blood glucose irrespective of initial/baseline glucose level (relative hypoglycemia) as a result of IIT. More vulnerable are hospitalized non-diabetic individuals in whom corticotrophin releasing hormone-arginine-vasopressin-catecholamine system is already been activated before additional adrenal activation takes place after IIT. For better outcomes, no doubt glycemic control is necessary in patients in ICU but not at the cost of hypoglycemia and blood glucose target, if even IIT is used, may not be fixed but should be individualized which depends upon patient's present condition, age, duration of diabetes, existing medications and concomitant illness.
Samaritan Health Physicians
February 18, 2011
Appples v Pears
I appreciate the extensive review of in hospital glucose targets Pehaps I misunderstand, but I think the stated goal of 140-200 includes all blood glucose levels . It appears in looking at the references that most of them dealt with patients who are NPO, whether because they are critically ill, postoperative or have had recent neurological events . Most of the time in the hospital, if a patient is eating we check PREprandial capillary glucose. If the PREprandial blood glucose is 200, the post meal sugar will be higher, outside the target range.I don't interpret this review as suggesting that mealtime insulin coverage is not needed if the pre-meal sugar is <200. This is the interpretation of many of my collegues. Please clarfy this
Mary T. Korytkowski
University of Pittsburgh
February 24, 2011
Defining the Glycemic Targets for Hospitalized Patients
The American College of Physicians (ACP) Clinical Practice Guideline on inpatient glucose control recommends against intensified insulin therapy (IIT) in medical and surgical patients in the hospital (1). This recommendation is based on a systematic review finding no consistent evidence to support strict glycemic control, defined as glucose targets of 4.4-6.1 mmol/L (80-110 mg/dL) (1, 2). The use of intensive insulin therapy to achieve these targets is associated with an increase in risk for hypoglycemia, which is related to an increased risk of hospital complications and mortality (3).
The ACP guideline also recommends that the upper glycemic target be changed to include blood glucose levels as high as 11.1 mmol/L (200 mg/dL) in ICU and non-ICU settings (1). Evidence from observational and randomized controlled trials has shown that glucose levels above 10 mmol/L (180 mg/dL) impair neutrophil function, increase risk for infections, prolong length of hospital stay and increase mortality in ICU patients (3). In addition, recent randomized control trials in non-ICU patients have shown that targeting pre-meal and random glucose levels between 6.1- 10 mmol/L (110-180 mg/dL), respectively, decrease the risk for infectious and other complications (4).
The ACP guides practice for the majority of internal medicine physicians across the United States and beyond. It is of concern that these guidelines were published without reference to either a recent Consensus Statement or the 2011 Clinical Practice recommendations for hospitalized patients which advocate glycemic targets of 7.8-10 mmol/L (140 to 180 mg/dL) for the majority of critically and non-critically ill hospitalized patients (3, 5). These are levels can be safely achieved without increasing risk for hypoglycemia.
It is our concern that variability in recommendations for glycemic targets by different professional organizations can result in both confusion and clinical inertia among those who deliver this care. Publications such as the ACP Clinical Guideline has the potential for misinterpretation with a weakening of current efforts to achieve reasonable glycemic goals that have been demonstrated to reduce risks of undertreated hyperglycemia in hospitalized patients.
1. Qaseem A, Humphrey L, Chou R, Snow V, Shekelle P, for the Clinical Guidelines Committee of the American College of Physicians. Use of Intensive Insulin Therapy for the Management of Glycemic Control in Hospitalized Patients: A Clinical Practice Guideline From the American College of Physicians. Annals of Internal Medicine. 2011;154(4):260-267.
2. Kansagara D, Fu R, Freeman M, Wolf F, Helfand M. Intensive Insulin Therapy in Hospitalized Patients: A Systematic Review. Annals of Internal Medicine. 2011;154(4):268-282.
3. Moghissi ES, Korytkowski MT, DiNardo MM, et al. American Association of Clinical Endocrinologists and American Diabetes Association Consensus Statement on Inpatient Glycemic Control. Diabetes Care. 2009;32(6):1119- 1131.
4. Umpierrez GE, Smiley D, Jacobs S, et al. Randomized Study of Basal- Bolus Insulin Therapy in the Inpatient Management of Patients With Type 2 Diabetes Undergoing General Surgery (RABBIT 2 Surgery). Diabetes Care. 2011;34(2):256-261.
5. American Diabetes Association. Standards of medical care for patients with diabetes mellitus. . Diabetes Care. 2011;34(Suppl 1).
Anthony P. Furnary
Starr-Wood Cardiac Group
February 26, 2011
To the editor:
I read with interest the clinical practice guideline on intensive insulin therapy published by the ACP (1). Specifically in regards to coronary artery bypass (CABG) patients with diabetes, ACP recommendations 2 and 3 are unfounded and not supported by the data cited. Only two of the 14 RCTs used for the ACP meta-analysis included CABG patients (2,3). In both, intensive insulin therapy-directed tight glycemic control (IIT-TGC) significantly reduced in-hospital mortality and surgical wound infection rates. All of the remaining studies considered in the meta-analysis excluded cardiac surgical patients by design. Those studies should not be used to broadly "over-rule" the significant effects of ITT-TGC that have been repeatedly proven in diabetes CABG patients.
To dilute the positive effects of these two cardiac surgical RCTs with 12 medical/non-cardiac surgical studies of IIT-TGC, which were ineffective in reducing mortality and infection, and then broadly claim that IIT-TGC should not be performed in all patients - including diabetes CABG patients -- is both irresponsible and dangerous.
The detrimental effects of hyperglycemia on mortality and surgical wound infections were first elucidated in the diabetes cardiac surgery patient population in the 1990's by our large (now >8000 patients) prospective observational studies from the Portland Diabetes Project. (4,5) These detrimental effects were proven to persist for 3 full days from the time of open-heart surgery, regardless of patient location within the hospital (SICU or ward). Eradication of hyperglycemia with ITT-TGC for 3 full days eliminated the increased risks of mortality and surgical site infection in this prominent portion (31%) of the cardiac surgery population. Kirdemir subsequently confirmed these same findings in a RCT (2). A sub-analysis of cardiac surgical patients from the Leuven SICU study re-confirmed the protective causal effects of IIT-TGC in cardiac surgical patients (6). Even the neurosurgical RCT by Bilotta confirmed the effects of tight IIT on surgical wound infections.
Hypoglycemia is an obvious potential detrimental consequence of IIT, but it is highly dependent on the protocol used, patient population studied and hospital environment in which it is used. The Portland Protocol at a target range of 70-110 carries a 1.0% risk (per patient) of severe hypoglycemia (<40) in the diabetes CABG patients on whom it is used for 3 days, even in the non-ICU ward (7). This is far lower than any other protocol assessed in the ACP meta-analysis.
The ACP and the AIM should withdraw its recommended guidelines with respect to CABG patients with diabetes; re-examine ALL of the evidence specific to this important patient cohort; and revise its guidelines appropriately and with haste... lest more patients die or become injured as a result of this misguided guideline becoming widely adopted in the wrong patient population.
Anthony P. Furnary, MD Senior Cardiothoracic Surgeon Starr-Wood Cardiac Group Director, Portland Diabetes Project Portland, OR
1. Qaseem A, Humphrey LL, Chou r,SnowV, Shekelle P for the Clinical Guidelines Committee of the American College of Physicians : Use of Intensive Insulin Therapy for the Management of Glycemic Control in Hospitalized Patients: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2011;154:260-267.
2. Kirdemir P, Yildirim V, Kiris I, Gulmen S, Kuralay E, Ibrisim E, et al. Does continuous insulin therapy reduce postoperative supraventricular tachycardia incidence after coronary artery bypass operations in diabetic patients? J Cardiothorac Vasc Anesth. 2008;22:383- 7. [PMID: 18503925]
3. van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, et al. Intensive insulin therapy in the critically ill patients. N Engl J Med. 2001;345:1359-67. [PMID: 11794168]
4. Furnary AP, Zerr KJ, Grunkemeier GL, Starr A. Continuous intravenous insulin infusion reduces incidence of deep sternal wound infection in diabetic patients after cardiac surgical procedures. Ann Thorac Surg Feb 1999; 67:352-362.
5. Furnary AP, Gao G, Grunkemeier GL, Wu YX, Zerr KJ, Bookin SO, Floten HS, Starr A. Continuous insulin infusion reduces mortality in patients with diabetes undergoing coronary artery bypass grafting. J Thorac Cardiovasc Surg. May 2003; 125(5):1007-21.
6. Vanhorebeek I; Ingels C; Van den Berghe G. ?Intensive insulin therapy in high-risk cardiac surgery patients: evidence from the Leuven randomized study. Seminars in thoracic and cardiovascular surgery 2006;18(4):309-16.
7. Furnary A, Wu YX. 2011 Arnold O Beckman Conference: Glycemic Control in the Hospital: Evidence, Issues and Future Directions -- The Portland Studies. Upcoming presentation San Diego, CA 4/12/2011.
March 5, 2011
Excellent guideline but requires little modifications
I like to draw our attention to a brief discussion on the pathophysiology and consequences of hypoglycemia and role of a physician towards the prevention of such a dreadful endocrine emergency. There are two basic causes of mortality in case of hypoglycemia. 1.Cardiac death 2.Brain death. In case of blood glucose when goes 3.9mmol/L or below, body's defense mechanism; sympathetic, adrenal and combined sympatho-adrenal effects become activated targeting to restore blood glucose back to normal through glycogenolysis and gluconeogenesis. In the individuals with comparatively intact vasculature (without endothelial dysfunction); persons without diabetes, or in persons with diabetes at young age and without any comorbid illness, such compensatory responses go unnoticed without any detectable symptoms of hypoglycemia or adverse outcomes. In patients with long standing diabetes, hyperglycemia is associated with high level of advanced glycosylated end products (AGEs) e.g. HbA1C and production of increased level of reactive oxygen species (ROS), which along with high level of proinflammatory cytokines (TNF-alpha, IL-6, PAI-1, angiotensinogen, hs-CRP, homocysteine etc.) lead to decrease of endothelial nitric oxide synthase (eNOS) through replacement of L-arginine by asymmetric dimethylarginine (ADMA) with ultimate deficiency of NO. On the other hand, high level of ROS lead to the production of high level of ox-LDL-P which are readily engulfed by macrophages at the subendothelial layer leading to expedite atherosclerosis. In addition to these, hyperglycemia is also associated with renin-angiotensin-aldosterone-system (RAAS) activation. All these factors cause endothelial dysfunction. Longer duration of hyperglycemia associated with higher rate of endothelial dysfunction. Patients with severely affected endothelium can not cope with both adrenergic and cholinergic activation  resulting adverse cardiovascular outcomes; myocardial infarction, ischemic stroke, severe ventricular tachycardia and death. Such activation may take place during any sudden drop of blood glucose from any baseline level e.g. relative hypoglycemia. Gradual loss of effective epinephrine counter regulatory mechanism in patients with long standing diabetes  may lead to neuroglycopenia and brain death without any apparent adrenergic or cholinergic symptoms. Diabetes patients under beta-blocker may also found to have diminished sympatho-adrenal activation resulting hypoglycemia unawareness leading to neuroglycopenia . Recently published 5-years result of ACCORD trial showed that intensive glycemic control reduced 5-year nonfatal MI but increased 5-year mortality where author recommends not going for stringent glycemic control in patients with advanced type 2 diabetes . Gerstein in this result noted that persons having lower HbA1C and less hyperglycemic at baseline appeared to have greater benefit from intensive glycemic control in terms of cardiovascular outcomes. Increased mortality was found in intensive arm, only in whom, whose on-treatment baseline A1C was higher. Previously, Matthew C. Riddle MD, Professor of Medicine at Oregon Health and Science University told in his article  that rapid reduction of blood glucose not resulted in increased mortality who maintained A1C around 6% but rate of mortality increased linearly with increase of A1C from 6% to 9% at baseline. From basic to practice. Here is a big lesson for physician. We should not forget about the baseline A1C during IIT, if required, in patients in ICU presenting with hyperglycemia. According to my opinion recent 3-part clinical practice guideline from ACP about the IIT in hospitalized patients is a very good recommendation but some modifications are required. 1.Same glycemic target should not be applied to all patients. Glycemic target should be individualized. 2.Such target should depend upon baseline HbA1C, age, duration of hyperglycemia, presence of any comorbid illness specifically cardiovascular and concomitant medication if any.
1.Diabetes. 2011 Feb;60(2):602-6.
3.Indian Heart J. 2010 Mar-Apr;62:101-10
4.The ACCORD Study Group. N Engl J Med 2011; 364:818-828 March 3, 2011.
5.Riddle MC. Diabetes Care. 2010;33:983-990.
Southern Illinois University School of Medicine, Springfield, Illinois
March 25, 2011
Re:Comment on the ACP Guidelines for the Management of Glycemic Control in Hospitalized Patients
ACP guidelines are timely since there is no replicable convincing evidence that intensified insulin therapy in ICU's or outside the ICU setting reduce mortality and morbidity in magnitudes reported earlier. There is a compelling need to get away from the exclusive glucocentric view. There may indeed be subsets of patients such as those post CABG where intensified glucose control offers distinct advantage. Understanding of pathobiology of diabetes is still far from complete, and it should be no surprise that we still may not have good handle on how to manage it in all different situations. Till there is conclusive irrevocable evidence we should not stray from our primary charge - First do no harm.
Romesh Khardori, MD.,PhD
April 14, 2011
We thank Drs. Bentson, Furnary, Garg, and Korytkowski for their comments regarding the American College of Physicians' recent clinical guideline on inpatient glycemic control .
Dr. Bentson assumes that our guideline should not be interpreted as meaning that patients on oral diets should not get insulin if a pre- prandial glucose is less than 200 mg/dl. He is correct. While this population of hospitalized patients has not been specifically studied in terms of target thresholds, our guideline was about the use of intensive insulin therapy to keep blood sugars below a low threshold, such as 110 mg/dl, primarily in very ill hospitalized patients on parenteral nutrition. It should not be interpreted as meaning that diabetic patients on insulin should not use their normal dosing of insulin while in the hospital, for example, the use of pre-meal insulin as part based on the pre-prandial measurement of blood glucose.
We agree with Dr. Furnary that the evidence base for CABG patients is relatively limited. However, the evidence that is available in cardiac surgery patients specifically and operative patients more broadly does not convincingly show consistent evidence of benefit from the use of IIT to achieve very strict glucose targets, while there is some evidence of harm. The van den Berghe SICU study did indeed find that IIT was associated with both lower mortality and rate of septicemia, but IIT was not associated with lower rates of septicemia in the subgroup of cardiac surgery patients to which Dr. Furnary refers, and surgical wound infection rates were not reported [2, 3]. The potential reasons for discrepancies between the van den Berghe SICU study and subsequent studies are described in the evidence report . Kirdemir et al reported a dramatic 92% reduction in the risk of sternal wound infection associated with IIT use which seems disproportionate to the very modest reductions in average blood glucose in the intervention group (172 vs 195 mg/dL). Of note, this study's quality was limited by important baseline differences between groups and unclear blinding of outcome assessors. An additional poor-quality study examining two groups of CABG patients found no infection risk reduction from perioperative IIT . On the other hand, a prespecified subgroup analysis of operative patients in the NICE-SUGAR trial found significantly higher mortality associated with IIT titrated to very strict glucose targets (RR 1.31; 95% CI 1.07 - 1.61) . The Portland Protocol is an observational study and was therefore not included in the analysis of health outcome data. We agree, however, that its ability to achieve low rates of hypoglycemia - at least in the selected patients tolerating the protocol for three or more days - highlights significant lessons about the importance of gradual implementation and nursing buy-in, but it may also reflect selective reporting of patients least likely to be harmed . Factors such as protocol, hospital, and implementation characteristics probably contribute to the safety of IIT use and these issues are summarized in the evidence report appendix and discussed in the guideline [1, 4].
As far as Dr. Garg's comments are concerned, our guideline does not mean that insulin should not be used to control blood sugar, rather insulin should not be used to try and achieve "tight control" as defined in the RCTs that have assessed this, usually meaning glucose consistently under 110mg/dL. These RCTs have generally found few, if any, benefits for tight control yet certainly an increase in the risk of hypoglycemic events.
Dr. Korytkowski raises the question about the discrepancy between various guidelines regarding the upper limit of the blood glucose level. This discrepancy probably exists because there are no data from trials that unequivocally establish the threshold above which the benefits from glucose control exceed the harms. ACP based its choice on the glucose values attempted or achieved in the "control" groups in the studies of intensive insulin infusions, most of which failed to show appreciable benefits for the intervention . We concluded that there was no evidence to support attempting to achieve better glucose levels than that achieved in the "control" groups of these studies (blood glucose target levels ranged from 140 to 200mg/dL). The very recently published RABBIT 2 trial referenced by Dr. Korytkowski was not designed to assess the relative benefits of a strict vs. less strict glucose target as glucose targets were the same in both groups. However, the group randomized to the basal-bolus strategy did achieve lower mean blood glucose and appeared to have a lower incidence of wound infections at the expense of a higher risk of hypoglycemia.
Current Addresses of Authors:
Devan Kansagara, MD, MCR Veterans Affairs Medical Center 3710 SW U.S. Veterans Hospital Road, Mailcode R&D 71, Portland, OR 97239
Paul Shekelle, MD, PhD Greater Los Angeles VA Health Center/RAND 1776 Main Street, Santa Monica, CA 90401
Amir Qaseem, MD, PhD, MHA American College of Physicians 190 N. Independence Mall West, Philadelphia, PA 19106
1. Qaseem, A., et al., Use of intensive insulin therapy for the management of glycemic control in hospitalized patients: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 154(4): p. 260-7.
2. van den Berghe, G., et al., Intensive insulin therapy in the critically ill patients. New England Journal of Medicine, 2001. 345: p. 1359-1367.
3. Vanhorebeek I, Ingels C, and Van den Berghe G, Intensive insulin therapy in high-risk cardiac surgery patients: evidence from the Leuven randomized study. Seminars in thoracic and cardiovascular surgery, 2006. 18(4): p. 309-16.
4. Kansagara, D., et al., Intensive insulin therapy in hospitalized patients: a systematic review. Ann Intern Med. 154(4): p. 268-82.
5. Smith, A., et al., Coronary revascularization: a procedure in transition from on-pump to off-pump? The role of glucose-insulin-potassium revisited in a randomized, placebo-controlled study. Journal of Cardiothoracic & Vascular Anesthesia, 2002. 16: p. 413-420.
6. Nice-Sugar Study, et al., Intensive versus conventional glucose control in critically ill patients. New England Journal of Medicine, 2009. 360: p. 1283-1297.
7. Furnary AP, Wu Y, and Bookin SO, Effect of hyperglycemia and continuous intravenous insulin infusions on outcomes of cardiac surgical procedures: the Portland Diabetic Project. Endocrine Practice, 2004. 10 Suppl 2(21- 33).
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