advancing glycemic control in an inpatient setting · nice-sugar: intensive vs conventional glucose...
TRANSCRIPT
![Page 1: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/1.jpg)
Advancing Glycemic Control in an Inpatient Setting
1
![Page 2: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/2.jpg)
Background
2
![Page 3: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/3.jpg)
Diabetes Statistics
CDC Nat’l Diabetes Fact Sheet, 2014WHO. Diabetes Action Now. 2004.
3
![Page 4: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/4.jpg)
Prevalence of Obesity & Diabetes (U.S. Adults Aged > 18 Years)Obesity (BMI ≥30 kg/m2)
Diabetes
CDC’s Division of Diabetes Translation. National Diabetes Surveillance System available at http://www.cdc.gov/diabetes/statistics
4
![Page 5: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/5.jpg)
Number and Percentage of U.S. Population with Diabetes, 1958-2009
Perc
enta
ge w
ith D
iabe
tes
0
5
10
15
20
25
0
1
2
3
4
5
6
7
8
1958 62 66 70 74 78 82 86 90 94 98 02 06
Num
ber w
ith D
iabe
tes (
Mill
ions
)
YearPercentage with Diabetes Number with Diabetes
CDC’s Division of Diabetes Translation. National Diabetes Surveillance System available at http://www.cdc.gov/diabetes/statistics
5
![Page 6: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/6.jpg)
Significance• The Center for Disease Control reports 29.1 million people
(9.3% of the U.S. population) have diabetes
• Diabetes is 7th leading cause of death
• 20-50% of inpatients have diabetes or hyperglycemia
• 1 in 4 patients admitted to hospitals have a known diabetesdiagnosis
• 30% of patients with diabetes have 2 or more hospitaladmissions per year.
1: Umpierrez et al J Clin Endocrinol Metab 2002; 87: 978-82.2. CDC Nat’l Diabetes Fact Sheet, 2014
6
![Page 7: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/7.jpg)
Why Does this Matter?• Significant impact on morbidity
and mortality– New hyperglycemia, higher in
hospital death rate– Missed diabetic diagnosis,
readmit 30.6% (vs 9.4%)– (Noncardiac) perioperative risk
of death increased with an ORof 1.19 for every 1mmol/Lincrease in BG
Robbins JM, Webb DA Med Care 2006; 44:292-6.Noordzji et al Eur J Endocrinol 2007; 156: 137-42. Crit Care Med 2009; 37:3001-3009
7
![Page 8: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/8.jpg)
Why does this matter?• Regulatory Interest
– Emerging Metrics for CMS
• NQF2362, Hyperglycemia (2 values >200)
• NQF2363, Hypoglycemia (any value <40)
8
![Page 9: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/9.jpg)
Number of US Hospital Discharges with Diabetes as Any-Listed Diagnosis
Centers for Disease Control and Prevention. Diabetes Data and Trends. Available at: http://www.cdc.gov/diabetes/statistics/dmany/fig1.htm. accessed September 11, 2008.
9
![Page 10: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/10.jpg)
Hyperglycemia and Mortalityin the Medical Intensive Care Unit
N=1826 ICU patients.Krinsley JS. Mayo Clin Proc. 2003;78:1471-1478.
10
![Page 11: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/11.jpg)
Mortality Increases With Increasesin Average BG Levels
Post-CABG
CABG, coronary artery bypass graft.
Furnary AP et al. J Thorac Cardiovasc Surg. 2003;125:1007-1021.11
![Page 12: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/12.jpg)
Mortality Risk is Greater in Hyperglycemic Patients Without History of Diabetes
No History Diabetes, N=152,910
Mea
n BG
(mg/
dL)
111-145
146-199
200-300
>300
Odds Ratio
History Diabetes, N= 62,868
Odds Ratio
Falciglia M, et al. Crit Care Med. Epub ahead of print, Aug 2009.12
![Page 13: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/13.jpg)
Hyperglycemia is Linked to Mortality Regardless of Diabetes Status
180-day Mortality in Patients Admitted for MI (%)
Rady MY, et al. Mayo Clin Proc. 2005;80:1558-1567.Ainla MIT, et al. Diabet. Med. 2005; 22:1321-1325.
13
![Page 14: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/14.jpg)
Mortality in Inpatients with “New Hyperglycemia”
In-hospital Mortality Rate
(%)
Patients With Normoglycemia
Umpierrez GE, et al. J Clin Endocrinol Metab. 2002; 87:978-982.
Newly Discovered
Hyperglycemia
Patients With History of Diabetes
14
![Page 15: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/15.jpg)
Admission Hyperglycemia Is Also AssociatedWith Adverse Outcomes in Non-ICU Settings
% o
f Pat
ient
s
N = 2471
Non-ICU patients with community-acquired pneumonia
*P = .03; †P = .01. ‡ Complications include all in-hospital complications except for abnormalities of glucose.
Admission BG Level
McAlister FA et al. Diabetes Care. 2005;28:810-815.15
![Page 16: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/16.jpg)
Outcomes Associated WithGlycemic Control in the Hospital
16
![Page 17: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/17.jpg)
Benefits of Tight Glycemic Control: Observational Studies and Early Intervention Trials
Study Setting Population Clinical Outcome
Furnary, 1999 ICU DM undergoing open heart surgery 65% ↓ infection
Furnary, 2003 ICU DM undergoing CABG 57% ↓ mortality
Krinsley, 2004 Medical/surgical ICU Mixed, no Cardiac 29% ↓ mortality
Malmberg, 1995 CCU Mixed 28% ↓ mortalityAfter 1 year
Van den Berghe, 2001* Surgical ICU Mixed, with CABG 42% ↓ mortality
Lazar, 2004 OR and ICU CABG and DM 60% ↓ A Fib post op survival 2 yr
*RCT, randomized clinical trial.
Kitabchi & Umpierrez. Metabolism. 2008;57:116-120.17
![Page 18: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/18.jpg)
Intensive Insulin Managementin Medical-Surgical ICU
Baseline group (n = 800)Krinsley JS. Mayo Clin Proc. 2004; 79:992-1000.
Glucose management group (n = 800)
18
![Page 19: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/19.jpg)
Intensive Insulin Therapy in CriticallyIll Patients: SICU
Relative Risk Reduction (%)
Van den Berghe G, et al. N Engl J Med. 2001;345:1359-1367.19
![Page 20: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/20.jpg)
Severe Hypoglycemia in the MedicalICU - 2nd Leuven Study
Conventional Intensive(605) (595)
Hypoglycemia events # (%) 19 (3.1) 111 (18.7)
Two or more episodes 5 (0.8) 23 (3.9)
Glucose level (mg/dL) 31 ± 8 32 ± 5
Identified hypoglycemia as an “independent risk factor for death.”
Van den Berghe G, et al. N Engl J Med. 2006;354:449-461.
20
![Page 21: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/21.jpg)
NICE-SUGAR Study OutcomesOutcome Measure
Intensive Group
Conventional Group
Morning BG (mg/dL) 118 + 25 145 + 26
Hypoglycemia (≤ 40mg/dL)
206/3016 (6.8%)
15/3014(0.5%)
28 Day Mortality (p=0.17) 22.3% 20.8%
90 Day Mortality (p=0.02) 27.5% 24.9%
Finfer S, et al. N Engl J Med. 2009;360:1283-1297.21
![Page 22: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/22.jpg)
NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients
Kaplan–Meier Estimates For The Probability Of Survival
% HR = 1.11 95 confidence interval:(1.01-1.23)
Finfer S, et al. N Engl J Med. 2009;360:1283-1297.22
![Page 23: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/23.jpg)
Summary of the Clinical Trials• Hyperglycemia is associated with poor clinical
outcomes across many disease states in thehospital setting
• Despite the inconsistencies in the clinical trial results, good glucose management remains important in hospitalized patients
• It is likely that benefits on outcomes can bederived from somewhat higher glucose targets than previously proposed
• More conservative glucose targets would be predicted to result in lower rates of hypoglycemia
23
![Page 24: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/24.jpg)
Landmark Trials: Why basal bolus?
• RABBIT2: Diabetes Care 2007– Patients with Type 2 diabetes not on insulin admitted
for medical diagnoses had better glycemic control withOUT significant adverse events on a combined basal-bolus insulin regimen
• RABBIT2 Surgery: Diabetes 2011– Patients with Type 2 diabetes undergoing surgery had
better glycemic control on a combined basal bolus regimen
24
![Page 25: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/25.jpg)
What Should We Take Awayfrom These Trials?
• Moderate glucose control, as opposed to near-normal control (tight), is likely sufficient to improve clinical outcomes in the ICU setting
• Hyperglycemia and hypoglycemia are markers of poor outcomes in critically and non-critically ill patients
• Importantly, the recent studies do not endorse a laissez-faire attitude toward inpatient hyperglycemia that was prevalent a decade ago
25
![Page 26: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/26.jpg)
Background-The Evidence
CCU VanDenBer gheet al. NEJM 2001
Tight Control
NICESUGAR NEJM 2009
Moderate Control
SQ Sliding Scale Monotherapy
RABBIT2 Diabetes Care 2007
RABBIT2 Surgery Diabetes 2011
Basal Bolus Therapy
26
![Page 27: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/27.jpg)
Current Recommendations
27
![Page 28: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/28.jpg)
ADA/SCC Target Glucose Levels in Critical Care/ICU Patients
• American Diabetes Association– Starting threshold of >180 mg/dL– Once IV insulin is started, the glucose level should be maintained between 140 and
180 mg/dL– Lower glucose targets (110-140 mg/dL) may be appropriate in selected patients – Targets <110 mg/dL or >180 mg/dL are not recommended
• Society of Critical Care Medicine– Starting threshold of >150 mg/dL and absolutely at 180 mg/dL– Use protocol to achieve low rate of hypoglycemia <70 mg/dL– Minimal excursions of <100 mg/dL
1. Diabetes Care 2016; 39 (Suppl. 1):S99-S1042. Crit. Care Med 2012 Vol 40, No 12. Guidelines for the use of an insulin infusion for the management of hyperglycemia in critically ill patients
28
![Page 29: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/29.jpg)
ADA/Endocrine Society Target Glucose Levels in Non–Critical Care Patients
• Endocrine Society– Premeal glucose targets <100-140 mg/dL– Random BG <180 mg/dL– To avoid hypoglycemia, reassess insulin regimen if BG levels fall below 100 mg/dL– Occasional patients may be maintained with a glucose range below and/or above
these cut-points
• American Diabetes Association– Target 140 – 180 mg/dL– Certain groups <140 mg/dL– Certain groups with higher targets (terminally ill or comorbities)
Hypoglycemia = BG <70 mg/dLSevere hypoglycemia = BG <40 mg/dL
1. Umpierrez, GE; Hellman, R; Korytkowski, M; Kosiborod, M; Maynard, G; Montori, VM, Seley, JJ; Van den Berghe, G. (2012). Management of Hyperglycemia in Hospitalized Patients in Non-Critical Care Setting: An Endocrine Society Clinical Practice Guideline. (2012). J ClinEndocrinol Metab 97: 16–382. Diabetes Care 2016; 39 (Suppl. 1): S99-S104
29
![Page 30: Advancing Glycemic Control in an Inpatient Setting · NICE-SUGAR: Intensive vs Conventional Glucose Control in Critically Ill Patients. Kaplan–Meier Estimates For The Probability](https://reader035.vdocuments.net/reader035/viewer/2022062603/5f13d92ed5213902151b1974/html5/thumbnails/30.jpg)
Thank you
30