New Approaches to Managing Inpatient Hyperglycemia ACP Meeting MTP Session, April 24 th , 2009 Review of Recent Developments in Context Greg Maynard MD, MSc Clinical Professor of Medicine and Chief, Division of Hospital Medicine, University of California, San Diego
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New Approaches to Managing Inpatient Hyperglycemia
ACP Meeting MTP Session, April 24th, 2009
Review of Recent Developments
in Context
Greg Maynard MD, MScClinical Professor of Medicine and Chief,
Division of Hospital Medicine,University of California, San Diego
Greg Maynard MD, MScGreg Maynard MD, MSc
Has no relationships with any entity Has no relationships with any entity producing, marketing, re-selling, or producing, marketing, re-selling, or
distributing health care goods or services distributing health care goods or services consumed by, or used on, patients.consumed by, or used on, patients.
Disclosure of Financial RelationshipsDisclosure of Financial Relationships
Van Den Berghe G, et al. N Engl J Med. 2001:345:1359; Van Den Berghe G, et al. N Engl J Med. 2006;354:449-461; Brunkhorst et al, N Engl J Med 358:125-39, 2008Goldberg PA, et al. Diabetes Care. 2004;27:461; Goldberg PA, et al. J Cardiothorac Vasc Anes. 2004;18:690; Davidson PC. Diabetes Care. 2005;28:2418.NICE – SUGAR investigators NEJM 2009 360 (13) 1283-1297
UCSD Insulin Infusion200 Med Surg patients
>16,000 values Upper Limit – 150 mg /dL
Mean BG126 Median BG121 below 90 6.1% 91-150 76.6% above 150 17.3% % below 70 < 2% Only 2 patients with any glucose < 40 mg/dL
Study Type: Prospective, randomized, open-label trial
Patient Population: 130 subjects with DM2 Oral hypoglycemic agents or insulin therapy
Study Sites: Grady Memorial Hospital, AtlantaJackson Memorial Hospital, Miami
Randomized Basal Bolus versus Sliding Scale Regular Insulin Therapy in patients with type 2 Diabetes (RABBIT-2 Trial)
• D/C oral antidiabetic drugs on admission
• Starting total daily dose (TDD): – 0.4 U/kg/d x BG between 140-200 mg/dL– 0.5 U/kg/d x BG between 201-400 mg/dL
• Half of TDD as insulin glargine and half as rapid-acting insulin (lispro, aspart, glulisine)– Insulin glargine - once daily, at the same time/day. – Rapid-acting insulin- three equally divided doses (AC)
Smiley & Umpierrez, Southern Med J, June 2006
(RABBIT-2 Trial) Basal / Bolus arm
Blood Glucose Levels During Isulin Treatment
Days of Therapy
Blo
od
glu
cose
(m
g/d
L)
100
120
140
160
180
200
220
240
Admit 1 2 3 4 5 6 7 8 9 10
SSRI
Lantus + glulisine
Mean Blood Glucose Levels During Insulin Therapy
* p<0.01¶ p<0.05
¶* * *
¶ ¶ ¶
Day 3: P=0.06
Umpierrez, Diabetes Care 30: 2007
Basal–Bolus Insulin Regimen in Basal–Bolus Insulin Regimen in Noncritically Ill Patients Noncritically Ill Patients
Days of Therapy
0 1 2 3 4 5 6 7 8 9 10 11 12
Blo
od G
luco
se (
mg/
dL)
100
120
140
160
180
200
220
240
260
280
300
SSRILantus plus Glulisine
Admit 1 2 3 4 1 2 3 4 5 6 7
Blood Glucose Levels in Patients Who Failed SSRI:Transition to Basal Bolus Insulin
Failure was defined as 3 consecutive BG values > 240 mg/dL during SSRI
¶
P: NS P: 0.02
¶¶
¶¶
Umpierrez, Diabetes Care 30: 2007
RABBIT 2
• Improved glycemic control with basal / bolus insulin regimen compared to SSRI
• Subset that failed with SSRI controlled with basal / bolus
• No difference in hypoglycemia – (3% of patients in each arm)
Umpierrez, Diabetes Care 30: 2007
Effect of Structured Insulin Orders and an Insulin Management Algorithm -
UCSD• 400 bed academic center• All adult monitored stays on Med / Surg wards
with dx of DM or Documented Hyperglycemia n = 9,314 > 7 readings n = 5,530
• What is effect of implementing a structured insulin order set?
• What is the incremental effect of an insulin management protocol?– Insulin Use Patterns– Glycemic Control – Hypoglycemia
Maynard et al, JHM January 2009; 4: 3-15
The Use of Basal Insulin Increases(sliding scale only regimens decline)
Percent Sliding Scale Insulin Only
0
10
20
30
40
50
60
70
80
Per
cent
10/20/03
New Order Set
01/20/04
CPOE - TH
72% of 477 insulin regimens SSI only in May-Oct 2003 vs 26% of 499 in Mar-Aug 2004
% of 9,314 Patient-Stays with Uncontrolled Hyperglycemia
A Win / Win Situation5,530 patients with DM or Hyperglycemia and > 7
POC Glucose readings TP3:TP1
RR Uncontrolled Patient-Day
0.77 (0.74 - 0.80)
RR Uncontrolled Patient-Stay (70% controlled vs 60%)
0.73 (0.66 - 0.81)
RR Hypoglycemic Patient-Day (prevents 208 / year)
0.68 (0.59 – 0.80)
RR Hypoglycemic Patient-Stay
0.77 (0.64 – 0.92)
Maynard et al, JHM January 2009; 4: 3-15
Methods for Managing Methods for Managing Hospitalized Non-ICU Patients Hospitalized Non-ICU Patients
Basal/bolus regimen: Detemir was given once daily and Novolog before meals.NPH/regular regimen: NPH and Regular insulin were given twice daily, 2/3 A.M., 1/3 P.M.
Data are ± SEM
HypoglycemiaHypoglycemia
• Detemir/Aspart Group:Detemir/Aspart Group:– 22 patients (32.8%) had ≥ 1 BG < 60 mg/dL22 patients (32.8%) had ≥ 1 BG < 60 mg/dL– 3 patients (4.5%) had a < 40 mg/dL (0.2%)3 patients (4.5%) had a < 40 mg/dL (0.2%)
• NPH/Regular Group:NPH/Regular Group:– 16 patients (25.4%) had ≥ 1 BG < 60 mg/dL 16 patients (25.4%) had ≥ 1 BG < 60 mg/dL – 1 patient (1.6%) had a BG < 40 mg/dL1 patient (1.6%) had a BG < 40 mg/dL
ADA, 68th Scientific Sessions, 2008; JCEM, in press
Umpierrez et al, ADA, 68th Scientific Sessions, 2008; JCEM, in press Umpierrez et al, Diabetes Care 30:2181–2186, 2007
Blood Glucose Concentration During SSRI, NPH-regular, and Basal Bolus Regimen in Medical Patients with Type 2
Diabetes
DEAN Trial
Percent of Glucose values within target (< 140 mg/dl)
RABBIT-2 Trial
% %38%
66%
48%45%
*
* P < 0.01
Umpierrez et al. JCEM, in press Umpierrez et al. Diabetes Care 30:2181–86, 2007
%
25.4
32.8
Rate of Hypoglycemia(# patients with BG < 60 mg/dl)
33
%
DEAN TrialRABBIT-2 Trial
Umpierrez et al. JCEM, in press Umpierrez et al. Diabetes Care 30:2181–86, 2007
Summary – Ward Glycemic Control
• Optimal Glycemic Target Uncertain – My bias: Fasting should likely be < 150 mg/dL– Upper limit of no sugars > 180 mg/dL reasonable
• Basal / Bolus regimens with Glargine / RAA-insulin more effective than sliding scale and present no higher risk of hypoglycemia
• Well executed order sets / protocols can improve glycemic Well executed order sets / protocols can improve glycemic control control and reduceand reduce hypoglycemia. hypoglycemia.
• Detemir/aspart resulted in equivalent glycemic control to a Detemir/aspart resulted in equivalent glycemic control to a split-mixed NPH and regular regimen (but hypoglycemia split-mixed NPH and regular regimen (but hypoglycemia higher than with RABBIT 2 regimen and UCSD regimens) higher than with RABBIT 2 regimen and UCSD regimens)