master template

1
Atlanta Diabetes Associates
Original Title A SEMI-CLOSED LOOP INTRAVENOUS
INSULIN ALGORITHM, SHOWN TO BE SAFE, SIMPLE,
AND EFFECTIVE IN 82,078 HOURS OF OPERATION New
Title GLUCOMMANDER AN ADAPTIVE,
COMPUTER- DIRECTED SYSTEM FOR IV INSULIN, SHOWN
TO BE SAFE, SIMPLE, AND EFFECTIVE IN 120,618
HOURS OF OPERATION
Paul C. Davidson, R. Dennis Steed, and Bruce W.
Bode
2
GlucommanderPractical Alternative to Complex IV
Insulin Protocols

• Computer Based Algorithm for IV Insulin
• Invented by Davidson and Steed in 1984
• 19 Years Experience
• Developed for Marketing by MiniMed and Boehringer
  Manheim Corp.
• Glucose Management System (GMS)
• Shelved Pending FDA Approval of IV Insulin
• Useful and Safe for Any Application of IV Insulin

3
Intravenous Insulin with Severe Illness

• Three major recent studies
• DIGAMI Prospective Randomized Study of
  Intensive Insulin Treatment
  on Long
  Term Survival After Acute Myocardial Infarction
  in Patients with Diabetes Mellitus
• Malmberg, et al. BMJ. 19973141512-1515.
• Portland Continuous Insulin Infusion Reduces
  Mortality in Patients with Diabetes Undergoing
  Coronary Artery Bypass Grafting
• Fumary et al J Thorac Cardiovasc Surg
  20031231007-21
• Leuven Intensive Insulin Therapy in Critically
  Ill Patients
• Van den Berghe et al N Engl J Med 2001 345
  1359-67

4
Cardiovascular RiskMortality After MI Reduced
by Insulin Therapy in the DIGAMI Study
IV Insulin 48 hours, then 4 injections daily
All Subjects
Low-risk and Not Previously on Insulin
.7
.7
(N 620)
(N 272)
.6
.6
Risk reduction (51)
Risk reduction (28)
.5
.5
P .011
P .0004
.4
.4
.3
.3
.2
.2
.1
.1
0
0
0
1
2
3
4
5
0
1
2
3
4
5
Years of Follow-up
Years of Follow-up
Malmberg, et al. BMJ. 19973141512-1515.
6-11
5
Mortality of DM Patients Undergoing CABG
Fumary et al J Thorac Cardiovasc Surg
20031231007-21
6
ICU Mortality Effect of Average BG Van den Berghe
et al (Crit Care Med 2003 31359-366)
P0.0009
BGgt150
110ltBGlt150
P0.026
BGlt110
7
IV Insulin Based Studies DIGAMI, Portland, Leuven

• All three have IV insulin protocols
• Complex
• Require ICU housing
• Specially trained nurses
• Dedicated supervision
• Consequently not widely accepted

8
Portland Protocol Furnary et al J Thorac
Cardiovasc Surg 20031231007-21
1. Start Portland protocol during surgery and
continue through 7 AM of the third POD. Patients
who are not receiving enteral nutrition on the
third POD should remain on this protocol

until receiving at least 50 of
a full liquid or soft American Diabetes
Association diet. 2. For patients with previously
undiagnosed DM who have hyperglycemia, start
Portland protocol if blood glucose is greater
than 200 mg/dL. Consult endocrinologist on POD 2
for DM
workup and
follow-up orders. 3. Start infusion by pump
piggyback to maintenance intravenous line as
shown in Appendix Table 1. 4. Test blood glucose
level by finger stick method or arterial line
drop sample. Frequency of blood glucose testing
is as follows a. When blood glucose level
greater than 200 mg/dL, check every 30 minutes.
b. When blood glucose level is less than 200
mg/dL, check every hour. c. When titrating
vasopressors, (eg, epinephrine) check every 30
minutes. d. When blood glucose level is 100 to
150 mg/dL with less than 15 mg/dL change and
insulin rate remains unchanged for 4 hours
(stable infusion rate), then you may test
every 2 hours. e. You may stop testing every 2
hours on POD 3 (see items 1 and 8). f. At
night on telemetry unit, test every 2 hours if
blood glucose level is 150 to 200 mg/dL test
every 4 hours if blood glucose level is less than
150 mg/dL and stable infusion rate
exists. 5. Insulin titration according to blood
glucose level is performed as follows a. When
blood glucose level is less than 50 mg/dL, stop
insulin and give 25 mL 50 dextrose in water.
Recheck blood glucose level in 30 minutes.
When blood glucose level is greater than 75
mg/dL, restart with rate 50 of previous rate.
b. When blood glucose level is 50 to 75 mg/dL,
stop insulin. Recheck blood glucose level in 30
minutes if previous blood glucose level was
greater than 100 then give 25 mL 50
dextrose in water. When blood glucose level is
greater than 75 mg/dL, restart with rate 50 of
previous rate. c. When blood glucose
level is 75 to 100 mg/dL and less than 10 mg/dL
lower than last test, decrease rate by 0.5 U/h.
If blood glucose level is more
than 10 mg/Dl lower than last test, decrease
rate by 50. If blood glucose level is the same
or greater than last test, maintain same rate.
d. When blood glucose level is 101 to 150
mg/dL, maintain rate. e. When blood glucose
level is 151 to 200 mg/dL and 20 mg/dL lower than
last test, maintain rate. Otherwise increase rate
by 0.5 U/h. f. When blood glucose level is
greater than 200 mg/dL and at least 30 mg/dL
lower than last test, maintain rate. If blood
glucose level is less than 30 mg/dL lower
than last test (or is higher than last test),
increase rate by 1 U/h and, if greater than 240
mg/dL, administer intravenous bolus of
regular insulin per initial intravenous insulin
bolus dosage scale (see item 3). Recheck blood
glucose level in 30 minutes. g. If blood
glucose level is greater than 200 mg/dL and has
not decreased after three consecutive increases
in insulin, then double insulin rate. h. If
blood glucose level is greater than 300 mg/dL for
four consecutive readings, call physician for
additional intravenous bolus orders. 6. American
Diabetes Association 1800-kcal diabetic diet
starts with any intake by mouth. 7. Postmeal
subcutaneous Humalog insulin supplement is given
in addition to insulin infusion when oral intake
has advanced beyond clear liquids. a. If
patient eats 50 or less of servings on
breakfast, lunch, or dinner tray, then give 3
units of Humalog insulin subcutaneously
immediately after that meal. b. If patient
eats more than 50 of servings on breakfast,
lunch, or supper tray, then give 6 units of
Humalog insulin subcutaneously immediately
after that meal. 8. On third POD, restart
preadmission glycemic control medication unless
patient is not tolerating enteral nutrition and
is still receiving an insulin drip.
9
Complexity versus Simplicity
Van den Berghe Orders
Glucommander Orders

• .Arterial BG q 1-2 hours, then q 4 hours if
  stable
• .If BG gt220 give 4 units/hr
• .If BG gt110 mg/dl give 2 units/hr.
• .If F/U BG in 1-2 hours gt140 mg/dl Increase
  insulin 1-2 units/hr.
• .If F/U BG in 1-2 hours 121-140 mg/dl increase
  insulin 0.5-1 unit/hr.
• .If F/U BG 110-120 mg/dl increase insulin
  0.1-0.15 units/hr.
• .If BG 81-110 mg/dl then do not change.
• .If BG decreases gt50 decrease insulin 50.
• .If BG 61-80 mg/dl decrease insulin reduced as
  dictated by previous BG level.
• .Repeat BG in one hour.
• .If B 41-60 mg/dl discontinue insulin.
• .If BG gt40 mg/dl give 10 Gm glucose IV. Repeat q
  1 hr until BG 81-110 mg/dl.
• .If BGT decreases gt20 in 81-110 mg/dl range
  decrease insulin 20.
• .If patient transferred from ICU and insulin lt2
  units/hr, DC insulin.
• .If patient transferred from ICU and insulin gt2
  units/hr get endocrine consult.

Requires ICU nurses trained in protocol and study
physician
Administered by floor nurse and any physician
10
Glucommander

. Summary of Performance Glucose Averages for
3404 Patients
Glucose mgm/dl
Percentiles
Percentiles
90
50
10
Hours
11
INSPIRATION FOR GLUCOMMANDER
Practical Closed Loop Insulin Delivery
A System for the Maintenance of Overnight
Euglycemia and the Calculation of Basal Insulin
Requirements in Insulin-Dependent Diabetics NEIL
H. WHITE, M.D., DONALD SKOR, M.D., JULIO V.
SANTIAGO, M.D. Saint Louis, Missouri Ann Int
Med 1982 97210-214
1/slope Multiplier 0.02
6
5
4
Insulin Rate (U/hr)
3
2
1
0
0
100
200
300
400
Glucose (mg/dl)
12
Historical Perspective
Glucommander Multipliers

• IV Insulin Algorithm
• Insulin (BG-60) x Multiplier
• Whites Multiplier Not Applicable
• for Majority
• Based on Type 1 Pediatric Pump Patients
• IV Insulin Used Frequently in Stressed Type 2
• Only 14 Stabilized at 0.02

N2364 Runs
White 0.02
13
Glucommander 5802 Runs and 120,618 BGs 1985-1998
14
GlucommanderPrinciples
Insulin Units / Hour
Glucose mgm / dl
15
Typical Glucommander Run
Glucose
Glucose
Hi
Low
Multiplier
Multiplier
Insulin
Insulin
Hours
16
Glucommander Average and Standard Deviation of of
All Runs 1985 to 1998 5808 runs, 120,618 BGs
17
Glucommander...Complete Data
Set 1985 to 1998 Beyond Data Analyzed by
Boehringer Manheim/MiniMed in 1995

• 13 years of data from Glucommander.
• 5802 Runs over 120,618 hours.
• Correction of hyperglycemia
• Mean starting BG259 mg/dL (SD 127).
• Mean stable lt150 after three hours.
• Subsequent stability in target range for 60 hrs.
• 90 of patients achieved BGlt180 within 8 hrs.
• Experience with Hypoglycemia
• BGs lt50 were 0.6 of total BGs.
• 2.6 all runs had one BG lt40. All were
  immediately corrected to 100 with IV glucose,
  insulin held 30 min, then modified.
• No severe hypoglycemia.

18
Hypoglycemia on Glucommander 5772 Runs
Lauren lt40 mg/dl 5.2
19
Glucommander

.Correction of HypoglycemiaIV 50 Glucose
(100-BG) X 0.15 Grams
N 886
Glucose (mg/dl)
Time (min)
20
Conformity of Blood Glucose to Glucommander Target
21
IV Insulin Protocols

• Correct with minimal insulin
• Least reactive hypoglycemia
• Cut insulin quickly
• Correct hyperglycemia quickly
• Limit intracellular dehydration
• Start insulin aggressively
• Avoid prolonged hyperglycemia
• Less intracellular edema with correction
• Many protocols in use
• Few with outcomes

ADA Diabetes Care 26S109-S117,2003 Watts
Diabetes Care 10722-28,1987 Umpierrze Personal
Commication Markovitz Endocr Pract
810-18,2002 Metchick Am J Med 133317-323,
2002 Van den Berghe N Engl J Med 3461586-8,
2002 Fumary J.Thor CV Surg 1251007-1021, 2003
22
GlucommanderComparsion to Other Systems
ADA 38 u
WATTS 46 U
UMPIERRZE 34 u
IV DRIP 38 u
Glucommander 33 u
LEVETAN 32 u
MARKOVITZ 33 u
Insulin Units / Hour
METCHICK 37 u
VAN DEN BERGHE 41 u
MARKS 52 u
FUMARY 19 u
Glucose mgm / dl
23
GlucommanderSimilar Systems

• Features in Common
• Early high dose
• Decrease in parallel with BG
• End up at common dose
• Similar total dose

ADA 38 u
IV DRIP 38 u
Glucommander 33 u
MARKOVITZ 33 u
Insulin Units / Hour
Glucose mgm / dl
24
Glucommander

. Surgical Series Compared to Watts Algorithm
Watts
Glucommander
Watts et al Diab Care 1987 10722-728
25
Glucommander

. Surgical Series Compared to Watts Algorithm
Glucommander
Watts
26
How has the Glucommander been used?

• Treatment of ketoacidosis
• Hyperosmolar non-ketotic state
• Perioperative glucose management
• Labor and delivery
• Myocardial infarction
• Critically ill patients in ICU
• Hyperalimentation
• Gastroparesis with intractable nausea and
  vomiting
• Estimating a patients insulin sensitivity
• A guide for dosing insulin
• Estimating total insulin dose, correction factor,
  CHO/Ins

27
Clinical Experience with Glucommander

• Simple, safe, and effective method for
  maintaining glycemic control
• Extensively studied
• Standardized treatment method applicable in a
  wide variety of conditions
• Available for review, www.glucommander.com
• Opportunity to improve clinical outcome now

not when and if
28
Glucommander Available for review on
internet www.glucommander.com Slides available
at www.adaendo.com