master template

1
Atlanta Diabetes Associates
New Title GLUCOMMANDER A COMPUTER-DIRECTED IV
INSULIN SYSTEM SHOWN TO BE SAFE, SIMPLE, AND
EFFECTIVE IN 120,618 HOURS OF OPERATION
Paul C. Davidson, R. Dennis Steed, and Bruce W.
Bode
Frequently Asked Questions
2
Abstract
Intensive IV insulin therapy reduces mortality
and morbidity when used in the surgical ICU and
when used post-myocardial infarction. The
methods of regulating IV insulin are complex and
their application is usually limited to ICUs.
We have developed and tested a computerized
algorithm utilizing bedside blood glucoses and
programming an IV pump, which limits the need for
ICU housing and large amounts of nursing time.
BGs are obtained at variable intervals related
to trending of the values. We have data on
3473 patients over 82,078 hours showing
correction of hyperglycemia from an median level
of 292 mg/dl (range 181-1568) to lt180 mg/dl in a
median time of 3.1 hours with subsequent
stability in target range for 60 hours. The
overall percent rate of BG lt60 was 1.5. No
severe hypoglycemia occurred. The algorithm
has been used in 70 hospitals for DKA, HHNK,
peri-operative management including CABG, labor
and delivery, post-myocardial infarction, TPN,
and reversing glucose toxicity. In hospitals
where it is available, the system is universally
accepted by nurses, anesthesiologists, surgeons,
intensivists, and PCPs. We have attempted to
commercialize the system. This was precluded by
the FDA who will not approve a device for dosing
and delivery of IV insulin off label, A
demonstration of the algorithm is viewable at
http//glucommander.com.
3
What is the Glucommander?

• Glucommander is a computer-based system for
  controlling blood glucose in hospital patients on
  IV or tube-feeding.
• Works by prompting the on-site measurement of
  glucose and advising an intravenous insulin
  infusion rate.
• Located in a computer at the patients bedside or
  nearby nursing station.

4
How is the Glucommander used?

• Physician orders Glucommander therapy, specifying
  initial parameters.
• Nurse enters these parameters and the current
  glucose.
• Glucommander recommends an insulin infusion rate
  and a time to check the next BG test.
• At the recommended time Glucommander prompts the
  nurse to measure BG and enter it.
• Glucommander recommends an insulin infusion rate
  and a time to check the next BG test.
• This process is repeated indefinitely.

5
How much insulin is infused with the Glucommander?

• Infusion follows the formula
• Insulin / hr multiplier x (BG 60)
• Multiplier is a parameter which is
  automatically adjusted based on the glucose
  pattern and response to insulin.

6
How does it work?
Hi
Low

• A multiplier is selected.
• Insulin infusion is proportional to BG reading.
• Multiplier is adjusted to achieve targeted BG.

Insulin Units / Hour
Insulin
Glucose
Glucose mgm / dl
7
How does the Glucommander adjust the multiplier?

• If the BG is above target and failing to
  decrease, the multiplier will increase.
• If the BG is below target and failing to
  increase, the multiplier will decrease.

8
How does this program control a patient?
Glucose
Glucose
Hi
Low
Multiplier
Multiplier
Insulin
Insulin
Hours
9
How is the Glucommander ordered?

• To order, the physician must specify five
  parameters
• The low end of the target range for BG.
• The high end of the target range for BG.
• The initial multiplier. This reflects the
  physicians best estimate for the multiplier,
  although the Glucommander will adjust this based
  on the glucose response.
• The maximum time interval between BG
  measurements.
• The insulin concentration (used to translate the
  units per hour to milliliters per hour).

10
How should I set the target range?
A higher target range will result in less risk of
hypoglycemia (at the expense of a higher average
glucose). Our experience

• As low as 80 to 95 for healthy patients being
  stabilized overnight in preparation for testing.
  
• As high as 140 to 200 for patients undergoing
  surgery with an anesthesiologist who is
  uncomfortable with BGs in the normal range.

11
How do I choose initial multiplier?

• Normal adult A multiplier of 0.01 is a good
  initial choice. It is a bit low, but it will be
  automatically adjusted upwards as needed.
• It is possible to solve for the multiplier from
  experience?
• Multiplier insulin rate / (BG
  60)
• For example, if you know that a patient on
  an insulin pump has previously required 0.5 units
  per hour to maintain a glucose of 100, a
  multiplier of 0.5 / (100 60) 0.0125 could be
  used.

12
How should I set maximum time interval?

• Depends on perceived risk of sudden shift in the
  blood glucose.
• 120 minutes is reasonable for most patients.
• 60 minutes for patients in surgery or critically
  ill.
• BG can be entered more frequently than the
  Glucommander requests.

13
What is an appropriate insulin concentration?

• Dependent on infusion device.
• Select to allow adjustment of the infusion rate
  by increments of less than 0.1 units per hour.
• Currently using 0.5 units per cc solution in
  infusers that are adjustable to the nearest 0.1
  ml per hour.
• Infusion can be adjusted by 0.05 unit per hour.
• Higher concentrations can be used in volume
  critical patients with insulin resistance.

14
What else must be ordered?

• An appropriate IV or tube feeding.
• To ensure a constant glucose flux, a controller
  should be used. The insulin drip is typically
  piggy backed into a maintenance IV at a side
  port close to the infusion catheter to eliminate
  lag in insulin delivery.

15
How often are blood sugars checked?

• From 20 minutes to Maximum Interval specified in
  the initial orders.
• Typically about an hour. Interval is programmed
  by Glucommander to increase when BGs stabilize
  in the target range and decrease if BGs are low
  or falling rapidly.

16
Can the patient eat or receive glucose in IV
fluids?
Works well when the rate that glucose enters
patients system is constant.

• Constant rate of infusion of glucose-containing
  IV solutions.
• Constant enteral tube feeding.
• No discrete meals.

17
How well does Glucommander work? 5802 Runs over
120,618 hours From 1985 to 1998 Average and
Standard Deviation
18
How has the Glucommander been used?

• Treatment of ketoacidosis
• Perioperative glucose management
• Hyperosmolar non-ketotic state
• Gastroparesis with intractable nausea and
  vomiting
• Labor and delivery
• Learning a patients insulin sensitivity
• Critically ill patients on ICU
• Myocardial infarction
• Hyperalimentation

19
Experience

• Glucommander is an evolution of protocols already
  in clinical use.
• Over 120,000 hours of experience in over 5000
  runs.
• Safe and effective
• Only one run out of 50 with transient,
  non-problematic hypoglycemia.
• Average of all runs to target in four hours.
• In all cases, the Glucommanders recommendations
  have been appropriate.
• Appropriate recovery from all occurrences of the
  following deviations
• Interruptions in IV fluids or tube feedings.
• Improper entry of initial parameters.
• Disconnected insulin infusion pumps.
• Patients receiving trays of food when they should
  not, etc.
• Eliminates ambiguity in the complex orders used
  to write insulin drips.
• Results in a much more accurate implementation of
  physicians intentions.
• Capable of stabilizing blood sugar even if the
  patient is fasting.

20
Why hasnt Glucommander been available?

• MiniMed and Boehringer Manheim Corp contracted
  for exclusive rights.
• Roche purchased Boehringer Manheim.
• Medtronic Purchased MiniMed.
• Roche and Medtronic divorced.
• Neither Lilly nor Novo are willing to fund
  clinical safety studies for IV insulin.
• FDA will not approve commercialization of device
  for IV use of insulin off-label.

How can I get use of Glucommander?

• Available for review on internet,
  www.glucommander.com
• For how to market a dedicated computer
  application we need your advice. We, as
  clinicians, do not know how to get this valuable
  tool to the patient with diabetes.
• Contact us Glucommander_at_adaendo.com