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© 2019 Monarch Medical Technologies – Confidential & Proprietary 1
Glycemic Management in a ModernAge: The Use of an Electronic
Glycemic Management System
November 1, 2019
© 2019 Monarch Medical Technologies – Confidential & Proprietary 2
Introduction
Alana Weber MSN, RN, CCRNMonarch Medical TechnologiesClinical Specialist
© 2019 Monarch Medical Technologies – Confidential & Proprietary 3
Agenda
• Discuss challenges to inpatient glycemic optimization
• Review what an electronic glucose management system (eGMS) is and the benefits ofuse
• Assess what to look for in an eGMS
• Describe how EndoTool is a unique and effective solution compared to standardpractices
© 2019 Monarch Medical Technologies – Confidential & Proprietary 4
Challenges to InpatientGlycemic Management
© 2019 Monarch Medical Technologies – Confidential & Proprietary 5
Poor Glycemic Management is a Problem
Infection◦ Patients with higher glucose levels have higher
rates of infection
Patient Safety◦ Hypoglycemia is the top source of inpatient
adverse drug events (ADEs)
Cost of Care◦ Roughly $98 billion is spent on inpatient diabetes
annually, and each year approximately 1.5 millionindividuals are newly diagnosed
Length of Stay◦ An increase in blood glucose levels is associated
with a longer length of stay
Ramos et al .Annals of Surgery . 2008; 248 (Suppl 4): 585-591)Society of Hospital of Medicine, 2016. Lecture presented at New York State Partnership for Patients.Renda, A., MD. 2018. Lecture presented at AADE 18, Baltimore.
© 2019 Monarch Medical Technologies – Confidential & Proprietary 6
Brody School of Medicine , East Carolina University:1574 CABG patients
• Each 50 mg/dL increase in perioperative BG level*
◦ Added 0.76 days to LOS
◦ Increased hospital cost by $2824
Portland Diabetic Project: 5510 CABG patients, 1987-2005
• Each 50 mg/dL increase in 3-BG** level added 1 day to LOS
• Treatment-induced LOS savings: 1.8 days/patient
– Actual non-OR charge for 1 CABG LOS day = $1150
– Savings from use of intensive insulin protocol, 1.8 x 1150 = $2081
Level of Glycemia Impacts Length of Stay
* Perioperative BG = average of day of and day after surgery.** 3-BG: 3-day average perioperative blood glucose.Both studies: Levels measured up to >250 mg/dL; lowest level measured <150 mg/dL, no threshold effect
Estrada et al. Ann Thorac Surg. 2003;75:1392-1399; Furnary, et al.Endocr Pract. 2006;12(Suppl 3):22-26.
© 2019 Monarch Medical Technologies – Confidential & Proprietary 7
Inpatient Glucose Management is Complicated
Critically Ill Noncritically ill
Hyperglycemia(BG>180 mg/dL)
32.2% patient-days 32.0% patient-days
Hypoglycemia(BG<70 mg/dL)
6.3% patient-days 5.7% patient-days
Swanson CM, et al. Endocr Pract. 2011;17:853-861.
• Insulin is a “high alert”medication that is frequentlyassociated with medication errors
• Lack of standardization
• Fewer inpatient diabetesspecialists
• Nurses are over-burdened
• Adherence to protocols is low
Glucose Abnormalities in the Hospital Are Common!
© 2019 Monarch Medical Technologies – Confidential & Proprietary 8
Paper Protocols are Challenging
Paper protocols are complex, time-consuming, and prone to medication error
© 2019 Monarch Medical Technologies – Confidential & Proprietary 9
New Anticipated Quality Measures for GlucoseControl
• Two new electronic clinical quality measures are under CMS review:
◦ Severe Hyperglycemia The percentage of hospital days in severe hyperglycemia, defined as an
elevated blood glucose greater than300 mg/dL or not measured that dayand not preceded by two consecutive days where glucose levels were allmeasured and less than 200 mg/dL.
◦ Severe Hypoglycemia The rate of severe hypoglycemic events(<40 mg/dL) within 24 hours of
administration of antihyperglycemic medication and no subsequentglucose value greater than 80 mg/dL within five minutes of the low glucoseevent.
• Once implemented, collected data may be used in quality reportingprograms.
© 2019 Monarch Medical Technologies – Confidential & Proprietary 10
“The complexity of inpatient glycemicmanagement necessitates a systemapproach that facilitates safe practicesand reduces the risk for errors”.
-AACE and ADA Consensus Statement on InpatientGlycemic Control.
© 2019 Monarch Medical Technologies – Confidential & Proprietary 11
EndoTool Glucose Management System
• Proprietary technology that uses complex algorithms to model, predict and adapt dosing toeach patient’s physiology and individual response
• Precise insulin dose recommendation for intravenous and subcutaneous delivery
• FDA Class ll medical device with more than 15+ years of experience and more than 300facilities under contract
© 2019 Monarch Medical Technologies – Confidential & Proprietary 12
What is an eGMS?Electronic glucose management systems (eGMS) use algorithms to guide insulin delivery, based onblood glucose readings and other patient information.
EGMS Glucommander Glucostabilizer GlucoCare EndoTool
Algorithm Variable multiplier Multiplier or ISF Δ infusion rate MultifactorialModel
Reported timeto target (hrs)
4.8 [56] 6.9 [60] 4.3 [63] 2.3 [54]
Reportedhypoglycemicrates
3.9% (<40 mg/dL),42.9%(<60 mg/dL) [56] 12.9% (<70mg/dL) [57]
0.4% (<50mg/dL) [60]
0.3%(<40mg/dL),17.6%(<70mg/dL) [63]
0.05% [52], 0.03%[54] (<40mg/dL), 0.46%(<70mg/dL) [54]
Salinas P, Mendez CE. Glucose Management Technologies for the Critically Ill
Electronic Glucose Management Systems Commonly Used in the ICU
© 2019 Monarch Medical Technologies – Confidential & Proprietary 13
A 7-Year, Retrospective Study at a 900-bed AMC
• Blood glucose levels were brought to target morerapidly
◦ 1.5 to 2.3 hours (4.5 to 4.8 hours for cardiovascular patients)
• Minimal hypoglycemia was observed◦ 0.03% for glucose values <40 mg/dL; 0.93% for <70
mg/dL,◦ Significant reductions over time in hypoglycemia
frequency (<70 mg/dL), from 1.04% in 2009 to 0.46% in2015
• Infections decreased◦ HAC-8 rates were reduced from 0.083 per 1,000 patients
in 2008 to 0.032 per 1,000 patients in 2011
AMC Case Study
Vidant Medical Center, a 900-bed Tertiary Care Teaching Hospital
Retrospective data analysis of 492,078 BG readings between 2009and 2015
© 2019 Monarch Medical Technologies – Confidential & Proprietary 14
Use of an eGMS in Cardiac Surgery ICU
• Organization moved to EndoTool IV from PaperProtocol because they were unable to meet SCIP andSTS outcomes measures consistently
• All patients on insulin infusion:◦ Post op cardiac surgery patients (initiated in OR or pre-
operatively) x 48 hours minimum post op.
◦ All thoracic, vascular, ECMO (non-surgical) and Esophagectomy patients with 2 consecutive BG> 180 mg/dL.
• Data analysis showed:◦ More patient achieving target glucose levels
◦ Faster time to goal
◦ Increased prevention of hyperglycemia
◦ Significantly reduced hypoglycemia
Cardiac ICU Case Study
Virginia-based Academic Medical Center
14-bed Cardiac Surgery ICU
Retrospective data analysis of 2,169 patientsbetween 2013 and 2016
© 2019 Monarch Medical Technologies – Confidential & Proprietary 15
Case Study: EndoTool IV Safer than Paper Protocolin Cardiac Surgery ICU
© 2019 Monarch Medical Technologies – Confidential & Proprietary 16
Case Study: EndoTool IV Safer than Paper Protocolin Cardiac Surgery ICU
© 2019 Monarch Medical Technologies – Confidential & Proprietary 17
Use of an eGMS for Managing Glucose in ChallengingPatient Cases
• Flagship hospital moved to EndoTool IV for saferand more patient-specific glycemic management
• After success in the hospital, the technologyintroduced in 6 of the 7 community hospitals a partof the system
• A retrospective analysis found that the difference inincidence of hypoglycemia between the two groupsindicates that an eGMS is a safer approach formanaging insulin infusions for DKA patients
DKA Patient Case Study
Six Community Hospitals in Eastern Carolina
Retrospective data analysis of all admittedpatients with DKA between 2014 and 2016
• December 1, 2014-March 30, 201540 patients on paper protocolDecember 1, 2015-March 30, 201642 patients on software program
© 2019 Monarch Medical Technologies – Confidential & Proprietary 18
© 2019 Monarch Medical Technologies – Confidential & Proprietary 19
Summary of Research on Computer Protocols vsLinear Paper Protocols
Peckham, A. (2015). Comparison of Computer and Paper-Based Protocols for Managing Hyperglycemia in Critical IllPatients. Scholar Archive. Paper 3605
• Decreased severe hypoglycemia• Significantly decreased standard deviation of
glucose in medical, cardiac trauma andneuroscience ICU
• No difference in mortality or length of stay
Hassan E. (2015). Hyperglycemia management in the hospital setting. American Journalof Health-System Pharmacy, 64, S9-14. https://doi-org.lopesalum.idm.oclc.org/10.2146/ajhp070102
• Computer decision support systems can help reduce the riskof insulin infusion rate calculation errors and standardize insulin therapy.
Glass, M., Ferguson, K. , & Rumbak, M. (2015). Evaluation of Glucose ManagementSoftware in Critically Ill Patients with Hyperglycemic Crises.
• The management of computerized glucose management system EndoToolis both safe and effective at lowering BG in DKA and HHS patients. Themean rate of glucose reduction was 87 mg/dL/hr and a reduction of atleast 50 mg/dL was achieved in 84% of patients.
© 2019 Monarch Medical Technologies – Confidential & Proprietary 20
Summary of Research on Computer Protocols vsLinear Paper Protocols
Mann, E. A., Allen, D. A., Serio-Melvin, M. L., & Wolf, S. E.(2012) Clinician Satisfaction With Computer DecisionDupport in the Intensive Care Unit. Dimension CriticalCare Nursing. 2012:31(1): 31-36)
• Nurses perceived EndoTool to be superior tothe Burn DSS protocol for:
1. adequacy of training2. comfort in the system3. ease of use and4. trust in the recommendation (P<.001)
Crocketm S. E. et al. (2012). Risk of Postoperative Hypoglycemia inCardiovascular Surgical Patients Receiving Computer-Based VersusPaper-Based Insulin Therapy. Endocrine Practice Vol 18 No. 4
• Computerized glucose management system cansuccessfully attain goal glucose levels with significantreduction in hypoglycemia compared to paper protocol.
© 2019 Monarch Medical Technologies – Confidential & Proprietary 21
What to Look for in an eGMS
© 2019 Monarch Medical Technologies – Confidential & Proprietary 22
EndoTool adjusts to each patient’s unique physiologyand individual response with11 patient-specific factors:
• Blood glucose level
• Diabetes mellitusdiagnosis
• Age
• Sex
• Height
• Weight
• sCr
• eGFR
• Carbohydrateintake
• Steroid presence
• Estimated residualextracellular insulin(EREI)
1. Individualized Insulin Dosing
© 2019 Monarch Medical Technologies – Confidential & Proprietary 23
Estimated Residual Extracellular Insulin (EREI)
• EREI is a patented feature of the IV application that predicts and adjusts for residual insulin.◦ This is an estimate of excess or extra insulin (excess over the planned dose) in the subject’s extracellular space that occurs
when a subject’s intravenous insulin dose is reduced AND the current glucose level is close to or below the upper glucosetarget.
◦ EREI is also similar in concept to Insulin On Board for subcutaneous insulin
• Based on a patient’s kidney function and response to insulin dosing, the software adjusts a patient’snext insulin dose to prevent subsequent hypoglycemia.
EMR BG Time Stamp Actual BG Time
© 2019 Monarch Medical Technologies – Confidential & Proprietary 24
EndoTool® IV Hypoglycemia OutcomesBefore and After EREI
1.05%
0.36%
0.11%0.04%
0.3%
0.135%
0.04% 0.025%
0.00%
0.20%
0.40%
0.60%
0.80%
1.00%
1.20%
<70 BG Readings <60 BG Readings <50 BG Readings <40 BG Readings
Before & After EREI – 900 Bed Facility
EndoTool V1 (Vidant 2009-2014) EndoTool V2 (Vidant 2015)
%o
fTo
talR
ead
ing
71%Improvement
63%Improvement
64%Improvement
38%Improvement
© 2019 Monarch Medical Technologies – Confidential & Proprietary 25
EndoTool IVdetermines the safestdose for each patientbased on the individualresponse to insulin
Other SystemsTreat based weight,last glucose reading,and a FIXED multiplier
22 YO155 lb. (70.4 Kg.)
5’ 10”Unknown DMsCr: 0.7 mg/dL
45 YO85 lb. (38.6 Kg.)
5’ 4”Type 1 DM
sCr: 2.2 mg/dL
33 YO215 lb. (97.7 Kg.)
6’ 0”Type 2 DM
sCr: 1.9 mg/dL
62 YO240 lb. (109.1 Kg.)
5’ 10”Type 2 DM
sCr: 1.1 mg/dL
Blood Glucose 300 mg/dL 300mg/dL 300mg/dL 300 mg/dL
Atlanta Protocol 5 5 5 5
Yale Protocol 4.5 4.5 4.5 4.5
Portland Protocol 5 6.5 5 5
EndoTool IV 6.5 3.4 13 18
© 2019 Monarch Medical Technologies – Confidential & Proprietary 26
EndoTool’s Non-Linear Dosing Curve
EndoTool
Linear (paper)Protocol
5
1
2
3
Blood Glucose
Insu
lin
4
Initialunderdose
Residual Insulin& Possible
Hypoglycemia
300 mg/dL
Target Range
1
3
5
68
7
9 2
4
10
SafeStart*
SafeDose*
SafeControl*
• Dose recommendationsbased on the trend over thelast 4 data points and thecurrent to uniquely treatpatient’s glucose response
• More than 70 decision pointcalculations focused onsafety and control
© 2019 Monarch Medical Technologies – Confidential & Proprietary 27
2. The Safest Patient Outcomes
98.4%PATIENTS ACHIEVE
CONTROL
<3hrsAVG TIME
TO CONTROL
0.009%< 40 mg/dL
BLOOD GLUCOSE READINGS(statically zero severe hypoglycemia)
46%FINGER STICKREDUCTION
95%HYPOGLYCEMIA
REDUCTION
54%HOSPITAL AQUIRED INFECTION
REDUCTION
*EndoTool IV Outcomes; Data on file
© 2019 Monarch Medical Technologies – Confidential & Proprietary 28
30
15
10
5
050 100 150 200 250 300
IVIn
suli
n,
un
its
pe
rh
ou
r
Blood Glucose, mg/dL
Example 2:1:00pm: BG of 300mg/dL
Example 11:00pm: BG of 300mg/dL
2:00pm: BG of 285 mg/dL (Inadequate Response)
Up-regulation prior to next dosing calculation
2:00pm: BG of 175 mg/dL (Excessive Response)
Down-regulation prior to next dosing calculationGoal Range
Personalized Control for the SAFEST Dosing
Goal Range: 100 - 140
© 2019 Monarch Medical Technologies – Confidential & Proprietary 29
3. Real-Time Analytics to Measure Performance
• EndoTool Analytics◦ 14 predefined patient, unit, facility and
provider-level reports
◦ Ability to easily export data and share in PDF or CSV files
• Self- Service Analytics◦ Pre-built data warehouse that can be used to:
Generate standard monthly reports
Support ad-hoc reporting
Extract EndoTool data and combine in ownlocal Enterprise data warehouse
© 2019 Monarch Medical Technologies – Confidential & Proprietary 30
4. Comprehensive EMR Integration
Patient demographics to EndoTool
Documentation from EndoTool to EMR
Clinical values to EndoTool:
Height
Weight
Creatinine
Hemoglobin A1c
Diabetes type
Point of care glucose
EMR single-sign-on launch from EMR
• Integrates with all major EMRSystems via HL7
• Keeps users in a single record
• Simplifies order sets
• Removes double confirmation inEMR
• Reduces clicks and duplicateinput
Patient Demographics,Lab Results, More…
Dosage Recommendation& Timing of Next Lab Test
HospitalSystems
© 2019 Monarch Medical Technologies – Confidential & Proprietary 31
4. Robust Support
DISCOVERY EDUCATION
GO-LIVE SUPPORT
• Readiness assessment
• Clinical parameters
• Technical system design
• On-site super user training
• Customized e-learning andquizzes
• Resident training book
• On-site for super-userand technical training
• Clinical Specialistpresent for go-live
• 24/7/365 remotesupport
• Ongoing optimizationand reviews
PARTNERS
• Dedicated project teamconsisting of project manager,clinical specialist, andtechnical consultant
PLANNING
• Customized project planbased on hospital practicesand process
© 2019 Monarch Medical Technologies – Confidential & Proprietary 32
EndoTool Demo
© 2019 Monarch Medical Technologies – Confidential & Proprietary 33
Thank you!
Alana Weber MSN, RN, [email protected]
855-END-RISK (363-7475)