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Glucose Management for Inpatients: A multidisciplinary approach. Paul M. Szumita, PharmD BCPS Clinical Pharmacy Practice Manager Brigham & Women’s Hospital Boston, MA. Learning Objectives. Review the benefits and risks of insulin therapy in the hospital setting

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paul m szumita pharmd bcps clinical pharmacy practice manager brigham women s hospital boston ma

Glucose Management for Inpatients: A multidisciplinary approach

Paul M. Szumita, PharmD BCPS

Clinical Pharmacy Practice Manager

Brigham & Women’s Hospital Boston, MA

learning objectives
Learning Objectives
  • Review the benefits and risks of insulin therapy in the hospital setting
  • Identify the essential elements that need to be addressed when implementing a glycemic control program
  • Propose critical elements that should be addressed when transitioning a patient from one setting to another
case 1 60 y o with t2dm
Case 1: 60 y/o with T2DM
  • Home regimen
    • glipizide 10 mg/day, metformin 1 g bid
  • Admitted to GMS with CAP
    • Good appetite
    • 60 kg
    • Lab glucose 250 (A1C 7%), creatinine 1.0

How should this patients diabetes be Managed in-house?

case 2 65 y o female
Case 2: 65 y/o Female
  • 80 kg, no history of diabetes
  • Admitted to SICU post CAGB
  • First Glucose value = 153

How should this patients glucose be

In-house?

continuum of risk
Continuum of Risk
  • Clear association between hyperglycemia and bad outcome
    • Morbidity and mortality
  • So, what is the “best” glucose level?
    • Maximize efficacy
    • Minimize adverse events from both hyperglycemia and hypoglycemia
intensive insulin therapy in surgical medical icu patients
Intensive Insulin Therapy in Surgical/Medical ICU Patients

Van den Berghe G et al. N Engl J Med. 2001; 345:1359-67.

Van den Berghe G et al. N Engl J Med. 2006; 354:449-61.

slide7

Post hoc Analysis of Surgical ICU Mortality: Effect of Average BG

BG>150

110<BG<150

p=0.0009

p=0.026

BG<110

BG = blood glucose

in mg/dL

Van den Berghe G et al. Crit Care Med. 2003; 31:359-66.

four year follow up
Four-Year Follow Up

p

Intensive Treatment

Cumulative 4-Year Survival

Conventional Treatment

Days after ICU Admission

Ingels C et al. Eur Heart J. 2006 Apr 11 [Epub ahead of print].

hyperglycemia and mortality intensive care units
Hyperglycemia and Mortality: Intensive Care Units

Mortality Rate (%)

Mean Glucose Value (mg/dL)

Krinsley JS. Mayo Clin Proc. 2003; 78:1471-8.

non icu patients
Non-ICU Patients
  • No randomized controlled trials available
    • Currently rely on data from observational studies
  • Hyperglycemia in general medical and surgical units associated with the following:
    • Up to an 18-fold increase in in-hospital mortality
    • Longer length of stay (9 vs. 4.5 days)
    • More subsequent nursing home care
    • Greater risk of infection

Umpierrez GE et al. J Clin Endocrinol Metab. 2002; 87:978-82.

slide11
Hyperglycemia: An Independent Marker of In-Hospital Mortality in Patients withOR WITHOUT Established Diabetes

Total In-patient Mortality

16.0% *

Mortality (%)

3.0%

1.7%

Normoglycemia Known New

Diabetes Hyperglycemia

* p < 0.01

Umpierrez GE et al. J Clin Endocrinol Metabol. 2002; 87:978-82.

potential benefits of improved inpatient glycemic control
Potential Benefits of Improved Inpatient Glycemic Control
  • Improving hyperglycemia may improve or avoid
    • Complications of myocardial infarction and stroke
    • Complications of vascular and cardiac surgery
    • Dehydration, venous thromboembolism (VTE), electrolyte disturbances
    • Gastric emptying, nausea, emesis
    • Infection, healing rates
slide13

Inpatient Target Plasma Glucose Levels (mg/dL)

ACE

ADA

  • American College of Endocrinology. Endocrine Practice 2004; 10: 77-82.
  • American Diabetes Association. Diabetes Care. 2008; 31:S1-S110.
creating the glycemic target at your institution
Creating the Glycemic Target at Your Institution?
  • Clear association between hyperglycemia and bad outcomes… But…
    • Should different patients have different goals?
    • How long should control be maintained?
    • Is the glucose control or the therapeutic use of insulin responsible for beneficial effects?
    • What is the most effective and safest way to control glucose in different settings?
  • Many other questions
best practices
Best Practices
  • Glucose control teams/champions
  • Assess current quality
  • Standardized insulin protocols/order sets
  • Decision support for protocols
  • Address Safety issues
  • Comprehensive educational programs
  • Continuous quality assessment and quality improvement
  • Data/information sharing
glycemic control team champions
Glycemic Control Team/Champions
  • Hospitalists
  • Pharmacists
  • Endocrinologists
  • Intensivists
  • Nurses
  • Administrator
  • Informatics
  • Food service / nutrition / diabetes educators
  • Local champions

ACE/ADA Task Force on Inpatient Diabetes.Diabetes Care. 2006; 29:1955-62.

Szumita PM. Pharmacy Times. 2007;(April):110-22.

glycemic control team
Glycemic Control Team
  • Team will be the driving force for:
    • Institution’s goal/target
      • Ambulatory
      • ICU
      • Non-ICU
    • Establish policies working with hospital committees
    • Create/adopt protocols
    • QA & QI projects
    • Addressing safety issues
    • Formulary decisions
    • Education programs
    • Overcome barriers

ACE/ADA Task Force on Inpatient Diabetes.Diabetes Care. 2006; 29:1955-62.

Szumita PM. Pharmacy Times. 2007;(April):110-22.

Shojania K. JAMA. 2006; 296 (4); 427-440

assess current quality or glucometrics
Assess Current Quality or“Glucometrics”
  • Glycemic control
    • A1c
    • Glucose
  • Hypoglycemia rates
  • Medication use patterns
  • Documentation and plan for improvement
types of protocols order sets
Types of Protocols/Order Sets
  • Ambulatory Patients
  • Non-ICU SC insulin regimen order set
    • Non-pregnant
    • Pregnant/OB
    • Emergency Department
    • PACU/OR
  • Incorporating many different scenarios
    • NPO
    • Tube Feeds
    • Half meals
    • Full meals
    • TPN
types of protocols order sets20
Types of Protocols/Order Sets
  • DKA/HHS order set
  • ICU (Non-DKA/HHS) order set
    • IV insulin protocol
    • Transition to SC from IV (ICU)
  • Hypoglycemia order set
  • Transition to out-patient
decision support
Decision Support
  • Informatics solutions
    • Reminder “pop-ups” for patients:
      • With hyperglycemia  order protocol
      • With hyperglycemia on protocol adjust insulin dose
      • With hypoglycemia on protocol  adjust insulin dose
      • At risk for hyperglycemia  order protocol
      • At risk of hypoglycemia order protocol
  • Patient lists
    • By team or unit
  • Nurse-protocols (institution-wide)
    • Limits decision by team
  • Opt-out protocols
safety issues
Safety Issues
  • Oral agents
    • Class side effects
  • Insulin is perennially on the list of medication responsible for errors in hospitals
    • IV Drips preparation/storage
    • SC insulin devices
    • Bar code scanning
    • Hypoglycemia protocol with all meds known to cause hypoglycemia
    • Smart pump technology
    • Computerized multiplication factor IV insulin protocols
    • Limit formulary
insulin vial to device
Insulin Vial to Device
  • 2005 ASHP Recommendations for Safe Use of Insulin in Hospitals
    • Floor stock insulin should be minimized or eliminated
    • Pharmacy should provide insulin devices or draw up individual doses of basal insulins
  • Enhance nurse and patient safety
    • “Automatic” safety needle (no recapping)
    • Bar-coding
    • Infection control issue
  • Economic benefit
    • Less waste (3 mL vs. 10 mL)

American Society of Health-System Pharmacists. Available at: http://www.ashp.org/emplibrary/Safe_Use_of_Insulin.pdf

education
Education
  • Educate the educators to allow for local ownership
    • All levels and professions
      • MD
      • PA
      • RN
      • NP
      • RPh
      • Dietitians
      • PCA
  • Continuous education
  • Feedback with metrics and improvements initiatives
  • Patient education
continuous quality assessment and quality improvement
Continuous quality assessment and quality improvement
  • Perfection may not be attainable with the first improvement project
    • Document incremental improvement
    • Pilots allows opportunities for controlled assessment in a small number of patients
    • Evaluate, efficacy, safety and costs of each change
  • Repeat
  • Repeat
continuous quality assessment and quality improvement26
Continuous quality assessment and quality improvement
  • Lessons learned from experience
    • No protocol or treatment algorithm is perfect
  • Goals of quality improvement:
    • Achieves goals better than existing practice
    • As safe or safer
data sharing
Data Sharing
  • Share data or “metrics” of quality improvement initiatives
    • Diabetes committee/ Glycemic Control Team
    • ICU, Surgical, Hospitalists leadership
    • P&T committee
    • Nurse administration
    • Nurse educators
    • Nurse clinical practice
    • Bedside clinicians
  • Share Data via institution to institution
    • Publication
    • Colleague to colleague
role of the pharmacist
Role of the Pharmacist
  • Physical/local champions
  • Active member of glucose control team
  • Political lobbying within institution
  • Protocol selection/development
  • Formulary decisions
  • Education
  • Implementation of protocols
  • Work with local IS teams
  • Bedside advocate
  • Safety initiatives
  • Quality assessment/improvement leader

Szumita PM. Pharmacy Times. 2007;(April):110-22.

Shojania K. JAMA. 2006; 296 (4); 427-440

just some barriers
Just Some Barriers
  • Lack of institutional consensus regarding goals
  • No standardized approach to testing and treatment
  • Inadequate insulin drip protocol
  • Non-adherence to national guidelines
  • Fear of hypoglycemia
  • Culture
  • POCT and lab
  • Communication
  • Health-care resources

Anger KE et al. Pharmacotherapy. 2006; 26:214-28.

Szumita PM. Pharmacy Times. 2007;(April):110-22.

ACE/ADA Task Force on Inpatient Diabetes.Diabetes Care. 2006; 29:1955-62.

Shojania K. JAMA. 2006; 296 (4); 427-440

fear of hypoglycemia
Fear of Hypoglycemia
  • Fear of hypoglycemia may impede
    • Willingness of clinicians to target lower glucose values
  • Clinicians should fully understand
    • Hyperglycemia and its associated morbidity and mortality
    • Hypoglycemia and its associated morbidity and mortality
    • Risk factors for hypoglycemia
      • Inadequate glucose intake
      • Infrequent glucose monitoring
      • Lack of communication
      • Inability to report symptoms
      • Concomitant drug therapy
      • Nothing-by-mouth status
      • Underlying disease states

Anger KE et al. Pharmacotherapy. 2006; 26:214-28.

ways to address fear of hypoglycemia
Ways to AddressFear of Hypoglycemia
  • Address hypoglycemia in glucose management guideline
    • Treatment
    • Prevention
  • Guideline should have laboratory and point-of-care testing (POCT) monitoring frequencies
  • Instructions on how to restart insulin therapy
  • Education, Education, Education
overcoming barriers
Overcoming Barriers
  • Multidisciplinary approach
    • By in for all
  • Incorporate best practices strategies to overcome each barrier
  • No single barrier is impossible to overcome
general principals
General Principals
  • Acute hyperglycemia is bad
  • Treating hyperglycemia in the hospital setting
    • Avoid oral agents
    • Insulin is generally the treatment of choice
  • Insulin in tops on the list of medication errors in hospitals
  • Need protocolized care throughout institution
approach to hyperglycemia in hospitalized patients
Approach to Hyperglycemia in Hospitalized Patients
  • Inpatient situations are unstable
  • Change from home to inpatient regimen
  • No single algorithm suitable for all patients
  • Review BBG  adjust meds frequently
  • Reassess medications at dischargechange back to outpatient (home) regimen
medications in the inpatient setting
Medications in the Inpatient Setting
  • Insulin drips
    • indicated for most ICU patients
  • Oral agents
    • should RARELY be used
  • SubQ insulin
    • indicated for MOST non-ICU patients
creating and implementing an effective i v insulin protocol
Creating and Implementing an Effective I.V. Insulin Protocol
  • American Diabetes Association (ADA) goal glucose in the ICU is less than 110 mg/dL
  • In the “real world,” this goal is VERY DIFFICULT
no ideal protocol in the literature
No Ideal Protocol in the Literature
  • Many have been described
  • Few have been rigorously evaluated
  • Few are designed to reach goal of 80-110 mg/dL
intensive insulin therapy in critically ill patients
Intensive Insulin Therapy in Critically Ill Patients

No serious hypoglycemic events.

Van den Berghe G et al. N Engl J Med. 2001; 345:1359-67.

Van den Berghe G et al. N Engl J Med. 2006; 354:449-61.

multiplier protocol concept a simple calculation
“Multiplier” Protocol Concept: A Simple Calculation
  • (Blood glucose – 60) X multiplication factor = new insulin infusion rate for that hour
    • The multiplication factor changes depending on the change in glucose value

Osburne RC et al. Diabetes Educ. 2006; 32:394-403.

Davidson PC et al. Diabetes Care. 2005; 28:2418-23.

paper multiplier protocol
Paper “Multiplier” Protocol

Lien LF et al. Endocr Pract. 2005; 11:240-53.

slide43

Outcomes of

Electronic “Multiplier” Protocol

Davidson PC et al. Diabetes Care. 2005; 28:2418-23.

bhip protocol
BHIP Protocol

*Never stop the insulin. The minimum rate should be 0.5 units/hour.

case 2 65 y o female45
Case 2: 65 y/o Female
  • 80 kg, no history of diabetes
  • Admitted to SICU post CAGB
  • First Glucose value = 153

How should this patients glucose be

In-house?

lessons learned
Lessons Learned
  • Implement a protocol which achieves goals better than existing protocol
  • The new protocol has got to be safe
  • We need to continue to further improve protocols in the literature
  • Consider computer protocol

No Protocol is Perfect

approach to hyperglycemia in hospitalized patients47
Approach to Hyperglycemia in Hospitalized Patients
  • Inpatient situations are unstable
  • Change from home to inpatient regimen
  • No single algorithm suitable for all patients
  • Review BBG  adjust meds frequently
  • Reassess medications at dischargechange back to outpatient (home) regimen
problems with oral agents in the hospital
Problems with Oral Agents in the Hospital
  • Sulfonylureas (e.g., glyburide, glipizide, etc.)
    • Hypoglycemia (long acting)
    • ? Coronary artery disease
  • Metformin
    • Lactic acidosis risk
      • Renal insufficiency, hypotension, heart failure
    • GastrointestinaI
      • Nausea, abdominal pain, diarrhea
  • Thiazolidinediones (TZDs or “glitazones”) (e.g., rosiglitazone)
    • Possible liver toxicity
    • Fluid overload, heart failure
    • Inability to titrate (very slow onset of action)
effective subq insulin regimens have three components
Effective SubQ Insulin Regimens Have THREE COMPONENTS
  • Basal insulin
    • Controls fasting and pre-meal glucose
  • Nutritional insulin
    • Controls glucose from nutritional sources such as discrete meals, tube feeds, or TPN
  • Supplemental/Correction insulin
    • Used to cover unexpected hyperglycemia that was not controlled by scheduled basal and nutritional insulin
basal insulin
Basal Insulin
  • Either NPH or long-acting insulin
    • (Also can be provided with insulin drip)
  • Should never be held in type 1 diabetes
  • May sometimes, but not usually, be held or reduced if a type 2 diabetic patient is NPO
which patients need basal insulin in the hospital
Which Patients Need Basal Insulin in the Hospital?
  • “Insulin-deficient” patients should always have basal insulin (even if receiving nothing by mouth):
    • Type 1 DM or DKA, pancreatic insufficiency
    • A history of type 2 DM for 10 years or more
    • On any insulin for 5 years or more
    • Wide fluctuations of glucose values
  • Preprandial glucose > ?130, 150 mg/dL
  • Any glucose > 180 mg/dL
nutritional insulin patient eating discrete meals
Nutritional Insulin:Patient Eating Discrete Meals
  • Preferred treatment is rapid-acting qac
  • Insulin drip does NOT cover this well
    • Patients on drip who are eating need subQ rapid-acting, in addition to drip
  • Do not give unless FOOD TRAY IS PRESENT
  • Give 0-15 minutes before a meal
  • Can be given immediately (<15 min) after meal
  • HOLD if NPO or not eating
nutritional insulin patient on tube feeds
Nutritional Insulin:Patient on Tube Feeds
  • Usually treated with regular insulin q 6 h if on continuous tube feeds
  • Also can be covered by an insulin drip
  • HOLD if tube feeds are stopped or held
    • May give IV dextrose until 4-6 hours after the last dose of regular was given
correction supplemental sliding scale insulin
Correction/Supplemental (Sliding Scale) Insulin
  • Should be given IN ADDITION to basal and nutritional insulin
  • Patients on larger doses of insulin (basal and nutritional) require higher dose scales
  • Avoid at bedtime unless glucose is very high
slide56

Starting Basal-Bolus from Scratch

Calculate starting total daily dose (TDD)

  • 0.3 units/kg/day (hypoglycemia risk factors, naïve patient)
  • 0.5 units/kg/day (Standard- conservative for most patients)
  • 0.6 – 0.7 units/kg/day (overweight to obese)

Adjust TDD up or down based on

  • Past response to insulin
  • Presence of hyperglycemia inducing agents, stress

This is very conservative and safe (adjust up as needed)

Basal insulin = 40-50% of TDD

  • Long acting-acting insulin QD or BID or intermediate acting insulin BID

Goal: FBG and pre-meal glucose = 80-110 mg/dL

case 1 60 y o with t2dm57
Case 1: 60 y/o with T2DM
  • Home regimen
    • glipizide 10 mg/day, metformin 1 g bid
  • Admitted to GMS with CAP
  • Good appetite
  • 60 kg
  • Lab glucose 250 (A1C 7%), creatinine 1.0

How should this patients diabetes be

managed while in house?

rationale for inpatient insulin
Rationale For Inpatient Insulin
  • Even though she is well-controlled at home
    • She is stressed, which increases her insulin requirement
    • Her glucose is already 250 mg/dL (and you will be stopping her oral agents)
slide60

As long as you give the patient adose of insulin lower than their total insulin requirement, if the glucose starts to go too low, theirendogenous insulin production will decrease to compensate!

determining insulin regimen 60 kg patient type ii dm

BASAL

NUTRITIONAL

~50%

Determining Insulin Regimen 60 KG patient type II DM

Estimate Total Daily Dose (TDD)

e.g. 0.5 Units/kg/day * 60 kg = 30 units/day

~50%

e.g. Basal

e.g. Prandial qac

slide66

Insulin Requirement During Continuous Dextrose, TPN or Enteral Feedings

Tube Feeds Off

8 12 6 10

why not use sliding scale alone
Why Not Use Sliding Scale Alone?
  • It doesn’t work!!
  • Reactive, not proactive
  • Leads to rollercoaster patterns of glycemia
  • Increases risk for “stacking” of insulin and hypoglycemia
patient status
Patient status
  • Treatment may differ for many reasons:
    • Eating meal
    • NPO
    • Tube feeds
    • TPN
    • ICU

Diabetes Care; 27 (2) 2004

case 3 70 y o with t2dm
Case 3: 70 y/o with T2DM
  • Home regimen
    • Metformin 1000 mg bid
  • Admitted with CHF exacerbation
  • Eating meals
  • 100 kg
  • Lab glucose 250, creatinine 1.0

How should this patients diabetes be

managed while in house?

100 kg eating meals bg 250
100 kg, Eating meals, BG 250
  • BBG frequency
  • qac and qhs
  • TDD insulin (~0.5-0.7 U kg/day)
  • 100 kg * 0.7 U/kg/day = 70 units
  • Basal (~50% TDD)
  • NPH 18 bid (AM and HS)
  • Nutritional (prandial) (~50% TDD)
  • Rapid-acting 11 units qac
  • Correction (supplemental) (<40, 40-80, >80)
  • medium dose algorithm aspart qac and hs
case 4 patient with t1dm
Case 4: Patient with T1DM
  • Home regimen
    • Glargine 15 Qhs
    • LISPRO 5 qac
  • Admitted with pancreatitis
  • NPO
  • 60 kg
  • Lab glucose 140
tidm npo 15 glargine aspart
TIDM; NPO; 15 Glargine/Aspart
  • BBG frequency
  • q6h
  • TDD insulin (~0.5-0.7 U kg/day) vs. home
  • 60 kg * 0.5 U/kg/day = 30 units
  • Basal (~50% TDD)
  • 15 glargine HS
  • Nutritional (prandial) (~50% TDD)
  • 0
  • Correction (supplemental) (<40, 40-80, >80)
  • Low dose algorithm regular q6h
approach to hyperglycemia in hospitalized patients73
Approach to Hyperglycemia in Hospitalized Patients
  • Inpatient situations are unstable
  • Change from home to inpatient regimen
  • No single algorithm suitable for all patients
  • Daily adjustment of insulin regimen
  • Reassess medications at dischargechange back to appropriate outpatient (home) regimen
have a discharge plan tailored to patient
Have a Discharge PlanTailored to Patient!
  • Diabetes and insulin education, survival skills: START EARLY and repeat
  • Follow up and community resources
  • Covered by insurance
  • Patient and family can understand
  • Reconcile medications
  • Language, health literacy, and cultural barriers
  • Use HbA1c
  • Insulin requirement may decrease post discharge
conclusions
Conclusions
  • Diabetes and hyperglycemia are associated with:
    • Increased length of stay
    • Increased hospitalization
    • Increase mortality
    • Increase cost to the health care system
    • Increase rate of infection
  • Insulin is most likely the most effective and safest treatment of inpatient hyperglycemia
  • Insulin regimens should be physiologically based