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Subcutaneous Insulin in Hospitalized Patients. Cheryl W. O’Malley, MD Cheryl.Omalley@bannerhealth.com. Welcome Glycemic Control “Experts”. Prepare yourself for the questions…. “Why do we need to worry about glycemic control, hasn’t that been proven to harm patients?”

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subcutaneous insulin in hospitalized patients

Subcutaneous Insulin in Hospitalized Patients

Cheryl W. O’Malley, MD

Cheryl.Omalley@bannerhealth.com

prepare yourself for the questions
Prepare yourself for the questions…
  • “Why do we need to worry about glycemic control, hasn’t that been proven to harm patients?”
  • “Can’t we just use their home regimens?”
  • “We have become pretty good with sliding scale, I’d prefer to just use that?”
  • “I really don’t know how to dose insulin for someone who is ‘naïve’, can you help?”
  • “I don’t want to use these expensive regimens because non of our patients can afford them when they go home”
why is this important despite recent controversies
Why is this important despite recent controversies
  • Affects a large number of patients
  • Robust physiologic and observational data that some sort of control matters
  • Current consensus with the ADA/AACE is to target moderate control
  • Traditionally we have used sliding scale which doesn’t work
  • Safety issues related to insulin
current recommended glycemic control targets for icu 140 180 mg dl
Current Recommended Glycemic Control Targets for ICU= 140-180 mg/dL

NICE Sugar

118

<40 70 100 130 140 160 180 200 250 299 400

2009 AACE/ADA goals

slide6
“For the majority of noncritically ill patients treated with insulin, the premeal BG target should generally be <140 mg/dl in conjunction with random BG <180 mg/dl.
  • Modify regimen if < 100 mg/dL to minimize risk of hypoglycemia
  • DIABETES CARE, VOLUME 32, NUMBER 6, JUNE 2009
oral agents in the hospital
Oral Agents in the Hospital

Sulfonylureas

Hypoglycemia (long acting)

Metformin

Lactic acidosis risk =renal insufficiency, hypotension, CHF

GI (nausea, abd. pain, diarrhea)

Thiazoladinediones (TZDs) or “glitazones”

Possible liver toxicity

Fluid overload, CHF

Inability to titrate (very slow onset of action)

Only pioglitazone approved for use with insulin

case sliding scale only
Case: Sliding Scale Only

“non-fasting blood sugar upon admission was 560, the patient

had a redraw at 6:05 and it was 369.

Diabetes mellitus type 2, uncontrolled.

Once the patient's blood sugar is better controlled, will change

Accu-Checks to q.a.c and q.h.s. and cover with Apidra sliding scale

insulin and Lantus if necessary”

sliding scale alone doesn t work
Sliding Scale Alone Doesn’t Work

Sliding scale prospective cohort study

171 patients with type 1 DM

40% had BG>300

23% <70

In 80% of patients, the orders written at admission were never changed despite poor control

Quele et al, Arch Intern Med 1997: 157; 545-552

a look at the real world mayo scottsdale
A look at “the real world”: Mayo Scottsdale

Retrospective Analysis 2,916 discharges

Teaching hospital (200 bed; metro. Phoenix)

LOS 3 or more days; non-ICU

Mean 1st 24 hours 170  stay 167 mg/dL last 24 h 165 mg/dL

Highest tertile (mean 218 mg/dL)

46% still only on sliding scale regular insulin

only 60% increased insulin doses

Cook CB, et al. J Hosp Med. 2007.

slide14
Scheduled subcutaneous administration of insulin, with basal, nutritional, and correction components, is the preferred method for achieving and maintaining glucose control.”
  • DIABETES CARE, VOLUME 32, NUMBER 6, JUNE 2009
physiologic insulin secretion
Physiologic Insulin Secretion

Normal 24-Hour Profile

1. Nutritional Insulin: Promote glucose utilization

50

Insulin

(µU/mL)

25

2. Basal Insulin: Suppresses Glucose Production Between Meals And Overnight

0

Breakfast Lunch Supper

150

100

Glucose

(mg/dL)

50

3. Correction/ Supplemental Insulin: Additional insulin to treat hyperglycemia

0

7

8

9

10

11

12

1

2

3

4

5

6

7

8

9

A.M.

P.M.

Time of Day

pharmacokinetics of insulin preparations
Pharmacokinetics of Insulin Preparations

Short acting Analog

Regular

NPH

Glargine

Detemir

Insulin Effect

8 AM

8 AM

N

6 PM

10 PM

6-23

using exogenous insulin to imitate physiologic insulin secretion summary
Using Exogenous Insulin to Imitate Physiologic Insulin Secretion: Summary
  • Basal insulin: Use non-peaking, longer-acting insulins
    • Glargine or detemir are preferred
    • NPH also possible
  • Nutritional insulin: Depends on the type of nutrition
    • Rapid-acting insulin is preferred when patients are eating meals
    • Regular insulin also possible
  • Correctional insulin: Use rapid-acting (or regular) insulin
    • Usually the same as the nutritional insulin
slide20

RABBIT-2 Trial: Basal / Bolus arm

  • 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
  • TDD adjusted daily +/- 20% for BG >140 or < 70
  • 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

slide21

Mean Blood Glucose Levels During Insulin Therapy

*

*

*

* p<0.01

¶ p<0.05

Day 3: P=0.06

Umpierrez, Diabetes Care 30: 2007

slide22

Blood Glucose Levels in Patients Who Failed SSRI:

Transition to Basal Bolus Insulin

P: 0.02

P: NS

Failure was defined as 3 consecutive BG values > 240 mg/dL during SSRI

Umpierrez, Diabetes Care 30: 2007

slide23
130 nonsurgical non-critically ill patients age 18-80 with known type 2 diabetes admitted to noncritical care unit

Half of patients were receiving insulin prior to admission and received similar outpatient insulin dose in the hospital

Randomly assigned to:

Detemir once a day with premeal Aspart 3 times a day

NPH and regular twice a day before breakfast and dinner

Dosing

0.4 units per kg/day for BG 140-200

0.5 units per kg /day for BG > 200

Distribution of insulin

Determir group: 50% given as detemir and 50% as aspart

NPH group: 2/3 given as NPH and 1/3 as regular

DEAN Trial

Detemir with Aspart vs NPH with Regular Insulin Therapy in the Inpatient Management of Patients With Type 2 Diabetes

Umpierrez et al. J Clin Endocrinol Metab. 94:564 2009

slide24

DEAN-Trial

Detemir + Novolog

NPH + Regular

Blood glucose (mg/dL)

Duration of Therapy (days)

Data are ± SEM

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.

percent of glucose values within target 140 mg dl
Percent of Glucose Values Within Target (<140 mg/dl)

RABBIT-2 Trial

DEAN Trial

*

66%

48%

45%

%

%

38%

* P < 0.01

Umpierrez et al. Diabetes Care 30:2181–86, 2007

Umpierrez et al. JCEM, in press

slide26

Rate of Hypoglycemia

(# patients with BG < 60 mg/dl)

RABBIT-2 Trial

DEAN Trial

32.8

25.4

%

%

3

3

Umpierrez et al. Diabetes Care 30:2181–86, 2007

Umpierrez et al. JCEM, in press

dean trial discussion
DEAN Trial Discussion
  • 50% of patients were on insulin prior to admission
  • Detimir may need to be dosed bid
  • NPH/R and detimir/aspart were equivalent in this study.
  • Choice depends on physician preference, formulary choice, cost, and nursing considerations.
3 steps to using basal bolus insulin in the hospital
3 Steps to using basal/bolus insulin in the hospital
  • Determine total daily insulin dose
  • Divide up to 50% basal insulin, 50% bolus
  • Adjust daily
slide30

Step 1: Calculate Starting total daily dose (TDD):

  • IV requirements
  • Home dose—be careful of “I use basal + sliding scale”…how many units of all types of insulin do they use on any given day
  • Weight based 0.2-0.6 units/kg/day
    • AACE slides said 0.2-0.4
    • What we do at BGSMC
      • 0.3 ESRD or
      • 0.4 units/kg/day lean (BMI <25)
      • 0.5 units/kg/day overweight (BMI 25-30)
      • 0.6 units/kg/day obese (BMI >30)
physiologic insulin requirements in health and illness
Physiologic Insulin Requirementsin Health and Illness

Relative proportion of insulin

Clement, Braithwaite, Magee et al. Diabetes Care. 2004;27:553-591.

step 2 divide into scheduled basal vs nutritional insulin
Step 2: Divide into Scheduled Basal vs. Nutritional Insulin
  • 40-50% should generally be basal (glargine, detimir, or NPH)
  • Remaining 50-60% divided evenly and given to cover nutritional intake
    • Rapid acting (lispro, aspart, glulisine) easier to match with meals in hospital
    • Regular insulin also an option
case hypoglycemia why
Case: Hypoglycemia Why?

Home regimen:

Glargine 120 qhs, 60 q am

Byetta—held at admit

Glimipiride—held at admit

Glargine 120

Glargine 100

Glargine 60 units

total daily dose of insulin divided to match needs
Total Daily Dose of Insulin Divided to Match Needs
  • 50% “Bolus”
  • Rapid Acting
    • Lispro
    • Aspart
    • Glulisine
  • Short Acting
    • Regular

0

  • 50% “Basal”
  • Glargine
  • Detimir
  • NPH
problems if you discontinue all scheduled insulin
Problems if you discontinue all scheduled insulin
  • Sliding scale only
  • DKA
  • Severe uncontrolled hyperglycemia
step 3 adjust doses daily
Step 3: Adjust Doses Daily
  • If some BG were <100 mg/dL
    • Reduce TDD by 20-50%
    • Re-divide the new TDDI to preserve the desired ratio
  • If some were over 180 mg/dL and none less than 100 then
    • Add up ALL of the insulin given in the last 24 hours this was the real TDDI
    • Add 10% to the TDDI from the prior day
    • Re-divide the new TDDI to preserve the desired ratio
insanity doing the same thing over and over again and expecting different results albert einstein

“Insanity: Doing the same thing over and over again and expecting different results” – Albert Einstein

case 3 daily adjustments
Case 3: Daily Adjustments
  • 47 y.o. HF with DM type 2 X 13 years
  • Admitted for Pyelonephritis
  • HbA1c 9.4% & admission BG 370
  • Home regimen metformin 500 mg bid

Glargine 35 units glulisine 12 with meals

Glargine 64 units glulisine 20 with meals

management of hyperglycemia is a safety concern with risks due to
Management of Hyperglycemia is a safety concern with risks due to
  • Numerous insulin types with varying onset/peak and poor staff understanding.
  • Changes in food/CHO intake
  • Change in clinical status or medications
  • Failure to adjust daily based on BG patterns
  • Prolonged use of SSI as monotherapy
  • Poor coordination of BG testing with insulin administration and meal delivery
  • Poor communication during patient transfers
  • Errors in order writing and transcription
management of hyperglycemia is a safety concern with risks due to48
RISKS

Numerous insulin types

Changes in food/CHO intake

Poor coordination of BG testing with insulin administration and meal delivery

Errors in order writing and transcription

SOLUTIONS:

Order sets

Teams

Limiting insulin options on order sets

Include provisions for change in po intake

Management of Hyperglycemia is a safety concern with risks due to
3 1 steps to using basal bolus insulin in the hospital
3 (+1) Steps to Using Basal/Bolus Insulin in the Hospital

Determine total daily insulin dose

Divide up to 50% basal insulin, 50% bolus

Reassess daily

USE YOUR HOSPITAL ORDER SETS

effect of structured insulin orders and an insulin management algorithm ucsd
Effect of Structured Insulin Orders and an Insulin Management Algorithm – UCSD

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)

5,530 patients with DM or Hyperglycemia and > 7 POC Glucose readings TP3:TP1

Maynard G, et al. J Hosp Med. 2009.

challenging clinical situations
Challenging Clinical Situations

Patient receiving corticosteroids

Patient receiving TPN

Patient on enteral nutritional support

Continuous

Intermittent

corticosteroid therapy
Corticosteroid Therapy

Minimal elevation of fasting glucose

Exaggeration of postprandial hyperglycemia

Consider:

70% prandial insulin, 30% basal insulin in patients with established diabetes history

If already on insulin, add 10-20% to TDD

Increase correction scale

During the taper, be PROACTIVE

frequency of hyperglycemia in patients receiving high dose steroids
Frequency of hyperglycemia in patients receiving high dose steroids

> 1 BG > 200 mg/dl

> 2 BG > 200 mg/dl

90

81

75

%

64

56

60

52

41

30

0

All

No Hx DM

Hx DM

Donihi A et al Endocrine Practice 12:358, 296

slide56

Prednisone (mg/day)

NPH (units/kg/day)*

> 40

0.4

30

0.3

20

0.2

10

0.1

One Suggested Approach for Treatment of Hyperglycemia in Patients Receiving Glucocorticoid Therapy

*Administered in AM at time of prednisone administration

Glargine preferred if dexamethasone used or Prednisone given twice a day

Clore JN, Thurber-Hay L. Endocrine Practice 15:469 2009

how do steroids differ in their effects steroid potency and duration of action
How do Steroids Differ in their Effects?Steroid Potency and Duration of Action

20mg/d of prednisone ~= 80mg/d of hydrocortisone ~= 16mg/d of methylprednisolone ~= 3mg/d dexamethasone)

Glucocorticoid Potency

Biologic Half Life

Hydrocortisone

1

8-12 hours

Prednisone

4

18-36 hours

Methylprednisolone

5

18-36 hours

Dexamethasone

30-40

36-54 hours

slide58
TPN

TPN commonly leads to hyperglycemia in absence of diabetes

75% of patients with type 2 diabetes not previously treated with insulin will require insulin with TPN

Strategies-no studies comparing these

Usual Method: incremental doses added to TPN

Preferred?: separate IV infusion until requirements are known

Other: Basal/”bolus”

glycemic management of the patient receiving tpn
Glycemic Management of the Patient Receiving TPN

Suggested

In patients with known type 2 diabetes, add 1 unit for each 10 Grams of carbohydrate in the solution

Initiate Correctional Insulin Scale for BG > 140 mg/dl

Add 60 to 100% of previous days correctional insulin dose to next day’s TPN solution

Consider

Add basal long or intermediate acting insulin at a dose of 0.2 to 0.4 units per kg per day

enteral nutrition
Enteral Nutrition

High-fat formulas (monounsaturated fats) achieve better metabolic control that traditional high-carbohydrate preparations

Blood glucose control may be attainable with long-acting subcutaneous insulin preparations- insulin glargine (with constant nutrition)

Previous diabetes: ¾ TDD

Insulin naïve: 0.6 units/kg

continuous enteral tube feeds
Continuous Enteral Tube Feeds

Basal: Less than or equal to 50% of TDDI

Long acting at bedtime or morning

Intermediate divided equally bid or tid

Insulin drip

Prandial/Nutritional: 50% of TDDI

Rapid acting every 4 hours

Regular every 6 hours

Correction

Rapid acting every 4 hours

Have a plan for if TF stopped to give dextrose, e.g. hang D10 at same rate as TF were running.

slide63

Treatment Algorithm For Patients Receiving Continuous Enteral Nutrition

Patient with no prior history diabetes started on EN

BG < 130 mg/dl x 48 hrs

≥ 2 BG > 130 mg/dl

Discontinue BG Monitoring

Glargine 10 units + Correction Insulin q6h

All BG < 130 mg/dl

≥ 2 BG >180 mg/dl in prior 24 hours

Add 25-50% Correction Insulin to Glargine

Administer regular insulin q6h

Continue current regimen

slide64

Alternative Treatment Algorithm For Patients Receiving Continuous Enteral Nutrition

Patient with no prior history diabetes started on EN

BG < 130 mg/dl x 48 hrs

≥ 2 BG > 130 mg/dl

Discontinue BG Monitoring

All BG < 180 mg/dl

Initiate correction insulin q6h

Continue regimen

≥ 2 BG >180 mg/dl in prior 24 hours

≥ 1 BG > 250 mg/dl in prior 24 hours

Start Scheduled Insulin Therapy

slide65

Glargine

CI*

P value

Mean CBG during study mg/dl

163±31

161±30

.75

Hypoglycemia/pt days %

2.7

4.8

.34

Hyperglycemia/pt days %

49.3

47.6

.77

Blood Glucose Data on Participants According to Group

*CI= correction insulin

There were no group differences in adverse events.

Korytkowski M, Salata R, Koerbel G et al Diabetes Care 32:594, 2009

summary
Summary

50% of eligible subjects for this study had no previous history of type 2 diabetes or hyperglycemia

Both glargine and correction insulin (CI) (with the addition of NPH) were effective at achieving glycemic control in these patients with careful glucose monitoring and adjustments of the insulin regimen

13/25 patients randomized to correction insulin alone required NPH insulin to achieve glycemic control

No severe hypoglycemia events occurred during this study

Korytkowski M, Salata R, Koerbel G et al Diabetes Care 32:594, 2009

glycemic management of the patient receiving enteral nutrition
Glycemic Management of the Patient Receiving Enteral Nutrition

Continuous enteral nutrition (EN)

Basal: 40-50% of TDD as long or intermediate acting insulin given once twice a day

Short acting 50-60% of TDD given q6h*

Cycled enteral nutrition

Intermediate acting insulin given together with a rapid or short acting insulin with start of TF

Rapid or short acting insulin administered q4 to 6 hours for duration of EN administration

Correctional insulin given for BG above goal range

Bolus enteral nutrition

Rapid acting analog or short acting insulin given prior to each bolus

night time tube feeds
Night time tube feeds

Monitor blood sugars every 4 hours for the first few nights with supplemental scale coverage.

After the dosing is determined

Give a short acting insulin at the start of the tube feeds to cover the first several hours along with NPH to cover the rest of the night.

bolus tube feeds
Bolus Tube Feeds

Basal: 50% of TDDI

Long acting at bedtime or morning

Intermediate bid (50/50 or 2/3 am and 1/3 pm) or at bedtime

Insulin drip

Prandial/Nutritional 50% of TDDI

Rapid acting with each tube feeding

Regular before each tube feeding

Correction

Rapid acting every 4 hours

Regular every 6 hours

specific clinical situations
Specific Clinical Situations

Patients with insulin pumps

Patients who use CSII pump therapy in the outpatient setting can continue to use these devices as inpatients provided that they have the mental and physical capacity to do so.

Availability of hospital personnel with expertise in CSII therapy is recommended

A formal Inpatient Insulin Pump Protocol reduces

confusion and treatment variability.

inpatient csii protocol
Inpatient CSII Protocol

An insulin pump should NEVER be discontinued without initiation of either subcutaneous or intravenous insulin.

If the pump is discontinued for any reason, additional insulin (either IV or subcutaneous) MUST be given 30 minutes prior to discontinuation.

Patient is to self-manage insulin pump and nurse is to verify and document all basal rates and bolus doses administered.

Insulin pumps must be discontinued for an MRI. If the pump is interrupted for more than one hour, another insulin source needs to be ordered.

Noschese ML et al Endocrine Practice 15:415 2009

slide72

Hypoglycemic Events in Patients Continuing or Stopping CSII Therapy During their Hospital Stay

Pump On

Pump Off

Blood glucose mg/dl

Bailon RM et al Endocrine Practice 15:25 2009

slide73

Can U500 Regular Insulin Be Usedin the Hospital?

General Guidelines

Inpatient use of U500 insulin is reserved for patients who use this concentrated form of regular insulin as outpatients and who demonstrate a similar or greater degree of insulin resistance at time of hospital admission.

To avoid dosing errors that have potential for hypoglycemia, many hospitals regulate the administration of U500 insulin by requiring one or all of the following:

Order written as volume to be given using a TB syringe

All doses prepared in pharmacy

Alerts in patient room and on patient medicine administration record

challenges
Challenges

Improvements in glycemic control

**Education**

Evidence

DATA

Systems

Order Sets

Technology

Sliding Scale

the home stretch

The HOME stretch!

But my patient won’t be able to afford/manage/comply/etc with glargine/ rapid acting as an outpatient?

factors used for selecting discharge therapy for patients with known diabetes
Control at home and admission HbA1C

Home regimen prior to admission

Admission reason: Hypoglycemia, Acute MI, Related to hyperglycemia (DKA, HHS, etc.)

Physical limitations

New co-morbidities that may limit prior oral therapy

Hypoglycemia risk factors

Treatment goals (I.e. hospice)

Frequency of self monitoring

Financial $$$$

Factors Used for Selecting Discharge Therapy for Patients with Known Diabetes
initiating insulin
Initiating Insulin

HbA1c >7-8 on 2 agents, HbA1c>10, ketonuria or symptoms

Start with bedtime intermediate-acting or bedtime or morning long-acting insulin; Initiate with 10 units OR 0.2 units/kg OR basal dose in the hospital

Patient titration; Every 3 days, increase by 2 units until FBG < 110 OR Every day increase by 1 unit until FBG < 110

Physician titration: Every week by Treat to Target values

Continue treatment until goal reached

If hypoglycemia occurs, reduce bedtime dose by 4 units or 10%

slide80
Case

Transition to subcut: glargine 36+ scheduled Apidra 12 tid AC

Admission: sliding scale apidra BMI >35

Post op: Insulin gtt

Discharge

case follow up
Case Follow Up

HgbA1c 13.4%

Discharged on

Metformin 500 bid, instructed to increase to 1000 mg bid in one week if not too much gi side effects

Glipizide 5 mg bid

Glargine 30 units q hs

Diabetes education given

HgbA1c 6.8% 2.5 months later!

selecting discharge therapy take home messages
Selecting Discharge Therapy Take Home Messages

Good to do something but don’t get too aggressive because the time after discharge is high risk for hypoglycemia

Once A1C is >8.5% additional oral agents are unlikely to achieve goals

Insulin at bedtime with or without oral agents is a good initial strategy

Tailor glycemic target to individual

additional resources for physician education
Additional Resources for Physician Education
  • American Association of Clinical Endocrinology Inpatient glycemic control resource center
  • Johns Hopkins Consultative Medicine Essentials for Hospitalists
    • http://www.jhcape.com/betaX/site/article.cfm?ID=6
  • Quantia MD What is involved in the practical management of blood sugars postoperatively?
    • http://quantiamd.com/player/rqdjtgk?cid=53
  • Quantia MD What is involved in the practical management of insulin preoperatively?
    • http://quantiamd.com/player/rumyejs?cid=53
questions

Questions

Cheryl.OMalley@bannerhealth.com

references
References
  • Van den Berghe G, et al. Intensive insulin therapy in the critically ill patients. N Engl J
  • Med. 2001;345:1359-67.
  • Brunkhorst FM, et al. Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med. 2008;358(2):125–139.
  • Intensive versus Conventional Glucose Control in Critically Ill Patients, N Engl J med 360;13 march 26, 2009
  • Moghissi ES, et al. American Association of Clinical Endocrinologists and American Diabetes Association Consensus Statement on Inpatient Glycemic Control DIABETES CARE, VOLUME 32, NUMBER 6, JUNE 2009
  • Cook CB, et al. Inpatient Glucose Control: A Glycemic Survey of 126 U.S. Hospitals Journal of Hospital Medicine Vol 4 No 9 November/December 2009
  • Queale WS et al, Ann Int Med, 1997; 157
  • Becker T et al., Clinical outcomes associated with the use of subcutaneous insulin-by-glucose sliding scales to manage hyperglycemia in hospitalized patients with pneumonia Diabetes Research and Clinical Practice 78 (2007) 392–397
  • Umpierrez GE, et al, Randomized Study of Basal-Bolus Insulin Therapy in the Inpatient Management of Patients With Type 2 Diabetes (RABBIT 2 Trial), Diabetes Care 30: 2007