# Presentation: 025561

## Spotlight Case May 2004

**Too Tight Control: ****The Risks of Intensive Insulin Therapy**

## Source and Credits

- This presentation is based on the May 2004 AHRQ WebM&M Spotlight Case in Medicine
- CME credit is available through the Web site
- See the full article at _[http://webmm.ahrq.gov](http://webmm.ahrq.gov/)_
- Commentary by: Haya Rubin, MD, PhD, The Johns Hopkins University; Vera Fajtova, MD, Harvard Medical School
- Editor, AHRQ WebM&M: Robert Wachter, MD
- Spotlight Editor: Tracy Minichiello, MD
- Managing Editor: Erin Hartman, MS

## Objectives

*	**At the conclusion of this educational activity, participants should be able to:*
- Appreciate the advantages and potential complications of intensive insulin therapy in the hospitalized patient
- List hospital-based safeguards available to prevent insulin-related hypoglycemia
- Understand the difference between efficacy and effectiveness with regards to results of clinical trials

## Case: Too Much of a Good Thing

*	**A 28-year-old man with insulin-dependent diabetes mellitus was admitted with hyperglycemia and an infected foot ulcer. Due **to new hospital initiatives aimed at tighter glucose control, he was started on an insulin drip rather than subcutaneous (SQ) insulin. **The patient eventually required 8 units of regular insulin per hour to maintain a fingerstick glucose in the 180-220 mg/dL range. *

## Adverse Effects of Hyperglycemia

- Hyperglycemia > 200 mg/dL is associated with more infections in patients undergoing “clean” surgery
- In vitro, ambient glucose > 200 mg/dL reduces macrophage migration and phagocytosis

*Pomposelli JJ, et al. J Parenter Enteral Nutr. 1998;22:77-81; Rayfield EJ, et al. Am J Med. 1982;72:439-50.*

## Intensive Insulin Therapy in the Critically Ill Patient

- Wound infection rate decreased from 3% to 1% using nurse-managed IV insulin protocol to keep blood glucose < 200 mg/dL for 72 hours after heart surgery

*Furnary AP, et al. Ann Thorac Surg. 1999;67:352-62.*

## Intensive Insulin Therapy in the Critically Ill Patient

- 1500 critically ill patients randomized to:
- Intensive insulin therapy
- IV drip for BG > 110 mg/dL, goal 80-110
- Traditional insulin therapy
- IV insulin reserved for BG > 215 mg/dL
- Decreased morbidity and mortality in intensive insulin group

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

## Conventional vs. Intensive Therapy 

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

## SQ Insulin for Non-Critically Ill Patients

- Physiologic control of glucose requires basal insulin and supplementation with fast-acting agent with meals
- New insulin analogs meet both basal and mealtime insulin needs
- Daily insulin Glargine for basal (no adjustment for NPO status)
- Insulin Aspart or Lispro with meals adjusted for nutritional intake

## IV intensive insulin therapy may result in more frequent hypoglycemia
The use of intensive IV insulin has NOT been examined in the non-critically ill population

- The use of intensive IV insulin has NOT been examined in the non-critically ill population

**IV Insulin for Non-Critically Ill Patients**

## Case (cont.): Too Much of a Good Thing

*	**On hospital day 2, orthopedic surgery evaluated the patient and decided the wound needed surgical debridement. The orthopedic resident notified the cross-covering medicine resident that the patient would go to the OR the next day. In preparation for surgery, the orthopedic service made the patient “NPO after midnight.” At 2 am, when the nurse came to measure the hourly fingerstick, the patient was somnolent, tremulous, and diaphoretic, with a fingerstick glucose of 20 mg/dL.*

## What Went Wrong?

- Communication breakdown
- Efficacy vs. Effectiveness

## Communication Breakdown

- Orthopedic surgery wrote the NPO order; medicine wrote the insulin drip order
- Having multiple providers write orders can result in errors and poor outcomes
- Delays in diagnosis or treatment
- Unnecessary or duplicative testing
- Potential role of hospitalist in streamlining order writing and communication

*Pollack MM, et al. Crit Care Med. 2003:31:1620-9;                               Wachter RM. Ann Int Med. 1999;130:338-42.*

## Efficacy vs. Effectiveness

- Clinical trials often achieve lower rates of adverse events than seen in practice
- Patients rarely monitored as closely outside of trial
- Clinicians may apply therapy to patients excluded from trials
- Broadening inclusion criteria can lead to a lesser benefit in actual practice (effectiveness) than that seen in the trial (efficacy)

*Katzan IL, et al. JAMA. 2000;283:1151-8.*

## Intensive Insulin Therapy in the Non-Critically-Ill Patient?

- Hypoglycemia is most common complication of any insulin therapy
- Oral intake in the perioperative population is variable increasing risk of hypoglycemia
- Clinical trials thus far have used strict protocols
- Broad use of intensive insulin therapy outside of intensive care setting requires safeguards be put in place

## Improved Glycemic Control as a Quality Improvement Measure

- Most quality improvement efforts focused on the “underuse” of effective therapies
- Institute for Healthcare Improvement suggests monitoring a single, central outcome to help make QI projects practical
- Must remember to consider the potential adverse effects of increased use and increase monitoring/surveillance accordingly

- _[The Institute for Healthcare Improvement Web site](http://www.ihi.org/collaboratives/)_*; *_[QualityHealthCare](http://www.qualityhealthcare.org/qhc/workspace/tracker/)__[.org Web site](http://www.qualityhealthcare.org/qhc/workspace/tracker/)_*. *

## Intensive Insulin Therapy in the Non-Critically-Ill Patient

- Protocols should clearly outline:
- Drip adjustment at specific blood glucose levels
- Alterations in rate and IV fluid type if patient is NPO
- Frequency of glucose monitoring

*Lillis K. Health Manag Technol. 2003;24:36-7; **Bradley EH, et al. Jt Comm J Qual Saf. 2003;29:409-15. *

## Potential Interventions to Improve Safety of Intensive Insulin Therapy

- Automated order sets and preprinted order sheets
- Effective in reducing medication errors related to chemotherapy dosing
- Effective in ensuring appropriate therapy for myocardial infarction in emergency departments
- Where CPOE available, standard order sets for all patients with diabetes or with IV insulin drip ordered
- Automatic adjustments to drip and/or MD notification of change to NPO status (forcing function)

*Lillis K. Health Manag Technol. 2003;24:36-7; **Bradley EH, et al. Jt Comm J Qual Saf. 2003;29:409-15; **Farbstein K, Clough J. Jt Comm J Qual Improv. 2001;27:123-37.*

## 	The patient was treated with 1 ampule of D50 and his insulin drip was held. He recovered completely from this event.

**Case (cont.): Too Much of a Good Thing**

## Take-Home Points

- Both IV and SQ insulin can be safe and effective in controlling blood glucose in hospitalized patients when standard protocols are followed
- Recent data support the practice of tighter control with IV insulin in the surgical ICU
- Unclear if these results generalize to patients outside of the ICU
- Safety in clinical trials differs from safety in practice

## Take-Home Points

- Insulin drip protocols that have been tested should be implemented hospital-wide
- Various strategies (standard order sets, decision support, computerized forcing functions) can help prevent adverse events
- Quality improvement efforts that focus on “tight control” of physiologic parameters must incorporate efforts to monitor and prevent the most common adverse events of over-treatment