Hospital Harm - Severe Hypoglycemia

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This measure focuses on severe hypoglycemia as an outcome in the hospital inpatient setting. In a study published by the Office of the Inspector General (OIG), in 2018 adverse drug events represented 43% of all adverse events in hospitals among Medicare patients; of those events, hypoglycemia was among the top 5 adverse drug events (Office of the Inspector General, 2022).

Inpatient hypoglycemia can be life-threatening, and is associated with longer hospital stays and increased medical costs. Severe hypoglycemia (<40 mg/dL) occurs in 2–5% of hospitalized patients with diabetes mellitus, and medication-related hypoglycemic events are common causes of adverse drug events occurring in inpatient settings. Up to half of inpatient adverse drug events may be preventable, and recent studies show that rates of severe hypoglycemia vary across hospitals, suggesting opportunities for improved care (Santos, 2020). Rates of inpatient hypoglycemia events are considered an indicator of the quality of care provided by a hospital. Severe hypoglycemia events are largely avoidable by careful use of antihyperglycemic medication. Moreover, the rate of severe hypoglycemia varies across hospitals indicating an opportunity for improvement in care. The Agency for Healthcare Research and Quality (AHRQ) identified insulin and other hypoglycemic agents as high alert medications and associated adverse events to be included as a measure in the Medicare Patient Safety Monitoring System (MPSMS) (Classen et al., 2021). Hypoglycemic events are an adverse outcome that can cause patients to experience drowsiness, confusion, anxiety, irritability, sweating, weakness, increased heart rate, uncontrollable trembling, as well as loss of consciousness and seizure (American Diabetes Association, 2022; Cruz, 2022).

This measure focuses on severe hypoglycemia as an outcome in the hospital inpatient setting. In a study published by the Office of the Inspector General (OIG), in 2018 adverse drug events represented 43% of all adverse events in hospitals among Medicare patients; of those events, hypoglycemia was among the top 5 adverse drug events (Office of the Inspector General, 2022).

Inpatient hypoglycemia can be life-threatening, and is associated with longer hospital stays and increased medical costs. Severe hypoglycemia (<40 mg/dL) occurs in 2–5% of hospitalized patients with diabetes mellitus, and medication-related hypoglycemic events are common causes of adverse drug events occurring in inpatient settings. Up to half of inpatient adverse drug events may be preventable, and recent studies show that rates of severe hypoglycemia vary across hospitals, suggesting opportunities for improved care (Santos et al., 2020). Rates of inpatient hypoglycemia events are considered an indicator of the quality of care provided by a hospital. Severe hypoglycemia events are largely avoidable by careful use of antihyperglycemic medication. Moreover, the rate of severe hypoglycemia varies across hospitals indicating an opportunity for improvement in care. The Agency for Healthcare Research and Quality (AHRQ) identified insulin and other hypoglycemic agents as high alert medications and associated adverse events to be included as a measure in the Medicare Patient Safety Monitoring System (MPSMS) (Classen et al., 2021). Hypoglycemic events are an adverse outcome that can cause patients to experience drowsiness, confusion, anxiety, irritability, sweating, weakness, increased heart rate, uncontrollable trembling, as well as loss of consciousness and seizure (American Diabetes Association, 2022; Cruz, 2020). It has been found that fasting glucose levels <100 mg/dL are predictors of hypoglycemia within the next 24 hours (ElSayed et al., 2023).

From Section 16, Diabetes Care in the Hospital in the Standards of Medical Care in Diabetes by the American Diabetes Association, (American Diabetes Association, 2022):

16.9 A hypoglycemia management protocol should be adopted and implemented by each hospital or hospital system. A plan for preventing and treating hypoglycemia should be established for each patient. Episodes of hypoglycemia in the hospital should be documented in the medical record and tracked for quality improvement/quality assessment.

16.10 For individual patients, treatment regimens should be reviewed and changed as necessary to prevent further hypoglycemia when a blood glucose value of <70 mg/dL (3.9 mmol/L) is documented.

A standardized hospital-wide, nurse-initiated hypoglycemia treatment protocol should be in place to immediately address blood glucose levels of <70 mg/dL (3.9 mmol/L). In addition, individualized plans for preventing and treating hypoglycemia for each patient should also be developed. An American Diabetes Association consensus statement recommends that a patient’s treatment regimen be reviewed any time a blood glucose value of <70 mg/dL (3.9 mmol/L) occurs, as such readings often predict subsequent level 3 hypoglycemia. Episodes of hypoglycemia in the hospital should be documented in the medical record and tracked.

From the Endocrine Society clinical practice guideline on the Management of Hyperglycemia in Hospitalized Patients in Non-critical Care Setting, 2022:

Recommendation 1.1

In adults with insulin-treated diabetes hospitalized for noncritical illness who are at high risk of hypoglycemia, we suggest the use of real-time continuous glucose monitoring (CGM) with confirmatory bedside point-of-care blood glucose (POC-BG) monitoring for adjustments in insulin dosing rather than point-of-care blood glucose (POC-BG) testing alone in hospital settings where resources and training are available.

Recommendation 2.1

Management of patients with GC-associated hyperglycemia requires ongoing BG monitoring with adjustment of insulin dosing. All therapies require safeguards to avoid hypoglycemia when doses of GCs are tapered or abruptly discontinued.

Recommendation 10.1

In adults with no prior history of diabetes hospitalized for noncritical illness with hyperglycemia [defined as BG > 140 mg/dL (7.8 mmol/L)] during hospitalization, we suggest initial therapy with correctional insulin over scheduled insulin therapy (defined as basal or basal/bolus insulin) to maintain glucose targets in the range of 100 to 180 mg/dL (5.6 to 10.0 mmol/L). For patients with persistent hyperglycemia [≥2 POC-BG measurements ≥ 180 mg/dL (≥10.0 mmol/L) in a 24-hour period on correctional insulin alone], we suggest the addition of scheduled insulin therapy.

Recommendation 10.2

In adults with diabetes treated with diet or noninsulin diabetes medications prior to admission, we suggest initial therapy with correctional insulin or scheduled insulin therapy to maintain glucose targets in the range of 100 to 180 mg/dL (5.6 to 10.0 mmol/L). For hospitalized adults started on correctional insulin alone and with persistent hyperglycemia [≥2 point-of-care blood glucose (POC-BG) measurements ≥ 180 mg/dL in a 24-hour period (≥10.0 mmol/L)], we suggest addition of scheduled insulin therapy. We suggest initiation of scheduled insulin therapy for patients with confirmed admission blood glucose (BG) ≥ 180 mg/dL (≥10.0 mmol/L).

Recommendation 10.3

In adults with insulin-treated diabetes prior to admission who are hospitalized for noncritical illness, we recommend continuation of the scheduled insulin regimen modified for nutritional status and severity of illness to maintain glucose targets in the range of 100 to 180 mg/dL (5.6 to 10.0 mmol/L).

Remarks

Reductions in the dose of basal insulin (by 10% to 20%) at time of hospitalization may be required for patients on basal heavy insulin regimens (defined as doses of basal insulin ≥ 0.6 to 1.0 units/kg/day), in which basal insulin is being used inappropriately to cover meal-related excursions in BG.

From Section 16, Diabetes Care in the Hospital in the Standards of Medical Care in Diabetes by the American Diabetes Association, (American Diabetes Association, 2022):

16.9 A hypoglycemia management protocol should be adopted and implemented by each hospital or hospital system. A plan for preventing and treating hypoglycemia should be established for each patient. Episodes of hypoglycemia in the hospital should be documented in the medical record and tracked for quality improvement/quality assessment.

16.10 For individual patients, treatment regimens should be reviewed and changed as necessary to prevent further hypoglycemia when a blood glucose value of <70 mg/dL (3.9 mmol/L) is documented.

A standardized hospital-wide, nurse-initiated hypoglycemia treatment protocol should be in place to immediately address blood glucose levels of <70 mg/dL (3.9 mmol/L). In addition, individualized plans for preventing and treating hypoglycemia for each patient should also be developed. An American Diabetes Association consensus statement recommends that a patient’s treatment regimen be reviewed any time a blood glucose value of <70 mg/dL (3.9 mmol/L) occurs, as such readings often predict subsequent level 3 hypoglycemia. Episodes of hypoglycemia in the hospital should be documented in the medical record and tracked.

From the Endocrine Society clinical practice guideline on the Management of Hyperglycemia in Hospitalized Patients in Non-critical Care Setting (Korytkowski et al., 2022) as it relates to patients at high risk of hypoglycemia:

Recommendation 1.1

In adults with insulin-treated diabetes hospitalized for noncritical illness who are at high risk of hypoglycemia, we suggest the use of real-time continuous glucose monitoring (CGM) with confirmatory bedside point-of-care blood glucose (POC-BG) monitoring for adjustments in insulin dosing rather than point-of-care blood glucose (POC-BG) testing alone in hospital settings where resources and training are available.

Recommendation 2.1

Management of patients with glucocorticoid (GC)-associated hyperglycemia requires ongoing BG monitoring with adjustment of insulin dosing. All therapies require safeguards to avoid hypoglycemia when doses of GCs are tapered or abruptly discontinued.

Recommendation 10.1

In adults with no prior history of diabetes hospitalized for noncritical illness with hyperglycemia [defined as BG > 140 mg/dL (7.8 mmol/L)] during hospitalization, we suggest initial therapy with correctional insulin over scheduled insulin therapy (defined as basal or basal/bolus insulin) to maintain glucose targets in the range of 100 to 180 mg/dL (5.6 to 10.0 mmol/L). For patients with persistent hyperglycemia [≥2 POC-BG measurements ≥ 180 mg/dL (≥10.0 mmol/L) in a 24-hour period on correctional insulin alone], we suggest the addition of scheduled insulin therapy.

Recommendation 10.2

In adults with diabetes treated with diet or noninsulin diabetes medications prior to admission, we suggest initial therapy with correctional insulin or scheduled insulin therapy to maintain glucose targets in the range of 100 to 180 mg/dL (5.6 to 10.0 mmol/L). For hospitalized adults started on correctional insulin alone and with persistent hyperglycemia [≥2 point-of-care blood glucose (POC-BG) measurements ≥ 180 mg/dL in a 24-hour period (≥10.0 mmol/L)], we suggest addition of scheduled insulin therapy. We suggest initiation of scheduled insulin therapy for patients with confirmed admission blood glucose (BG) ≥ 180 mg/dL (≥10.0 mmol/L).

Recommendation 10.3

In adults with insulin-treated diabetes prior to admission who are hospitalized for noncritical illness, we recommend continuation of the scheduled insulin regimen modified for nutritional status and severity of illness to maintain glucose targets in the range of 100 to 180 mg/dL (5.6 to 10.0 mmol/L).

Remarks

Reductions in the dose of basal insulin (by 10% to 20%) at time of hospitalization may be required for patients on basal heavy insulin regimens (defined as doses of basal insulin ≥ 0.6 to 1.0 units/kg/day), in which basal insulin is being used inappropriately to cover meal-related excursions in BG.

Inpatient hospitalizations: Includes time in the emergency department and observation when the transition between these encounters (if they exist) and the inpatient encounter are within an hour or less of each other.

A severe hypoglycemic event (harm) is defined as a laboratory or point-of-care (POC) test for glucose with a result less than 40 mg/dL, where a hypoglycemic medication was given within the 24 hours prior to the start of the low glucose event (i.e., glucose result less than 40 mg/dL) and administered during the encounter (including emergency department and observation stays contiguous with the admission). The 24-hour timeframe extends from the end of the medication administration to the time of the glucose test.

The measure does not count a severe hypoglycemic event (harm) in the numerator if there is a repeat test for glucose with a result greater than 80 mg/dL within five minutes of this initial low glucose test. The purpose of the repeat test within 5 minutes is to eliminate false positives that can occur in POC testing. The 5-minute timeframe extends from the start of the severe hypoglycemic test to the time of the repeat hypoglycemic test.

Inpatient hospitalizations: Includes time in the emergency department and observation when the transition between these encounters (if they exist) and the inpatient encounter are within an hour or less of each other.

A severe hypoglycemic event (harm) is defined as a laboratory or point-of-care (POC) test for glucose with a result less than 40 mg/dL, where a hypoglycemic medication was given within the 24 hours prior to the start of the low glucose event (i.e., glucose result less than 40 mg/dL) and administered during the encounter (including emergency department and observation stays contiguous with the admission). The 24-hour timeframe extends from the end of the medication administration to the time of the glucose test.

The measure does not count a severe hypoglycemic event (harm) in the numerator if there is a repeat test for glucose with a result greater than 80 mg/dL within five minutes of this initial low glucose test. The purpose of the repeat test within 5 minutes is to eliminate false positives that can occur in POC testing. The 5-minute timeframe extends from the start of the severe hypoglycemic test to the time of the repeat hypoglycemic test.

Inpatient hospitalizations where the patient is 18 years of age or older at the start of the encounter, and at least one hypoglycemic medication was administered during the encounter.

The measure includes instances of administration of hypoglycemic medications in the emergency department or in observation status at the start of an inpatient hospitalization when assessing inclusion of encounters in the measure denominator.

Inpatient hospitalizations that end during the measurement period for patients age 18 and older and at least one hypoglycemic medication was administered during the encounter.

The measure includes instances of administration of hypoglycemic medications in the emergency department or in observation status at the start of an inpatient hospitalization when assessing inclusion of encounters in the measure denominator.

Inpatient hospitalizations that end during the measurement period for patients age 18 and older and at least one hypoglycemic medication administration starts during the encounter