High Risk for Hypoglycemia Guideline Resources

November 09, 2022

December XX, 2022

Full Guideline: Management of Individuals with Diabetes at High Risk for Hypoglycemia: An Endocrine Society Clinical Practice Guideline
JCEM | March 2023 (online December 2022)

Anthony L. McCall (Chair), David C. Lieb (Co-Chair), Roma Gianchandani, Heidemarie MacMaster, Gregory Maynard, M. Hassan Murad, Elizabeth Seaquist, Joseph Wolfsdorf, Robin Fein Wright, and Wojtek Wiercioch

The 2022 guideline on management of individuals with diabetes at high risk for hypoglycemia:

  • Updates the 2009 Evaluation and Management of Adult Hypoglycemic Disorders: Endocrine Society Clinical Practice Guideline and focuses on the treatment of individuals with diabetes at high risk for hypoglycemia.
  • Emphasizes the use of emerging diabetes technology and insulin therapy for glycemic management and education.

A systematic review supporting the Endocrine Society Clinical Practice Guideline for the management of individuals with diabetes at high risk for hypoglycemia [LINK COMING; PLEASE LINK THIS WHOLE TITLE]


Resources

Essential Points

  • Hypoglycemia is associated with a number of unwanted outcomes including distress in those with diabetes and their caregivers, reductions in quality of life (QOL), and reductions in medication adherence, leading to increased risks for diabetes-related comorbidities.
  • Individuals with type 1 diabetes (T1D) may have clinically significant episodes of hypoglycemia as often as twice per week.
  • Those with type 2 diabetes (T2D) are at lower risk for hypoglycemia unless they have specific clinical characteristics that increase that risk, including the use of medications known to be associated with hypoglycemia (e.g., insulin, sulfonylureas), long duration of diabetes, and renal and/or hepatic dysfunction.

List of Recommendations

Question 1. Should continuous glucose monitoring vs self-monitoring of blood glucose be used for people with type 1 diabetes receiving multiple daily injections?

Recommendation 1

We recommend continuous glucose monitoring (CGM) rather than self-monitoring of blood glucose (SMBG) by fingerstick for patients with type 1 diabetes (T1D) receiving multiple daily injections (MDIs). (1⊕⊕OO)

Remarks

  • Comprehensive patient education on how to use and troubleshoot CGM devices and interpret these data is critically important for maximum benefit and successful outcomes.
  • SMBG continues to be necessary to validate or confirm CGM values; for example, when symptoms do not match sensor glucose values and during the sensor warm-up period. Therefore, patients using CGM must continue to have access to SMBG.

Question 2. Should real-time continuous glucose monitoring and algorithm-driven insulin pumps vs multiple daily injections with self-monitoring of blood glucose three or more times daily be used for people with type 1 diabetes?

Recommendation 2

We suggest using real-time continuous glucose monitoring (CGM) and algorithm-driven insulin pumps (ADIPs) rather than multiple daily injections (MDIs) with self-monitoring of blood glucose (SMBG) three or more times daily for adults and children with type 1 diabetes (T1D). (2⊕⊕OO)

Remark

Fingerstick blood glucose (BG) monitoring may still be necessary to validate or confirm CGM values; therefore, with respect to use and insurance coverage, there will be times when SMBG must be used.

Question 3. Should professional or personal real-time continuous glucose monitoring vs no continuous glucose monitoring be used for people with type 2 diabetes in the outpatient setting who take insulin and/or sulfonylureas and are at high risk for hypoglycemia?

Recommendation 3

We suggest real-time continuous glucose monitoring (CGM) be used rather than no continuous glucose monitoring (CGM) for outpatients with type 2 diabetes (T2D) who take insulin and/or sulfonylureas (SUs) and are at risk for hypoglycemia. (2⊕OOO)

Remarks

  • Professional CGM is a diagnostic tool used for the short-term investigation of an individual’s glycemic profile to determine glycemic patterns and to assist with therapeutic management.
  • Personal CGM is a tool for patients to use in real time at home to assist the patient and their health care providers (HCPs) in making both short- and long-term adjustments in their therapeutic management.

Question 4. Should initiation of continuous glucose monitoring in the inpatient setting vs not using continuous glucose monitoring be used for select people at high risk for hypoglycemia?

Recommendation 4

We suggest initiation of continuous glucose monitoring (CGM) in the inpatient setting for select inpatients at high risk for hypoglycemia. (2⊕OOO)

Remarks

  • This should be performed via a hybrid approach in which CGM use is combined with periodic point-of-care blood glucose (POC-BG) testing to validate the accuracy of CGM.
  • Inpatient CGM use is not currently approved by the US Food and Drug Administration (FDA) but currently has enforcement discretion. It has been used in hospitals recently with emergency use authorization during the COVID-19 pandemic.

Question 5. Should continuation of personal continuous glucose monitoring in the inpatient setting vs discontinuation of continuous glucose monitoring be used for people at high risk for hypoglycemia who are already using it?

Recommendation 5

We suggest continuation of personal continuous glucose monitoring (CGM) in the inpatient setting with or without algorithm-driven insulin pump (ADIP) therapy rather than discontinuation. (2⊕OOO)

Remarks

  • This should be performed via a hybrid approach in which CGM use is combined with periodic point-of-care blood glucose (POC-BG) testing to validate the accuracy of CGM.
  • Inpatient CGM use is not currently approved by the US Food and Drug Administration (FDA) but currently has enforcement discretion. It has been used in hospitals recently with emergency use authorization during the COVID-19 pandemic.

Question 6. Should inpatient glycemic surveillance and management programs leveraging electronic health record data vs standard care be used for hospitalized people at risk for hypoglycemia?

Recommendation 6

We recommend that inpatient glycemic surveillance and management programs leveraging electronic health record (EHR) data be used for inpatients at risk for hypoglycemia. (1⊕OOO)

Remarks

    • The panel defined leveraging EHR data as specific hospital staff using glycemic data collected within the EHR (from all admitted patients) to identify those at risk for and those having hypoglycemic and hyperglycemic episodes to develop mechanisms for managing and mitigating these adverse outcomes. Standard care is lack of such a program.
    • EHR data leveraged includes patterns of glycemia with proactive alerts for high and for low trends, so that hypoglycemia and severe hyperglycemia can be identified in a systematic fashion. Staff can then intervene on these trends (eg, adjusting insulin infusion rates) to avoid unwanted outcomes (repeat hypoglycemia, glycemic variability, etc).

Question 7. Should long-acting insulin analogs vs human insulin be used for people on basal insulin therapy who are at high risk for hypoglycemia?

Recommendation 7

We suggest long-acting insulin analogs be used rather than human neutral protamine Hagedorn (NPH) insulin for adult and pediatric outpatients on basal insulin therapy who are at high risk for hypoglycemia. (2⊕OOO)

Remarks

  • Patients who are at high risk for hypoglycemia are defined as those with a history of severe hypoglycemia (requiring assistance to manage), impaired awareness of hypoglycemia (IAH), and/or medical conditions that predispose them to severe hypoglycemia including renal and hepatic dysfunction.
  • The panel placed high value on reducing severe hypoglycemia and found moderate-certainty evidence for severe hypoglycemia reduction as an outcome in those using long-acting analog insulins vs NPH insulin. However, the panel acknowledges that most studies of long-acting analog insulins do not assess for significant adverse effects (including cardiovascular outcomes) and that many studies were designed to demonstrate noninferiority of analog insulin compared with human NPH insulin.

Question 8. Should rapid-acting analogs vs regular (short acting) human insulin be used for people on basal-bolus therapy who are at high risk for hypoglycemia?

Recommendation 8

We suggest that rapid-acting insulin analogs be used rather than regular (short-acting) human insulins for adult and pediatric patients on basal-bolus insulin therapy who are at high risk for hypoglycemia. (2⊕OOO)

Remarks

  • Patients who are at high risk for hypoglycemia are defined as those with a history of severe hypoglycemia (requiring assistance to manage), impaired awareness of hypoglycemia (IAH), and/or medical conditions that predispose them to severe hypoglycemia including renal and hepatic dysfunction.
  • The panel placed high value on reducing severe hypoglycemia and found moderate-certainty evidence for reduction of mild-to-moderate and severe hypoglycemia as an outcome in those using rapid-acting analog insulins vs regular (short-acting) insulin. However, the panel acknowledges that many studies were designed to demonstrate noninferiority of analog insulin compared with human regular (short-acting) insulin. Also, many of the data available for review demonstrating reductions in hypoglycemia were in adults with type 1 diabetes (T1D); very few data were available regarding the pediatric population.

Question 9. Should a structured program of patient education with follow-up vs unstructured advice be used for people receiving insulin therapy who are at high risk for hypoglycemia?

Recommendation 9

We recommend that a structured program of patient education over unstructured advice be used for adult and pediatric outpatients with type 1 diabetes (T1D) or type 2 diabetes (T2D) receiving insulin therapy. (1⊕⊕OO)

Remarks

  • Structured education on how to avoid repeated hypoglycemia is critical, and this education should be performed by experienced diabetes clinicians. Moreover, insurance coverage for education should be available for all insulin-using patients.
  • The recommendation is not intended to limit structured education only to those on insulin therapy; for example, patients using SUs and meglitinides are also at risk for hypoglycemia, and the recommendation also applies to this patient population.

Question 10. Should glucagon preparations that do not have to be reconstituted vs preparations that do have to be reconstituted be used for people with severe hypoglycemia?

Recommendation 10

We recommend that glucagon preparations that do not have to be reconstituted over glucagon preparations that do have to be reconstituted (ie, available as a powder and diluent) be used for outpatients with severe hypoglycemia. (1⊕OOO)

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