Management of Individuals with Diabetes at High Risk for Hypoglycemia

Publication Date: December 7, 2022

Recommendations

Recommendation 1

Endocrine Society (ES) recommends CGM rather than self-monitoring of blood glucose (SMBG) by fingerstick for patients with T1D receiving multiple daily injections (MDIs). (Moderate, 1 – Strong recommendation for or against)
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; e.g., 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.
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Recommendation 2

ES suggests using real-time CGM and ADIPs rather than MDIs with SMBG three or more times daily for adults and children with T1D. (Moderate, 2 – Conditional recommendation for or against)
Remark:
  • Fingerstick blood glucose 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.
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Recommendation 3

ES suggests real-time CGM be used rather than no CGM for outpatients with T2D who take insulin and/or sulfonylureas and are at risk for hypoglycemia. (Very Low, 2 – Conditional recommendation for or against)
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 HCPs in making both short- and long-term adjustments in their therapeutic management.
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Recommendation 4

ES suggests initiation of CGM in the inpatient setting for select inpatients at high risk for hypoglycemia. (Very Low, 2 – Conditional recommendation for or against)
Remarks:
  • This should be done 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 U.S. 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.
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Recommendation 5

ES suggests continuation of personal CGM in the inpatient setting with or without ADIP therapy rather than discontinuation. (Very Low, 2 – Conditional recommendation for or against)
Remarks:
  • This should be done via a hybrid approach in which CGM use is combined with periodic POC-BG testing to validate the accuracy of CGM.
  • Inpatient CGM use is not currently approved by the U.S. 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.
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Recommendation 6

ES recommends that inpatient glycemic surveillance and management programs leveraging EHR data be used for inpatients at risk for hypoglycemia. (Very Low, 1 – Strong recommendation for or against)
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.
  • The 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 upon these trends (e.g. adjusting insulin infusion rates, etc) to avoid unwanted outcomes (repeat hypoglycemia, glycemic variability, etc).
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Recommendation 7

ES suggests long-acting insulin analogs be used rather than human NPH insulin for adult and pediatric outpatients on basal insulin therapy who are at high risk for hypoglycemia. (Very Low, 2 – Conditional recommendation for or against)
Remarks:
  • Patients who are at high risk for hypoglycemia are defined as those with a history of severe hypoglycemia (requiring assistance to manage), 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 versus 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 non-inferiority of analog insulin compared with human NPH insulin.
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Recommendation 8

ES suggests 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. (Very Low, 2 – Conditional recommendation for or against)
Remarks:
  • Patients who are at high risk for hypoglycemia are defined as those with a history of severe hypoglycemia (requiring assistance to manage), 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 versus regular (short-acting) insulin. However, the panel acknowledges that many studies were designed to demonstrate non-inferiority of analog insulin compared with human regular (short-acting) insulin. Also, much of the data available for review demonstrating reductions in hypoglycemia was in adults with T1D; very little data were available regarding the pediatric population.
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Recommendation 9

ES recommends that a structured program of patient education over unstructured advice be used for adult and pediatric outpatients with T1D or T2D receiving insulin therapy. (Very Low, 1 – Strong recommendation for or against)
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 sulfonylureas and meglitinides are also at risk for hypoglycemia, and the recommendation also applies to this patient population.
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Recommendation 10

ES recommends that glucagon preparations that do not have to be reconstituted over glucagon preparations that do have to be reconstituted (i.e., available as a powder and diluent) be used for outpatients with severe hypoglycemia. (Very Low, 1 – Strong recommendation for or against)
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Recommendation Grading

Disclaimer

Overview

Title

Management of Individuals with Diabetes at High Risk for Hypoglycemia

Authoring Organization

Publication Month/Year

December 7, 2022

Document Type

Guideline

Country of Publication

US

Document Objectives

To review and update the diabetes-specific parts of the 2009 Evaluation and Management of Adult Hypoglycemic Disorders: Endocrine Society Clinical Practice Guideline and to address developing issues surrounding hypoglycemia in both adults and children living with diabetes. The overriding objectives are to reduce and prevent hypoglycemia.

Target Patient Population

Adult and pediatric patients with T1D and T2D

Inclusion Criteria

Male, Female, Adolescent, Adult, Child, Older adult

Health Care Settings

Ambulatory, Hospital, Long term care, Outpatient

Intended Users

Nurse, nurse practitioner, physician, physician assistant

Scope

Counseling, Treatment

Diseases/Conditions (MeSH)

D003920 - Diabetes Mellitus, D003922 - Diabetes Mellitus, Type 1, D048909 - Diabetes Complications, D003924 - Diabetes Mellitus, Type 2, D061385 - Insulins, D007328 - Insulin, D015190 - Blood Glucose Self-Monitoring, D006943 - Hyperglycemia, D007003 - Hypoglycemia, D007004 - Hypoglycemic Agents, D007332 - Insulin Infusion Systems, D061266 - Insulin, Short-Acting, D061386 - Insulin, Regular, Human, D049528 - Insulin, Long-Acting, D061389 - Insulin, Regular, Pork, D001786 - Blood Glucose, D005947 - Glucose

Keywords

diabetes mellitus, systems of care, insulin, hyperglycemia, hypoglycemia, Continuous Glucose Monitoring, insulin pumps, glucagon, structured counseling, insulin analogs, blood glucose, blood glucose self-monitoring, hypoglycemic agents

Source Citation

McCall AL, Lieb D, Gianchandani R, et al. Management of Individuals with Diabetes at High Risk for Hypoglycemia: An Endocrine Society Clinical Practice Guideline, J Clin Endocrinol Metab. 2022, 108(3).

Supplemental Methodology Resources

Systematic Review Document

Methodology

Number of Source Documents
256
Literature Search Start Date
July 1, 2020
Literature Search End Date
April 1, 2022