Management of Individuals with Diabetes at High Risk for Hypoglycemia
Recommendations
Recommendation 1
- 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.
Recommendation 2
- 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.
Recommendation 3
- 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.
Recommendation 4
- 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.
Recommendation 5
- 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.
Recommendation 6
- 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).
Recommendation 7
- 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.
Recommendation 8
- 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.
Recommendation 9
- 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.
Recommendation 10
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Recommendation Grading
Disclaimer
Overview
Title
Management of Individuals with Diabetes at High Risk for Hypoglycemia
Authoring Organization
Endocrine Society
Publication Month/Year
December 7, 2022
Last Updated Month/Year
November 14, 2023
Supplemental Implementation Tools
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