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Severe Hypoglycemia Information

American Diabetes Association Recommendations for Severe Hypoglycemia1

As Risk Escalates, Clinicians Should Help Prepare Patients for Severe Hypoglycemia with Glucagon

ADA Classifications of Hypoglycemia

RecommendationGlycemia Criteria
GLUCOSE IS PREFERRED TREATMENT
Level 1		<70 mg/dL(3.9 mmol/L)

Requires ingestion of glucose or carbohydrate-containing food
ADA RECOMMENDS GLUCAGON BE PRESCRIBED
Level 2		<54 mg/dL (3.0 mmol/L)

Requires immediate action to resolve the hypoglycemic event. Cognitive impairment begins to emerge
GLUCAGON ADMINISTRATION MAY BE REQUIRED
Level 3		No specific glucose threshold

A severe hypoglycemic event characterized by altered mental and/or physical functioning requiring assistance for recovery

In type 2 diabetes, endogenous glucagon response can worsen over time―as in type 1 diabetes2,3

Patients with type 2 diabetes are at risk3,4

  • Pancreatic α-cell function declines and patients lose their ability to secrete glucagon in response to hypoglycemia4
  • In most patients with type 2 diabetes, this impaired glucagon response worsens over time—similar to type 1 diabetes3,4
  • Patients on exogenous insulin have a defective counter-regulatory response to decreased blood glucose, increasing the risk for severe hypoglycemia2,4

Patients report a variable range of circumstances that lead to severe hypoglycemia in their everyday lives5

Patient-identified Causes of Severe Hypoglycemic Events

Study design

  • Study to investigate the experiences of people with insulin-treated diabetes who have had severe hypoglycemic events (SHEs), in Germany, Spain, or the UK.
  • Patients with insulin-treated type 1 (n=319) or type 2 diabetes (n=320) who had experienced ≥1 SHE in the preceding year were enrolled. Their median age was 53 years (range: 16-94 years).
  • Data were collected using a questionnaire developed with the input of diabetes specialists, emergency physicians, and patients from focus groups.
  • Patients reported a variable range of circumstances that led to severe hypoglycemia in their everyday lives.

Patients may not tell you about severe hypoglycemia

In the US CRASH Survey, 4 in 10 people with diabetes on insulin reported they did NOT discuss their most recent severe hypoglycemia event with their doctor.6

In the US CRASH Survey, only 4% of people with diabetes reported they obtained a glucagon kit or confirmed that they already had one after their most recent severe hyperglycemia event.6

Study design: Conversations and Reactions Around Severe Hypoglycemia (CRASH) was a cross sectional, online survey using purposive sampling. Participants had to be ≥ 18 years of age at the time of screening, self-report type 1 (n=110) or type 2 (n=109) diabetes, and have experienced a recent severe hypoglycemia event (within the past 3 years) while taking insulin.6

Severe hypoglycemia can’t always be avoided, so make sure your patients with diabetes on insulin are prepared7

A1C may not reveal a patient’s glucose highs and lows1,8

Fifteen-day glucose traces of two patients with identical A1C of 8.0%8

  • Both patients had identical A1C, but Patient 2 had greater glucose variability, resulting in 7 episodes of level 2 hypoglycemia (≤50 mg/dL)
  • Patient 1 had no such hypoglycemic episodes
  • A1C reflects average glycemia and not glycemic variability, which is a major determinant of hypoglycemia risk

Study design8

  • An analysis of acute manifestations of glucose variability (including hypoglycemia) to review a) measures that assessed the amplitude of glucose variability from routine self-monitored blood glucose data and b) timing from continuous glucose monitoring data to determine the relationship of speed and magnitude of rapid glucose fluctuations to clinically relevant outcomes

References:

  1. American Diabetes Association. 6. Glycemic targets: standards of medical care in diabetes 2022. Diabetes Care. 2022;45(suppl. 1):S83-S96.
  2. McCrimmon RJ, Sherwin RS. Hypoglycemia in type 1 diabetes. Diabetes. 2010;59(10):2333-2339.
  3. Edelman SV, Blose JS. The impact of nocturnal hypoglycemia on clinical and cost-related issues in patients with type 1 and type 2 diabetes. Diabetes Educ. 2014;40(3):269-279.
  4. Cryer PE. Minireview: Glucagon in the pathogenesis of hypoglycemia and hyperglycemia in diabetes. Endocrinology. 2012;153(3):1039-1048.
  5. Lammert M, Hammer M, Frier BM, Management of severe hypoglycaemia: cultural similarities, differences and resource consumption in three European countries. J Med Econ. 2009;12(4):269-280.
  6. Snoek FJ, Jiletcovici A, Bushnell III DM, et al. Conversations and Reactions Around Severe Hypoglycemia (CRASH): US results from a global survey of people with T1DM or insulin-treated T2DM and caregivers. Diabetes. 2019;68(suppl 1). doi:10.2337/db19-285-OR.
  7. Donnelly LA, Morris AD, Frier BM, et al. Frequency and predictors of hypoglycaemia in Type 1 and insulin-treated Type 2 diabetes: a population-based study. Diabet Med. 2005;22(6):749-755.
  8. Kovatchev B, Corbelli C. Glucose variability: Timing, risk analysis, and relationship to hypoglycemia in diabetes. Diabetes Care. 2016;39:502-510.

Safety Summary

BAQSIMI is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure, insulinoma because of risk of hypoglycemia, and prior hypersensitivity reaction to glucagon or to any of the excipients in BAQSIMI. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension.

Warnings and Precautions

BAQSIMI is contraindicated in patients with pheochromocytoma because glucagon may stimulate release of catecholamines from the tumor. If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.

In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, BAQSIMI administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. BAQSIMI is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of BAQSIMI, give glucose orally or intravenously.

Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Discontinue BAQSIMI if symptoms of serious hypersensitivity reactions occur. Advise patients and/or caregivers to seek immediate medical attention if the patient experiences any symptoms of serious hypersensitivity reactions. BAQSIMI is contraindicated in patients with a prior hypersensitivity reaction.

BAQSIMI is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for BAQSIMI administration to be effective. Patients with these conditions should be treated with glucose.

Patients with insufficient hepatic stores of glycogen may not respond to BAQSIMI for the treatment of severe hypoglycemia. Insufficient hepatic stores of glycogen may be present in conditions such as states of starvation or in patients with adrenal insufficiency or chronic hypoglycemia.

Adverse Reactions

Most common (≥10%) adverse reactions associated with BAQSIMI are nausea, vomiting, headache, upper respiratory tract irritation (i.e., rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis), watery eyes, redness of eyes, and itchy nose, throat and eyes.

The following clinically significant adverse reactions are described elsewhere in labeling:

  • Substantial Increase in Blood Pressure in Patients with Pheochromocytoma
  • Hypoglycemia in Patients with Insulinoma
  • Serious Hypersensitivity Reactions
  • Lack of Efficacy in Patients with Decreased Hepatic Glycogen

Drug Interactions

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given BAQSIMI. In patients taking indomethacin, BAQSIMI may lose its ability to raise blood glucose or may even produce hypoglycemia. BAQSIMI may increase the anticoagulant effect of warfarin.

Please see Full Prescribing Information including Patient Information provided. Please see Instructions for Use included with the device.

Indication

BAQSIMI® is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 1 year and above.

BAQSIMI is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure, insulinoma because of risk of hypoglycemia, and prior hypersensitivity reaction to glucagon or to any of the excipients in BAQSIMI. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension.

Warnings and Precautions

BAQSIMI is contraindicated in patients with pheochromocytoma because glucagon may stimulate release of catecholamines from the tumor. If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.

In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, BAQSIMI administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. BAQSIMI is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of BAQSIMI, give glucose orally or intravenously.

Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Discontinue BAQSIMI if symptoms of serious hypersensitivity reactions occur. Advise patients and/or caregivers to seek immediate medical attention if the patient experiences any symptoms of serious hypersensitivity reactions. BAQSIMI is contraindicated in patients with a prior hypersensitivity reaction.

BAQSIMI is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for BAQSIMI administration to be effective. Patients with these conditions should be treated with glucose.

Patients with insufficient hepatic stores of glycogen may not respond to BAQSIMI for the treatment of severe hypoglycemia. Insufficient hepatic stores of glycogen may be present in conditions such as states of starvation or in patients with adrenal insufficiency or chronic hypoglycemia.

Adverse Reactions

Most common (≥10%) adverse reactions associated with BAQSIMI are nausea, vomiting, headache, upper respiratory tract irritation (i.e., rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis), watery eyes, redness of eyes, and itchy nose, throat and eyes.

The following clinically significant adverse reactions are described elsewhere in labeling:

  • Substantial Increase in Blood Pressure in Patients with Pheochromocytoma
  • Hypoglycemia in Patients with Insulinoma
  • Serious Hypersensitivity Reactions
  • Lack of Efficacy in Patients with Decreased Hepatic Glycogen

Drug Interactions

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given BAQSIMI. In patients taking indomethacin, BAQSIMI may lose its ability to raise blood glucose or may even produce hypoglycemia. BAQSIMI may increase the anticoagulant effect of warfarin.

Please see Full Prescribing Information including Patient Information provided. Please see Instructions for Use included with the device.

Indication

BAQSIMI® is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 1 year and above.

Baqsimi
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