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

View Description

Patients with type 1 diabetes (n equals 319) and patients with type 2 diabetes (n equals 320) reported the following self-identified causes of severe hypoglycemic events:

Irregular/insufficient food intake: 43 percent of type 1 patients; 47 percent of type 2 patients
Physical exercise/overexertion: 24 percent of type 1 patients; 23 percent of type 2 patients
Insulin dose miscalculation: 24 percent of type 1 patients; 16 percent of type 2 patients
Stressful situations: 12 percent of type 1 patients; 17 percent of type 2 patients
Oscillating blood glucose levels: 9 percent of type 1 patients; 8 percent of type 2 patients
Impaired hypoglycemia awareness: 8 percent of type 1 patients; 5 percent of type 2 patients

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

Warnings – Do not use BAQSIMI if:

  • you have a tumor in the gland on top of your kidneys (adrenal gland) called pheochromocytoma.
  • you have a tumor in your pancreas called insulinoma.
  • you are allergic to glucagon, or any other ingredient in BAQSIMI.

BAQSIMI may cause serious side effects, including:

High blood pressure. BAQSIMI can cause high blood pressure in certain people with tumors in their adrenal glands.

Low blood sugar. BAQSIMI can cause certain people with tumors in their pancreas to have low blood sugar.

Serious allergic reaction. Call your doctor or get medical help right away if you have a serious allergic reaction including:

  • rash
  • difficulty breathing
  • low blood pressure

Common side effects

The most common side effects of BAQSIMI include:

  • nausea
  • vomiting
  • headache
  • runny nose
  • discomfort in your nose
  • stuffy nose
  • redness in your eyes
  • itchy nose, throat, and eyes
  • watery eyes

These are not all the possible side effects of BAQSIMI. For more information, ask your doctor. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Before using

Before getting BAQSIMI, tell your health care provider about all your medical conditions, including if you:

  • have a tumor in your pancreas.
  • have not had food or water for a long time (prolonged fasting or starvation).
  • are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if BAQSIMI passes into your breast milk. You and your doctor should decide if you can use BAQSIMI while breastfeeding.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How to use

Read the detailed Instructions for Use that comes with BAQSIMI.

  • Use BAQSIMI exactly how your doctor tells you to use it.
  • Make sure your caregiver knows where you keep your BAQSIMI and how to use BAQSIMI the right way before you need their help.
  • Your doctor will tell you how and when to use BAQSIMI.
  • BAQSIMI contains only one dose of medicine and cannot be reused.
  • BAQSIMI should be given in one side of your nose (nostril) but does not need to be inhaled.
  • BAQSIMI will work even if you have a cold or are taking cold medicine.
  • After giving BAQSIMI, the caregiver should call for emergency medical help right away.
  • If the person does not respond after 15 minutes, another dose may be given, if available.
  • Tell your doctor each time you use BAQSIMI.
  • Store BAQSIMI at temperatures up to 86°F (30°C).
  • Keep BAQSIMI in the shrink-wrapped tube until you are ready to use it.

Keep BAQSIMI and all medicines out of the reach of children.

Learn more

BAQSIMI is a prescription medicine. For more information, call 1-800-423-4136.

This summary provides basic information about BAQSIMI but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about BAQSIMI and how to take it. Your doctor is the best person to help you decide if BAQSIMI is right for you.

BAQSIMI® is a registered trademark owned or licensed by Amphastar Pharmaceuticals, Inc., its subsidiaries, or affiliates.

Indication

BAQSIMI® (BAK-see-mee) is used to treat very low blood sugar (severe hypoglycemia) in people with diabetes ages 4 years and above.

It is not known if BAQSIMI is safe and effective in children under 4 years of age.

Warnings – Do not use BAQSIMI if:

  • you have a tumor in the gland on top of your kidneys (adrenal gland) called pheochromocytoma.
  • you have a tumor in your pancreas called insulinoma.
  • you are allergic to glucagon, or any other ingredient in BAQSIMI.

BAQSIMI may cause serious side effects, including:

High blood pressure. BAQSIMI can cause high blood pressure in certain people with tumors in their adrenal glands.

Low blood sugar. BAQSIMI can cause certain people with tumors in their pancreas to have low blood sugar.

Serious allergic reaction. Call your doctor or get medical help right away if you have a serious allergic reaction including:

  • rash
  • difficulty breathing
  • low blood pressure

Common side effects

The most common side effects of BAQSIMI include:

  • nausea
  • vomiting
  • headache
  • runny nose
  • discomfort in your nose
  • stuffy nose
  • redness in your eyes
  • itchy nose, throat, and eyes
  • watery eyes

These are not all the possible side effects of BAQSIMI. For more information, ask your doctor. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Before using

Before getting BAQSIMI, tell your health care provider about all your medical conditions, including if you:

  • have a tumor in your pancreas.
  • have not had food or water for a long time (prolonged fasting or starvation).
  • are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if BAQSIMI passes into your breast milk. You and your doctor should decide if you can use BAQSIMI while breastfeeding.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How to use

Read the detailed Instructions for Use that comes with BAQSIMI.

  • Use BAQSIMI exactly how your doctor tells you to use it.
  • Make sure your caregiver knows where you keep your BAQSIMI and how to use BAQSIMI the right way before you need their help.
  • Your doctor will tell you how and when to use BAQSIMI.
  • BAQSIMI contains only one dose of medicine and cannot be reused.
  • BAQSIMI should be given in one side of your nose (nostril) but does not need to be inhaled.
  • BAQSIMI will work even if you have a cold or are taking cold medicine.
  • After giving BAQSIMI, the caregiver should call for emergency medical help right away.
  • If the person does not respond after 15 minutes, another dose may be given, if available.
  • Tell your doctor each time you use BAQSIMI.
  • Store BAQSIMI at temperatures up to 86°F (30°C).
  • Keep BAQSIMI in the shrink-wrapped tube until you are ready to use it.

Keep BAQSIMI and all medicines out of the reach of children.

Learn more

BAQSIMI is a prescription medicine. For more information, call 1-800-423-4136.

This summary provides basic information about BAQSIMI but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about BAQSIMI and how to take it. Your doctor is the best person to help you decide if BAQSIMI is right for you.

BAQSIMI® is a registered trademark owned or licensed by Amphastar Pharmaceuticals, Inc., its subsidiaries, or affiliates.

Indication

BAQSIMI® (BAK-see-mee) is used to treat very low blood sugar (severe hypoglycemia) in people with diabetes ages 4 years and above.

It is not known if BAQSIMI is safe and effective in children under 4 years of age.