video showing severe hypoglycemia moment
THE MOMENT

Severe hypoglycemia can happen any day. For Karen, it was today

American Diabetes Association recommendation1


As Risk Escalates, Clinicians Should Help Prepare Patients For Severe Hypoglycemia With Glucagon

ADA Classifications of Hypoglycemia

Chart: American diabetes association classifications of hypoglycemia.

All patients on insulin are at risk for severe hypoglycemia1


Patients with type 2 diabetes are at risk2

  • Pancreatic α-cell function declines and patients lose their ability to secrete glucagon in response to hypoglycemia3,4
  • In most patients with type 2 diabetes, this impaired glucagon response worsens over time—similar to type 1 diabetes4,5
  • Patients on exogenous insulin have a defective counter-regulatory response to decreased blood glucose, increasing the risk for severe hypoglycemia6,7

Common Patient-Identified causes of severe hypoglycemia8


Patient-identified Causes of Severe Hypoglycemic Events

Chart: Patient reported causes of severe hypoglycemia.
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

The Dawn2 Study9


Adults with Type 1 or Type 2 Diabetes on Insulin with ≥1
Self-reported, Severe Hypoglycemic Event During the Past Year

Chart: Adults with type-one diabetes or type-two diabetes with greater than or equal to one self-reported severe hypoglycemic event during the past year.
Study design
  • Multinational survey conducted in 17 countries across 4 continents aiming to analyze the global incidence of severe hypoglycemia and its psychosocial correlates in adult patients with type 1 and type 2 diabetes
  • Participants were recruited using online, telephone, and in-person questionnaires that investigated the number of severe hypoglycemic episodes experienced by participants over the past 12 months

*Overall number of patients in the study includes insulin and non-insulin users. DAWN=Diabetes Attitudes, Wishes, and Needs.

A1C does not reveal glycemic variability1


Fifteen-day glucose traces of two patients with identical A1C of 8.0%10

Glucose variability chart
Study design
  • A perspective analysis of acute manifestations of glucose variability (GV) (including hypoglycemia) to review a) measures that assessed the amplitude of GV from routine self-monitored blood glucose data and b) timing from continuous glucose monitoring (CGM data), and determine the relationship of speed and magnitude of rapid glucose fluctuations to clinically relevant outcomes
  • A1C reflects average glycemiaand not glycemic variability, which is a major determinant of hypoglycemia risk1

References: 1. American Diabetes Association. Glycemic Targets: Standards of Medical Care in Diabetes—2019. Diabetes Care. 2019;42(suppl 1):S61-S70. 2. 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;22:749-755. 3. Kedia N. Diabetes MetabSyndrObes.2011;4:337-346. 4. Aronoff SL, et al. Diabetes Spectr.2004;17:183-190. 5. Edelman SV, et al. Diabetes Educ. 2014;40(3):269-279. 6. McCrimmonRJ, et al. Diabetes. 2010;59:2333-2339. 7.Cryer PE. Endocrinol. 2012; 153:1039-1048. 8. LammertM, et al. J Med Econ.2009;12(4):269-280. 9. HermannsN, et al. Global prevalence of hypoglycaemia: Association to treatment factors, self-management education and quality-of-life measurements. Poster presented at: 49thAnnual Meeting of the European Association for the Study of Diabetes (EASD); September 2013; Barcelona, Spain. Abstract 592. 10. Kovatchev B, Cobelli C. Diabetes Care.2016;39:502-510.

INDICATION AND IMPORTANT SAFETY INFORMATION
Indication and Important Safety Information

BAQSIMI™ is indicated for the treatment of severe hypoglycemia in patients with diabetes ages 4 years and above.

Important Safety Information
Contraindications
BAQSIMI is contraindicated in patients with pheochromocytoma, insulinoma, and known hypersensitivity 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 dramatic 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.
Allergic reactions have been reported with glucagon, these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. 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.

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.

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.

GN HCP ISI 24JUL2019

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