Prospective study evaluating the use of nasal glucagon for the treatment of moderate to severe hypoglycaemia in adults with type 1 diabetes in a real-world setting

Diabetes Obes Metab. 2018 May;20(5):1316-1320. doi: 10.1111/dom.13278. Epub 2018 Mar 22.

Abstract

In the present multicentre, open-label, prospective, phase III study, we evaluated the real-world effectiveness and ease of use of nasal glucagon (NG) in the treatment of moderate/severe hypoglycaemic events (HEs) in adults with type 1 diabetes (T1D). Patients and caregivers were taught how to use NG (3 mg) to treat moderate/severe HEs, record the time taken to awaken or return to normal status, and measure blood glucose (BG) levels over time. Questionnaires were used to collect information about adverse events and ease of use of NG. In the efficacy analysis population, 69 patients experienced 157 HEs. In 95.7% patients, HEs resolved within 30 minutes of NG administration. In all the 12 severe HEs, patients awakened or returned to normal status within 15 minutes of NG administration without additional external medical help. Most caregivers reported that NG was easy to use. Most adverse events were local and of low to moderate severity. In this study, a single, 3-mg dose of NG demonstrated real-life effectiveness in treating moderate and severe HEs in adults with T1D. NG was well tolerated and easy to use.

Keywords: adults; hypoglycaemia; nasal glucagon; type 1 diabetes.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intranasal
  • Adult
  • Blood Glucose / analysis
  • Blood Glucose Self-Monitoring
  • Caregivers
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Female
  • Glucagon / administration & dosage*
  • Glucagon / therapeutic use
  • Health Knowledge, Attitudes, Practice
  • Humans
  • Hypoglycemia / blood
  • Hypoglycemia / chemically induced
  • Hypoglycemia / drug therapy*
  • Hypoglycemia / physiopathology
  • Hypoglycemic Agents / adverse effects*
  • Hypoglycemic Agents / therapeutic use
  • Insulin / adverse effects*
  • Insulin / therapeutic use
  • Lost to Follow-Up
  • Male
  • Middle Aged
  • Patient Dropouts
  • Patient Education as Topic
  • Self Report
  • Severity of Illness Index
  • Syncope / etiology
  • Syncope / prevention & control
  • Time Factors

Substances

  • Blood Glucose
  • Hypoglycemic Agents
  • Insulin
  • Glucagon