Intranasal glucagon for treatment of insulin-induced hypoglycemia in adults with type 1 diabetes: A randomized crossover noninferiority study

T1D Exchange Intranasal Glucagon Investigators

Research output: Contribution to journalArticle

36 Citations (Scopus)

Abstract

Objective Treatment of severe hypoglycemia with loss of consciousness or seizure outside of the hospital setting is presently limited to intramuscular glucagon requiring reconstitution immediately prior to injection, a process prone to error or omission. A needle-free intranasal glucagon preparation was compared with intramuscular glucagon for treatment of insulin-induced hypoglycemia. Research Design and Methods At eight clinical centers, a randomized crossover noninferiority trial was conducted involving 75 adults with type 1 diabetes (mean age, 33±12 years; median diabetes duration, 18 years) to compare intranasal (3 mg) versus intramuscular (1 mg) glucagon for treatment of hypoglycemia induced by intravenous insulin. Success was defined as an increase in plasma glucose to ≥70 mg/dL or ≥20 mg/dL from the glucose nadir within 30 min after receiving glucagon. Results Mean plasma glucose at time of glucagon administrationwas 48±8 and 49±8mg/dL at the intranasal and intramuscular visits, respectively. Success criteria were met at all but one intranasal visit and at all intramuscular visits (98.7% vs. 100%; difference 1.3%, upper end of 1-sided 97.5% CI 4.0%). Mean time to success was 16 min for intranasal and 13 min for intramuscular (P

Original languageEnglish (US)
Pages (from-to)264-270
Number of pages7
JournalDiabetes Care
Volume39
Issue number2
DOIs
StatePublished - Feb 1 2016

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Glucagon
Type 1 Diabetes Mellitus
Hypoglycemia
Cross-Over Studies
Insulin
Glucose
Therapeutics
Unconsciousness
Needles
Seizures
Research Design
Injections

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

Cite this

Intranasal glucagon for treatment of insulin-induced hypoglycemia in adults with type 1 diabetes : A randomized crossover noninferiority study. / T1D Exchange Intranasal Glucagon Investigators.

In: Diabetes Care, Vol. 39, No. 2, 01.02.2016, p. 264-270.

Research output: Contribution to journalArticle

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abstract = "Objective Treatment of severe hypoglycemia with loss of consciousness or seizure outside of the hospital setting is presently limited to intramuscular glucagon requiring reconstitution immediately prior to injection, a process prone to error or omission. A needle-free intranasal glucagon preparation was compared with intramuscular glucagon for treatment of insulin-induced hypoglycemia. Research Design and Methods At eight clinical centers, a randomized crossover noninferiority trial was conducted involving 75 adults with type 1 diabetes (mean age, 33±12 years; median diabetes duration, 18 years) to compare intranasal (3 mg) versus intramuscular (1 mg) glucagon for treatment of hypoglycemia induced by intravenous insulin. Success was defined as an increase in plasma glucose to ≥70 mg/dL or ≥20 mg/dL from the glucose nadir within 30 min after receiving glucagon. Results Mean plasma glucose at time of glucagon administrationwas 48±8 and 49±8mg/dL at the intranasal and intramuscular visits, respectively. Success criteria were met at all but one intranasal visit and at all intramuscular visits (98.7{\%} vs. 100{\%}; difference 1.3{\%}, upper end of 1-sided 97.5{\%} CI 4.0{\%}). Mean time to success was 16 min for intranasal and 13 min for intramuscular (P",
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T1 - Intranasal glucagon for treatment of insulin-induced hypoglycemia in adults with type 1 diabetes

T2 - A randomized crossover noninferiority study

AU - T1D Exchange Intranasal Glucagon Investigators

AU - Rickels, Michael R.

AU - Ruedy, Katrina J.

AU - Foster, Nicole C.

AU - Piché, Claude A.

AU - Dulude, Hélène

AU - Sherr, Jennifer L.

AU - Tamborlane, William V.

AU - Bethin, Kathleen E.

AU - DiMeglio, Linda A.

AU - Wadwa, R. Paul

AU - Ahmann, Andrew

AU - Haller, Michael J.

AU - Nathan, Brandon M.

AU - Marcovina, Santica M.

AU - Rampakakis, Emmanouil

AU - Meng, Linyan

AU - Beck, Roy W.

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N2 - Objective Treatment of severe hypoglycemia with loss of consciousness or seizure outside of the hospital setting is presently limited to intramuscular glucagon requiring reconstitution immediately prior to injection, a process prone to error or omission. A needle-free intranasal glucagon preparation was compared with intramuscular glucagon for treatment of insulin-induced hypoglycemia. Research Design and Methods At eight clinical centers, a randomized crossover noninferiority trial was conducted involving 75 adults with type 1 diabetes (mean age, 33±12 years; median diabetes duration, 18 years) to compare intranasal (3 mg) versus intramuscular (1 mg) glucagon for treatment of hypoglycemia induced by intravenous insulin. Success was defined as an increase in plasma glucose to ≥70 mg/dL or ≥20 mg/dL from the glucose nadir within 30 min after receiving glucagon. Results Mean plasma glucose at time of glucagon administrationwas 48±8 and 49±8mg/dL at the intranasal and intramuscular visits, respectively. Success criteria were met at all but one intranasal visit and at all intramuscular visits (98.7% vs. 100%; difference 1.3%, upper end of 1-sided 97.5% CI 4.0%). Mean time to success was 16 min for intranasal and 13 min for intramuscular (P

AB - Objective Treatment of severe hypoglycemia with loss of consciousness or seizure outside of the hospital setting is presently limited to intramuscular glucagon requiring reconstitution immediately prior to injection, a process prone to error or omission. A needle-free intranasal glucagon preparation was compared with intramuscular glucagon for treatment of insulin-induced hypoglycemia. Research Design and Methods At eight clinical centers, a randomized crossover noninferiority trial was conducted involving 75 adults with type 1 diabetes (mean age, 33±12 years; median diabetes duration, 18 years) to compare intranasal (3 mg) versus intramuscular (1 mg) glucagon for treatment of hypoglycemia induced by intravenous insulin. Success was defined as an increase in plasma glucose to ≥70 mg/dL or ≥20 mg/dL from the glucose nadir within 30 min after receiving glucagon. Results Mean plasma glucose at time of glucagon administrationwas 48±8 and 49±8mg/dL at the intranasal and intramuscular visits, respectively. Success criteria were met at all but one intranasal visit and at all intramuscular visits (98.7% vs. 100%; difference 1.3%, upper end of 1-sided 97.5% CI 4.0%). Mean time to success was 16 min for intranasal and 13 min for intramuscular (P

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