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Epipen As an Alternative to Glucagon in the Treatment of Hypoglycemia in Children with Diabetes

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Epipen As an Alternative to Glucagon in the Treatment of Hypoglycemia in Children with Diabetes Emerging Treatments and Technologies ORIGINAL ARTICLE Epipen as an Alternative to Glucagon in the Treatment of Hypoglycemia in Children With Diabetes TERESA P.C. MONSOD, MD MARY BRONSON, BSN, RN tracurricular activities for reasons of WILLIAM V. TAMBORLANE, MD TONY YONG-ZHAN MA safety. LUISA CORALUZZI, BSN, RN JO ANN AHERN, MSN, CDE, APRN Even though stimulation of epineph- rine secretion is one of the main endoge- nous hormonal defenses against insulin- induced hypoglycemia in type 1 diabetes, use of epinephrine for treatment of severe OBJECTIVE — Fear of a severe hypoglycemic reaction is a major obstacle to achieving near- hypoglycemia in children has not been normal plasma glucose levels. Although parenteral glucagon is effective in treating these reac- tested. This is surprising because a pre- tions, it is cumbersome to use, causes severe nausea, and is impractical in the school setting. mixed and prefilled injection system for Epinephrine is available as a premixed injection (Epipen) that may be used by all care providers. Using Epipen to treat hypoglycemia may be an effective, safe, and easy-to-use alternative to parenteral epinephrine administration is glucagon. available for treatment of severe allergic reactions (Epipen; Dey Laboratories). RESEARCH DESIGN AND METHODS — Ten children (age 11.7 Ϯ 2.4 years) with Due to its ease of use and absence of se- type 1 diabetes were studied on two occasions. After an overnight equilibration period, hypo- vere side effects, teachers, administrators, glycemia was induced via an insulin pump (1 mU ⅐ kg–1 ⅐ min–1). At a blood glucose level of 2.8 and other school personnel are permitted mmol/l, either glucagon (1 mg) or epinephrine (0.3 mg), in random order, was administered to use the Epipen in emergency situa- intramuscularly and responses were monitored. tions. The present study was conse- quently undertaken to examine whether RESULTS — Plasma free insulin concentrations were similar in both studies. Plasma glucose parenteral injection of epinephrine using levels increased by 1.7 Ϯ 0.2 mmol/l (mean Ϯ SEM) in 10 min and by 2.6 Ϯ 0.2 mmol/l in 15 min with administration of glucagon and were not consistently increased with administration of the Epipen system could provide an effec- epinephrine (P Ͻ 0.01). Peak glucagon concentrations after administration of glucagon were tive alternative to injection of glucagon in Ͼ60-fold higher than basal concentrations. After administration of epinephrine, peak epineph- children with diabetes. rine levels were 20-fold higher than basal concentrations. RESEARCH DESIGN AND CONCLUSIONS — Epinephrine does not seem to be an adequate substitute for glucagon in METHODS the treatment of severe hypoglycemia. The effectiveness of glucagon in reversing hypoglycemia and its side effects of nausea and vomiting are likely related to the markedly supraphysiologic Study subjects plasma levels achieved with the standard intramuscular dose. Ten nonobese children (seven girls and three boys) with type 1 diabetes were Diabetes Care 24:701–704, 2001 studied. They had a mean (ϮSD) age of 11.7 Ϯ 2.4 years and duration of diabetes of 46 Ϯ 22 months. All of the patients evere hypoglycemia is the most fre- makes it difficult to use in an emergent were on a continuous subcutaneous insu- quent and feared acute complica- situation. In addition, the standard dose lin infusion and had good glycemic con- S tion of treatment of type 1 diabetes of glucagon is often associated with severe trol with a mean glycosylated hemoglobin during childhood. In fact, fear of a severe nausea and occasionally with vomiting, of 6.8 Ϯ 0.5 (normal value Ͻ6.4). None hypoglycemic reaction has become a ma- which can complicate recovery from hy- had clinical evidence of autonomic neu- jor obstacle in achieving lower glycosy- poglycemia by limiting the patient’s in- ropathy or severe hypoglycemia within lated hemoglobin levels with intensive take of oral carbohydrate. Because the preceding three months, and none treatment. Parenteral injection of 1.0 mg glucagon can only be administered by a were receiving any medication other than glucagon is the standard treatment for a licensed health professional in many insulin. The study was approved by the severe insulin reaction (1,2), but the need school systems, diabetic children may be Yale Human Investigation Committee, to reconstitute the hormone with diluent precluded from field trips and other ex- and all of the subjects and their parents ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● gave written informed consent. From the Department of Pediatrics, Division of Pediatric Endocrinology, Yale University, New Haven, Connecticut. Experimental protocol Address correspondence and reprint requests to Teresa P. C. Monsod, MD, Division of Pediatric Endo- Each patient was studied on two occa- crinology, Yale University School of Medicine, P.O. Box 208064, New Haven, CT 06520. E-mail: teresa. sions separated by an interval of at least 4 [email protected]. Received for publication 7 September 2000 and accepted in revised form 30 November 2000. weeks. On each occasion, the patient was A table elsewhere in this issue shows conventional and Syste`me International (SI) units and conversion admitted to the Yale Children’s Clinical factors for many substances. Research Center at 8:00 P.M. on the night DIABETES CARE, VOLUME 24, NUMBER 4, APRIL 2001 701 Epipen as an alternative to glucagon before the study. Each patient had eaten Table 1—Baseline and peak insulin levels during the two studies dinner before admission and had received the usual bolus of lispro insulin (Eli Lilly, Baseline Peak insulin levels Indianapolis, IN) for the meal. On admis- sion, an intravenous cannula was inserted Insulin dose Insulin dose Ϫ1 Ϫ1 in an antecubital vein for blood sampling (mU ⅐ kg ⅐ Insulin level (mU ⅐ kg ⅐ Insulin level Ϫ1 Ϫ1 and the patients were maintained on their min ) (pmol/l) min ) (pmol/l) usual overnight subcutaneous basal infu- Glucagon 0.3 Ϯ 0.14 73 Ϯ 3 1.0 152 Ϯ 8 sion of lispro insulin. Blood glucose levels Epipen 0.3 Ϯ 0.15 75 Ϯ 7 1.0 136 Ϯ 16 were measured hourly overnight and Data are means Ϯ SEM. Peak insulin levels were achieved at the time of hypoglycemia (0 min) and were maintained between 3.9 and 8.3 mmol/l maintained throughout the study. by giving an intravenous bolus of 20% dextrose if levels were Ͻ3.9 mmol/l and by increasing the subcutaneous infusion vestigators and the children were masked achieved and maintained in both studies. of insulin if levels were Ͼ8.3 mmol/l. to the drug that was being given. It took 101 Ϯ 11 min (range 45–170) to At 7:00 A.M. the following morning, induce hypoglycemia after the insulin in- blood samples were drawn for baseline Analytical methods fusion rate had been increased. The time hormone levels and the insulin infusion Plasma glucose levels were measured by needed to induce hypoglycemia was sim- –1 –1 was then increased to 1 mU ⅐ kg ⅐ min the glucose oxidase method with a Beck- ilar in both studies. and stayed at this rate for the duration of man glucose analyzer (Beckman Instru- Basal plasma glucagon levels were the study. During the following 60–120 ments, Brea, CA). Catecholamines were similar in the glucagon (45 Ϯ 0.2 ng/l) min, blood glucose levels were allowed to collected in ice tubes containing glutathi- and epinephrine (42 Ϯ 0.8 ng/l) studies decrease to 2.8 mmol/l. When the blood one and measured by high-performance (Fig. 1), and plasma glucagon concentra- glucose concentration was 2.8 mmol/l, ei- liquid chromatography assay. Plasma free tions did not change during induction of ther 1.0 mg glucagon or 0.3 mg epineph- insulin (measured after precipitation with hypoglycemia. Intramuscular injection of rine (via Epipen) was administered polyethylene glycol) and glucagon were glucagon resulted in a rapid and marked intramuscularly in the anterolateral as- measured by double-antibody radioim- increase in plasma glucagon concentra- pect of the thigh. The patients were then munoassays (Human Insulin and Gluca- tions to 3,032 Ϯ 420 ng/l with peak monitored for 1 h after administration of gon RIA kits; Linco Research, St. Charles, plasma glucagon values achieved 21 Ϯ 3 the drug. Blood samples were taken at 20- MO). All samples from each subject were min after administration of glucagon. In to 30-min intervals during the prehypo- measured in a single assay. The intra-assay contrast, no change in plasma glucagon glycemic period and at 5- to 10-min in- coefficients of variation for free insulin, values was observed after administration tervals during the hypoglycemia period glucagon, epinephrine, and norepineph- of epinephrine (P Ͻ 0.01 for comparison for measurement of insulin, glucagon, rine were 11, 7, 6.5, and 4%, respectively. between the two groups). epinephrine, and norepinephrine levels. As shown in Fig. 1, basal concentra- Blood glucose levels were measured at the Statistical analysis tions and the increase in the plasma epi- bedside at 5- to 10-min intervals through- Data in text and figures are presented as nephrine levels that were observed during out the study. means Ϯ SEM. The plasma glucose con- induction of hypoglycemia were similar Symptoms of hypoglycemia were as- centrations, hormone responses, and in both studies (from 189 Ϯ 26 to 595 Ϯ sessed at 15-min intervals with a ques- symptom responses in the two studies 120 pmol/l and from 174 Ϯ 11 to 644 Ϯ tionnaire in which subjects were asked to were compared by analysis of variance rate a set of symptoms on a scale of 0 with repeated-measures design. When 322 pmol/l in the glucagon and epineph- (nonexistent) to 6 (extreme).
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