Efficacy and Safety of Mini-Dose Glucagon for Treatment of Nonsevere Hypoglycemia in Adults With Type 1 Diabetes

Abstract Context Standard treatment of hypoglycemia is oral carbohydrate, but it often results in hyperglycemia and entails extra caloric intake. Objective To evaluate low-dose glucagon to treat mild hypoglycemia in ambulatory adults with type 1 diabetes (T1D). Design Randomized crossover trial (two...

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Veröffentlicht in:The journal of clinical endocrinology and metabolism 2017-08, Vol.102 (8), p.2994-3001
Hauptverfasser: Haymond, Morey W, DuBose, Stephanie N, Rickels, Michael R, Wolpert, Howard, Shah, Viral N, Sherr, Jennifer L, Weinstock, Ruth S, Agarwal, Shivani, Verdejo, Alandra S, Cummins, Martin J, Newswanger, Brett, Beck, Roy W
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container_end_page 3001
container_issue 8
container_start_page 2994
container_title The journal of clinical endocrinology and metabolism
container_volume 102
creator Haymond, Morey W
DuBose, Stephanie N
Rickels, Michael R
Wolpert, Howard
Shah, Viral N
Sherr, Jennifer L
Weinstock, Ruth S
Agarwal, Shivani
Verdejo, Alandra S
Cummins, Martin J
Newswanger, Brett
Beck, Roy W
description Abstract Context Standard treatment of hypoglycemia is oral carbohydrate, but it often results in hyperglycemia and entails extra caloric intake. Objective To evaluate low-dose glucagon to treat mild hypoglycemia in ambulatory adults with type 1 diabetes (T1D). Design Randomized crossover trial (two 3-week periods). Setting Five U.S. diabetes clinics. Patients Twenty adults with T1D using an insulin pump and continuous glucose monitor (CGM) and experiencing frequent mild hypoglycemia. Intervention Nonaqueous mini-dose glucagon (MDG) (150 µg) to treat nonsevere hypoglycemia. Main Outcome Measures Successful treatment was defined as blood glucose (BG) ≥50 mg/dL 15 minutes and ≥70 mg/dL 30 minutes after intervention, on the study meter. Two authors, blinded to treatment arm, independently judged each event as a clinical success or failure. Results Sixteen participants (mean age 39 years, 75% female, mean diabetes duration 23 years, mean hemoglobin A1c 7.2%) had 118 analyzable events with initial BG of 50 to 69 mg/dL. Successful treatment criteria were met for 58 (94%) of 62 events during the MDG period and 53 (95%) of 56 events during the glucose tablets (TABS) period (adjusted P = 0.99). Clinical assessments of success for these events were 97% and 96%, respectively. CGM-measured time in range did not differ between treatment groups during the 2 hours after events, but TABS resulted in higher maximum glucose (116 vs 102 mg/dL; P = 0.01) over the first hour. Conclusions Low-dose glucagon can successfully treat mild hypoglycemia and may be a useful alternative to treatment with oral carbohydrate when trying to avoid unnecessary caloric intake. It was found that small doses of a nonaqueous form of glucagon can treat mild hypoglycemia and may be a useful alternative to oral carbohydrate when trying to avoid unnecessary caloric intake.
doi_str_mv 10.1210/jc.2017-00591
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Objective To evaluate low-dose glucagon to treat mild hypoglycemia in ambulatory adults with type 1 diabetes (T1D). Design Randomized crossover trial (two 3-week periods). Setting Five U.S. diabetes clinics. Patients Twenty adults with T1D using an insulin pump and continuous glucose monitor (CGM) and experiencing frequent mild hypoglycemia. Intervention Nonaqueous mini-dose glucagon (MDG) (150 µg) to treat nonsevere hypoglycemia. Main Outcome Measures Successful treatment was defined as blood glucose (BG) ≥50 mg/dL 15 minutes and ≥70 mg/dL 30 minutes after intervention, on the study meter. Two authors, blinded to treatment arm, independently judged each event as a clinical success or failure. Results Sixteen participants (mean age 39 years, 75% female, mean diabetes duration 23 years, mean hemoglobin A1c 7.2%) had 118 analyzable events with initial BG of 50 to 69 mg/dL. Successful treatment criteria were met for 58 (94%) of 62 events during the MDG period and 53 (95%) of 56 events during the glucose tablets (TABS) period (adjusted P = 0.99). Clinical assessments of success for these events were 97% and 96%, respectively. CGM-measured time in range did not differ between treatment groups during the 2 hours after events, but TABS resulted in higher maximum glucose (116 vs 102 mg/dL; P = 0.01) over the first hour. Conclusions Low-dose glucagon can successfully treat mild hypoglycemia and may be a useful alternative to treatment with oral carbohydrate when trying to avoid unnecessary caloric intake. It was found that small doses of a nonaqueous form of glucagon can treat mild hypoglycemia and may be a useful alternative to oral carbohydrate when trying to avoid unnecessary caloric intake.</description><identifier>ISSN: 0021-972X</identifier><identifier>EISSN: 1945-7197</identifier><identifier>DOI: 10.1210/jc.2017-00591</identifier><identifier>PMID: 28591776</identifier><language>eng</language><publisher>Washington, DC: Endocrine Society</publisher><subject>Adult ; Blood Glucose - metabolism ; Blood Glucose Self-Monitoring ; Carbohydrates ; Cross-Over Studies ; Diabetes ; Diabetes mellitus ; Diabetes Mellitus, Type 1 - drug therapy ; Female ; Glucagon ; Glucagon - administration &amp; dosage ; Glucose ; Hemoglobin ; Hormones - administration &amp; dosage ; Humans ; Hyperglycemia ; Hypoglycemia ; Hypoglycemia - chemically induced ; Hypoglycemia - drug therapy ; Hypoglycemia - metabolism ; Hypoglycemic Agents - adverse effects ; Insulin ; Insulin - adverse effects ; Insulin Infusion Systems ; Male ; Middle Aged ; Severity of Illness Index ; Tablets</subject><ispartof>The journal of clinical endocrinology and metabolism, 2017-08, Vol.102 (8), p.2994-3001</ispartof><rights>Copyright © 2017 Endocrine Society 2017</rights><rights>Copyright © Oxford University Press 2015</rights><rights>Copyright © 2017 Endocrine Society</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4389-bac94d648ae47b54e3bbe08ac171007b2dd405a23cc32e3106c09ae09140441e3</citedby><cites>FETCH-LOGICAL-c4389-bac94d648ae47b54e3bbe08ac171007b2dd405a23cc32e3106c09ae09140441e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1970003393?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,777,781,21369,21370,27905,27906,33511,33512,33725,33726,43640,43786,64364,64366,64368,72218,72872,72877,72878,72880</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28591776$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Haymond, Morey W</creatorcontrib><creatorcontrib>DuBose, Stephanie N</creatorcontrib><creatorcontrib>Rickels, Michael R</creatorcontrib><creatorcontrib>Wolpert, Howard</creatorcontrib><creatorcontrib>Shah, Viral N</creatorcontrib><creatorcontrib>Sherr, Jennifer L</creatorcontrib><creatorcontrib>Weinstock, Ruth S</creatorcontrib><creatorcontrib>Agarwal, Shivani</creatorcontrib><creatorcontrib>Verdejo, Alandra S</creatorcontrib><creatorcontrib>Cummins, Martin J</creatorcontrib><creatorcontrib>Newswanger, Brett</creatorcontrib><creatorcontrib>Beck, Roy W</creatorcontrib><creatorcontrib>T1D Exchange Mini-dose Glucagon Study Group</creatorcontrib><creatorcontrib>for the T1D Exchange Mini-dose Glucagon Study Group</creatorcontrib><title>Efficacy and Safety of Mini-Dose Glucagon for Treatment of Nonsevere Hypoglycemia in Adults With Type 1 Diabetes</title><title>The journal of clinical endocrinology and metabolism</title><addtitle>J Clin Endocrinol Metab</addtitle><description>Abstract Context Standard treatment of hypoglycemia is oral carbohydrate, but it often results in hyperglycemia and entails extra caloric intake. Objective To evaluate low-dose glucagon to treat mild hypoglycemia in ambulatory adults with type 1 diabetes (T1D). Design Randomized crossover trial (two 3-week periods). Setting Five U.S. diabetes clinics. Patients Twenty adults with T1D using an insulin pump and continuous glucose monitor (CGM) and experiencing frequent mild hypoglycemia. Intervention Nonaqueous mini-dose glucagon (MDG) (150 µg) to treat nonsevere hypoglycemia. Main Outcome Measures Successful treatment was defined as blood glucose (BG) ≥50 mg/dL 15 minutes and ≥70 mg/dL 30 minutes after intervention, on the study meter. Two authors, blinded to treatment arm, independently judged each event as a clinical success or failure. Results Sixteen participants (mean age 39 years, 75% female, mean diabetes duration 23 years, mean hemoglobin A1c 7.2%) had 118 analyzable events with initial BG of 50 to 69 mg/dL. Successful treatment criteria were met for 58 (94%) of 62 events during the MDG period and 53 (95%) of 56 events during the glucose tablets (TABS) period (adjusted P = 0.99). Clinical assessments of success for these events were 97% and 96%, respectively. CGM-measured time in range did not differ between treatment groups during the 2 hours after events, but TABS resulted in higher maximum glucose (116 vs 102 mg/dL; P = 0.01) over the first hour. Conclusions Low-dose glucagon can successfully treat mild hypoglycemia and may be a useful alternative to treatment with oral carbohydrate when trying to avoid unnecessary caloric intake. It was found that small doses of a nonaqueous form of glucagon can treat mild hypoglycemia and may be a useful alternative to oral carbohydrate when trying to avoid unnecessary caloric intake.</description><subject>Adult</subject><subject>Blood Glucose - metabolism</subject><subject>Blood Glucose Self-Monitoring</subject><subject>Carbohydrates</subject><subject>Cross-Over Studies</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Diabetes Mellitus, Type 1 - drug therapy</subject><subject>Female</subject><subject>Glucagon</subject><subject>Glucagon - administration &amp; dosage</subject><subject>Glucose</subject><subject>Hemoglobin</subject><subject>Hormones - administration &amp; dosage</subject><subject>Humans</subject><subject>Hyperglycemia</subject><subject>Hypoglycemia</subject><subject>Hypoglycemia - chemically induced</subject><subject>Hypoglycemia - drug therapy</subject><subject>Hypoglycemia - metabolism</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Insulin</subject><subject>Insulin - adverse effects</subject><subject>Insulin Infusion Systems</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Severity of Illness Index</subject><subject>Tablets</subject><issn>0021-972X</issn><issn>1945-7197</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp10k1v1DAQBmALUdGlcOSKLHHh4jL-yDo-Vm1pK5X2wCK4WY4z6WZJ4tROqPLvSdhSJKSeLEuPXo39DiHvOBxzweHTzh8L4JoBZIa_ICtuVMY0N_olWQEIzowWPw7J65R2AFypTL4ihyKfsdbrFenPq6r2zk_UdSX96iocJhoq-qXuanYWEtKLZvTuLnS0CpFuIrqhxW5YzE3oEv7CiPRy6sNdM3lsa0frjp6UYzMk-r0etnQz9Ug5PatdgQOmN-Sgck3Ct4_nEfn2-Xxzesmuby-uTk-umVcyN6xw3qhyrXKHSheZQlkUCLnzXHMAXYiyVJA5Ib2XAiWHtQfjEAxXoBRHeUQ-7nP7GO5HTINt6-SxaVyHYUyWG9BSSKOzmX74j-7CGLt5ullpAJDSyFmxvfIxpBSxsn2sWxcny8EuVdidt0sV9k8Vs3__mDoWLZZP-u_fz0DtwUNoBozpZzM-YLRbdM2wnUMA1FrnbImEfL6xZRLz72Fh7J8bYb8N8jfuJp5F</recordid><startdate>201708</startdate><enddate>201708</enddate><creator>Haymond, Morey W</creator><creator>DuBose, Stephanie N</creator><creator>Rickels, Michael R</creator><creator>Wolpert, Howard</creator><creator>Shah, Viral N</creator><creator>Sherr, Jennifer L</creator><creator>Weinstock, Ruth S</creator><creator>Agarwal, Shivani</creator><creator>Verdejo, Alandra S</creator><creator>Cummins, Martin J</creator><creator>Newswanger, Brett</creator><creator>Beck, Roy W</creator><general>Endocrine Society</general><general>Copyright Oxford University Press</general><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QP</scope><scope>7T5</scope><scope>7TM</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>201708</creationdate><title>Efficacy and Safety of Mini-Dose Glucagon for Treatment of Nonsevere Hypoglycemia in Adults With Type 1 Diabetes</title><author>Haymond, Morey W ; DuBose, Stephanie N ; Rickels, Michael R ; Wolpert, Howard ; Shah, Viral N ; Sherr, Jennifer L ; Weinstock, Ruth S ; Agarwal, Shivani ; Verdejo, Alandra S ; Cummins, Martin J ; Newswanger, Brett ; Beck, Roy W</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4389-bac94d648ae47b54e3bbe08ac171007b2dd405a23cc32e3106c09ae09140441e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adult</topic><topic>Blood Glucose - metabolism</topic><topic>Blood Glucose Self-Monitoring</topic><topic>Carbohydrates</topic><topic>Cross-Over Studies</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Diabetes Mellitus, Type 1 - drug therapy</topic><topic>Female</topic><topic>Glucagon</topic><topic>Glucagon - administration &amp; dosage</topic><topic>Glucose</topic><topic>Hemoglobin</topic><topic>Hormones - administration &amp; dosage</topic><topic>Humans</topic><topic>Hyperglycemia</topic><topic>Hypoglycemia</topic><topic>Hypoglycemia - chemically induced</topic><topic>Hypoglycemia - drug therapy</topic><topic>Hypoglycemia - metabolism</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Insulin</topic><topic>Insulin - adverse effects</topic><topic>Insulin Infusion Systems</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Severity of Illness Index</topic><topic>Tablets</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Haymond, Morey W</creatorcontrib><creatorcontrib>DuBose, Stephanie N</creatorcontrib><creatorcontrib>Rickels, Michael R</creatorcontrib><creatorcontrib>Wolpert, Howard</creatorcontrib><creatorcontrib>Shah, Viral N</creatorcontrib><creatorcontrib>Sherr, Jennifer L</creatorcontrib><creatorcontrib>Weinstock, Ruth S</creatorcontrib><creatorcontrib>Agarwal, Shivani</creatorcontrib><creatorcontrib>Verdejo, Alandra S</creatorcontrib><creatorcontrib>Cummins, Martin J</creatorcontrib><creatorcontrib>Newswanger, Brett</creatorcontrib><creatorcontrib>Beck, Roy W</creatorcontrib><creatorcontrib>T1D Exchange Mini-dose Glucagon Study Group</creatorcontrib><creatorcontrib>for the T1D Exchange Mini-dose Glucagon Study Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Calcium &amp; 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Objective To evaluate low-dose glucagon to treat mild hypoglycemia in ambulatory adults with type 1 diabetes (T1D). Design Randomized crossover trial (two 3-week periods). Setting Five U.S. diabetes clinics. Patients Twenty adults with T1D using an insulin pump and continuous glucose monitor (CGM) and experiencing frequent mild hypoglycemia. Intervention Nonaqueous mini-dose glucagon (MDG) (150 µg) to treat nonsevere hypoglycemia. Main Outcome Measures Successful treatment was defined as blood glucose (BG) ≥50 mg/dL 15 minutes and ≥70 mg/dL 30 minutes after intervention, on the study meter. Two authors, blinded to treatment arm, independently judged each event as a clinical success or failure. Results Sixteen participants (mean age 39 years, 75% female, mean diabetes duration 23 years, mean hemoglobin A1c 7.2%) had 118 analyzable events with initial BG of 50 to 69 mg/dL. Successful treatment criteria were met for 58 (94%) of 62 events during the MDG period and 53 (95%) of 56 events during the glucose tablets (TABS) period (adjusted P = 0.99). Clinical assessments of success for these events were 97% and 96%, respectively. CGM-measured time in range did not differ between treatment groups during the 2 hours after events, but TABS resulted in higher maximum glucose (116 vs 102 mg/dL; P = 0.01) over the first hour. Conclusions Low-dose glucagon can successfully treat mild hypoglycemia and may be a useful alternative to treatment with oral carbohydrate when trying to avoid unnecessary caloric intake. It was found that small doses of a nonaqueous form of glucagon can treat mild hypoglycemia and may be a useful alternative to oral carbohydrate when trying to avoid unnecessary caloric intake.</abstract><cop>Washington, DC</cop><pub>Endocrine Society</pub><pmid>28591776</pmid><doi>10.1210/jc.2017-00591</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record>
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subjects Adult
Blood Glucose - metabolism
Blood Glucose Self-Monitoring
Carbohydrates
Cross-Over Studies
Diabetes
Diabetes mellitus
Diabetes Mellitus, Type 1 - drug therapy
Female
Glucagon
Glucagon - administration & dosage
Glucose
Hemoglobin
Hormones - administration & dosage
Humans
Hyperglycemia
Hypoglycemia
Hypoglycemia - chemically induced
Hypoglycemia - drug therapy
Hypoglycemia - metabolism
Hypoglycemic Agents - adverse effects
Insulin
Insulin - adverse effects
Insulin Infusion Systems
Male
Middle Aged
Severity of Illness Index
Tablets
title Efficacy and Safety of Mini-Dose Glucagon for Treatment of Nonsevere Hypoglycemia in Adults With Type 1 Diabetes
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