Continuous subcutaneous insulin infusion versus multiple daily injection regimens in children and young people at diagnosis of type 1 diabetes: pragmatic randomised controlled trial and economic evaluation
AbstractObjectiveTo compare the efficacy, safety, and cost utility of continuous subcutaneous insulin infusion (CSII) with multiple daily injection (MDI) regimens during the first year following diagnosis of type 1 diabetes in children and young people.DesignPragmatic, multicentre, open label, paral...
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description | AbstractObjectiveTo compare the efficacy, safety, and cost utility of continuous subcutaneous insulin infusion (CSII) with multiple daily injection (MDI) regimens during the first year following diagnosis of type 1 diabetes in children and young people.DesignPragmatic, multicentre, open label, parallel group, randomised controlled trial and economic evaluation.Setting15 paediatric National Health Service (NHS) diabetes services in England and Wales. The study opened to recruitment in May 2011 and closed in January 2017.ParticipantsPatients aged between 7 months and 15 years, with a new diagnosis of type 1 diabetes were eligible to participate. Patients who had a sibling with the disease, and those who took drug treatments or had additional diagnoses that could have affected glycaemic control were ineligible.InterventionsParticipants were randomised, stratified by age and treating centre, to start treatment with CSII or MDI within 14 days of diagnosis. Starting doses of aspart (CSII and MDI) and glargine or detemir (MDI) were calculated according to weight and age, and titrated according to blood glucose measurements and according to local clinical practice.Main outcome measuresPrimary outcome was glycaemic control (as measured by glycated haemoglobin; HbA1c) at 12 months. Secondary outcomes were percentage of patients in each treatment arm with HbA1c within the national target range, incidence of severe hypoglycaemia and diabetic ketoacidosis, change in height and body mass index (as measured by standard deviation scores), insulin requirements (units/kg/day), partial remission rate (insulin dose adjusted HbA1c |
doi_str_mv | 10.1136/bmj.l1226 |
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The study opened to recruitment in May 2011 and closed in January 2017.ParticipantsPatients aged between 7 months and 15 years, with a new diagnosis of type 1 diabetes were eligible to participate. Patients who had a sibling with the disease, and those who took drug treatments or had additional diagnoses that could have affected glycaemic control were ineligible.InterventionsParticipants were randomised, stratified by age and treating centre, to start treatment with CSII or MDI within 14 days of diagnosis. Starting doses of aspart (CSII and MDI) and glargine or detemir (MDI) were calculated according to weight and age, and titrated according to blood glucose measurements and according to local clinical practice.Main outcome measuresPrimary outcome was glycaemic control (as measured by glycated haemoglobin; HbA1c) at 12 months. Secondary outcomes were percentage of patients in each treatment arm with HbA1c within the national target range, incidence of severe hypoglycaemia and diabetic ketoacidosis, change in height and body mass index (as measured by standard deviation scores), insulin requirements (units/kg/day), partial remission rate (insulin dose adjusted HbA1c <9), paediatric quality of life inventory score, and cost utility based on the incremental cost per quality adjusted life year (QALY) gained from an NHS costing perspective.Results294 participants were randomised and 293 included in intention to treat analyses (CSI, n=144; MDI, n=149). At 12 months, mean HbA1c was comparable with clinically unimportant differences between CSII and MDI participants (60.9 mmol/mol v 58.5 mmol/mol, mean difference 2.4 mmol/mol (95% confidence interval −0.4 to 5.3), P=0.09). Achievement of HbA1c lower than 58 mmol/mol was low among the two groups (66/143 (46%) CSII participants v 78/142 (55%) MDI participants; relative risk 0.84 (95% confidence interval 0.67 to 1.06)). Incidence of severe hypoglycaemia and diabetic ketoacidosis were low in both groups. Fifty four non-serious and 14 serious adverse events were reported during CSII treatment, and 17 non-serious and eight serious adverse events during MDI treatment. Parents (but not children) reported superior PedsQL scores for those patients treated with CSII compared to those treated with MDI. CSII was more expensive than MDI by £1863 (€2179; $2474; 95% confidence interval £1620 to £2137) per patient, with no additional QALY gains (difference −0.006 (95% confidence interval −0.031 to 0.018)).ConclusionDuring the first year following type 1 diabetes diagnosis, no clinical benefit of CSII over MDI was identified in children and young people in the UK setting, and treatment with either regimen was suboptimal in achieving HbA1c thresholds. CSII was not cost effective.Trial registrationCurrent Controlled Trials ISRCTN29255275; European Clinical Trials Database 2010-023792-25.</description><identifier>ISSN: 0959-8138</identifier><identifier>EISSN: 1756-1833</identifier><identifier>DOI: 10.1136/bmj.l1226</identifier><identifier>PMID: 30944112</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Adolescent ; Bias ; Body mass index ; Child ; Child, Preschool ; Children ; Clinical trials ; Cost-Benefit Analysis ; Diabetes ; Diabetes mellitus ; Diabetes mellitus (insulin dependent) ; Diabetes Mellitus, Type 1 - drug therapy ; Diabetes Mellitus, Type 1 - economics ; Diagnosis ; Economics ; Education ; Ethnicity ; Evidence-based medicine ; Hemoglobin ; Humans ; Hypoglycemia ; Hypoglycemic Agents - administration & dosage ; Hypoglycemic Agents - adverse effects ; Hypoglycemic Agents - economics ; Infant ; Injection ; Injections, Subcutaneous ; Insulin ; Insulin - administration & dosage ; Insulin - adverse effects ; Insulin - economics ; Insulin Infusion Systems ; Ketoacidosis ; Medical diagnosis ; Patients ; Pediatrics ; Quality of Life ; Quality-Adjusted Life Years ; Remission ; Systematic review ; Teenagers ; Treatment Outcome ; Young adults</subject><ispartof>BMJ (Online), 2019-04, Vol.365, p.l1226-l1226</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions 2019 BMJ This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to 2019 BMJ</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b432t-2900b56ea2376661957894059c9e24e9da982a0ff389ecec7b3bdc4eb1aced1e3</citedby><cites>FETCH-LOGICAL-b432t-2900b56ea2376661957894059c9e24e9da982a0ff389ecec7b3bdc4eb1aced1e3</cites><orcidid>0000-0003-3128-5574</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30944112$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Blair, Joanne C</creatorcontrib><creatorcontrib>McKay, Andrew</creatorcontrib><creatorcontrib>Ridyard, Colin</creatorcontrib><creatorcontrib>Thornborough, Keith</creatorcontrib><creatorcontrib>Bedson, Emma</creatorcontrib><creatorcontrib>Peak, Matthew</creatorcontrib><creatorcontrib>Didi, Mohammed</creatorcontrib><creatorcontrib>Annan, Francesca</creatorcontrib><creatorcontrib>Gregory, John W</creatorcontrib><creatorcontrib>Hughes, Dyfrig A</creatorcontrib><creatorcontrib>Gamble, Carrol</creatorcontrib><creatorcontrib>SCIPI investigators</creatorcontrib><title>Continuous subcutaneous insulin infusion versus multiple daily injection regimens in children and young people at diagnosis of type 1 diabetes: pragmatic randomised controlled trial and economic evaluation</title><title>BMJ (Online)</title><addtitle>BMJ</addtitle><description>AbstractObjectiveTo compare the efficacy, safety, and cost utility of continuous subcutaneous insulin infusion (CSII) with multiple daily injection (MDI) regimens during the first year following diagnosis of type 1 diabetes in children and young people.DesignPragmatic, multicentre, open label, parallel group, randomised controlled trial and economic evaluation.Setting15 paediatric National Health Service (NHS) diabetes services in England and Wales. The study opened to recruitment in May 2011 and closed in January 2017.ParticipantsPatients aged between 7 months and 15 years, with a new diagnosis of type 1 diabetes were eligible to participate. Patients who had a sibling with the disease, and those who took drug treatments or had additional diagnoses that could have affected glycaemic control were ineligible.InterventionsParticipants were randomised, stratified by age and treating centre, to start treatment with CSII or MDI within 14 days of diagnosis. Starting doses of aspart (CSII and MDI) and glargine or detemir (MDI) were calculated according to weight and age, and titrated according to blood glucose measurements and according to local clinical practice.Main outcome measuresPrimary outcome was glycaemic control (as measured by glycated haemoglobin; HbA1c) at 12 months. Secondary outcomes were percentage of patients in each treatment arm with HbA1c within the national target range, incidence of severe hypoglycaemia and diabetic ketoacidosis, change in height and body mass index (as measured by standard deviation scores), insulin requirements (units/kg/day), partial remission rate (insulin dose adjusted HbA1c <9), paediatric quality of life inventory score, and cost utility based on the incremental cost per quality adjusted life year (QALY) gained from an NHS costing perspective.Results294 participants were randomised and 293 included in intention to treat analyses (CSI, n=144; MDI, n=149). At 12 months, mean HbA1c was comparable with clinically unimportant differences between CSII and MDI participants (60.9 mmol/mol v 58.5 mmol/mol, mean difference 2.4 mmol/mol (95% confidence interval −0.4 to 5.3), P=0.09). Achievement of HbA1c lower than 58 mmol/mol was low among the two groups (66/143 (46%) CSII participants v 78/142 (55%) MDI participants; relative risk 0.84 (95% confidence interval 0.67 to 1.06)). Incidence of severe hypoglycaemia and diabetic ketoacidosis were low in both groups. Fifty four non-serious and 14 serious adverse events were reported during CSII treatment, and 17 non-serious and eight serious adverse events during MDI treatment. Parents (but not children) reported superior PedsQL scores for those patients treated with CSII compared to those treated with MDI. CSII was more expensive than MDI by £1863 (€2179; $2474; 95% confidence interval £1620 to £2137) per patient, with no additional QALY gains (difference −0.006 (95% confidence interval −0.031 to 0.018)).ConclusionDuring the first year following type 1 diabetes diagnosis, no clinical benefit of CSII over MDI was identified in children and young people in the UK setting, and treatment with either regimen was suboptimal in achieving HbA1c thresholds. CSII was not cost effective.Trial registrationCurrent Controlled Trials ISRCTN29255275; European Clinical Trials Database 2010-023792-25.</description><subject>Adolescent</subject><subject>Bias</subject><subject>Body mass index</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Children</subject><subject>Clinical trials</subject><subject>Cost-Benefit Analysis</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Diabetes mellitus (insulin dependent)</subject><subject>Diabetes Mellitus, Type 1 - drug therapy</subject><subject>Diabetes Mellitus, Type 1 - economics</subject><subject>Diagnosis</subject><subject>Economics</subject><subject>Education</subject><subject>Ethnicity</subject><subject>Evidence-based medicine</subject><subject>Hemoglobin</subject><subject>Humans</subject><subject>Hypoglycemia</subject><subject>Hypoglycemic Agents - administration & dosage</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Hypoglycemic Agents - economics</subject><subject>Infant</subject><subject>Injection</subject><subject>Injections, Subcutaneous</subject><subject>Insulin</subject><subject>Insulin - administration & dosage</subject><subject>Insulin - adverse effects</subject><subject>Insulin - economics</subject><subject>Insulin Infusion Systems</subject><subject>Ketoacidosis</subject><subject>Medical diagnosis</subject><subject>Patients</subject><subject>Pediatrics</subject><subject>Quality of Life</subject><subject>Quality-Adjusted Life Years</subject><subject>Remission</subject><subject>Systematic review</subject><subject>Teenagers</subject><subject>Treatment Outcome</subject><subject>Young adults</subject><issn>0959-8138</issn><issn>1756-1833</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp1kk1v1DAQhiMEoqvSA38AWYIDPaT4I3FiDpXQqnxIlbjAOXKcydYrxw7-WGl_JP8Ju1sqQOI09swzr94ZTVW9JPiKEMbfjcv-yhBK-ZNqQ7qW16Rn7Gm1waIVdU9Yf1ZdhLDHGFPW9YK3z6szhkXTEEI31c-ts1Hb5FJAIY0qRWmhfLQNyWib45yCdhYdwIecX5KJejWAJqnNMZf3oGKpe9jpBWzpROpOm8mDRdJO6OiS3aEVXOmSEU1a7qwLOiA3o3hcAZGSGyFCeI9WL3eLjFohn5vdogNMSGWT3hmTn9Frae51IWdzXSE4SJNkMfGiejZLE-DiIZ5X3z_efNt-rm-_fvqy_XBbjw2jsaYC47HlIPNGOOdEtHkxDW6FEkAbEJMUPZV4nlkvQIHqRjZOqoGRSAUTAXZeXZ901zQuMCnI9qQZVq8X6Y-Dk3r4u2L13bBzh4E3DccdzwJvHwS8-5EgxCEPqsCY0_YHSjEjjHadyOjrf9C9S97m8QpFO0poU6jLE6W8C8HD_GiG4KHcyZDvZLi_k8y--tP9I_n7KjLw5gSUnv_r_AJDdswZ</recordid><startdate>20190403</startdate><enddate>20190403</enddate><creator>Blair, Joanne C</creator><creator>McKay, Andrew</creator><creator>Ridyard, Colin</creator><creator>Thornborough, Keith</creator><creator>Bedson, Emma</creator><creator>Peak, Matthew</creator><creator>Didi, Mohammed</creator><creator>Annan, Francesca</creator><creator>Gregory, John W</creator><creator>Hughes, Dyfrig A</creator><creator>Gamble, Carrol</creator><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group Ltd</general><scope>9YT</scope><scope>ACMMV</scope><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>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88I</scope><scope>8AF</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>ASE</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FPQ</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K6X</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M2O</scope><scope>M2P</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-3128-5574</orcidid></search><sort><creationdate>20190403</creationdate><title>Continuous subcutaneous insulin infusion versus multiple daily injection regimens in children and young people at diagnosis of type 1 diabetes: pragmatic randomised controlled trial and economic evaluation</title><author>Blair, Joanne C ; McKay, Andrew ; Ridyard, Colin ; Thornborough, Keith ; Bedson, Emma ; Peak, Matthew ; Didi, Mohammed ; Annan, Francesca ; Gregory, John W ; Hughes, Dyfrig A ; Gamble, Carrol</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b432t-2900b56ea2376661957894059c9e24e9da982a0ff389ecec7b3bdc4eb1aced1e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adolescent</topic><topic>Bias</topic><topic>Body mass index</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Children</topic><topic>Clinical trials</topic><topic>Cost-Benefit Analysis</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Diabetes mellitus (insulin dependent)</topic><topic>Diabetes Mellitus, Type 1 - drug therapy</topic><topic>Diabetes Mellitus, Type 1 - economics</topic><topic>Diagnosis</topic><topic>Economics</topic><topic>Education</topic><topic>Ethnicity</topic><topic>Evidence-based medicine</topic><topic>Hemoglobin</topic><topic>Humans</topic><topic>Hypoglycemia</topic><topic>Hypoglycemic Agents - administration & dosage</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Hypoglycemic Agents - economics</topic><topic>Infant</topic><topic>Injection</topic><topic>Injections, Subcutaneous</topic><topic>Insulin</topic><topic>Insulin - administration & dosage</topic><topic>Insulin - adverse effects</topic><topic>Insulin - economics</topic><topic>Insulin Infusion Systems</topic><topic>Ketoacidosis</topic><topic>Medical diagnosis</topic><topic>Patients</topic><topic>Pediatrics</topic><topic>Quality of Life</topic><topic>Quality-Adjusted Life Years</topic><topic>Remission</topic><topic>Systematic review</topic><topic>Teenagers</topic><topic>Treatment Outcome</topic><topic>Young adults</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Blair, Joanne C</creatorcontrib><creatorcontrib>McKay, Andrew</creatorcontrib><creatorcontrib>Ridyard, Colin</creatorcontrib><creatorcontrib>Thornborough, Keith</creatorcontrib><creatorcontrib>Bedson, Emma</creatorcontrib><creatorcontrib>Peak, Matthew</creatorcontrib><creatorcontrib>Didi, Mohammed</creatorcontrib><creatorcontrib>Annan, Francesca</creatorcontrib><creatorcontrib>Gregory, John W</creatorcontrib><creatorcontrib>Hughes, Dyfrig A</creatorcontrib><creatorcontrib>Gamble, Carrol</creatorcontrib><creatorcontrib>SCIPI investigators</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><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>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Index</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>SciTech Premium Collection</collection><collection>British Nursing Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ (Online)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Blair, Joanne C</au><au>McKay, Andrew</au><au>Ridyard, Colin</au><au>Thornborough, Keith</au><au>Bedson, Emma</au><au>Peak, Matthew</au><au>Didi, Mohammed</au><au>Annan, Francesca</au><au>Gregory, John W</au><au>Hughes, Dyfrig A</au><au>Gamble, Carrol</au><aucorp>SCIPI investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Continuous subcutaneous insulin infusion versus multiple daily injection regimens in children and young people at diagnosis of type 1 diabetes: pragmatic randomised controlled trial and economic evaluation</atitle><jtitle>BMJ (Online)</jtitle><addtitle>BMJ</addtitle><date>2019-04-03</date><risdate>2019</risdate><volume>365</volume><spage>l1226</spage><epage>l1226</epage><pages>l1226-l1226</pages><issn>0959-8138</issn><eissn>1756-1833</eissn><abstract>AbstractObjectiveTo compare the efficacy, safety, and cost utility of continuous subcutaneous insulin infusion (CSII) with multiple daily injection (MDI) regimens during the first year following diagnosis of type 1 diabetes in children and young people.DesignPragmatic, multicentre, open label, parallel group, randomised controlled trial and economic evaluation.Setting15 paediatric National Health Service (NHS) diabetes services in England and Wales. The study opened to recruitment in May 2011 and closed in January 2017.ParticipantsPatients aged between 7 months and 15 years, with a new diagnosis of type 1 diabetes were eligible to participate. Patients who had a sibling with the disease, and those who took drug treatments or had additional diagnoses that could have affected glycaemic control were ineligible.InterventionsParticipants were randomised, stratified by age and treating centre, to start treatment with CSII or MDI within 14 days of diagnosis. Starting doses of aspart (CSII and MDI) and glargine or detemir (MDI) were calculated according to weight and age, and titrated according to blood glucose measurements and according to local clinical practice.Main outcome measuresPrimary outcome was glycaemic control (as measured by glycated haemoglobin; HbA1c) at 12 months. Secondary outcomes were percentage of patients in each treatment arm with HbA1c within the national target range, incidence of severe hypoglycaemia and diabetic ketoacidosis, change in height and body mass index (as measured by standard deviation scores), insulin requirements (units/kg/day), partial remission rate (insulin dose adjusted HbA1c <9), paediatric quality of life inventory score, and cost utility based on the incremental cost per quality adjusted life year (QALY) gained from an NHS costing perspective.Results294 participants were randomised and 293 included in intention to treat analyses (CSI, n=144; MDI, n=149). At 12 months, mean HbA1c was comparable with clinically unimportant differences between CSII and MDI participants (60.9 mmol/mol v 58.5 mmol/mol, mean difference 2.4 mmol/mol (95% confidence interval −0.4 to 5.3), P=0.09). Achievement of HbA1c lower than 58 mmol/mol was low among the two groups (66/143 (46%) CSII participants v 78/142 (55%) MDI participants; relative risk 0.84 (95% confidence interval 0.67 to 1.06)). Incidence of severe hypoglycaemia and diabetic ketoacidosis were low in both groups. Fifty four non-serious and 14 serious adverse events were reported during CSII treatment, and 17 non-serious and eight serious adverse events during MDI treatment. Parents (but not children) reported superior PedsQL scores for those patients treated with CSII compared to those treated with MDI. CSII was more expensive than MDI by £1863 (€2179; $2474; 95% confidence interval £1620 to £2137) per patient, with no additional QALY gains (difference −0.006 (95% confidence interval −0.031 to 0.018)).ConclusionDuring the first year following type 1 diabetes diagnosis, no clinical benefit of CSII over MDI was identified in children and young people in the UK setting, and treatment with either regimen was suboptimal in achieving HbA1c thresholds. CSII was not cost effective.Trial registrationCurrent Controlled Trials ISRCTN29255275; European Clinical Trials Database 2010-023792-25.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>30944112</pmid><doi>10.1136/bmj.l1226</doi><orcidid>https://orcid.org/0000-0003-3128-5574</orcidid><oa>free_for_read</oa></addata></record> |
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identifier | ISSN: 0959-8138 |
ispartof | BMJ (Online), 2019-04, Vol.365, p.l1226-l1226 |
issn | 0959-8138 1756-1833 |
language | eng |
recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6446076 |
source | Jstor Complete Legacy; MEDLINE |
subjects | Adolescent Bias Body mass index Child Child, Preschool Children Clinical trials Cost-Benefit Analysis Diabetes Diabetes mellitus Diabetes mellitus (insulin dependent) Diabetes Mellitus, Type 1 - drug therapy Diabetes Mellitus, Type 1 - economics Diagnosis Economics Education Ethnicity Evidence-based medicine Hemoglobin Humans Hypoglycemia Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - adverse effects Hypoglycemic Agents - economics Infant Injection Injections, Subcutaneous Insulin Insulin - administration & dosage Insulin - adverse effects Insulin - economics Insulin Infusion Systems Ketoacidosis Medical diagnosis Patients Pediatrics Quality of Life Quality-Adjusted Life Years Remission Systematic review Teenagers Treatment Outcome Young adults |
title | Continuous subcutaneous insulin infusion versus multiple daily injection regimens in children and young people at diagnosis of type 1 diabetes: pragmatic randomised controlled trial and economic evaluation |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-08T07%3A53%3A36IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Continuous%20subcutaneous%20insulin%20infusion%20versus%20multiple%20daily%20injection%20regimens%20in%20children%20and%20young%20people%20at%20diagnosis%20of%20type%201%20diabetes:%20pragmatic%20randomised%20controlled%20trial%20and%20economic%20evaluation&rft.jtitle=BMJ%20(Online)&rft.au=Blair,%20Joanne%20C&rft.aucorp=SCIPI%20investigators&rft.date=2019-04-03&rft.volume=365&rft.spage=l1226&rft.epage=l1226&rft.pages=l1226-l1226&rft.issn=0959-8138&rft.eissn=1756-1833&rft_id=info:doi/10.1136/bmj.l1226&rft_dat=%3Cproquest_pubme%3E2202721249%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2202721249&rft_id=info:pmid/30944112&rfr_iscdi=true |