Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data

Objective To determine the clinical effectiveness of real time continuous glucose monitoring compared with self monitoring of blood glucose in type 1 diabetes.Design Meta-analysis of randomised controlled trials.Data sources Cochrane database for randomised controlled trials, Ovid Medline, Embase, G...

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Veröffentlicht in:BMJ 2011-07, Vol.343 (7815), p.138-138
Hauptverfasser: Pickup, John C, Freeman, Suzanne C, Sutton, Alex J
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Freeman, Suzanne C
Sutton, Alex J
description Objective To determine the clinical effectiveness of real time continuous glucose monitoring compared with self monitoring of blood glucose in type 1 diabetes.Design Meta-analysis of randomised controlled trials.Data sources Cochrane database for randomised controlled trials, Ovid Medline, Embase, Google Scholar, lists of papers supplied by manufacturers of continuous glucose monitors, and cited literature in retrieved articles.Studies reviewed Randomised controlled trials of two or more months’ duration in men and non-pregnant women with type 1 diabetes that compared real time continuous glucose monitoring with self monitoring of blood glucose and where insulin delivery was the same in both arms.Analysis Two step meta-analysis of individual patient data with the primary outcome of final glycated haemoglobin (HbA1c) percentage and area under the curve of hypoglycaemia (glucose concentration
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The overall mean difference in HbA1c for continuous glucose monitoring versus self monitoring of blood glucose was −0.30% (95% confidence interval −0.43% to −0.17%) (−3.0, −4.3 to −1.7 mmol/mol). A best fit regression model of determinants of final HbA1c showed that for every one day increase of sensor usage per week the effect of continuous glucose monitoring versus self monitoring of blood glucose increased by 0.150% (95% credibility interval −0.194% to −0.106%) (1.5, −1.9 to −1.1 mmol/mol) and every 1% (10 mmol/mol) increase in baseline HbA1c increased the effect by 0.126% (−0.257% to 0.0007%) (1.3, −2.6 to 0.0 mmol/mol). The model estimates that, for example, a patient using the sensor continuously would experience a reduction in HbA1c of about 0.9% (9 mmol/mol) when the baseline HbA1c is 10% (86 mmol/mol). The overall reduction in area under the curve of hypoglycaemia was −0.28 (−0.46 to −0.09), corresponding to a reduction in median exposure to hypoglycaemia of 23% for continuous glucose monitoring compared with self monitoring of blood glucose. In a best fit regression model, baseline area under the curve of hypoglycaemia was only weakly related to the effect of continuous glucose monitoring compared with self monitoring of blood glucose on hypoglycaemia outcome, and sensor usage was unrelated to hypoglycaemia at outcome.Conclusions Continuous glucose monitoring was associated with a significant reduction in HbA1c percentage, which was greatest in those with the highest HbA1c at baseline and who most frequently used the sensors. Exposure to hypoglycaemia was also reduced during continuous glucose monitoring. The most cost effective or appropriate use of continuous glucose monitoring is likely to be when targeted at people with type 1 diabetes who have continued poor control during intensified insulin therapy and who frequently use continuous glucose monitoring.</description><edition>International edition</edition><identifier>ISSN: 0959-8138</identifier><identifier>ISSN: 0959-8146</identifier><identifier>ISSN: 0959-535X</identifier><identifier>EISSN: 1468-5833</identifier><identifier>EISSN: 1756-1833</identifier><identifier>DOI: 10.1136/bmj.d3805</identifier><identifier>PMID: 21737469</identifier><identifier>CODEN: BMJOAE</identifier><language>eng</language><publisher>England: British Medical Journal Publishing Group</publisher><subject>Adult ; Blood ; Blood glucose ; Blood Glucose - metabolism ; Blood Glucose Self-Monitoring ; Clinical trials ; Clinical Trials (Epidemiology) ; Confidence intervals ; Diabetes ; Diabetes mellitus ; Diabetes Mellitus, Type 1 - blood ; Diabetes Mellitus, Type 1 - prevention &amp; control ; Evidence-based medicine ; Experimentation ; Female ; Glucose ; Glucose monitoring ; Glycated Hemoglobin A - metabolism ; Hemoglobin ; Humans ; Hypoglycaemia ; Hypoglycemia ; Hypoglycemia - metabolism ; Hypoglycemia - prevention &amp; control ; Immunology (Including Allergy) ; Insulin ; Internet ; Male ; Meta analysis ; Metabolic Disorders ; Pregnancy ; Quantitative Research ; Randomized Controlled Trials as Topic ; Real time ; Self ; Sensors ; Treatment Outcome ; Type 1 diabetes mellitus ; Young Adult</subject><ispartof>BMJ, 2011-07, Vol.343 (7815), p.138-138</ispartof><rights>Pickup et al 2011</rights><rights>BMJ Publishing Group Ltd 2011</rights><rights>Copyright: 2011 © Pickup et al 2011</rights><rights>Copyright BMJ Publishing Group Jul 16, 2011</rights><rights>Pickup et al 2011 2011 Pickup et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b550t-624ae34843245bc8358154eb3785b1c45fd209ab573cea43ebd1aabb9b04f9ef3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://bmj.com/content/343/bmj.d3805.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttp://bmj.com/content/343/bmj.d3805.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>114,115,230,314,780,784,803,885,3196,23571,27924,27925,30999,31000,58017,58250,77600,77631</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21737469$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pickup, John C</creatorcontrib><creatorcontrib>Freeman, Suzanne C</creatorcontrib><creatorcontrib>Sutton, Alex J</creatorcontrib><title>Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data</title><title>BMJ</title><addtitle>BMJ</addtitle><description>Objective To determine the clinical effectiveness of real time continuous glucose monitoring compared with self monitoring of blood glucose in type 1 diabetes.Design Meta-analysis of randomised controlled trials.Data sources Cochrane database for randomised controlled trials, Ovid Medline, Embase, Google Scholar, lists of papers supplied by manufacturers of continuous glucose monitors, and cited literature in retrieved articles.Studies reviewed Randomised controlled trials of two or more months’ duration in men and non-pregnant women with type 1 diabetes that compared real time continuous glucose monitoring with self monitoring of blood glucose and where insulin delivery was the same in both arms.Analysis Two step meta-analysis of individual patient data with the primary outcome of final glycated haemoglobin (HbA1c) percentage and area under the curve of hypoglycaemia (glucose concentration &lt;3.9 mmol/L) during either treatment, followed by one step metaregression exploring patient level determinants of HbA1c and hypoglycaemia.Results Six trials were identified, consisting of 449 patients randomised to continuous glucose monitoring and 443 to self monitoring of blood glucose. The overall mean difference in HbA1c for continuous glucose monitoring versus self monitoring of blood glucose was −0.30% (95% confidence interval −0.43% to −0.17%) (−3.0, −4.3 to −1.7 mmol/mol). A best fit regression model of determinants of final HbA1c showed that for every one day increase of sensor usage per week the effect of continuous glucose monitoring versus self monitoring of blood glucose increased by 0.150% (95% credibility interval −0.194% to −0.106%) (1.5, −1.9 to −1.1 mmol/mol) and every 1% (10 mmol/mol) increase in baseline HbA1c increased the effect by 0.126% (−0.257% to 0.0007%) (1.3, −2.6 to 0.0 mmol/mol). The model estimates that, for example, a patient using the sensor continuously would experience a reduction in HbA1c of about 0.9% (9 mmol/mol) when the baseline HbA1c is 10% (86 mmol/mol). The overall reduction in area under the curve of hypoglycaemia was −0.28 (−0.46 to −0.09), corresponding to a reduction in median exposure to hypoglycaemia of 23% for continuous glucose monitoring compared with self monitoring of blood glucose. In a best fit regression model, baseline area under the curve of hypoglycaemia was only weakly related to the effect of continuous glucose monitoring compared with self monitoring of blood glucose on hypoglycaemia outcome, and sensor usage was unrelated to hypoglycaemia at outcome.Conclusions Continuous glucose monitoring was associated with a significant reduction in HbA1c percentage, which was greatest in those with the highest HbA1c at baseline and who most frequently used the sensors. Exposure to hypoglycaemia was also reduced during continuous glucose monitoring. The most cost effective or appropriate use of continuous glucose monitoring is likely to be when targeted at people with type 1 diabetes who have continued poor control during intensified insulin therapy and who frequently use continuous glucose monitoring.</description><subject>Adult</subject><subject>Blood</subject><subject>Blood glucose</subject><subject>Blood Glucose - metabolism</subject><subject>Blood Glucose Self-Monitoring</subject><subject>Clinical trials</subject><subject>Clinical Trials (Epidemiology)</subject><subject>Confidence intervals</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Diabetes Mellitus, Type 1 - blood</subject><subject>Diabetes Mellitus, Type 1 - prevention &amp; control</subject><subject>Evidence-based medicine</subject><subject>Experimentation</subject><subject>Female</subject><subject>Glucose</subject><subject>Glucose monitoring</subject><subject>Glycated Hemoglobin A - metabolism</subject><subject>Hemoglobin</subject><subject>Humans</subject><subject>Hypoglycaemia</subject><subject>Hypoglycemia</subject><subject>Hypoglycemia - metabolism</subject><subject>Hypoglycemia - prevention &amp; control</subject><subject>Immunology (Including Allergy)</subject><subject>Insulin</subject><subject>Internet</subject><subject>Male</subject><subject>Meta analysis</subject><subject>Metabolic Disorders</subject><subject>Pregnancy</subject><subject>Quantitative Research</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Real time</subject><subject>Self</subject><subject>Sensors</subject><subject>Treatment Outcome</subject><subject>Type 1 diabetes mellitus</subject><subject>Young Adult</subject><issn>0959-8138</issn><issn>0959-8146</issn><issn>0959-535X</issn><issn>1468-5833</issn><issn>1756-1833</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><sourceid>7QJ</sourceid><recordid>eNqFkt9uFCEUxidGY5u1Fz6AhqiJ8WLqMMAMeGFiNlqNm3rjn0sCA7NlZWALTHWf0leS2d2u1aTxgkDy_fg45_AVxUNYnUKImpdyWJ0qRCtypziGuKEloQjdLY4rRlhJIaJHxUmMq6qqatRS1pD7xVENW9Tihh0Xv87sphN6MB3ovEvBW2AcSJu1BhAoI6ROOgI1BuOWIGhhQTKD3rLGjX6MYGnHzkcNBu9M8luu88NaBK3AD5MuQNS2v6n6Hkjrvbq--QoMOolSOGE30cRJD8IpP5iYLfZV2XxMwQgbwRgnF-OUuTJqzBWtRTLaJaBEEg-Ke32G9Ml-nxVf3r39PH9fLj6dfZi_WZSSkCqVTY2FRphiVGMiO4oIhQRrmSdEJOww6VVdMSFJizotMNJSQSGkZLLCPdM9mhWvd77rUQ5adfn9ICxfBzOIsOFeGP634swFX_orjiCCEDbZ4PneIPjLUcfEc7-dtlY4ncfKKW0xq_Mf_p9sSVvXbf7qWfHkH3Llx5DnOtkh3MK8MvT0NggyjBiErKWZerGjuuBjDLo_tAYrPuWO59zxbe4y-_jmLA7kdcoy8GgHrGLOwB8dVQTWBGW93OkmJv3zoIvwnTfZgvDzr3O-OP9I2TdU88nv2Y6fari9rt8Cxv2p</recordid><startdate>20110707</startdate><enddate>20110707</enddate><creator>Pickup, John C</creator><creator>Freeman, Suzanne C</creator><creator>Sutton, Alex J</creator><general>British Medical Journal Publishing Group</general><general>BMJ Publishing Group</general><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group Ltd</general><scope>9YT</scope><scope>ACMMV</scope><scope>BSCLL</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>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>Q9U</scope><scope>7QJ</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20110707</creationdate><title>Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data</title><author>Pickup, John C ; Freeman, Suzanne C ; Sutton, Alex J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b550t-624ae34843245bc8358154eb3785b1c45fd209ab573cea43ebd1aabb9b04f9ef3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adult</topic><topic>Blood</topic><topic>Blood glucose</topic><topic>Blood Glucose - metabolism</topic><topic>Blood Glucose Self-Monitoring</topic><topic>Clinical trials</topic><topic>Clinical Trials (Epidemiology)</topic><topic>Confidence intervals</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Diabetes Mellitus, Type 1 - blood</topic><topic>Diabetes Mellitus, Type 1 - prevention &amp; control</topic><topic>Evidence-based medicine</topic><topic>Experimentation</topic><topic>Female</topic><topic>Glucose</topic><topic>Glucose monitoring</topic><topic>Glycated Hemoglobin A - metabolism</topic><topic>Hemoglobin</topic><topic>Humans</topic><topic>Hypoglycaemia</topic><topic>Hypoglycemia</topic><topic>Hypoglycemia - metabolism</topic><topic>Hypoglycemia - prevention &amp; control</topic><topic>Immunology (Including Allergy)</topic><topic>Insulin</topic><topic>Internet</topic><topic>Male</topic><topic>Meta analysis</topic><topic>Metabolic Disorders</topic><topic>Pregnancy</topic><topic>Quantitative Research</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Real time</topic><topic>Self</topic><topic>Sensors</topic><topic>Treatment Outcome</topic><topic>Type 1 diabetes mellitus</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pickup, John C</creatorcontrib><creatorcontrib>Freeman, Suzanne C</creatorcontrib><creatorcontrib>Sutton, Alex J</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>Istex</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 &amp; 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Medical Complete (Alumni)</collection><collection>Nursing &amp; 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 &amp; 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 Basic</collection><collection>Applied Social Sciences Index &amp; Abstracts (ASSIA)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pickup, John C</au><au>Freeman, Suzanne C</au><au>Sutton, Alex J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data</atitle><jtitle>BMJ</jtitle><addtitle>BMJ</addtitle><date>2011-07-07</date><risdate>2011</risdate><volume>343</volume><issue>7815</issue><spage>138</spage><epage>138</epage><pages>138-138</pages><issn>0959-8138</issn><issn>0959-8146</issn><issn>0959-535X</issn><eissn>1468-5833</eissn><eissn>1756-1833</eissn><coden>BMJOAE</coden><abstract>Objective To determine the clinical effectiveness of real time continuous glucose monitoring compared with self monitoring of blood glucose in type 1 diabetes.Design Meta-analysis of randomised controlled trials.Data sources Cochrane database for randomised controlled trials, Ovid Medline, Embase, Google Scholar, lists of papers supplied by manufacturers of continuous glucose monitors, and cited literature in retrieved articles.Studies reviewed Randomised controlled trials of two or more months’ duration in men and non-pregnant women with type 1 diabetes that compared real time continuous glucose monitoring with self monitoring of blood glucose and where insulin delivery was the same in both arms.Analysis Two step meta-analysis of individual patient data with the primary outcome of final glycated haemoglobin (HbA1c) percentage and area under the curve of hypoglycaemia (glucose concentration &lt;3.9 mmol/L) during either treatment, followed by one step metaregression exploring patient level determinants of HbA1c and hypoglycaemia.Results Six trials were identified, consisting of 449 patients randomised to continuous glucose monitoring and 443 to self monitoring of blood glucose. The overall mean difference in HbA1c for continuous glucose monitoring versus self monitoring of blood glucose was −0.30% (95% confidence interval −0.43% to −0.17%) (−3.0, −4.3 to −1.7 mmol/mol). A best fit regression model of determinants of final HbA1c showed that for every one day increase of sensor usage per week the effect of continuous glucose monitoring versus self monitoring of blood glucose increased by 0.150% (95% credibility interval −0.194% to −0.106%) (1.5, −1.9 to −1.1 mmol/mol) and every 1% (10 mmol/mol) increase in baseline HbA1c increased the effect by 0.126% (−0.257% to 0.0007%) (1.3, −2.6 to 0.0 mmol/mol). The model estimates that, for example, a patient using the sensor continuously would experience a reduction in HbA1c of about 0.9% (9 mmol/mol) when the baseline HbA1c is 10% (86 mmol/mol). The overall reduction in area under the curve of hypoglycaemia was −0.28 (−0.46 to −0.09), corresponding to a reduction in median exposure to hypoglycaemia of 23% for continuous glucose monitoring compared with self monitoring of blood glucose. In a best fit regression model, baseline area under the curve of hypoglycaemia was only weakly related to the effect of continuous glucose monitoring compared with self monitoring of blood glucose on hypoglycaemia outcome, and sensor usage was unrelated to hypoglycaemia at outcome.Conclusions Continuous glucose monitoring was associated with a significant reduction in HbA1c percentage, which was greatest in those with the highest HbA1c at baseline and who most frequently used the sensors. Exposure to hypoglycaemia was also reduced during continuous glucose monitoring. The most cost effective or appropriate use of continuous glucose monitoring is likely to be when targeted at people with type 1 diabetes who have continued poor control during intensified insulin therapy and who frequently use continuous glucose monitoring.</abstract><cop>England</cop><pub>British Medical Journal Publishing Group</pub><pmid>21737469</pmid><doi>10.1136/bmj.d3805</doi><tpages>1</tpages><edition>International edition</edition><oa>free_for_read</oa></addata></record>
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language eng
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source MEDLINE; BMJ Journals - NESLi2; Applied Social Sciences Index & Abstracts (ASSIA); JSTOR
subjects Adult
Blood
Blood glucose
Blood Glucose - metabolism
Blood Glucose Self-Monitoring
Clinical trials
Clinical Trials (Epidemiology)
Confidence intervals
Diabetes
Diabetes mellitus
Diabetes Mellitus, Type 1 - blood
Diabetes Mellitus, Type 1 - prevention & control
Evidence-based medicine
Experimentation
Female
Glucose
Glucose monitoring
Glycated Hemoglobin A - metabolism
Hemoglobin
Humans
Hypoglycaemia
Hypoglycemia
Hypoglycemia - metabolism
Hypoglycemia - prevention & control
Immunology (Including Allergy)
Insulin
Internet
Male
Meta analysis
Metabolic Disorders
Pregnancy
Quantitative Research
Randomized Controlled Trials as Topic
Real time
Self
Sensors
Treatment Outcome
Type 1 diabetes mellitus
Young Adult
title Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data
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