A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial

Management of type 1 diabetes is challenging. We compared outcomes using a commercially available hybrid closed-loop system versus a new investigational system with features potentially useful for adolescents and young adults with type 1 diabetes. In this multinational, randomised, crossover trial (...

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Published in:The Lancet (British edition) 2021-01, Vol.397 (10270), p.208-219
Main Authors: Bergenstal, Richard M, Nimri, Revital, Beck, Roy W, Criego, Amy, Laffel, Lori, Schatz, Desmond, Battelino, Tadej, Danne, Thomas, Weinzimer, Stuart A, Sibayan, Judy, Johnson, Mary L, Bailey, Ryan J, Calhoun, Peter, Carlson, Anders, Isganaitis, Elvira, Bello, Rachel, Albanese-O'Neill, Anastasia, Dovc, Klemen, Biester, Torben, Weyman, Kate, Hood, Korey, Phillip, Moshe
Format: Article
Language:English
Subjects:
Adolescents
Adult
Adults
Automation
Blood Glucose Self-Monitoring - instrumentation
Closed loop systems
Control algorithms
Daytime
Diabetes
Diabetes mellitus (insulin dependent)
Diabetes Mellitus, Type 1 - drug therapy
Endocrinology
Feedback control
Female
Fuzzy logic
Germany
Glucose
Glucose monitoring
Guardians
Health services
Hemoglobin
Humans
Hybrid systems
Hyperglycemia
Hyperglycemia - prevention & control
Hypoglycemia
Insulin
Insulin - therapeutic use
Insulin Infusion Systems
Israel
Kidney diseases
Male
Regulatory approval
Sensors
Social factors
Socioeconomic data
Socioeconomic factors
Socioeconomics
Teenagers
United States
Young Adult
Young adults
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cited_by cdi_FETCH-LOGICAL-c492t-434299b4b215f117fac399ad171b617741ece8df9136e600bdc8b05bbd0ee53b3
cites cdi_FETCH-LOGICAL-c492t-434299b4b215f117fac399ad171b617741ece8df9136e600bdc8b05bbd0ee53b3
container_end_page 219
container_issue 10270
container_start_page 208
container_title The Lancet (British edition)
container_volume 397
creator Bergenstal, Richard M
Nimri, Revital
Beck, Roy W
Criego, Amy
Laffel, Lori
Schatz, Desmond
Battelino, Tadej
Danne, Thomas
Weinzimer, Stuart A
Sibayan, Judy
Johnson, Mary L
Bailey, Ryan J
Calhoun, Peter
Carlson, Anders
Isganaitis, Elvira
Bello, Rachel
Albanese-O'Neill, Anastasia
Dovc, Klemen
Biester, Torben
Weyman, Kate
Hood, Korey
Phillip, Moshe
description Management of type 1 diabetes is challenging. We compared outcomes using a commercially available hybrid closed-loop system versus a new investigational system with features potentially useful for adolescents and young adults with type 1 diabetes. In this multinational, randomised, crossover trial (Fuzzy Logic Automated Insulin Regulation [FLAIR]), individuals aged 14–29 years old, with a clinical diagnosis of type 1 diabetes with a duration of at least 1 year, using either an insulin pump or multiple daily insulin injections, and glycated haemoglobin (HbA1c) levels of 7·0–11·0% (53–97 mmol/mol) were recruited from seven academic-based endocrinology practices, four in the USA, and one each in Germany, Israel, and Slovenia. After a run-in period to teach participants how to use the study pump and continuous glucose monitor, participants were randomly assigned (1:1) using a computer-generated sequence, with a permuted block design (block sizes of two and four), stratified by baseline HbA1c and use of a personal MiniMed 670G system (Medtronic) at enrolment, to either use of a MiniMed 670G hybrid closed-loop system (670G) or the investigational advanced hybrid closed-loop system (Medtronic) for the first 12-week period, and then participants were crossed over with no washout period, to the other group for use for another 12 weeks. Masking was not possible due to the nature of the systems used. The coprimary outcomes, measured with continuous glucose monitoring, were proportion of time that glucose levels were above 180 mg/dL (>10·0 mmol/L) during 0600 h to 2359 h (ie, daytime), tested for superiority, and proportion of time that glucose levels were below 54 mg/dL (10·0 mmol/L) was 42% (SD 13) at baseline, 37% (9) during use of the 670G system, and 34% (9) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] −3·00% [95% CI −3·97 to −2·04]; p
doi_str_mv 10.1016/S0140-6736(20)32514-9
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We compared outcomes using a commercially available hybrid closed-loop system versus a new investigational system with features potentially useful for adolescents and young adults with type 1 diabetes. In this multinational, randomised, crossover trial (Fuzzy Logic Automated Insulin Regulation [FLAIR]), individuals aged 14–29 years old, with a clinical diagnosis of type 1 diabetes with a duration of at least 1 year, using either an insulin pump or multiple daily insulin injections, and glycated haemoglobin (HbA1c) levels of 7·0–11·0% (53–97 mmol/mol) were recruited from seven academic-based endocrinology practices, four in the USA, and one each in Germany, Israel, and Slovenia. After a run-in period to teach participants how to use the study pump and continuous glucose monitor, participants were randomly assigned (1:1) using a computer-generated sequence, with a permuted block design (block sizes of two and four), stratified by baseline HbA1c and use of a personal MiniMed 670G system (Medtronic) at enrolment, to either use of a MiniMed 670G hybrid closed-loop system (670G) or the investigational advanced hybrid closed-loop system (Medtronic) for the first 12-week period, and then participants were crossed over with no washout period, to the other group for use for another 12 weeks. Masking was not possible due to the nature of the systems used. The coprimary outcomes, measured with continuous glucose monitoring, were proportion of time that glucose levels were above 180 mg/dL (&gt;10·0 mmol/L) during 0600 h to 2359 h (ie, daytime), tested for superiority, and proportion of time that glucose levels were below 54 mg/dL (&lt;3·0 mmol/L) calculated over a full 24-h period, tested for non-inferiority (non-inferiority margin 2%). Analysis was by intention to treat. Safety was assessed in all participants randomly assigned to treatment. This trial is registered with ClinicalTrials.gov, NCT03040414, and is now complete. Between June 3 and Aug 22, 2019, 113 individuals were enrolled into the trial. Mean age was 19 years (SD 4) and 70 (62%) of 113 participants were female. Mean proportion of time with daytime glucose levels above 180 mg/dL (&gt;10·0 mmol/L) was 42% (SD 13) at baseline, 37% (9) during use of the 670G system, and 34% (9) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] −3·00% [95% CI −3·97 to −2·04]; p&lt;0·0001). Mean 24-h proportion of time with glucose levels below 54 mg/dL (&lt;3·0 mmol/L) was 0·46% (SD 0·42) at baseline, 0·50% (0·35) during use of the 670G system, and 0·46% (0·33) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] −0·06% [95% CI −0·11 to −0·02]; p&lt;0·0001 for non-inferiority). One severe hypoglycaemic event occurred in the advanced hybrid closed-loop system group, determined to be unrelated to study treatment, and none occurred in the 670G group. Hyperglycaemia was reduced without increasing hypoglycaemia in adolescents and young adults with type 1 diabetes using the investigational advanced hybrid closed-loop system compared with the commercially available MiniMed 670G system. Testing an advanced hybrid closed-loop system in populations that are underserved due to socioeconomic factors and testing during pregnancy and in individuals with impaired awareness of hypoglycaemia would advance the effective use of this technology National Institute of Diabetes and Digestive and Kidney Diseases.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(20)32514-9</identifier><identifier>PMID: 33453783</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adolescents ; Adult ; Adults ; Automation ; Blood Glucose Self-Monitoring - instrumentation ; Closed loop systems ; Control algorithms ; Daytime ; Diabetes ; Diabetes mellitus (insulin dependent) ; Diabetes Mellitus, Type 1 - drug therapy ; Endocrinology ; Feedback control ; Female ; Fuzzy logic ; Germany ; Glucose ; Glucose monitoring ; Guardians ; Health services ; Hemoglobin ; Humans ; Hybrid systems ; Hyperglycemia ; Hyperglycemia - prevention &amp; control ; Hypoglycemia ; Insulin ; Insulin - therapeutic use ; Insulin Infusion Systems ; Israel ; Kidney diseases ; Male ; Regulatory approval ; Sensors ; Social factors ; Socioeconomic data ; Socioeconomic factors ; Socioeconomics ; Teenagers ; United States ; Young Adult ; Young adults</subject><ispartof>The Lancet (British edition), 2021-01, Vol.397 (10270), p.208-219</ispartof><rights>2021 Elsevier Ltd</rights><rights>Copyright © 2021 Elsevier Ltd. 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We compared outcomes using a commercially available hybrid closed-loop system versus a new investigational system with features potentially useful for adolescents and young adults with type 1 diabetes. In this multinational, randomised, crossover trial (Fuzzy Logic Automated Insulin Regulation [FLAIR]), individuals aged 14–29 years old, with a clinical diagnosis of type 1 diabetes with a duration of at least 1 year, using either an insulin pump or multiple daily insulin injections, and glycated haemoglobin (HbA1c) levels of 7·0–11·0% (53–97 mmol/mol) were recruited from seven academic-based endocrinology practices, four in the USA, and one each in Germany, Israel, and Slovenia. After a run-in period to teach participants how to use the study pump and continuous glucose monitor, participants were randomly assigned (1:1) using a computer-generated sequence, with a permuted block design (block sizes of two and four), stratified by baseline HbA1c and use of a personal MiniMed 670G system (Medtronic) at enrolment, to either use of a MiniMed 670G hybrid closed-loop system (670G) or the investigational advanced hybrid closed-loop system (Medtronic) for the first 12-week period, and then participants were crossed over with no washout period, to the other group for use for another 12 weeks. Masking was not possible due to the nature of the systems used. The coprimary outcomes, measured with continuous glucose monitoring, were proportion of time that glucose levels were above 180 mg/dL (&gt;10·0 mmol/L) during 0600 h to 2359 h (ie, daytime), tested for superiority, and proportion of time that glucose levels were below 54 mg/dL (&lt;3·0 mmol/L) calculated over a full 24-h period, tested for non-inferiority (non-inferiority margin 2%). Analysis was by intention to treat. Safety was assessed in all participants randomly assigned to treatment. This trial is registered with ClinicalTrials.gov, NCT03040414, and is now complete. Between June 3 and Aug 22, 2019, 113 individuals were enrolled into the trial. Mean age was 19 years (SD 4) and 70 (62%) of 113 participants were female. Mean proportion of time with daytime glucose levels above 180 mg/dL (&gt;10·0 mmol/L) was 42% (SD 13) at baseline, 37% (9) during use of the 670G system, and 34% (9) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] −3·00% [95% CI −3·97 to −2·04]; p&lt;0·0001). Mean 24-h proportion of time with glucose levels below 54 mg/dL (&lt;3·0 mmol/L) was 0·46% (SD 0·42) at baseline, 0·50% (0·35) during use of the 670G system, and 0·46% (0·33) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] −0·06% [95% CI −0·11 to −0·02]; p&lt;0·0001 for non-inferiority). One severe hypoglycaemic event occurred in the advanced hybrid closed-loop system group, determined to be unrelated to study treatment, and none occurred in the 670G group. Hyperglycaemia was reduced without increasing hypoglycaemia in adolescents and young adults with type 1 diabetes using the investigational advanced hybrid closed-loop system compared with the commercially available MiniMed 670G system. Testing an advanced hybrid closed-loop system in populations that are underserved due to socioeconomic factors and testing during pregnancy and in individuals with impaired awareness of hypoglycaemia would advance the effective use of this technology National Institute of Diabetes and Digestive and Kidney Diseases.</description><subject>Adolescents</subject><subject>Adult</subject><subject>Adults</subject><subject>Automation</subject><subject>Blood Glucose Self-Monitoring - instrumentation</subject><subject>Closed loop systems</subject><subject>Control algorithms</subject><subject>Daytime</subject><subject>Diabetes</subject><subject>Diabetes mellitus (insulin dependent)</subject><subject>Diabetes Mellitus, Type 1 - drug therapy</subject><subject>Endocrinology</subject><subject>Feedback control</subject><subject>Female</subject><subject>Fuzzy logic</subject><subject>Germany</subject><subject>Glucose</subject><subject>Glucose monitoring</subject><subject>Guardians</subject><subject>Health services</subject><subject>Hemoglobin</subject><subject>Humans</subject><subject>Hybrid systems</subject><subject>Hyperglycemia</subject><subject>Hyperglycemia - prevention &amp; 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Nimri, Revital ; Beck, Roy W ; Criego, Amy ; Laffel, Lori ; Schatz, Desmond ; Battelino, Tadej ; Danne, Thomas ; Weinzimer, Stuart A ; Sibayan, Judy ; Johnson, Mary L ; Bailey, Ryan J ; Calhoun, Peter ; Carlson, Anders ; Isganaitis, Elvira ; Bello, Rachel ; Albanese-O'Neill, Anastasia ; Dovc, Klemen ; Biester, Torben ; Weyman, Kate ; Hood, Korey ; Phillip, Moshe</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c492t-434299b4b215f117fac399ad171b617741ece8df9136e600bdc8b05bbd0ee53b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adolescents</topic><topic>Adult</topic><topic>Adults</topic><topic>Automation</topic><topic>Blood Glucose Self-Monitoring - instrumentation</topic><topic>Closed loop systems</topic><topic>Control algorithms</topic><topic>Daytime</topic><topic>Diabetes</topic><topic>Diabetes mellitus (insulin dependent)</topic><topic>Diabetes Mellitus, Type 1 - drug therapy</topic><topic>Endocrinology</topic><topic>Feedback control</topic><topic>Female</topic><topic>Fuzzy logic</topic><topic>Germany</topic><topic>Glucose</topic><topic>Glucose monitoring</topic><topic>Guardians</topic><topic>Health services</topic><topic>Hemoglobin</topic><topic>Humans</topic><topic>Hybrid systems</topic><topic>Hyperglycemia</topic><topic>Hyperglycemia - prevention &amp; control</topic><topic>Hypoglycemia</topic><topic>Insulin</topic><topic>Insulin - therapeutic use</topic><topic>Insulin Infusion Systems</topic><topic>Israel</topic><topic>Kidney diseases</topic><topic>Male</topic><topic>Regulatory approval</topic><topic>Sensors</topic><topic>Social factors</topic><topic>Socioeconomic data</topic><topic>Socioeconomic factors</topic><topic>Socioeconomics</topic><topic>Teenagers</topic><topic>United States</topic><topic>Young Adult</topic><topic>Young adults</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bergenstal, Richard M</creatorcontrib><creatorcontrib>Nimri, Revital</creatorcontrib><creatorcontrib>Beck, Roy W</creatorcontrib><creatorcontrib>Criego, Amy</creatorcontrib><creatorcontrib>Laffel, Lori</creatorcontrib><creatorcontrib>Schatz, Desmond</creatorcontrib><creatorcontrib>Battelino, Tadej</creatorcontrib><creatorcontrib>Danne, Thomas</creatorcontrib><creatorcontrib>Weinzimer, Stuart A</creatorcontrib><creatorcontrib>Sibayan, Judy</creatorcontrib><creatorcontrib>Johnson, Mary L</creatorcontrib><creatorcontrib>Bailey, Ryan J</creatorcontrib><creatorcontrib>Calhoun, Peter</creatorcontrib><creatorcontrib>Carlson, Anders</creatorcontrib><creatorcontrib>Isganaitis, Elvira</creatorcontrib><creatorcontrib>Bello, Rachel</creatorcontrib><creatorcontrib>Albanese-O'Neill, Anastasia</creatorcontrib><creatorcontrib>Dovc, Klemen</creatorcontrib><creatorcontrib>Biester, Torben</creatorcontrib><creatorcontrib>Weyman, Kate</creatorcontrib><creatorcontrib>Hood, Korey</creatorcontrib><creatorcontrib>Phillip, Moshe</creatorcontrib><creatorcontrib>FLAIR 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>News PRO</collection><collection>Pharma and Biotech Premium PRO</collection><collection>Global News &amp; 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Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>ProQuest Newsstand Professional</collection><collection>Biological Sciences</collection><collection>ProQuest Consumer Health Database</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>PML(ProQuest Medical Library)</collection><collection>Psychology Database (ProQuest)</collection><collection>Research Library</collection><collection>Science Database (ProQuest)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</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 One Psychology</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bergenstal, Richard M</au><au>Nimri, Revital</au><au>Beck, Roy W</au><au>Criego, Amy</au><au>Laffel, Lori</au><au>Schatz, Desmond</au><au>Battelino, Tadej</au><au>Danne, Thomas</au><au>Weinzimer, Stuart A</au><au>Sibayan, Judy</au><au>Johnson, Mary L</au><au>Bailey, Ryan J</au><au>Calhoun, Peter</au><au>Carlson, Anders</au><au>Isganaitis, Elvira</au><au>Bello, Rachel</au><au>Albanese-O'Neill, Anastasia</au><au>Dovc, Klemen</au><au>Biester, Torben</au><au>Weyman, Kate</au><au>Hood, Korey</au><au>Phillip, Moshe</au><aucorp>FLAIR Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2021-01-16</date><risdate>2021</risdate><volume>397</volume><issue>10270</issue><spage>208</spage><epage>219</epage><pages>208-219</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><abstract>Management of type 1 diabetes is challenging. We compared outcomes using a commercially available hybrid closed-loop system versus a new investigational system with features potentially useful for adolescents and young adults with type 1 diabetes. In this multinational, randomised, crossover trial (Fuzzy Logic Automated Insulin Regulation [FLAIR]), individuals aged 14–29 years old, with a clinical diagnosis of type 1 diabetes with a duration of at least 1 year, using either an insulin pump or multiple daily insulin injections, and glycated haemoglobin (HbA1c) levels of 7·0–11·0% (53–97 mmol/mol) were recruited from seven academic-based endocrinology practices, four in the USA, and one each in Germany, Israel, and Slovenia. After a run-in period to teach participants how to use the study pump and continuous glucose monitor, participants were randomly assigned (1:1) using a computer-generated sequence, with a permuted block design (block sizes of two and four), stratified by baseline HbA1c and use of a personal MiniMed 670G system (Medtronic) at enrolment, to either use of a MiniMed 670G hybrid closed-loop system (670G) or the investigational advanced hybrid closed-loop system (Medtronic) for the first 12-week period, and then participants were crossed over with no washout period, to the other group for use for another 12 weeks. Masking was not possible due to the nature of the systems used. The coprimary outcomes, measured with continuous glucose monitoring, were proportion of time that glucose levels were above 180 mg/dL (&gt;10·0 mmol/L) during 0600 h to 2359 h (ie, daytime), tested for superiority, and proportion of time that glucose levels were below 54 mg/dL (&lt;3·0 mmol/L) calculated over a full 24-h period, tested for non-inferiority (non-inferiority margin 2%). Analysis was by intention to treat. Safety was assessed in all participants randomly assigned to treatment. This trial is registered with ClinicalTrials.gov, NCT03040414, and is now complete. Between June 3 and Aug 22, 2019, 113 individuals were enrolled into the trial. Mean age was 19 years (SD 4) and 70 (62%) of 113 participants were female. Mean proportion of time with daytime glucose levels above 180 mg/dL (&gt;10·0 mmol/L) was 42% (SD 13) at baseline, 37% (9) during use of the 670G system, and 34% (9) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] −3·00% [95% CI −3·97 to −2·04]; p&lt;0·0001). Mean 24-h proportion of time with glucose levels below 54 mg/dL (&lt;3·0 mmol/L) was 0·46% (SD 0·42) at baseline, 0·50% (0·35) during use of the 670G system, and 0·46% (0·33) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] −0·06% [95% CI −0·11 to −0·02]; p&lt;0·0001 for non-inferiority). One severe hypoglycaemic event occurred in the advanced hybrid closed-loop system group, determined to be unrelated to study treatment, and none occurred in the 670G group. Hyperglycaemia was reduced without increasing hypoglycaemia in adolescents and young adults with type 1 diabetes using the investigational advanced hybrid closed-loop system compared with the commercially available MiniMed 670G system. Testing an advanced hybrid closed-loop system in populations that are underserved due to socioeconomic factors and testing during pregnancy and in individuals with impaired awareness of hypoglycaemia would advance the effective use of this technology National Institute of Diabetes and Digestive and Kidney Diseases.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>33453783</pmid><doi>10.1016/S0140-6736(20)32514-9</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record>
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identifier ISSN: 0140-6736
ispartof The Lancet (British edition), 2021-01, Vol.397 (10270), p.208-219
issn 0140-6736
1474-547X
language eng
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source ScienceDirect Journals
subjects Adolescents
Adult
Adults
Automation
Blood Glucose Self-Monitoring - instrumentation
Closed loop systems
Control algorithms
Daytime
Diabetes
Diabetes mellitus (insulin dependent)
Diabetes Mellitus, Type 1 - drug therapy
Endocrinology
Feedback control
Female
Fuzzy logic
Germany
Glucose
Glucose monitoring
Guardians
Health services
Hemoglobin
Humans
Hybrid systems
Hyperglycemia
Hyperglycemia - prevention & control
Hypoglycemia
Insulin
Insulin - therapeutic use
Insulin Infusion Systems
Israel
Kidney diseases
Male
Regulatory approval
Sensors
Social factors
Socioeconomic data
Socioeconomic factors
Socioeconomics
Teenagers
United States
Young Adult
Young adults
title A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial
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