214-OR: Cambridge Hybrid Closed-Loop in Children and Adolescents with T1D: A Multicentre Six-Month Randomised Trial
Aims: We assessed safety and efficacy of Cambridge hybrid closed-loop (HCL) compared with usual care over 6 months in children and young people with T1D. Methods: In an open-label multicentre multinational parallel randomised controlled trial, we randomly assigned participants on insulin pump therap...
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| creator | FUCHS, JULIA BOUGHTON, CHARLOTTE K. ALLEN, JANET M. WILINSKA, MALGORZATA E. TAUSCHMANN, MARTIN DENVIR, LOUISE THANKAMONY, AJAY CAMPBELL, FIONA WADWA, R. PAUL BUCKINGHAM, BRUCE A. DAVIS, NIKKI DIMEGLIO, LINDA MAURAS, NELLY BESSER, RACHEL GHATAK, ATRAYEE WEINZIMER, STUART A. HOOD, KOREY K. FOX, D. STEVEN KANAPKA, LAUREN KOLLMAN, CRAIG SIBAYAN, JUDY BECK, ROY HOVORKA, ROMAN |
| description | Aims: We assessed safety and efficacy of Cambridge hybrid closed-loop (HCL) compared with usual care over 6 months in children and young people with T1D. Methods: In an open-label multicentre multinational parallel randomised controlled trial, we randomly assigned participants on insulin pump therapy aged 6 to 18 years to receive either HCL therapy (CL) or continue usual care (control) for 6 months. We used the same Cambridge model predictive control algorithm in two consecutive hardware iterations, FlorenceM then CamAPS FX. Primary endpoint was central laboratory HbA1c at 6 months. Results: We randomised 133 participants: 65 to CL and 68 to control (baseline HbA1c 8.2±0.7% vs. 8.3±0.8%). At 6 months mean HbA1c was 0.32% lower in CL compared to control (95% CI -0.59 to -0.04; p=0.02). Closed-loop usage was low (40% [26, 53]; median [IQR]) with FlorenceM due to hardware issues, and high (93% [88, 96]) with CamAPS FX. In the CamAPS FX CL group (n=21) HbA1c was 1.05% lower (95% CI -1.43 to -0.67; p |
| doi_str_mv | 10.2337/db21-214-OR |
| format | Article |
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PAUL ; BUCKINGHAM, BRUCE A. ; DAVIS, NIKKI ; DIMEGLIO, LINDA ; MAURAS, NELLY ; BESSER, RACHEL ; GHATAK, ATRAYEE ; WEINZIMER, STUART A. ; HOOD, KOREY K. ; FOX, D. STEVEN ; KANAPKA, LAUREN ; KOLLMAN, CRAIG ; SIBAYAN, JUDY ; BECK, ROY ; HOVORKA, ROMAN</creator><creatorcontrib>FUCHS, JULIA ; BOUGHTON, CHARLOTTE K. ; ALLEN, JANET M. ; WILINSKA, MALGORZATA E. ; TAUSCHMANN, MARTIN ; DENVIR, LOUISE ; THANKAMONY, AJAY ; CAMPBELL, FIONA ; WADWA, R. PAUL ; BUCKINGHAM, BRUCE A. ; DAVIS, NIKKI ; DIMEGLIO, LINDA ; MAURAS, NELLY ; BESSER, RACHEL ; GHATAK, ATRAYEE ; WEINZIMER, STUART A. ; HOOD, KOREY K. ; FOX, D. STEVEN ; KANAPKA, LAUREN ; KOLLMAN, CRAIG ; SIBAYAN, JUDY ; BECK, ROY ; HOVORKA, ROMAN ; DAN05 CONSORTIUM</creatorcontrib><description>Aims: We assessed safety and efficacy of Cambridge hybrid closed-loop (HCL) compared with usual care over 6 months in children and young people with T1D. Methods: In an open-label multicentre multinational parallel randomised controlled trial, we randomly assigned participants on insulin pump therapy aged 6 to 18 years to receive either HCL therapy (CL) or continue usual care (control) for 6 months. We used the same Cambridge model predictive control algorithm in two consecutive hardware iterations, FlorenceM then CamAPS FX. Primary endpoint was central laboratory HbA1c at 6 months. Results: We randomised 133 participants: 65 to CL and 68 to control (baseline HbA1c 8.2±0.7% vs. 8.3±0.8%). At 6 months mean HbA1c was 0.32% lower in CL compared to control (95% CI -0.59 to -0.04; p=0.02). Closed-loop usage was low (40% [26, 53]; median [IQR]) with FlorenceM due to hardware issues, and high (93% [88, 96]) with CamAPS FX. In the CamAPS FX CL group (n=21) HbA1c was 1.05% lower (95% CI -1.43 to -0.67; p<0.0001) compared to control (n=25). CGM-based metrics favoured CamAPS FX group without increase in hypoglycaemia (Table). Treatment-related adverse event rates were low and similar between groups. Conclusion: Cambridge HCL is safe and significantly improves glycaemic control in children and young people with T1D. Efficacy relies on consistent usage of closed-loop, as demonstrated by CamAPS FX.</description><identifier>ISSN: 0012-1797</identifier><identifier>EISSN: 1939-327X</identifier><identifier>DOI: 10.2337/db21-214-OR</identifier><language>eng</language><publisher>New York: American Diabetes Association</publisher><subject>Adolescents ; Adverse events ; Children ; Childrens health ; Clinical trials ; Closed loop systems ; Control algorithms ; Diabetes ; Diabetes mellitus (insulin dependent) ; Drug delivery systems ; Hypoglycemia ; Insulin ; Pediatrics ; Side effects ; Teenagers</subject><ispartof>Diabetes (New York, N.Y.), 2021-06, Vol.70 (Supplement_1)</ispartof><rights>Copyright American Diabetes Association Jun 1, 2021</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c1061-f49eb0689f2c00157607f4dc93c701805976e66eaee771553f6bc749b01b9b173</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids></links><search><creatorcontrib>FUCHS, JULIA</creatorcontrib><creatorcontrib>BOUGHTON, CHARLOTTE K.</creatorcontrib><creatorcontrib>ALLEN, JANET M.</creatorcontrib><creatorcontrib>WILINSKA, MALGORZATA E.</creatorcontrib><creatorcontrib>TAUSCHMANN, MARTIN</creatorcontrib><creatorcontrib>DENVIR, LOUISE</creatorcontrib><creatorcontrib>THANKAMONY, AJAY</creatorcontrib><creatorcontrib>CAMPBELL, FIONA</creatorcontrib><creatorcontrib>WADWA, R. PAUL</creatorcontrib><creatorcontrib>BUCKINGHAM, BRUCE A.</creatorcontrib><creatorcontrib>DAVIS, NIKKI</creatorcontrib><creatorcontrib>DIMEGLIO, LINDA</creatorcontrib><creatorcontrib>MAURAS, NELLY</creatorcontrib><creatorcontrib>BESSER, RACHEL</creatorcontrib><creatorcontrib>GHATAK, ATRAYEE</creatorcontrib><creatorcontrib>WEINZIMER, STUART A.</creatorcontrib><creatorcontrib>HOOD, KOREY K.</creatorcontrib><creatorcontrib>FOX, D. STEVEN</creatorcontrib><creatorcontrib>KANAPKA, LAUREN</creatorcontrib><creatorcontrib>KOLLMAN, CRAIG</creatorcontrib><creatorcontrib>SIBAYAN, JUDY</creatorcontrib><creatorcontrib>BECK, ROY</creatorcontrib><creatorcontrib>HOVORKA, ROMAN</creatorcontrib><creatorcontrib>DAN05 CONSORTIUM</creatorcontrib><title>214-OR: Cambridge Hybrid Closed-Loop in Children and Adolescents with T1D: A Multicentre Six-Month Randomised Trial</title><title>Diabetes (New York, N.Y.)</title><description>Aims: We assessed safety and efficacy of Cambridge hybrid closed-loop (HCL) compared with usual care over 6 months in children and young people with T1D. Methods: In an open-label multicentre multinational parallel randomised controlled trial, we randomly assigned participants on insulin pump therapy aged 6 to 18 years to receive either HCL therapy (CL) or continue usual care (control) for 6 months. We used the same Cambridge model predictive control algorithm in two consecutive hardware iterations, FlorenceM then CamAPS FX. Primary endpoint was central laboratory HbA1c at 6 months. Results: We randomised 133 participants: 65 to CL and 68 to control (baseline HbA1c 8.2±0.7% vs. 8.3±0.8%). At 6 months mean HbA1c was 0.32% lower in CL compared to control (95% CI -0.59 to -0.04; p=0.02). Closed-loop usage was low (40% [26, 53]; median [IQR]) with FlorenceM due to hardware issues, and high (93% [88, 96]) with CamAPS FX. In the CamAPS FX CL group (n=21) HbA1c was 1.05% lower (95% CI -1.43 to -0.67; p<0.0001) compared to control (n=25). CGM-based metrics favoured CamAPS FX group without increase in hypoglycaemia (Table). Treatment-related adverse event rates were low and similar between groups. Conclusion: Cambridge HCL is safe and significantly improves glycaemic control in children and young people with T1D. Efficacy relies on consistent usage of closed-loop, as demonstrated by CamAPS FX.</description><subject>Adolescents</subject><subject>Adverse events</subject><subject>Children</subject><subject>Childrens health</subject><subject>Clinical trials</subject><subject>Closed loop systems</subject><subject>Control algorithms</subject><subject>Diabetes</subject><subject>Diabetes mellitus (insulin dependent)</subject><subject>Drug delivery systems</subject><subject>Hypoglycemia</subject><subject>Insulin</subject><subject>Pediatrics</subject><subject>Side effects</subject><subject>Teenagers</subject><issn>0012-1797</issn><issn>1939-327X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNotkE1LAzEQhoMoWKsn_0DAo0QzyW7S9FbWjwpbCrWCt7AfWZuy3dRki_bfm6UyhxlmnnlneBG6BfrAOJePdcmAMEjIcnWGRqC4IpzJz3M0ohQYAankJboKYUspFTFGKJzoKc6KXelt_WXw_DgUOGtdMDXJndtj2-FsY9vamw4XXY1ntWtNqEzXB_xj-w1ew9MUz_Di0PZ2aHuD3-0vWbguDldxxe1sVMNrb4v2Gl00RRvMzX8eo4-X53U2J_ny9S2b5aQCKoA0iTIlFRPVsCq-n0pBZZPUleKVpDChqZLCCGEKY6SENOWNKCuZqJJCqUqQfIzuTrp7774PJvR66w6-iyc1SwVjQlGASN2fqMq7ELxp9N7bXeGPGqgeXNWDqzr6pJcr_geM52gH</recordid><startdate>20210601</startdate><enddate>20210601</enddate><creator>FUCHS, JULIA</creator><creator>BOUGHTON, CHARLOTTE K.</creator><creator>ALLEN, JANET M.</creator><creator>WILINSKA, MALGORZATA E.</creator><creator>TAUSCHMANN, MARTIN</creator><creator>DENVIR, LOUISE</creator><creator>THANKAMONY, AJAY</creator><creator>CAMPBELL, FIONA</creator><creator>WADWA, R. PAUL</creator><creator>BUCKINGHAM, BRUCE A.</creator><creator>DAVIS, NIKKI</creator><creator>DIMEGLIO, LINDA</creator><creator>MAURAS, NELLY</creator><creator>BESSER, RACHEL</creator><creator>GHATAK, ATRAYEE</creator><creator>WEINZIMER, STUART A.</creator><creator>HOOD, KOREY K.</creator><creator>FOX, D. STEVEN</creator><creator>KANAPKA, LAUREN</creator><creator>KOLLMAN, CRAIG</creator><creator>SIBAYAN, JUDY</creator><creator>BECK, ROY</creator><creator>HOVORKA, ROMAN</creator><general>American Diabetes Association</general><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>NAPCQ</scope></search><sort><creationdate>20210601</creationdate><title>214-OR: Cambridge Hybrid Closed-Loop in Children and Adolescents with T1D: A Multicentre Six-Month Randomised Trial</title><author>FUCHS, JULIA ; BOUGHTON, CHARLOTTE K. ; ALLEN, JANET M. ; WILINSKA, MALGORZATA E. ; TAUSCHMANN, MARTIN ; DENVIR, LOUISE ; THANKAMONY, AJAY ; CAMPBELL, FIONA ; WADWA, R. 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STEVEN</creatorcontrib><creatorcontrib>KANAPKA, LAUREN</creatorcontrib><creatorcontrib>KOLLMAN, CRAIG</creatorcontrib><creatorcontrib>SIBAYAN, JUDY</creatorcontrib><creatorcontrib>BECK, ROY</creatorcontrib><creatorcontrib>HOVORKA, ROMAN</creatorcontrib><creatorcontrib>DAN05 CONSORTIUM</creatorcontrib><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><jtitle>Diabetes (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>FUCHS, JULIA</au><au>BOUGHTON, CHARLOTTE K.</au><au>ALLEN, JANET M.</au><au>WILINSKA, MALGORZATA E.</au><au>TAUSCHMANN, MARTIN</au><au>DENVIR, LOUISE</au><au>THANKAMONY, AJAY</au><au>CAMPBELL, FIONA</au><au>WADWA, R. PAUL</au><au>BUCKINGHAM, BRUCE A.</au><au>DAVIS, NIKKI</au><au>DIMEGLIO, LINDA</au><au>MAURAS, NELLY</au><au>BESSER, RACHEL</au><au>GHATAK, ATRAYEE</au><au>WEINZIMER, STUART A.</au><au>HOOD, KOREY K.</au><au>FOX, D. STEVEN</au><au>KANAPKA, LAUREN</au><au>KOLLMAN, CRAIG</au><au>SIBAYAN, JUDY</au><au>BECK, ROY</au><au>HOVORKA, ROMAN</au><aucorp>DAN05 CONSORTIUM</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>214-OR: Cambridge Hybrid Closed-Loop in Children and Adolescents with T1D: A Multicentre Six-Month Randomised Trial</atitle><jtitle>Diabetes (New York, N.Y.)</jtitle><date>2021-06-01</date><risdate>2021</risdate><volume>70</volume><issue>Supplement_1</issue><issn>0012-1797</issn><eissn>1939-327X</eissn><abstract>Aims: We assessed safety and efficacy of Cambridge hybrid closed-loop (HCL) compared with usual care over 6 months in children and young people with T1D. Methods: In an open-label multicentre multinational parallel randomised controlled trial, we randomly assigned participants on insulin pump therapy aged 6 to 18 years to receive either HCL therapy (CL) or continue usual care (control) for 6 months. We used the same Cambridge model predictive control algorithm in two consecutive hardware iterations, FlorenceM then CamAPS FX. Primary endpoint was central laboratory HbA1c at 6 months. Results: We randomised 133 participants: 65 to CL and 68 to control (baseline HbA1c 8.2±0.7% vs. 8.3±0.8%). At 6 months mean HbA1c was 0.32% lower in CL compared to control (95% CI -0.59 to -0.04; p=0.02). Closed-loop usage was low (40% [26, 53]; median [IQR]) with FlorenceM due to hardware issues, and high (93% [88, 96]) with CamAPS FX. In the CamAPS FX CL group (n=21) HbA1c was 1.05% lower (95% CI -1.43 to -0.67; p<0.0001) compared to control (n=25). CGM-based metrics favoured CamAPS FX group without increase in hypoglycaemia (Table). Treatment-related adverse event rates were low and similar between groups. Conclusion: Cambridge HCL is safe and significantly improves glycaemic control in children and young people with T1D. Efficacy relies on consistent usage of closed-loop, as demonstrated by CamAPS FX.</abstract><cop>New York</cop><pub>American Diabetes Association</pub><doi>10.2337/db21-214-OR</doi></addata></record> |
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| subjects | Adolescents Adverse events Children Childrens health Clinical trials Closed loop systems Control algorithms Diabetes Diabetes mellitus (insulin dependent) Drug delivery systems Hypoglycemia Insulin Pediatrics Side effects Teenagers |
| title | 214-OR: Cambridge Hybrid Closed-Loop in Children and Adolescents with T1D: A Multicentre Six-Month Randomised Trial |
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