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The effect of closed-loop glucose control on C-peptide secretion in youth with newly diagnosed type 1 diabetes: the CLOuD RCT

Charlotte K Boughton Orcid Logo, Janet M Allen, Julia Ware Orcid Logo, Malgorzata E Wilinska Orcid Logo, Sara Hartnell, Ajay Thankamony Orcid Logo, Tabitha Randell Orcid Logo, Atrayee Ghatak, Rachel EJ Besser Orcid Logo, Daniela Elleri, Nicola Trevelyan Orcid Logo, Fiona M Campbell Orcid Logo, David Rankin Orcid Logo, Barbara Kimbell Orcid Logo, Julia Lawton Orcid Logo, Judy Sibayan Orcid Logo, Peter Calhoun Orcid Logo, Ryan Bailey, Gareth Dunseath Orcid Logo, Roman Hovorka Orcid Logo

Efficacy and Mechanism Evaluation, Volume: 11, Issue: 8

Swansea University Author: Gareth Dunseath Orcid Logo

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DOI (Published version): 10.3310/ktfr5698

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Background We assessed whether a sustained period of intensive glucose control with hybrid closed-loop for 12 months following diagnosis of type 1 diabetes in children and adolescents can preserve C-peptide secretion compared to standard insulin therapy. Methods In an open-label, multicentre, random...

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Published in: Efficacy and Mechanism Evaluation
ISSN: 2050-4373
Published: National Institute for Health and Care Research 2024
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fullrecord <?xml version="1.0" encoding="utf-8"?><rfc1807 xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:xsd="http://www.w3.org/2001/XMLSchema"><bib-version>v2</bib-version><id>67316</id><entry>2024-08-05</entry><title>The effect of closed-loop glucose control on C-peptide secretion in youth with newly diagnosed type 1 diabetes: the CLOuD RCT</title><swanseaauthors><author><sid>fccbba9edcaee08a839a3c5cff8cbe19</sid><ORCID>0000-0001-6022-862X</ORCID><firstname>Gareth</firstname><surname>Dunseath</surname><name>Gareth Dunseath</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2024-08-05</date><deptcode>MEDS</deptcode><abstract>Background We assessed whether a sustained period of intensive glucose control with hybrid closed-loop for 12 months following diagnosis of type 1 diabetes in children and adolescents can preserve C-peptide secretion compared to standard insulin therapy. Methods In an open-label, multicentre, randomised, parallel trial, youth aged 10–16.9 years were randomised within 21 days of type 1 diabetes diagnosis to hybrid closed-loop or standard insulin therapy (control). Primary end point was the difference in mixed-meal C-peptide area under the curve 12 months post diagnosis. Key secondary end points included time spent in target glucose range, glycated haemoglobin and time spent below target glucose range at 12 months. Analysis was by intention to treat. The Closed Loop from Onset in Type 1 Diabetes consortium secured external funding for participants to continue on beyond 12 months, but the funding by National Institute for Health and Care Research and the results reported here refer only to the 12 months follow-up. Results We randomised 97 participants (mean ± standard deviation age 12 ± 2 years), 51 to closed-loop and 46 to control therapy. There was no difference in C-peptide area under the curve at 12 months between groups [geometric mean (interquartile range) closed-loop (n = 46): 0.35 pmol/ml (0.16, 0.49) vs. control (n = 37): 0.46 pmol/ml (0.22, 0.69); mean adjusted difference –0.06 (95% confidence interval –0.14 to 0.03); p = 0.19]. The proportion of time in target range 3.9–10.0 mmol/l based on 14-day masked LibrePro (Abbott Diabetes Care, Maidenhead, UK) sensor glucose data at 12 months was 10 percentage points (95% confidence interval 2 to 17) higher in the closed-loop group (64 ± 14%) compared to control group (54 ± 23%). Arithmetic mean glycated haemoglobin A1c was lower in the closed-loop group by 4 mmol/mol (0.4%) [95% confidence interval 0 to 8 mmol/mol (0.0% to 0.7%)] at 12 months. The mean difference in time spent &lt; 3.9 mmol/l between groups was 0.9 percentage points (95% confidence interval –1.0 to 2.8). Three severe hypoglycaemic events occurred in the closed-loop group (two participants), and one in the control group; one diabetic ketoacidosis occurred in the closed-loop group. Conclusions A sustained period of hybrid closed-loop glucose control following diagnosis of type 1 diabetes in children and adolescents does not slow down the decline in residual C-peptide secretion compared with standard insulin therapy. Despite the lack of effect on C-peptide, glycaemic control was sustained in the closed-loop group, whereas glycaemic control deteriorated in the control group 6 to 9 months after diagnosis and closed-loop safely accommodated the variability in exogenous insulin requirements which occur with beta-cell recovery post diagnosis. Limitations of the study included no central measurement of auto-antibodies at diagnosis. There was imbalance in the rate of diabetic ketoacidosis at diagnosis which is associated with a more rapid decline in C-peptide secretion, but this was adjusted for in the analyses. This highlights the need for improved therapies to allow youth to achieve recommended glycaemic targets from onset of type 1 diabetes irrespective of the lack of effect on residual C-peptide secretion. Future work includes ongoing follow-up of the study population for up to 4 years after diagnosis to observe how any differences in glycaemic control between treatment groups develop over time. Trial registration This trial is registered as Clinicaltrials.gov NCT02871089. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 14/23/09), the Helmsley Trust (2016PG-T1D045 and 2016PG-T1D046), and JDRF (22-2013-266 and 2-RSC-2019-828-M-N), and is published in full in Efficacy and Mechanism Evaluation; Vol. 11, No. 8. See the NIHR Funding and Awards website for further award information. Additional support for the artificial pancreas work was from the NIHR Cambridge Biomedical Research Centre and NIHR Oxford Biomedical Research Centre. Abbott Diabetes Care supplied free glucose monitoring devices, and Dexcom supplied discounted continuous glucose monitoring devices. Medtronic supplied discounted insulin pumps, phone enclosures, continuous glucose monitoring devices, and pump consumables.</abstract><type>Journal Article</type><journal>Efficacy and Mechanism Evaluation</journal><volume>11</volume><journalNumber>8</journalNumber><paginationStart/><paginationEnd/><publisher>National Institute for Health and Care Research</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint/><issnElectronic>2050-4373</issnElectronic><keywords/><publishedDay>1</publishedDay><publishedMonth>5</publishedMonth><publishedYear>2024</publishedYear><publishedDate>2024-05-01</publishedDate><doi>10.3310/ktfr5698</doi><url/><notes/><college>COLLEGE NANME</college><department>Medical School</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>MEDS</DepartmentCode><institution>Swansea University</institution><apcterm>Another institution paid the OA fee</apcterm><funders>This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 14/23/09), the Helmsley Trust (2016PG-T1D045 and 2016PG-T1D046), and JDRF (22-2013-266 and 2-RSC-2019-828-M-N), and is published in full in Efficacy and Mechanism Evaluation; Vol. 11, No. 8. See the NIHR Funding and Awards website for further award information. Additional support for the artificial pancreas work was from the NIHR Cambridge Biomedical Research Centre and NIHR Oxford Biomedical Research Centre. Abbott Diabetes Care supplied free glucose monitoring devices, and Dexcom supplied discounted continuous glucose monitoring devices. Medtronic supplied discounted insulin pumps, phone enclosures, continuous glucose monitoring devices, and pump consumables.</funders><projectreference/><lastEdited>2024-09-18T14:21:23.6206357</lastEdited><Created>2024-08-05T11:01:49.4848273</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Medicine</level></path><authors><author><firstname>Charlotte K</firstname><surname>Boughton</surname><orcid>0000-0003-3272-9544</orcid><order>1</order></author><author><firstname>Janet M</firstname><surname>Allen</surname><order>2</order></author><author><firstname>Julia</firstname><surname>Ware</surname><orcid>0000-0002-4497-0979</orcid><order>3</order></author><author><firstname>Malgorzata E</firstname><surname>Wilinska</surname><orcid>0000-0002-1564-8083</orcid><order>4</order></author><author><firstname>Sara</firstname><surname>Hartnell</surname><order>5</order></author><author><firstname>Ajay</firstname><surname>Thankamony</surname><orcid>0000-0001-6290-3553</orcid><order>6</order></author><author><firstname>Tabitha</firstname><surname>Randell</surname><orcid>0000-0002-1703-1589</orcid><order>7</order></author><author><firstname>Atrayee</firstname><surname>Ghatak</surname><order>8</order></author><author><firstname>Rachel EJ</firstname><surname>Besser</surname><orcid>0000-0002-4645-6324</orcid><order>9</order></author><author><firstname>Daniela</firstname><surname>Elleri</surname><order>10</order></author><author><firstname>Nicola</firstname><surname>Trevelyan</surname><orcid>0000-0002-5991-2691</orcid><order>11</order></author><author><firstname>Fiona M</firstname><surname>Campbell</surname><orcid>0000-0002-7618-6759</orcid><order>12</order></author><author><firstname>David</firstname><surname>Rankin</surname><orcid>0000-0002-5835-3402</orcid><order>13</order></author><author><firstname>Barbara</firstname><surname>Kimbell</surname><orcid>0000-0003-4510-9862</orcid><order>14</order></author><author><firstname>Julia</firstname><surname>Lawton</surname><orcid>0000-0002-8016-7374</orcid><order>15</order></author><author><firstname>Judy</firstname><surname>Sibayan</surname><orcid>0009-0005-9298-133x</orcid><order>16</order></author><author><firstname>Peter</firstname><surname>Calhoun</surname><orcid>0000-0002-5325-7200</orcid><order>17</order></author><author><firstname>Ryan</firstname><surname>Bailey</surname><order>18</order></author><author><firstname>Gareth</firstname><surname>Dunseath</surname><orcid>0000-0001-6022-862X</orcid><order>19</order></author><author><firstname>Roman</firstname><surname>Hovorka</surname><orcid>0000-0003-2901-461x</orcid><order>20</order></author></authors><documents><document><filename>67316__31363__6f73ed97e90c43a1bd1aa4a17bd338b3.pdf</filename><originalFilename>67316.VOR.pdf</originalFilename><uploaded>2024-09-18T14:18:32.5469829</uploaded><type>Output</type><contentLength>2115244</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>© 2024 Boughton et al. 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spelling v2 67316 2024-08-05 The effect of closed-loop glucose control on C-peptide secretion in youth with newly diagnosed type 1 diabetes: the CLOuD RCT fccbba9edcaee08a839a3c5cff8cbe19 0000-0001-6022-862X Gareth Dunseath Gareth Dunseath true false 2024-08-05 MEDS Background We assessed whether a sustained period of intensive glucose control with hybrid closed-loop for 12 months following diagnosis of type 1 diabetes in children and adolescents can preserve C-peptide secretion compared to standard insulin therapy. Methods In an open-label, multicentre, randomised, parallel trial, youth aged 10–16.9 years were randomised within 21 days of type 1 diabetes diagnosis to hybrid closed-loop or standard insulin therapy (control). Primary end point was the difference in mixed-meal C-peptide area under the curve 12 months post diagnosis. Key secondary end points included time spent in target glucose range, glycated haemoglobin and time spent below target glucose range at 12 months. Analysis was by intention to treat. The Closed Loop from Onset in Type 1 Diabetes consortium secured external funding for participants to continue on beyond 12 months, but the funding by National Institute for Health and Care Research and the results reported here refer only to the 12 months follow-up. Results We randomised 97 participants (mean ± standard deviation age 12 ± 2 years), 51 to closed-loop and 46 to control therapy. There was no difference in C-peptide area under the curve at 12 months between groups [geometric mean (interquartile range) closed-loop (n = 46): 0.35 pmol/ml (0.16, 0.49) vs. control (n = 37): 0.46 pmol/ml (0.22, 0.69); mean adjusted difference –0.06 (95% confidence interval –0.14 to 0.03); p = 0.19]. The proportion of time in target range 3.9–10.0 mmol/l based on 14-day masked LibrePro (Abbott Diabetes Care, Maidenhead, UK) sensor glucose data at 12 months was 10 percentage points (95% confidence interval 2 to 17) higher in the closed-loop group (64 ± 14%) compared to control group (54 ± 23%). Arithmetic mean glycated haemoglobin A1c was lower in the closed-loop group by 4 mmol/mol (0.4%) [95% confidence interval 0 to 8 mmol/mol (0.0% to 0.7%)] at 12 months. The mean difference in time spent < 3.9 mmol/l between groups was 0.9 percentage points (95% confidence interval –1.0 to 2.8). Three severe hypoglycaemic events occurred in the closed-loop group (two participants), and one in the control group; one diabetic ketoacidosis occurred in the closed-loop group. Conclusions A sustained period of hybrid closed-loop glucose control following diagnosis of type 1 diabetes in children and adolescents does not slow down the decline in residual C-peptide secretion compared with standard insulin therapy. Despite the lack of effect on C-peptide, glycaemic control was sustained in the closed-loop group, whereas glycaemic control deteriorated in the control group 6 to 9 months after diagnosis and closed-loop safely accommodated the variability in exogenous insulin requirements which occur with beta-cell recovery post diagnosis. Limitations of the study included no central measurement of auto-antibodies at diagnosis. There was imbalance in the rate of diabetic ketoacidosis at diagnosis which is associated with a more rapid decline in C-peptide secretion, but this was adjusted for in the analyses. This highlights the need for improved therapies to allow youth to achieve recommended glycaemic targets from onset of type 1 diabetes irrespective of the lack of effect on residual C-peptide secretion. Future work includes ongoing follow-up of the study population for up to 4 years after diagnosis to observe how any differences in glycaemic control between treatment groups develop over time. Trial registration This trial is registered as Clinicaltrials.gov NCT02871089. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 14/23/09), the Helmsley Trust (2016PG-T1D045 and 2016PG-T1D046), and JDRF (22-2013-266 and 2-RSC-2019-828-M-N), and is published in full in Efficacy and Mechanism Evaluation; Vol. 11, No. 8. See the NIHR Funding and Awards website for further award information. Additional support for the artificial pancreas work was from the NIHR Cambridge Biomedical Research Centre and NIHR Oxford Biomedical Research Centre. Abbott Diabetes Care supplied free glucose monitoring devices, and Dexcom supplied discounted continuous glucose monitoring devices. Medtronic supplied discounted insulin pumps, phone enclosures, continuous glucose monitoring devices, and pump consumables. Journal Article Efficacy and Mechanism Evaluation 11 8 National Institute for Health and Care Research 2050-4373 1 5 2024 2024-05-01 10.3310/ktfr5698 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University Another institution paid the OA fee This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 14/23/09), the Helmsley Trust (2016PG-T1D045 and 2016PG-T1D046), and JDRF (22-2013-266 and 2-RSC-2019-828-M-N), and is published in full in Efficacy and Mechanism Evaluation; Vol. 11, No. 8. See the NIHR Funding and Awards website for further award information. Additional support for the artificial pancreas work was from the NIHR Cambridge Biomedical Research Centre and NIHR Oxford Biomedical Research Centre. Abbott Diabetes Care supplied free glucose monitoring devices, and Dexcom supplied discounted continuous glucose monitoring devices. Medtronic supplied discounted insulin pumps, phone enclosures, continuous glucose monitoring devices, and pump consumables. 2024-09-18T14:21:23.6206357 2024-08-05T11:01:49.4848273 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Charlotte K Boughton 0000-0003-3272-9544 1 Janet M Allen 2 Julia Ware 0000-0002-4497-0979 3 Malgorzata E Wilinska 0000-0002-1564-8083 4 Sara Hartnell 5 Ajay Thankamony 0000-0001-6290-3553 6 Tabitha Randell 0000-0002-1703-1589 7 Atrayee Ghatak 8 Rachel EJ Besser 0000-0002-4645-6324 9 Daniela Elleri 10 Nicola Trevelyan 0000-0002-5991-2691 11 Fiona M Campbell 0000-0002-7618-6759 12 David Rankin 0000-0002-5835-3402 13 Barbara Kimbell 0000-0003-4510-9862 14 Julia Lawton 0000-0002-8016-7374 15 Judy Sibayan 0009-0005-9298-133x 16 Peter Calhoun 0000-0002-5325-7200 17 Ryan Bailey 18 Gareth Dunseath 0000-0001-6022-862X 19 Roman Hovorka 0000-0003-2901-461x 20 67316__31363__6f73ed97e90c43a1bd1aa4a17bd338b3.pdf 67316.VOR.pdf 2024-09-18T14:18:32.5469829 Output 2115244 application/pdf Version of Record true © 2024 Boughton et al. This work was produced by Boughton et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence. true eng https://creativecommons.org/licenses/by/4.0/
title The effect of closed-loop glucose control on C-peptide secretion in youth with newly diagnosed type 1 diabetes: the CLOuD RCT
spellingShingle The effect of closed-loop glucose control on C-peptide secretion in youth with newly diagnosed type 1 diabetes: the CLOuD RCT
Gareth Dunseath
title_short The effect of closed-loop glucose control on C-peptide secretion in youth with newly diagnosed type 1 diabetes: the CLOuD RCT
title_full The effect of closed-loop glucose control on C-peptide secretion in youth with newly diagnosed type 1 diabetes: the CLOuD RCT
title_fullStr The effect of closed-loop glucose control on C-peptide secretion in youth with newly diagnosed type 1 diabetes: the CLOuD RCT
title_full_unstemmed The effect of closed-loop glucose control on C-peptide secretion in youth with newly diagnosed type 1 diabetes: the CLOuD RCT
title_sort The effect of closed-loop glucose control on C-peptide secretion in youth with newly diagnosed type 1 diabetes: the CLOuD RCT
author_id_str_mv fccbba9edcaee08a839a3c5cff8cbe19
author_id_fullname_str_mv fccbba9edcaee08a839a3c5cff8cbe19_***_Gareth Dunseath
author Gareth Dunseath
author2 Charlotte K Boughton
Janet M Allen
Julia Ware
Malgorzata E Wilinska
Sara Hartnell
Ajay Thankamony
Tabitha Randell
Atrayee Ghatak
Rachel EJ Besser
Daniela Elleri
Nicola Trevelyan
Fiona M Campbell
David Rankin
Barbara Kimbell
Julia Lawton
Judy Sibayan
Peter Calhoun
Ryan Bailey
Gareth Dunseath
Roman Hovorka
format Journal article
container_title Efficacy and Mechanism Evaluation
container_volume 11
container_issue 8
publishDate 2024
institution Swansea University
issn 2050-4373
doi_str_mv 10.3310/ktfr5698
publisher National Institute for Health and Care Research
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
active_str 0
description Background We assessed whether a sustained period of intensive glucose control with hybrid closed-loop for 12 months following diagnosis of type 1 diabetes in children and adolescents can preserve C-peptide secretion compared to standard insulin therapy. Methods In an open-label, multicentre, randomised, parallel trial, youth aged 10–16.9 years were randomised within 21 days of type 1 diabetes diagnosis to hybrid closed-loop or standard insulin therapy (control). Primary end point was the difference in mixed-meal C-peptide area under the curve 12 months post diagnosis. Key secondary end points included time spent in target glucose range, glycated haemoglobin and time spent below target glucose range at 12 months. Analysis was by intention to treat. The Closed Loop from Onset in Type 1 Diabetes consortium secured external funding for participants to continue on beyond 12 months, but the funding by National Institute for Health and Care Research and the results reported here refer only to the 12 months follow-up. Results We randomised 97 participants (mean ± standard deviation age 12 ± 2 years), 51 to closed-loop and 46 to control therapy. There was no difference in C-peptide area under the curve at 12 months between groups [geometric mean (interquartile range) closed-loop (n = 46): 0.35 pmol/ml (0.16, 0.49) vs. control (n = 37): 0.46 pmol/ml (0.22, 0.69); mean adjusted difference –0.06 (95% confidence interval –0.14 to 0.03); p = 0.19]. The proportion of time in target range 3.9–10.0 mmol/l based on 14-day masked LibrePro (Abbott Diabetes Care, Maidenhead, UK) sensor glucose data at 12 months was 10 percentage points (95% confidence interval 2 to 17) higher in the closed-loop group (64 ± 14%) compared to control group (54 ± 23%). Arithmetic mean glycated haemoglobin A1c was lower in the closed-loop group by 4 mmol/mol (0.4%) [95% confidence interval 0 to 8 mmol/mol (0.0% to 0.7%)] at 12 months. The mean difference in time spent < 3.9 mmol/l between groups was 0.9 percentage points (95% confidence interval –1.0 to 2.8). Three severe hypoglycaemic events occurred in the closed-loop group (two participants), and one in the control group; one diabetic ketoacidosis occurred in the closed-loop group. Conclusions A sustained period of hybrid closed-loop glucose control following diagnosis of type 1 diabetes in children and adolescents does not slow down the decline in residual C-peptide secretion compared with standard insulin therapy. Despite the lack of effect on C-peptide, glycaemic control was sustained in the closed-loop group, whereas glycaemic control deteriorated in the control group 6 to 9 months after diagnosis and closed-loop safely accommodated the variability in exogenous insulin requirements which occur with beta-cell recovery post diagnosis. Limitations of the study included no central measurement of auto-antibodies at diagnosis. There was imbalance in the rate of diabetic ketoacidosis at diagnosis which is associated with a more rapid decline in C-peptide secretion, but this was adjusted for in the analyses. This highlights the need for improved therapies to allow youth to achieve recommended glycaemic targets from onset of type 1 diabetes irrespective of the lack of effect on residual C-peptide secretion. Future work includes ongoing follow-up of the study population for up to 4 years after diagnosis to observe how any differences in glycaemic control between treatment groups develop over time. Trial registration This trial is registered as Clinicaltrials.gov NCT02871089. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 14/23/09), the Helmsley Trust (2016PG-T1D045 and 2016PG-T1D046), and JDRF (22-2013-266 and 2-RSC-2019-828-M-N), and is published in full in Efficacy and Mechanism Evaluation; Vol. 11, No. 8. See the NIHR Funding and Awards website for further award information. Additional support for the artificial pancreas work was from the NIHR Cambridge Biomedical Research Centre and NIHR Oxford Biomedical Research Centre. Abbott Diabetes Care supplied free glucose monitoring devices, and Dexcom supplied discounted continuous glucose monitoring devices. Medtronic supplied discounted insulin pumps, phone enclosures, continuous glucose monitoring devices, and pump consumables.
published_date 2024-05-01T14:21:22Z
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