dc.contributor.author |
Jefferies, Craig A |
|
dc.contributor.author |
Boucsein, Alisa |
|
dc.contributor.author |
Styles, Sara E |
|
dc.contributor.author |
Chamberlain, Bronte |
|
dc.contributor.author |
Michaels, Venus R |
|
dc.contributor.author |
Crockett, Hamish R |
|
dc.contributor.author |
De Lange, Michel |
|
dc.contributor.author |
Lala, Anita |
|
dc.contributor.author |
Cunningham, Vicki |
|
dc.contributor.author |
Wiltshire, Esko J |
|
dc.contributor.author |
Serlachius, Anna S |
|
dc.contributor.author |
Wheeler, Benjamin J |
|
dc.coverage.spatial |
United States |
|
dc.date.accessioned |
2024-03-13T01:58:46Z |
|
dc.date.available |
2024-03-13T01:58:46Z |
|
dc.date.issued |
2023-12 |
|
dc.identifier.citation |
(2023). Diabetes Technology and Therapeutics, 25(12), 827-835. |
|
dc.identifier.issn |
1520-9156 |
|
dc.identifier.uri |
https://hdl.handle.net/2292/67677 |
|
dc.description.abstract |
Objective: To investigate whether intermittently scanned continuous glucose monitoring (isCGM) reduced glycated hemoglobin (HbA1c) compared with capillary self-monitored capillary blood glucose (SMBG) in children with type 1 diabetes (T1D) and elevated glycemic control.
Research Design and Methods: This multicenter 12-week 1:1 randomized, controlled, parallel-arm trial included 100 participants with established T1D aged 4–13 years (mean 10.9 ± 2.3 years) naive to isCGM and with elevated HbA1c 7.5%–12.2% [58–110 mmol/mol] [mean HbA1c was 9.05 (1.3)%] [75.4 (13.9) mmol/mol]. Participants were allocated to 12-week intervention (isCGM; FreeStyle Libre 2.0; Abbott Diabetes Care, Witney, United Kingdom) (n = 49) or control (SMBG; n = 51). The primary outcome was the difference in change of HbA1c from baseline to 12 weeks.
Results: There was no evidence of a difference between groups for change in HbA1c at 12 weeks (0.23 [95% confidence interval; CI: −0.21 to 0.67], P = 0.3). However, glucose-monitoring frequency increased with isCGM +4.89/day (95% CI 2.97–6.81; P < 0.001). Percent time below range (TBR) <3.9 mmol/L (70–180 mg/dL) was reduced with isCGM −6.4% (10.6 to −4.2); P < 0.001. There were no differences in within group changes for Parent or Child scores of psychosocial outcomes at 12 weeks.
Conclusions: For children aged 4–13 years with elevated HbA1C isCGM led to improvements in glucose testing frequency and reduced time below range. However, isCGM did not translate into reducing HbA1C or psychosocial outcomes compared to usual care over 12-weeks. The trial is registered within the Australian New Zealand Trial Registry on February 19, 2020 (ACTRN12620000190909p; ANZCTR.org.au) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1237-0090) |
|
dc.format.medium |
Print-Electronic |
|
dc.language |
eng |
|
dc.publisher |
Mary Ann Liebert |
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dc.relation.ispartofseries |
Diabetes Technology & Therapeutics |
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dc.rights |
Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. |
|
dc.rights.uri |
https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm |
|
dc.rights.uri |
http://creativecommons.org/licenses/by/4.0 |
|
dc.subject |
Humans |
|
dc.subject |
Diabetes Mellitus, Type 1 |
|
dc.subject |
Blood Glucose |
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dc.subject |
Hypoglycemic Agents |
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dc.subject |
Blood Glucose Self-Monitoring |
|
dc.subject |
Child |
|
dc.subject |
Australia |
|
dc.subject |
Glycated Hemoglobin |
|
dc.subject |
FreeStyle Libre 2 |
|
dc.subject |
Glycemic control |
|
dc.subject |
Intermittently scanned continuous glucose monitoring |
|
dc.subject |
Self monitoring of capillary blood glucose |
|
dc.subject |
Type 1 diabetes |
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dc.subject |
children |
|
dc.subject |
32 Biomedical and Clinical Sciences |
|
dc.subject |
3202 Clinical Sciences |
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dc.subject |
Diabetes |
|
dc.subject |
Comparative Effectiveness Research |
|
dc.subject |
Clinical Research |
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dc.subject |
Clinical Trials and Supportive Activities |
|
dc.subject |
Pediatric |
|
dc.subject |
Autoimmune Disease |
|
dc.subject |
Prevention |
|
dc.subject |
Metabolic and endocrine |
|
dc.subject |
3 Good Health and Well Being |
|
dc.subject |
Science & Technology |
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dc.subject |
Life Sciences & Biomedicine |
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dc.subject |
Endocrinology & Metabolism |
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dc.subject |
GLUCOSE |
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dc.subject |
HYPOGLYCEMIA |
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dc.subject |
ADOLESCENTS |
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dc.subject |
TECHNOLOGY |
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dc.subject |
ADULTS |
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dc.subject |
1103 Clinical Sciences |
|
dc.subject |
1116 Medical Physiology |
|
dc.title |
Effects of 12-Week Freestyle Libre 2.0 in Children with Type 1 Diabetes and Elevated HbA1c: A Multicenter Randomized Controlled Trial |
|
dc.type |
Journal Article |
|
dc.identifier.doi |
10.1089/dia.2023.0292 |
|
pubs.issue |
12 |
|
pubs.begin-page |
827 |
|
pubs.volume |
25 |
|
dc.date.updated |
2024-02-14T20:05:10Z |
|
dc.rights.holder |
Copyright: The authors |
en |
dc.identifier.pmid |
37782139 (pubmed) |
|
pubs.author-url |
https://www.liebertpub.com/doi/10.1089/dia.2023.0292 |
|
pubs.end-page |
835 |
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pubs.publication-status |
Published |
|
dc.rights.accessrights |
http://purl.org/eprint/accessRights/OpenAccess |
en |
pubs.subtype |
research-article |
|
pubs.subtype |
Multicenter Study |
|
pubs.subtype |
Randomized Controlled Trial |
|
pubs.subtype |
Journal Article |
|
pubs.elements-id |
988308 |
|
pubs.org-id |
Liggins Institute |
|
pubs.org-id |
Medical and Health Sciences |
|
pubs.org-id |
School of Medicine |
|
pubs.org-id |
Psychological Medicine Dept |
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dc.identifier.eissn |
1557-8593 |
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pubs.record-created-at-source-date |
2024-02-15 |
|
pubs.online-publication-date |
2023-10-20 |
|