Effect of 6 months’ flash glucose monitoring in adolescents and young adults with type 1 diabetes and suboptimal glycaemic control: managing diabetes in a ‘flash’ randomised controlled trial protocol
Abstract Background Teenagers and young adults with type 1 diabetes (T1D) experience significant burden managing this serious chronic condition and glycaemic control is at its unhealthiest during this life stage. Flash glucose monitoring (FGM) is a new technology that reduces the burden of glucose m...
Main Authors: | , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
BMC
2019-05-01
|
Series: | BMC Endocrine Disorders |
Subjects: | |
Online Access: | http://link.springer.com/article/10.1186/s12902-019-0378-z |
id |
doaj-09e173319e894a918b7cc846313fcb70 |
---|---|
record_format |
Article |
spelling |
doaj-09e173319e894a918b7cc846313fcb702020-11-25T03:44:38ZengBMCBMC Endocrine Disorders1472-68232019-05-0119111310.1186/s12902-019-0378-zEffect of 6 months’ flash glucose monitoring in adolescents and young adults with type 1 diabetes and suboptimal glycaemic control: managing diabetes in a ‘flash’ randomised controlled trial protocolSara E. Boucher0Andrew R. Gray1Martin de Bock2Esko J. Wiltshire3Barbara C. Galland4Paul A. Tomlinson5Jenny Rayns6Karen E. MacKenzie7Benjamin J. Wheeler8Department of Women’s and Children’s Health, Dunedin School of Medicine, University of OtagoCentre for Biostatistics, Division of Health Sciences, University of OtagoDepartment of Paediatrics, University of OtagoDepartment of Paediatrics and Child Health, University of Otago WellingtonDepartment of Women’s and Children’s Health, Dunedin School of Medicine, University of OtagoPaediatric Department, Southern District Health BoardEndocrinology Department, Southern District Health BoardDepartment of Paediatrics, University of OtagoDepartment of Women’s and Children’s Health, Dunedin School of Medicine, University of OtagoAbstract Background Teenagers and young adults with type 1 diabetes (T1D) experience significant burden managing this serious chronic condition and glycaemic control is at its unhealthiest during this life stage. Flash glucose monitoring (FGM) is a new technology that reduces the burden of glucose monitoring by easily and discreetly displaying glucose information when an interstitial glucose sensor worn on the upper arm is scanned with a handheld reader, as opposed to traditional capillary glucose sampling by finger prick (otherwise known as self-monitored blood glucose, SMBG). The effectiveness of this technology and impacts of its long-term use in youth with pre-existing suboptimal glycaemic control are unknown. This study therefore aims to investigate the effectiveness of FGM in addition to standard care in young people with T1D. Methods This is a two phase study programme including a multi-centre randomised, parallel-group study consisting of a 6-month comparison between SMBG and FGM, with an additional 6-month continuation phase. We will enrol adolescents with T1D aged 13–20 years (inclusive), with suboptimal glycaemic control (mean glycated haemoglobin (HbA1c) in past 6 months ≥75 mmol/mol [≥9%]). Participants will be randomly allocated (1:1) to FGM (FreeStyle Libre; intervention group) or to continue SMBG with capillary blood glucose testing (usual care group). All participants will continue other aspects of standard care with the study only providing the FreeStyle Libre. At 6 months, the control group will cross over to the intervention. The primary outcome is the between group difference in changes in HbA1c at 6 months. Additional outcomes include a range of psychosocial and health economic measures as well as FGM acceptability. Discussion >If improvements are found, this will further encourage steps towards integrating FGM into regular diabetes care for youth with unhealthy glycaemic control, with the expectation it will reduce daily diabetes management burden and improve short- and long-term health outcomes in this high-risk group. Trial registration This trial was registered with the Australian New Zealand Clinical Trials Registry on 5 March 2018 (ACTRN12618000320257p) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1205-5784).http://link.springer.com/article/10.1186/s12902-019-0378-zAdolescentsFlash glucose monitoringFreeStyle libreGlucose monitoringGlycaemic controlIntermittent continuous glucose monitoring |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Sara E. Boucher Andrew R. Gray Martin de Bock Esko J. Wiltshire Barbara C. Galland Paul A. Tomlinson Jenny Rayns Karen E. MacKenzie Benjamin J. Wheeler |
spellingShingle |
Sara E. Boucher Andrew R. Gray Martin de Bock Esko J. Wiltshire Barbara C. Galland Paul A. Tomlinson Jenny Rayns Karen E. MacKenzie Benjamin J. Wheeler Effect of 6 months’ flash glucose monitoring in adolescents and young adults with type 1 diabetes and suboptimal glycaemic control: managing diabetes in a ‘flash’ randomised controlled trial protocol BMC Endocrine Disorders Adolescents Flash glucose monitoring FreeStyle libre Glucose monitoring Glycaemic control Intermittent continuous glucose monitoring |
author_facet |
Sara E. Boucher Andrew R. Gray Martin de Bock Esko J. Wiltshire Barbara C. Galland Paul A. Tomlinson Jenny Rayns Karen E. MacKenzie Benjamin J. Wheeler |
author_sort |
Sara E. Boucher |
title |
Effect of 6 months’ flash glucose monitoring in adolescents and young adults with type 1 diabetes and suboptimal glycaemic control: managing diabetes in a ‘flash’ randomised controlled trial protocol |
title_short |
Effect of 6 months’ flash glucose monitoring in adolescents and young adults with type 1 diabetes and suboptimal glycaemic control: managing diabetes in a ‘flash’ randomised controlled trial protocol |
title_full |
Effect of 6 months’ flash glucose monitoring in adolescents and young adults with type 1 diabetes and suboptimal glycaemic control: managing diabetes in a ‘flash’ randomised controlled trial protocol |
title_fullStr |
Effect of 6 months’ flash glucose monitoring in adolescents and young adults with type 1 diabetes and suboptimal glycaemic control: managing diabetes in a ‘flash’ randomised controlled trial protocol |
title_full_unstemmed |
Effect of 6 months’ flash glucose monitoring in adolescents and young adults with type 1 diabetes and suboptimal glycaemic control: managing diabetes in a ‘flash’ randomised controlled trial protocol |
title_sort |
effect of 6 months’ flash glucose monitoring in adolescents and young adults with type 1 diabetes and suboptimal glycaemic control: managing diabetes in a ‘flash’ randomised controlled trial protocol |
publisher |
BMC |
series |
BMC Endocrine Disorders |
issn |
1472-6823 |
publishDate |
2019-05-01 |
description |
Abstract Background Teenagers and young adults with type 1 diabetes (T1D) experience significant burden managing this serious chronic condition and glycaemic control is at its unhealthiest during this life stage. Flash glucose monitoring (FGM) is a new technology that reduces the burden of glucose monitoring by easily and discreetly displaying glucose information when an interstitial glucose sensor worn on the upper arm is scanned with a handheld reader, as opposed to traditional capillary glucose sampling by finger prick (otherwise known as self-monitored blood glucose, SMBG). The effectiveness of this technology and impacts of its long-term use in youth with pre-existing suboptimal glycaemic control are unknown. This study therefore aims to investigate the effectiveness of FGM in addition to standard care in young people with T1D. Methods This is a two phase study programme including a multi-centre randomised, parallel-group study consisting of a 6-month comparison between SMBG and FGM, with an additional 6-month continuation phase. We will enrol adolescents with T1D aged 13–20 years (inclusive), with suboptimal glycaemic control (mean glycated haemoglobin (HbA1c) in past 6 months ≥75 mmol/mol [≥9%]). Participants will be randomly allocated (1:1) to FGM (FreeStyle Libre; intervention group) or to continue SMBG with capillary blood glucose testing (usual care group). All participants will continue other aspects of standard care with the study only providing the FreeStyle Libre. At 6 months, the control group will cross over to the intervention. The primary outcome is the between group difference in changes in HbA1c at 6 months. Additional outcomes include a range of psychosocial and health economic measures as well as FGM acceptability. Discussion >If improvements are found, this will further encourage steps towards integrating FGM into regular diabetes care for youth with unhealthy glycaemic control, with the expectation it will reduce daily diabetes management burden and improve short- and long-term health outcomes in this high-risk group. Trial registration This trial was registered with the Australian New Zealand Clinical Trials Registry on 5 March 2018 (ACTRN12618000320257p) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1205-5784). |
topic |
Adolescents Flash glucose monitoring FreeStyle libre Glucose monitoring Glycaemic control Intermittent continuous glucose monitoring |
url |
http://link.springer.com/article/10.1186/s12902-019-0378-z |
work_keys_str_mv |
AT saraeboucher effectof6monthsflashglucosemonitoringinadolescentsandyoungadultswithtype1diabetesandsuboptimalglycaemiccontrolmanagingdiabetesinaflashrandomisedcontrolledtrialprotocol AT andrewrgray effectof6monthsflashglucosemonitoringinadolescentsandyoungadultswithtype1diabetesandsuboptimalglycaemiccontrolmanagingdiabetesinaflashrandomisedcontrolledtrialprotocol AT martindebock effectof6monthsflashglucosemonitoringinadolescentsandyoungadultswithtype1diabetesandsuboptimalglycaemiccontrolmanagingdiabetesinaflashrandomisedcontrolledtrialprotocol AT eskojwiltshire effectof6monthsflashglucosemonitoringinadolescentsandyoungadultswithtype1diabetesandsuboptimalglycaemiccontrolmanagingdiabetesinaflashrandomisedcontrolledtrialprotocol AT barbaracgalland effectof6monthsflashglucosemonitoringinadolescentsandyoungadultswithtype1diabetesandsuboptimalglycaemiccontrolmanagingdiabetesinaflashrandomisedcontrolledtrialprotocol AT paulatomlinson effectof6monthsflashglucosemonitoringinadolescentsandyoungadultswithtype1diabetesandsuboptimalglycaemiccontrolmanagingdiabetesinaflashrandomisedcontrolledtrialprotocol AT jennyrayns effectof6monthsflashglucosemonitoringinadolescentsandyoungadultswithtype1diabetesandsuboptimalglycaemiccontrolmanagingdiabetesinaflashrandomisedcontrolledtrialprotocol AT karenemackenzie effectof6monthsflashglucosemonitoringinadolescentsandyoungadultswithtype1diabetesandsuboptimalglycaemiccontrolmanagingdiabetesinaflashrandomisedcontrolledtrialprotocol AT benjaminjwheeler effectof6monthsflashglucosemonitoringinadolescentsandyoungadultswithtype1diabetesandsuboptimalglycaemiccontrolmanagingdiabetesinaflashrandomisedcontrolledtrialprotocol |
_version_ |
1724513598356586496 |