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GP-OSMOTIC trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice
INTRODUCTION: Optimal glycaemia can reduce type 2 diabetes (T2D) complications. Observing retrospective continuous glucose monitoring (r-CGM) patterns may prompt therapeutic changes but evidence for r-CGM use in T2D is limited. We describe the protocol for a randomised controlled trial (RCT) examini...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6059310/ https://www.ncbi.nlm.nih.gov/pubmed/30018097 http://dx.doi.org/10.1136/bmjopen-2017-021435 |
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author | Furler, John O’Neal, David Norman Speight, Jane Blackberry, Irene Manski-Nankervis, Jo-Anne Thuraisingam, Sharmala de La Rue, Katie Ginnivan, Louise Browne, Jessica Lea Holmes-Truscott, Elizabeth Khunti, Kamlesh Dalziel, Kim Chiang, Jason Audehm, Ralph Kennedy, Mark Clark, Malcolm Jenkins, Alicia Josephine Liew, Danny Clarke, Philip Best, James |
author_facet | Furler, John O’Neal, David Norman Speight, Jane Blackberry, Irene Manski-Nankervis, Jo-Anne Thuraisingam, Sharmala de La Rue, Katie Ginnivan, Louise Browne, Jessica Lea Holmes-Truscott, Elizabeth Khunti, Kamlesh Dalziel, Kim Chiang, Jason Audehm, Ralph Kennedy, Mark Clark, Malcolm Jenkins, Alicia Josephine Liew, Danny Clarke, Philip Best, James |
author_sort | Furler, John |
collection | PubMed |
description | INTRODUCTION: Optimal glycaemia can reduce type 2 diabetes (T2D) complications. Observing retrospective continuous glucose monitoring (r-CGM) patterns may prompt therapeutic changes but evidence for r-CGM use in T2D is limited. We describe the protocol for a randomised controlled trial (RCT) examining intermittent r-CGM use (up to 14 days every three months) in T2D in general practice (GP). METHODS AND ANALYSIS: General Practice Optimising Structured MOnitoring To achieve Improved Clinical Outcomes is a two-arm RCT asking ‘does intermittent r-CGM in adults with T2D in primary care improve HbA1c?’ PRIMARY OUTCOME: Absolute difference in mean HbA1c at 12 months follow-up between intervention and control arms. Secondary outcomes: (a) r-CGM per cent time in target (4–10 mmol/L) range, at baseline and 12 months; (b) diabetes-specific distress (Problem Areas in Diabetes). ELIGIBILITY: Aged 18–80 years, T2D for ≥1 year, a (past month) HbA1c>5.5 mmol/mol (0.5%) above their individualised target while prescribed at least two non-insulin hypoglycaemic therapies and/or insulin (therapy stable for the last four months). Our general glycaemic target is 53 mmol/mol (7%) (patients with a history of severe hypoglycaemia or a recorded diagnosis of hypoglycaemia unawareness will have a target of 64 mmol/mol (8%)). Our trial compares r-CGM use and usual care. The r-CGM report summarising daily glucose patterns will be reviewed by GP and patient and inform treatment decisions. Participants in both arms are provided with 1 hour education by a specialist diabetes nurse. The sample (n=150/arm) has 80% power to detect a mean HbA1c difference of 5.5 mmol/mol (0.5%) with an SD of 14.2 (1.3%) and alpha of 0.05 (allowing for 10% clinic and 20% patient attrition). ETHICS AND DISSEMINATION: University of Melbourne Human Ethics Sub-Committee (ID 1647151.1). Dissemination will be in peer-reviewed journals, conferences and a plain-language summary for participants. TRIAL REGISTRATION NUMBER: ACTRN12616001372471; Pre-results. |
format | Online Article Text |
id | pubmed-6059310 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-60593102018-07-27 GP-OSMOTIC trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice Furler, John O’Neal, David Norman Speight, Jane Blackberry, Irene Manski-Nankervis, Jo-Anne Thuraisingam, Sharmala de La Rue, Katie Ginnivan, Louise Browne, Jessica Lea Holmes-Truscott, Elizabeth Khunti, Kamlesh Dalziel, Kim Chiang, Jason Audehm, Ralph Kennedy, Mark Clark, Malcolm Jenkins, Alicia Josephine Liew, Danny Clarke, Philip Best, James BMJ Open Diabetes and Endocrinology INTRODUCTION: Optimal glycaemia can reduce type 2 diabetes (T2D) complications. Observing retrospective continuous glucose monitoring (r-CGM) patterns may prompt therapeutic changes but evidence for r-CGM use in T2D is limited. We describe the protocol for a randomised controlled trial (RCT) examining intermittent r-CGM use (up to 14 days every three months) in T2D in general practice (GP). METHODS AND ANALYSIS: General Practice Optimising Structured MOnitoring To achieve Improved Clinical Outcomes is a two-arm RCT asking ‘does intermittent r-CGM in adults with T2D in primary care improve HbA1c?’ PRIMARY OUTCOME: Absolute difference in mean HbA1c at 12 months follow-up between intervention and control arms. Secondary outcomes: (a) r-CGM per cent time in target (4–10 mmol/L) range, at baseline and 12 months; (b) diabetes-specific distress (Problem Areas in Diabetes). ELIGIBILITY: Aged 18–80 years, T2D for ≥1 year, a (past month) HbA1c>5.5 mmol/mol (0.5%) above their individualised target while prescribed at least two non-insulin hypoglycaemic therapies and/or insulin (therapy stable for the last four months). Our general glycaemic target is 53 mmol/mol (7%) (patients with a history of severe hypoglycaemia or a recorded diagnosis of hypoglycaemia unawareness will have a target of 64 mmol/mol (8%)). Our trial compares r-CGM use and usual care. The r-CGM report summarising daily glucose patterns will be reviewed by GP and patient and inform treatment decisions. Participants in both arms are provided with 1 hour education by a specialist diabetes nurse. The sample (n=150/arm) has 80% power to detect a mean HbA1c difference of 5.5 mmol/mol (0.5%) with an SD of 14.2 (1.3%) and alpha of 0.05 (allowing for 10% clinic and 20% patient attrition). ETHICS AND DISSEMINATION: University of Melbourne Human Ethics Sub-Committee (ID 1647151.1). Dissemination will be in peer-reviewed journals, conferences and a plain-language summary for participants. TRIAL REGISTRATION NUMBER: ACTRN12616001372471; Pre-results. BMJ Publishing Group 2018-07-17 /pmc/articles/PMC6059310/ /pubmed/30018097 http://dx.doi.org/10.1136/bmjopen-2017-021435 Text en © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Diabetes and Endocrinology Furler, John O’Neal, David Norman Speight, Jane Blackberry, Irene Manski-Nankervis, Jo-Anne Thuraisingam, Sharmala de La Rue, Katie Ginnivan, Louise Browne, Jessica Lea Holmes-Truscott, Elizabeth Khunti, Kamlesh Dalziel, Kim Chiang, Jason Audehm, Ralph Kennedy, Mark Clark, Malcolm Jenkins, Alicia Josephine Liew, Danny Clarke, Philip Best, James GP-OSMOTIC trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice |
title | GP-OSMOTIC trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice |
title_full | GP-OSMOTIC trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice |
title_fullStr | GP-OSMOTIC trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice |
title_full_unstemmed | GP-OSMOTIC trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice |
title_short | GP-OSMOTIC trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice |
title_sort | gp-osmotic trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-cgm) on hba1c in adults with type 2 diabetes in general practice |
topic | Diabetes and Endocrinology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6059310/ https://www.ncbi.nlm.nih.gov/pubmed/30018097 http://dx.doi.org/10.1136/bmjopen-2017-021435 |
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