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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

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 and Best, James 2018, 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, BMJ open, vol. 8, no. 7, pp. 1-10, doi: 10.1136/bmjopen-2017-021435.

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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
Author(s) Furler, John
O'Neal, David Norman
Speight, JaneORCID iD for Speight, Jane orcid.org/0000-0002-1204-6896
Blackberry, Irene
Manski-Nankervis, Jo-Anne
Thuraisingam, Sharmala
de La Rue, Katie
Ginnivan, Louise
Browne, Jessica LeaORCID iD for Browne, Jessica Lea orcid.org/0000-0001-7294-8114
Holmes-Truscott, ElizabethORCID iD for Holmes-Truscott, Elizabeth orcid.org/0000-0001-9139-4663
Khunti, Kamlesh
Dalziel, Kim
Chiang, Jason
Audehm, Ralph
Kennedy, Mark
Clark, Malcolm
Jenkins, Alicia Josephine
Liew, Danny
Clarke, Philip
Best, James
Journal name BMJ open
Volume number 8
Issue number 7
Article ID e021435
Start page 1
End page 10
Total pages 10
Publisher BMJ Publishing Group
Place of publication London, Eng.
Publication date 2018-07-17
ISSN 2044-6055
Keyword(s) clinical trials
primary care
Summary 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.
Language eng
DOI 10.1136/bmjopen-2017-021435
Field of Research 170106 Health, Clinical and Counselling Psychology
Socio Economic Objective 920104 Diabetes
HERDC Research category C1 Refereed article in a scholarly journal
Grant ID NHMRC 1104241
Copyright notice ©2018, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution non-commercial licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30111683

Document type: Journal Article
Collections: School of Psychology
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.