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Diabetes and endocrinology
Protocol
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
  1. John Furler1,
  2. David Norman O’Neal2,
  3. Jane Speight3,4,
  4. Irene Blackberry5,
  5. Jo-Anne Manski-Nankervis1,
  6. Sharmala Thuraisingam1,
  7. Katie de La Rue1,
  8. Louise Ginnivan1,
  9. Jessica Lea Browne3,4,
  10. Elizabeth Holmes-Truscott3,4,
  11. Kamlesh Khunti6,
  12. Kim Dalziel7,
  13. Jason Chiang1,
  14. Ralph Audehm1,
  15. Mark Kennedy1,
  16. Malcolm Clark1,
  17. Alicia Josephine Jenkins8,
  18. Danny Liew9,
  19. Philip Clarke10,
  20. James Best11
  1. 1 Department of General Practice, University of Melbourne, Carlton, Victoria, Australia
  2. 2 Department of Medicine, St Vincent’s Hospital, University of Melbourne, Melbourne, Australia
  3. 3 School of Psychology, Deakin University, Geelong, Victoria, Australia
  4. 4 The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, Victoria, Australia
  5. 5 Latrobe University, Wodonga, Victoria, Australia
  6. 6 Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK
  7. 7 University of Melbourne, Melbourne, Australia
  8. 8 NHMRC Clinical Trials Centre, The University of Sydney, NSW 2006, Australia
  9. 9 Centre of Cardiovascular Research and Education in Therapeutics, Monash University, Melbourne, Victoria, Australia
  10. 10 University of Melbourne, Melbourne, Australia
  11. 11 Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore
  1. Correspondence to Dr John Furler; j.furler{at}unimelb.edu.au

Abstract

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.

  • primary care
  • clinical trials

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/.

https://doi.org/10.1136/bmjopen-2017-021435

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    Footnotes

    • Contributors JF, DNO’N, JS, IB, J-AM-N, KK, KD and JB developed the study concept and aims and initiated the project. ST, KdLR, LG, JLB, EH-T, JC, RA, MK, MC, AJJ, DL, PC and JB assisted in further development of the protocol. JF was responsible for drafting the manuscript. KdLR, ST and LG implemented the protocol and oversaw collection of the data. All authors contributed to the final manuscript.

    • Funding This work was supported by the National Health and Medical Research Council Project Grant (ID APP1104241). Additional funding has been provided by Sanofi Australia . In-kind support has been provided by Abbott Diabetes Care, which has provided the Libre Pro reader devices, sensors and software.

    • Disclaimer The funding body and industry partners have had no involvement in the design of the study and will have no role in the collection, analysis and interpretation of data or in writing any manuscripts describing the study outcomes. Study sponsor and funders have had no role in study design or data analysis plans.

    • Competing interests JF has received unrestricted educational grants for research support from Roche, Sanofi and Medtronic; JS is a member of the Accu-Check Advisory Board (Roche Diabetes Care) and also served on the advisory boards of Janssen and Medtronic. Her research group has received unrestricted educational grants from AstraZeneca, Medtronic and Sanofi Diabetes; sponsorship to attend educational meetings from Medtronic, Roche Diabetes Care, and Sanofi Diabetes; consultancy income and/or speaker fees from Abbott Diabetes Care, AstraZeneca, Roche Diagnostics Australia and Sanofi Diabetes; DON is on advisory boards to Abbott Diabetes Care, and Novo-Nordisk. DON, DL and JMN have had various financial relationships with pharmaceutical industries outside the submitted work including consultancies, grants, lectures, educational activities and travel. IB has received investigator initiated grant from Medtronic and Sanofi Diabetes. EHT has undertaken research funded by an unrestricted educational grant from Abbott Diabetes Care to ACBRD and has served on an AstraZeneca advisory board. JLB has received consultancy income (paid to the ACBRD) from Sanofi ANZ and Roche Diagnostics, and travel funds from AstraZeneca, and has served on a Sanofi ANZ advisory board. KK has acted as a consultant, speaker or received grants for research from Astra Zeneca, Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Janssen, Boehringer Ingelheim and Roche. JF was supported by a National Health and Medical Research Council Career Development Fellowship and then a Translating Research into Practice Fellowship. JS, JLB and EH-T are supported by core funding to the Australian Centre for Behavioural Research in Diabetes from Diabetes Victoria and Deakin University.

    • Patient consent Obtained.

    • Ethics approval University of Melbourne Human Ethics Sub-Committee.

    • Provenance and peer review Not commissioned; externally peer reviewed.