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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
Authors: 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
Keywords: Clinical Trials
Primary Care
Issue Date: 2018
Source: Furler, J., O’Neal, D. N., Speight, J., Blackberry, I., Manski-Nankervis, J.-A., Thuraisingam, S., . . . Best, J. (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, 8(7), e021435-. doi:10.1136/bmjopen-2017-021435
Series/Report no.: BMJ Open
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).
DOI: 10.1136/bmjopen-2017-021435
Rights: © 2018 Author(s) (or their employer(s)). 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:
Fulltext Permission: open
Fulltext Availability: With Fulltext
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