scholarly journals Update on the General Practice Optimising Structured Monitoring to Improve Clinical Outcomes in Type 2 Diabetes (GP-OSMOTIC) trial: statistical analysis plan for a multi-centre randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Sharmala Thuraisingam ◽  
Patty Chondros ◽  
Max Catchpool ◽  
Kim Dalziel ◽  
Jo-Anne Manski-Nankervis ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
General Practice ◽  
Statistical Analysis ◽  
Randomised Controlled Trial ◽  
Clinical Outcomes ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Randomised Controlled

scholarly journals Clinical outcomes of an integrated primary–secondary model of care for individuals with complex type 2 diabetes: a non-inferiority randomised controlled trial

Diabetologia ◽  
2018 ◽  
Vol 62 (1) ◽  
pp. 41-52 ◽  
Author(s):  
Anthony W. Russell ◽  
Maria Donald ◽  
Samantha J. Borg ◽  
Jianzhen Zhang ◽  
Letitia H. Burridge ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Randomised Controlled Trial ◽  
Clinical Outcomes ◽  
Controlled Trial ◽  
Model Of Care ◽  
Complex Type ◽  
Randomised Controlled

scholarly journals 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 ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e021435 ◽  
Author(s):  
John Furler ◽  
David Norman O’Neal ◽  
Jane Speight ◽  
Irene Blackberry ◽  
Jo-Anne Manski-Nankervis ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
General Practice ◽  
Randomised Controlled Trial ◽  
Continuous Glucose Monitoring ◽  
Controlled Trial ◽  
Glucose Monitoring ◽  
Absolute Difference ◽  
Randomised Controlled ◽  
Retrospective Continuous Glucose Monitoring

IntroductionOptimal 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 analysisGeneral 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 outcomeAbsolute 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).EligibilityAged 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 disseminationUniversity 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.

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