102-LB: GP-OSMOTIC: An RCT to Determine the Effect of 3-Monthly Retrospective Continuous Glucose Monitoring (rCGM) on 12-Month HbA1c in Adults with Type 2 Diabetes (T2D) in Primary Care
Authors: FURLER JOHN , O’NEAL DAVID N. , SPEIGHT JANE , MANSKI-NANKERVIS JO-ANNE E. , THURAISINGAM SHARMALA , HOLMES-TRUSCOTT ELIZABETH , DE LA RUE KATIE R. , GINNIVAN LOUISE E. , DOYLE REBECCA C. , KHUNTI KAMLESH , CATCHPOOL MAX , DALZIEL KIM , CHIANG JASON I. , BLACKBERRY IRENE , AUDEHM RALPH , KENNEDY MARK , CLARK MALCOLM J. , JENKINS ALICIA J. , JANUSZEWSKI ANDRZEJ S. , LIEW DANNY , CLARKE PHILIP M. , BEST JAMES D. 
Published: June 2019

Introduction: Reviewing rCGM patterns may prompt lifestyle or therapeutic changes to achieve glycaemic targets but evidence for rCGM use in primary care management of T2D is limited.

Methods: Two-arm RCT. Participants: Adults with T2D, HbA1c ≥0.5% above target, prescribed ≥2 non-insulin glycemia medications or insulin. Intervention: 1-hour diabetes education and (at 0/3/6/9/12 months): HbA1c assessment + wearing FreeStyle Libre Pro (Abbott) for up to 14 days prior to being discussed at a clinic visit. Physicians were trained in interpreting ambulatory glucose profiles. Control: 3-monthly ‘usual care’ clinic visits + r-CGM device worn (blinded, research data) at 0 and 12 months. Primary outcome: difference in mean HbA1c at 12 months. Secondary outcomes: mean differences in time in range (TIR: 4-10 mmol/L) and diabetes-specific distress (PAID) at 12 months, and HbA1c at 6 months. ITT analysis.

Results: In 25 primary care practices, participants were: 299 adults with T2D, aged (mean(SD)) 60(10) years, HbA1c: 8.9(1.2)%, diabetes duration (median(IQR)) of 12(8,20) years. At 12 months, the between-group difference in mean HbA1c was 0.2% (p=0.112). The estimated mean percentage TIR was 8.4% higher in the intervention than the control arm (p=0.004). Diabetes-specific distress did not differ between arms (0.5; p=0.71). At 6 months, HbA1c was significantly lower in the intervention arm (0.5%; p&lt;0.001). We found little evidence of changes in the number of glycemic medications in either arm.

Discussion: Use of 3-monthly rCGM in adults with T2D in primary care does not improve HbA1c at 12 months. We showed a statistically and clinically significant reduction in HbA1c at 6 months in the intervention group, as well as significant improvements in TIR at 12 months, with no change in diabetes distress. Our findings suggest the primary impact of r-CGM use on HbA1c in this setting is short term, and not associated with increase in the number of diabetes medications.

Disclosure

J. Furler: Research Support; Self; Abbott, Sanofi. D.N. O’Neal: None. J. Speight: Research Support; Self; AstraZeneca, Medtronic, Sanofi. Speaker’s Bureau; Self; Novo Nordisk A/S, Roche Diabetes Care. J.E. Manski-Nankervis: Research Support; Self; Australian National Health and Medical Research Council, Boehringer Ingelheim International GmbH, Diabetes Australia, Eli Lilly and Company. Speaker’s Bureau; Self; RACGP. S. Thuraisingam: None. E. Holmes-Truscott: Research Support; Self; Sanofi. Speaker’s Bureau; Self; Novo Nordisk Inc. K.R. De La Rue: None. L.E. Ginnivan: None. R.C. Doyle: None. K. Khunti: Advisory Panel; Self; Amgen Inc., AstraZeneca, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Pfizer Inc., Sanofi-Aventis, Servier, Takeda Pharmaceutical Company Limited. Research Support; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Pfizer Inc., Sanofi-Aventis. Speaker’s Bureau; Self; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Menarini Group, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi, Servier, Takeda Pharmaceutical Company Limited. M. Catchpool: None. K. Dalziel: None. J.I. Chiang: None. I. Blackberry: None. R. Audehm: Advisory Panel; Self; AstraZeneca, Novartis Pharmaceuticals Corporation. M. Kennedy: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi. M.J. Clark: None. A.J. Jenkins: Advisory Panel; Self; Abbott, Australian Diabetes Society, Medtronic. Research Support; Self; Abbott, GlySens Incorporated, Medtronic, Mylan. Speaker’s Bureau; Self; Eli Lilly and Company, Novo Nordisk Inc. A.S. Januszewski: None. D. Liew: Advisory Panel; Self; AstraZeneca, Bayer AG. Research Support; Self; AbbVie Inc., AstraZeneca, Bristol-Myers Squibb Company, CSL Behring, Pfizer Inc. P.M. Clarke: None. J.D. Best: Consultant; Self; Abbott.

Funding

National Health and Medical Research Council of Australia (APP1104241); Sanofi Australia; Abbott Diabetes Care