64-OR: Sustained Intensive Treatment and Long-Term Effects on A1C Reduction (SILVER Study) by CGM in Persons with T1D Treated with MDI
Authors: LIND MARCUS , OLAFSDOTTIR ARNDIS F. , HIRSCH IRL B. , BOLINDER JAN , DAHLQVIST SOFIA , PIVODIC ALDINA , HELLMAN JARL , WIJKMAN MAGNUS O. , SCHWARCZ ERIK , ALBREKTSSON HENRIK , HEISE TIM , POLONSKY WILLIAM 
Published: June 2020

CGM reduces A1c and time in hypoglycemia in persons with T1D treated with MDI evaluated over short time periods. It’s unclear to what extent CGM improves glucose control, treatment satisfaction, hypoglycemia fear and diabetes-related QoL long term.

The GOLD trial was a 16 month randomized crossover trial of CGM use in persons with T1D treated with MDI. The SILVER study is an extension in which patients continued CGM use (DexcomG4/G5) for 1 year with clinical visits every 3 months.

The primary endpoint, A1c change during long-term CGM use compared with SMBG during GOLD (from end of SMBG in GOLD until end of SILVER study/1.0-1.5 years), showed decreased A1c of 0.35% (95% CI 0.19-0.50), p&lt;0.001. TIR increased by 8.6% (95% CI 5.1-12.0,p&lt;0.001), from 43.0 -51.0%. Time in hypoglycemia &lt;54 and &lt;70 mg/dl decreased from 2.1- 0.6%, p&lt;0.001 and from 5.4- 2.9%, p&lt;0.001, respectively. From randomization and screening in GOLD, A1c decreased by 0.45% (p&lt;0.001) and 0.68% (p&lt;0.001) after 2.5 years, respectively. Wellbeing WHO-5, p&lt;0.001, treatment satisfaction DTSQ, p&lt;0.001 and hypoglycemia confidence, p&lt;0.001 increased. Diabetes-distress decreased PAID, p=0.006 over the time period.

The SILVER study supports beneficial long-term effects by CGM use on A1c, TIR, hypoglycemia, treatment satisfaction, wellbeing, hypoglycemia confidence and diabetes distress in persons with T1D treated with MDI.

Disclosure

M. Lind: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Merck Sharp & Dohme Corp., Novo Nordisk Inc. Consultant; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk Inc. Research Support; Self; Dexcom, Inc., Novo Nordisk Inc. A.F. Olafsdottir: None. I.B. Hirsch: Consultant; Self; Abbott, Bigfoot Biomedical, Roche Diabetes Care. Research Support; Self; Medtronic, Omnipod. J. Bolinder: Advisory Panel; Self; Abbott. Consultant; Self; Novo Nordisk A/S. Speaker’s Bureau; Self; AstraZeneca. S. Dahlqvist: None. A. Pivodic: None. J. Hellman: Advisory Panel; Self; Abbott, Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. Speaker’s Bureau; Self; Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Sanofi. M.O. Wijkman: None. E. Schwarcz: Advisory Panel; Self; Sanofi. Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc. H. Albrektsson: None. T. Heise: Advisory Panel; Self; Mylan, Novo Nordisk A/S. Research Support; Self; ADOCIA, Aerami, Becton, Dickinson and Company, Biocon, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Gan & Lee Pharmaceuticals, MedImmune, Merck KGaA, Mylan, Nordic Bioscience, Novo Nordisk A/S, Poxel SA, Sanofi, Xeris Pharmaceuticals, Inc., Zealand Pharma A/S. Speaker’s Bureau; Self; Eli Lilly and Company, Novo Nordisk A/S. W. Polonsky: Advisory Panel; Self; Intarcia Therapeutics, Roche Diabetes Care. Consultant; Self; Abbott, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk Inc., Onduo, Sanofi US, Xeris Pharmaceuticals, Inc.

Funding

Dexcom, Inc.