Sustained Intensive treatment and Long-term Effects on HbA1c Reduction (SILVER Study) by CGM in persons with type 1 diabetes treated with MDI

Abstract

Objective: Continuous Glucose Monitoring (CGM) reduces HbA1c and time spent in hypoglycemia in persons with type 1 diabetes treated with multiple daily insulin injections (MDI) when evaluated over shorter time periods. It is unclear to what extent CGM improves and helps to maintain glucose control, treatment satisfaction, diabetes distress, hypoglycemic concerns and overall well-being over longer periods of time <p><br> Research design and methods: The GOLD trial was a randomized crossover trial performed over 16 months of CGM treatment in persons with type 1 diabetes treated with MDI. Persons completing the trial (n=141) were invited to participate in the current SILVER extension study in which 107 patients continued CGM treatment over 1 year along with the support of a diabetes nurse every 3 months. <br> <br> </p> <p>Results: The primary endpoint, change in HbA1c over 1.0-1.5 years CGM use compared with previous self-monitoring of blood glucose (SMBG) during GOLD, showed a decrease in HbA1c of 0.35% (95% CI 0.19-0.50), p<0.001. Time spent in hypoglycemia <3.0 mmol/l (54 mg/dl) and <4.0 mmol/l (72 mg/dl) decreased from 2.1% to 0.6% (p<0.001) and from 5.4% to 2.9% (p<0.001), respectively. Overall well-being (WHO-5, p=0.009), treatment satisfaction (DTSQ, p<0.001) and hypoglycemic confidence (p<0.001) increased, while hypoglycemic fear (HFS-Worry, p=0.016) decreased and diabetes distress tended to decrease (PAID, p=0.06). From randomization and screening in GOLD, HbA1c was lowered by 0.45% (p<0.001) and 0.68% (p<0.001) after 2.3 and 2.5 years, respectively. <br> <br> Conclusions: The SILVER study supports beneficial long-term effects from CGM on HbA1c, hypoglycemia, treatment satisfaction, well-being and hypoglycemic confidence in persons with T1D managed with MDI. </p>