Sustained Intensive Treatment and Long-term Effects on HbA_1c Reduction (SILVER Study) by CGM in People With Type 1 Diabetes Treated With MDI.

Abstract

Continuous glucose monitoring (CGM) reduces HbA_1c and time spent in hypoglycemia in people with type 1 diabetes (T1D) 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. The GOLD trial was a randomized crossover trial performed over 16 months of CGM treatment in people with T1D treated with MDI. People completing the trial (<i>n</i> = 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. The primary end point of the change in HbA_1c over 1.0-1.5 years of CGM use compared with previous self-monitoring of blood glucose during GOLD showed a decrease in HbA_1c of 0.35% (95% CI 0.19-0.50, <i>P</i> < 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% (<i>P</i> < 0.001) and from 5.4% to 2.9% (<i>P</i> < 0.001), respectively. Overall well-being (World Health Organization 5-item well-being index, <i>P</i> = 0.009), treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire, <i>P</i> < 0.001), and hypoglycemic confidence (<i>P</i> < 0.001) increased, while hypoglycemic fear (Hypoglycemia Fear Survey-Worry, <i>P</i> = 0.016) decreased and diabetes distress tended to decrease (Problem Areas in Diabetes Scale, <i>P</i> = 0.06). From randomization and screening in GOLD, HbA_1c was lowered by 0.45% (<i>P</i> < 0.001) and 0.68% (<i>P</i> < 0.001) after 2.3 and 2.5 years, respectively. The SILVER study supports beneficial long-term effects from CGM on HbA_1c, hypoglycemia, treatment satisfaction, well-being, and hypoglycemic confidence in people with T1D managed with MDI.