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