SILVER study shows sustained benefits with CGM use for MDI users
medwireNews: A 1-year extension of the GOLD study shows that people with type 1 diabetes taking insulin via multiple daily injections (MDI) retain the glycemic control benefits of continuous glucose monitoring (CGM) over the long term.
The SILVER study included 107 people with type 1 diabetes who consented to participate in the extension, comprising 77.5% of the original GOLD trial population. These participants continued to use CGM for a further 12 months.
At the end of this period, their average glycated hemoglobin (HbA1c) was 7.96% (64 mmol/mol), reported Marcus Lind (University of Gothenburg, Sweden) at the virtual ADA 80th Scientific Sessions.
This was a significant 0.35% (4 mmol/mol) lower than in the phases of GOLD during which the participants were using self-monitored blood glucose (SMBG). GOLD consisted of two 6-month periods of CGM and SMBG use, undertaken in a randomly assigned order with a 4-month washout period between.
The time spent in hypoglycemia (glucose <3.0 mmol/mol; 54 mg/dL) reduced from 2.1% with SMBG to 0.6% in SILVER, and while Lind noted this may seem like a small reduction, he stressed that “there is actually 70% less time in hypoglycemia.”
Participants also had a significant increase in the time spent within target blood glucose range, reduced glycemic variability, and reductions in the amount of time spent in hyperglycemia.
Lind reported that study participants who had continued into SILVER directly from a CGM phase of GOLD maintained approximately the same HbA1c level as they had achieved during the randomized trial.
And participants who entered SILVER from a SMBG phase had significant HbA1c reductions, despite them having reduced clinical contact in SILVER, consisting of brief consultations with a diabetes nurse every 3 months.
Lind concluded that switching to CGM has lasting benefits for people with type 1 diabetes, and “hence more patients worldwide – since SMBG is still most common in most countries – should preferentially have the option to switch to CGM.”
However, he stressed that despite the overall improvements, many of the SILVER study participants were “far from reaching targets” such as time in range, and that additional options such as semi-closed loop insulin delivery systems may be needed for some subgroups.
“And finally,” Lind said, “I think one of the most important implications is that improved support [for] CGM in persons with type 1 diabetes managed with MDI needs to be developed to reach targets of glycemic metrics in many patients.”
He noted that good support for people using injections tends to be lacking, and is needed, because although it may not be as close to physiologic insulin delivery as semi-closed loops can offer, it is cheaper, and many people may prefer it.
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