REPLACE-BG Trial: Making Safe Insulin Dosing Decisions Based on CGM Data

Anne Peters, MD, Director of the USC Clinical Diabetes Program was one the investigators on the REPLACE-BG Trial, which was conducted to show that insulin could be dosed off of values from a continuous glucose monitor (CGM).

The team compared approximately 226 patients who were dosing off of finger sticks to those who were dosing off of the CGM. Peters explained that they worked really hard to get patients in this trial that were both adherent and didn’t have many issues with hypoglycemia.

The patients were randomized 2:1, and more were on CGM alone compared to those on the finger sticks. They used the Dexcom G4 even though it had enhanced algorithms. Regardless they saw no increase in hypoglycemia and time and range (blood sugar between 70-180)

But according to Peters, “What was amazing was that there was zero difference. We believed this, but we needed to prove it.”

Peters highlighted that there are a variety of caveats, but, nonetheless, this finding was part of the dataset that went to the FDA who was willing to approve use of CGM as strip replacement. They now call it therapeutic CGM, which means it can replace finger sticks, but not the calibration finger sticks. But, the only sensor that’s been approved this way is the Dexcom G5; their data proving its usefulness and safety led to the CMS for Medicare’s approval of therapeutic CGM for seniors. So patients over the age of 65 can now have access to using CGM through Medicare, which is a huge victory, because up until now, CGM was no longer covered for patients who turned 65, yet patients above the age of 65 are more at risk for hypoglycemia.

“I’m thrilled, because the research led to a change in policy,” said Peters.