medwireNews: Results of a randomized trial suggest that continuous glucose monitoring (CGM) can be used without regular confirmatory blood glucose monitoring (BGM) among adult insulin pump users with well-controlled type 1 diabetes.
In the noninferiority REPLACE-BG (A Randomized Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Type 1 Diabetes) study, participants from 14 US sites were assigned to receive either CGM alone or CGM with confirmatory BGM.
Tonya Riddlesworth (Jaeb Center for Health Research, Tampa, Florida, USA) and colleagues found that the mean time spent within target blood glucose range (70–180 mg/dL) as measured by CGM was 63% at baseline and at 26 weeks among 148 participants undergoing CGM only, compared with 65% at both timepoints for 76 patients in the CGM+BGM group, with an adjusted difference of 0% between groups.
The similar findings at baseline and follow-up in both groups likely reflect “the excellent glycemic control of most participants entering the trial,” report the study authors in Diabetes Care.
The team also observed “virtually identical” measures of hyperglycemia, hypoglycemia, and glucose variability in the two groups, with “little change” over the study period, and findings were similar in different patient subgroups based on age, diabetes duration, use of CGM prior to study enrollment, baseline measures, and education.
Together, these results indicate that CGM alone was “noninferior to using CGM and BGM together,” say the researchers.
They explain that using CGM without confirmatory BGM could benefit patients with type 1 diabetes “by reducing their burden of multiple daily fingersticks when using CGM and can enhance the cost-effectiveness of CGM therapy by reducing the number of daily BGM test strips.”
None of the participants receiving CGM alone experienced severe hypoglycemic events, compared with one patient in the CGM+BGM group. None of the study participants experienced diabetic ketoacidosis.
Riddlesworth and team note that this safety profile “has applicability to assessing risk involved with artificial pancreas systems that automate insulin delivery based on CGM sensor glucose measurements.”
They caution that the study findings may not be generalizable to type 1 diabetes patients who did not meet their specific inclusion criteria, such as those “with significant hypoglycemia unawareness or a substantial amount of CGM-measured hypoglycemia.”
Noting that the trial was also restricted to patients who were able to document when a bolus insulin dose was required, they add that “it seems reasonable to apply the results to individuals who use multiple daily injections of insulin who otherwise fit the profile of the study participants.”
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