This article is more than 5 years old. Information may no longer be current.
CGM without confirmatory blood glucose monitoring safe, effective in type 1 diabetes
Click Here to Manage Email Alerts
In adults with type 1 diabetes, continuous glucose monitoring without confirmatory blood glucose monitoring was as safe and effective as continuous glucose monitoring with confirmatory blood glucose monitoring, according to study results.
“Recently, the FDA changed the labeling for the Dexcom CGM to indicate that insulin dosing can be done based on CGM alone for both pump users and injection users,” Roy W. Beck, MD, PhD, executive director of the Jaeb Center for Health Research in Tampa, Florida, told Endocrine Today. “The REPLACE-BG study, which is the first clinical trial that has evaluated insulin dosing based on CGM, has provided results supportive of the FDA decisions.”
Beck and colleagues evaluated adults (mean age, 44 years) with type 1 diabetes (mean diabetes duration, 24 years; mean baseline HbA1c, 7%) randomly assigned to CGM alone (n = 149) or CGM plus blood glucose monitoring (n = 77) for 26 weeks to determine whether the use of CGM alone is as safe and effective as CGM plus blood glucose monitoring. At baseline, 47% of all participants were CGM users.
Duration of CGM use was comparable between the two groups throughout the study with the CGM-alone group using it 6.7 days per week and the CGM plus blood glucose monitoring group using it 6.8 days per week. The CGM plus blood glucose monitoring group had more blood glucose monitoring tests per day from meter downloads, including the two daily required tests (5.4 tests) compared with the CGM-alone group (2.8 tests; P < .001).
At baseline and 26 weeks, the CGM-alone group spent a mean 63% of time in the range of 70 mg/dL to 180 mg/dL compared with 65% in the CGM plus blood glucose monitoring group. No significant differences were found between the groups for mean glucose, hyperglycemia, hypoglycemia or glycemic variability; there was no change in mean HbA1c.
No serious adverse events related to monitoring or occurrences of diabetic ketoacidosis occurred in either group. One participant in the CGM plus blood glucose monitoring group experienced a severe hypoglycemic event compared with none in the CGM-alone group.
“Based on the study results, clinicians and patients should have a reasonable comfort level for dosing of insulin based on CGM alone,” Beck told Endocrine Today. “Although we only studied adults with type 1 diabetes using an insulin pump, it is reasonable to consider dosing insulin based on CGM only to be safe for injection users as well as younger patients and the small proportion of patients with type 2 diabetes who use CGM. An important caveat in broadly generalizing the findings of the study is that it is necessary that the sensor be properly calibrated. The Dexcom sensor used in the trial requires two blood glucose measurements per day for calibration. These need to be done properly, for instance, following hand-washing, with a good blood glucose meter to ensure CGM sensor accuracy. With proper calibration, the study results should broadly apply to Dexcom CGM users.” – by Amber Cox
For more information:
Roy W. Beck, MD, PhD, can be reached at rbeck@jaeb.org.
Disclosure: Beck reports that his employer has received research support and study supplies from Abbot Diabetes Care and Dexcom. Please see the full study for a list of all other authors’ relevant financial disclosures.
Click Here to Manage Email Alerts