Adults with type 1 diabetes at low risk of severe hypoglycemia have safely and effectively used a continuous glucose monitor (CGM) system without finger pricking to check blood glucose levels, a trial confirms.
The findings from the 26-week REPLACE-BG trial could be significant in future therapeutic decisions regarding finger pricking among patients treated with CGMs.
Last year the US Food and Drug Administration (FDA) approved users of the Dexcom G5 CGM system to replace finger pricking with the readings given from the monitor in determining doses of insulin. Twice-daily blood tests are still required for reasons including calibrating the CGM, if the sensor is unable to provide data or if CGM results do not match the person’s symptoms.
However, these are US recommendations, and UK users of CGM devices should adhere to advice from their health tam.
Senior author Dr Roy W Beck, Jaeb Center for Health Research, Tampa, Florida, told Medscape Medical News: “The study results are supportive of the FDA decision. Based on the study results, clinicians and patients should have a reasonable comfort level for dosing of insulin based on CGM alone.”
A total of 226 adults with type 1 diabetes were involved in this trial, all of whom used insulin pumps and had a mean HbA1c of 7% (53 mmol/mol). Half the participants were using CGMs before the trial.
They were divided into one of two groups, either receiving CGM-only treatment or CGM plus blood glucose monitoring (BGM). The first group based all management decisions on the CGM readings; the second group tested their blood sugar levels whenever they injected bolus insulin, during hypoglycemia and before sleep.
No significant differences between the groups were observed regarding blood glucose control, hypoglycemia or hyperglycemia, regardless of confounding factors such as age, baseline HbA1c or CGM use prior to the study.
“I believe that it is likely that the same degree of safety is present in injection users using CGM who are under good control, as there is no reason to expect different results. But we can’t directly conclude this from the study,” said Beck.
“The safety also should be the same for both pump users and injection users who are not under good control, provided that they properly calibrate the sensor.”
The researchers stress, despite these findings, that clinicians should still ensure patients using CGMs should keep blood glucose meters and strips at hand at all times, in case any problems should emerge with their CGMs.
The findings appear online in the journal Diabetes Care.