Results from the Diamond trial indicated a 1% average A1C reduction after 24 weeks of regular use compared to a baseline, as well as more time spent in the target blood glucose range and less time spent in hypoglycemia and hyperglycemia, the company said.
The 158-patient trial was the 1st and only randomized, controlled study examining the benefit of CGM for MDI insulin therapy, according to DexCom.
Data from the trial, was published today in the Journal of the American Medical Association, the San Diego, Calif.-based company said.
“In the diabetes community, there is a commonly held belief that insulin pump users are better candidates for using CGM, and that patients on an MDI regimen wouldn’t benefit either because they wouldn’t be willing to wear a CGM device or they wouldn’t use the information to make the changes needed for better glucose control. The Diamond study makes significant headway in proving that a wide range of diabetes patients taking insulin injections can benefit from CGM use,” Dr. Roy Beck of Tampa, Fla.’s Center for Health Research said in a press release.
At 24 weeks, the average A1C reduction in subjects in the CGM group was 1% compared to a baseline, higher than the 0.4% of patients in the SMBG control group. A subset of subjects with A1C greater than 8.5% – deemed uncontrolled – reported a 1.3% reduction in A1C at 24 weeks, the company reported.
Patients in the CGM arm reported a 49% reduction in time spent under 70mg/dL, a 53% reduction in time spent under 60mg/dL and a 69% reduction in time spent under 50mg/dL, according to the study.
Results also indicated a significant reduction in night hypoglycemia, at 0.6% with CGM therapy versus 2.9% at baseline. Tine spent in hyperglycemia were also lower for CGM patients, with an average of 58 minutes, while time spent in range was clocked at 1.3 hours.
Significant A1C reductions were recorded regardless of education level, math ability or age, DexCom said, which “dispels the perception that CGM is too complicated to use.”
“With improved accuracy and reliability in CGM technology, patients have built trust in the devices and use them as the primary tool for monitoring their glucose. We are delighted that the DexCom CGM System was able to demonstrate significant benefits among a diverse group of patients, but more importantly, the positive outcomes in the 60+ population will be critical to our efforts in driving CGM coverage for Medicare-eligible patients,” CEO & prez Kevin Sayer said in prepared remarks.
Earlier this month, DexCom that the Centers for Medicare & Medicaid classified therapeutic continuous glucose monitors as durable medical equipment under Medicare Part B. The company’s Dexcom G5 Mobile is the only CGM system that falls under this classification, according to DexCom, since patients can make treatment decisions using the device.
The post Study: DexCom touts low A1C, more “in range” time for MDI patients using CGM appeared first on MassDevice.
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