Dexcom announces the first and only randomised, controlled study focusing solely on the benefit of continuous glucose monitoring (CGM) for diabetes patients on multiple daily injections (MDI) insulin therapy. The DIaMonD study (Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes) is the first-of-its-kind study that demonstrates the impact of CGM on A1C and hypoglycemia in participants on a multiple daily injection insulin regimen.
Published in the January 24 issue of the Journal of the American Medical Association (JAMA), the study showed Dexcom CGM System users on MDI achieved a 1 per cent average A1C reduction after 24 weeks of regular use, compared to baseline. In addition to better glucose control, participants also increased time spent in target range and spent less time in hypoglycemia and hyperglycemia when they used a Dexcom CGM System compared to those who used only a standard meter to monitor their glucose.
"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," said Roy Beck, MD, Jaeb, Center for Health Research in Tampa, Florida.
The DIaMonD study included 158 adult participants with type 1 diabetes on MDI. At 24 weeks, the average A1C reduction (a measure of average blood glucose over a 2-3 month period) in subjects assigned to the CGM group (n=105) was 1 per cent compared to baseline. Subjects in the SMBG control group showed only a 0.4 per cent reduction (n=53); (p < .001). The CGM System used in the study was the Dexcom G4® PLATINUM CGM System with Software 505, made by DexCom, Inc., (NASDAQ:DXCM). The company's current flagship product, the Dexcom G5® Mobile CGM System, also uses this software.
A subset of subjects who were considered uncontrolled—an A1C greater than 8.5 per cent—saw a 1.3 per cent reduction in A1C from baseline at week 24.
Initially presented at the 76th Annual Meeting of the American Diabetes Association in June 2016, the DIaMonD study also tracked the amount of time patients spent in hypoglycemia and found a significant reduction in the CGM group compared to baseline:
- 49 per cent reduction in time spent < 70mg/dL(3.9 mmol/L)
- 53 per cent reduction in time spent < 60 mg/dL(3.3 mmol/L)
- 69 per cent reduction in time spent < 50mg/dL (2.8 mmol/L)
CGM users showed a significant reduction in hypoglycemia during the night, spending only 0.6 per cent of the time in hypoglycemia vs. 2.9 per cent at baseline. The study also found that CGM patients spent significantly less time (58 minutes) in hyperglycemia ( > 300mg/dL or 16.6 mmol/L) compared to baseline and demonstrated a substantial increase in time spent "in range" (70-180mg/dL or 3.9-10.0 mmol/L) of 1.3 hours.
Additionally, the study dispels the perception that CGM is too complicated to use, as patients demonstrated significant A1C reductions regardless of education level, math ability, or age. A high level of adherence was also achieved with 93% of patients still using the Dexcom CGM System ≥6 days/week at the end of the study.
"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," said Kevin Sayer, President and CEO, Dexcom. "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 US Medicare-eligible patients."