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 24 January in Journal of the American Medical Association (JAMA), the study showed Dexcom CGM System users on multiple daily injections (MDI) achieved a 1% average reduction in HbA1c 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 hypo and hyperglycemia when they used a Dexcom CGM System compared to those who used only a standard meter to monitor their glucose.
Roy Beck, MD, Jaeb, Center for Health Research in Tampa, Florida explains the impact saying, “There is a commonly held belief that insulin pump users are better candidates for using CGM, and that people using MDI 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.”
The DIaMonD study included 158 adult participants with Type 1 diabetes on MDI. At 24 weeks, the average HbA1c in subjects assigned to the CGM group was 1% compared to baseline. Subjects in the SMBG control group showed only a 0.4% reduction. The CGM System used in the study was the G4 Platinum CGM System with Software 505, made by DexCom, Inc.
A subset of subjects who were considered uncontrolled (an HbA1c greater than 8.3%) saw a 1.3% reduction in HbA1c from baseline at week 24.
Initially presented at the 76th Annual Meeting of the American Diabetes Association in June 2016, the study also tracked the amount of time patients spent in hypoglycemia and found a significant reduction in the CGM group compared to baseline:
• 49% reduction in time spent < 3.9 mmol/L
• 53% reduction in time spent < 3.3 mmol/L
• 69% reduction in time spent < 2.8 mmol/L CGM users showed a significant reduction in hypoglycemia during the night, spending only 0.6% of the time in hypoglycemia vs. 2.9% at baseline. The study also found that CGM patients spent significantly less time (58 minutes) in hyperglycemia (>16.6 mmol/L) compared to baseline and demonstrated a substantial increase in time spent ‘in range’ (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 HbA1c 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 more than days/week at the end of the study.
The DIaMonD study was conducted between October 2014 and May 2016 at 24 endocrinology practices in the United States using 158 adult subjects with Type 1 diabetes on MDI insulin therapy. The study delivered compelling evidence of significant improvements across several measures of glycemic control.
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