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Diabetes Technology Highlights

DEXCOM’S DIAMOND STUDY SHOWS CGM BENEFITS MDI AT SIX MONTHS: STRONG -0.6% A1C ADVANTAGE, +61 MORE MINUTES IN RANGE PER DAY

Joslin’s Dr. Elena Toschi reported positive results from Dexcom’s DIaMonD study, which randomized MDI users to six months of CGM (n=105) or six months of usual care (n=53).

HbA1c declined a strong 0.9% with CGM at six months vs. -0.4% with usual care (baseline: 8.6%), for an adjusted mean difference of -0.6% in favor of CGM (p<0.001). 

From press release Dexcom.

Nyhetsinfo

www red DiabetologNytt

 

The advantage for CGM was impressively consistent across age, baseline hypoglycemia, education, and diabetes numeracy – 60+ year-old CGM users saw the same benefit as 25-60 year-old users in this study

At the same time HbA1c declined, hypoglycemia significantly improved with CGM: a 30% improvement in time <70 mg/dl (-23 mins/day; p=0.006) and a strong 50% improvement in time <50 mg/dl (-11 mins per day; p=0.005), both outperforming 17% and 21% improvements with usual care (-15 mins, -6 mins).

While the absolute reductions are not huge here, the high HbA1c baseline patients were not experiencing an overwhelming amount of hypoglycemia at baseline.

On the high end, CGM users were spending 83 fewer minutes per day above range (>180 mg/dl) at 24 weeks, while the usual care group was spending nine more minutes per day above range (p=0.04). That translated to CGM users spending an hour more per day in range (70-180 mg/dl ) at 24 weeks, while the usual care group spent 15 fewer minutes per day in range (p=0.006). CGM trended towards less severe hypoglycemia: a 2% rate (two out of 105 patients) vs. a 4% rate in usual care (two out of 53 patients). 

Glycemic variability also significantly improved with CGM (median CV: 42% to 38%), but did not change in usual care (42% to 42%) (p<0.001). 

Daily SMBG tests declined as expected in the CGM group (from 5.1/day to 3.6/day), but stayed roughly similar in the usual care group (5.1/day to 4.6/day) (p<0.001). CGM wear >6 days per week was seen in an impressive 89% of patients at six months, a testament to the better technology and the tight adherence criteria (>85% wear) patients had to demonstrate during the blinded CGM phase before randomization.

The presentation said the “latest” Dexcom CGM was used, which we assume means the G4 sensor with Software 505. More study details below.

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