MOBILE: CGM benefits adults with type 2 diabetes using basal insulin in primary care
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Adults with type 2 diabetes prescribed basal insulin without prandial insulin therapy saw significant improvements in HbA1c 8 months after initiating real-time continuous glucose monitoring, according to an analysis of primary care data.
“The MOBILE research study provided the opportunity to test the concept of extending CGM benefits beyond the comfort-zone of the endocrinology division of diabetes specialists and to evaluate the introduction of a collaborative approach in managing type 2 diabetes with our primary care colleagues,” Athena Philis-Tsimikas, MD, a specialist in endocrinology, diabetes and metabolism and corporate vice president of the Scripps Whittier Diabetes Institute at Scripps Health, told Healio. “CGM offers remote monitoring capabilities and an elegantly summarized ambulatory glucose profile, providing brief and concise recommendations for the primary care provider after monthly review of the reports.
“Furthermore, this provided the chance to test CGM in a broader group of people with type 2 diabetes — those using basal insulin alone, a group not currently approved for ongoing use of CGM. Although it seems intuitive that ongoing and immediate feedback received from CGM related to food intake, exercise and daily medications can be a strong motivator to change behaviors and lead to optimized diabetes self-management, this has not been formally tested in a randomized controlled trial setting.”
Primary care data
In a randomized controlled trial, the MOBILE study group and colleagues analyzed data from 175 adults with type 2 diabetes receiving diabetes care in one of 15 primary care centers in the U.S. from July 2018 to July 2020 (mean age, 57 years; 50% women; 53% from underrepresented groups). Participants were prescribed one or two daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications (mean baseline HbA1c, 9.1%). Participants were randomly assigned 2:1 real-time CGM therapy (Dexcom G6; n = 116) or a traditional blood glucose meter (n = 59). Primary outcome was HbA1c at 8 months; secondary outcomes were CGM-measured time spent in the target glucose range (70-180 mg/dL), time spent in hyperglycemia ( 250mg/dL) and mean glucose level at 8 months. The findings were presented at the virtual International Conference on Advanced Technologies & Treatments for Diabetes and simultaneously published in JAMA.
At 8 months, mean HbA1c level decreased from 9.1% to 8% in the CGM group and from 9% to 8.4% in the blood glucose monitoring group, for an adjusted difference of 0.4 percentage points (95% CI, 0.8 to 0.1).
Compared with participants assigned a glucose meter, those using CGM experienced a significantly better mean percentage of CGM-measured time in range (mean, 59% vs. 43%; adjusted difference, 15 percentage points; 95% CI, 8-23).
Results were similar for the mean percentage of time spent in hyperglycemia (mean, 11% vs. 27%; adjusted difference, 16 percentage points; 95% CI, 21 to 11).
Severe hypoglycemic events occurred for one participant in each group.
“The improvement in HbA1c and time in range in the group using CGM was, of course, impressive and confirmed the benefit we were expecting,” Philis-Tsimikas told Healio. “Most interesting was that these findings were consistent across a diverse group of study participants from diverse racial/ethnic backgrounds — 52% of the total study group. Diverse racial/ethnic populations are disproportionately affected by diabetes, yet many times have limited access to diabetes technology. This study confirms the value of digital technology and CGM in improving glucose management and the need to offer the technology equally across all populations.”
Broadening access to CGM
The researchers acknowledged that it is unknown whether the observed benefits could be sustained for a longer duration of CGM use, adding that a 6-month extension phase may provide more insight. Virtual visits conducted during the pandemic — resulting in some participants not having HbA1c or CGM data — and greater contact with clinicians compared with usual care may have also influenced the findings, they wrote.
“This study demonstrated that a collaborative effort between diabetes specialists and primary care physicians using remote CGM provided greater benefit and yielded better glucose management in individuals with poorly controlled type 2 diabetes using basal but not prandial insulin than traditional blood glucose meters alone,” Philis-Tsimikas said. “Although excellent results were noted, about one-third of the group had an HbA1c that remained above 8%, which may indicate further recommendations for lifestyle and medical management may be needed. Future approaches that combine virtual visits with remote CGM may lead to even greater improvements.”
Reference:
Martens T, et al. JAMA. 2021;doi:10.1001/jama.2021.7444.
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Martens T. Effect of continuous glucose monitoring on glycemic control in patients with type 2 diabetes treated with basal insulin: A randomized clinical trial. Presented at: International Conference on Advanced Technologies & Treatments for Diabetes; June 2-5, 2021 (virtual meeting).
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