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In a 26-week randomized trial involving 283 adults with type 2 diabetes who were not using insulin, continuous glucose monitoring was associated with lower HbA1c and more time in the target glucose range than routine care. The trial found no severe hypoglycemia or hyperglycemia-related serious adverse events, but its results may not fully reflect use in routine practice.
A 26-week randomized trial found that adults with type 2 diabetes who were not treated with insulin had lower HbA1c and spent more time in the target glucose range when using a continuous glucose monitor (CGM) than participants receiving routine care. The CONNECT study involved 283 patients at U.S. primary care practices, adding trial evidence about CGM use in a group for whom evidence has been more limited.
At week 26, mean HbA1c in the CGM group fell from 8.8% to 7.2%. In the routine-care group, it fell from 8.7% to 8.0%. The adjusted mean difference between groups was -0.9 percentage points (95% confidence interval, -1.1 to -0.6; P<0.001), according to results reported by Roy W. Beck, MD, PhD, of the Jaeb Center for Health Research in Tampa, Florida, and colleagues in the New England Journal of Medicine.
Participants using CGMs spent 21 percentage points more time in the target glucose range of 70-180 mg/dL than those receiving routine care, a difference equivalent to about five additional hours per day. Time spent above 250 mg/dL was 15 percentage points lower in the CGM group. The researchers also reported small reductions in time below 70 mg/dL and below 54 mg/dL. No cases of severe hypoglycemia or serious adverse events related to hyperglycemia were observed during the trial.
Median CGM use was 97% of the time during the study. The report counted 33 adverse events in the CGM group and 24 in routine care; three events in the CGM group were sensor-related: two instances of bleeding at the insertion site and one event during sensor removal. These findings describe the trial period and participants, rather than establishing how often similar outcomes would occur in broader practice.
Evidence for CGM Beyond Insulin Use
The findings address a gap in evidence for people with type 2 diabetes who do not use insulin. CGMs measure glucose levels over time and can show patterns that may inform day-to-day decisions and discussions with health care providers. In this trial, the difference in HbA1c and time in range suggests that CGM use may support improved glucose management for adults similar to those enrolled.
The results do not show that CGM alone caused all the improvement or that every patient will benefit to the same degree. Medication changes occurred during the study: insulin or other glucose-lowering medicines were added for 31% of the CGM group and 17% of the routine-care group. The authors said those changes could not explain the improvement on their own, since they affected a minority of participants, and suggested that behavior changes may also have contributed.
For clinicians and patients, the trial provides randomized evidence that could inform decisions about monitoring beyond insulin-treated diabetes. It does not, by itself, settle questions about cost, access, the support needed to use CGM data, or the size and durability of benefits in everyday care.
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Why the Trial Focused on Primary Care
CGM recommendations have historically been supported by stronger evidence for people with type 1 diabetes and people with type 2 diabetes who use insulin. The trial authors noted that the 2026 American Diabetes Association Standards of Care cited level A evidence for CGM use among people receiving insulin, while citing level C evidence for people with diabetes not treated with insulin. That difference reflects the evidence available to support the recommendations, not a finding that CGM cannot help people outside the insulin-treated group.
CONNECT was conducted at 22 U.S. primary care practices, where most people with type 2 diabetes receive care. Participants were ages 21 to 84 and had a baseline HbA1c of at least 7.5%. They had not used real-time CGM in the previous six months or insulin in the previous 12 months, and their non-insulin glucose-lowering or weight-loss medicines had been stable for at least a month before enrollment. GLP-1 receptor agonists were used by 40% of participants, SGLT2 inhibitors by 37%, and both medication classes by 18%.
Providing care in primary care practices was intended to make the results more applicable to typical treatment settings. Still, the trial selected participants with elevated HbA1c and supplied sensors, and follow-up included study visits. Those features matter when comparing trial results with care outside a study.
“The improvement observed with CGM cannot be explained by medication changes alone but may have been due to modifications in behavioral habits that could affect glucose levels.”
— Roy W. Beck and colleagues
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Questions About Everyday CGM Use
The study followed participants for 26 weeks; it does not yet show whether the differences persist over longer periods. The authors also cautioned that the high device-use rate may reflect the study setting, including supplied sensors and the frequency of visits. Adherence and glucose benefits could be lower in routine use.
The trial does not establish how much of the observed improvement came from seeing CGM readings, changes in behavior, medication adjustments, or a combination of factors. Nor does the supplied report provide enough information to determine the cost-effectiveness of CGM, how coverage affects access, or whether results apply to people with lower starting HbA1c levels or different care needs. The absence of severe events in this trial should not be read as proof that such events cannot occur.
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Extension Study Will Track Durability
A 26-week extension phase is underway to assess whether participants continue using CGMs and whether the glucose-related effects last. That follow-up may help clarify durability beyond the initial trial period. Results from the extension and further studies in routine-care settings could help determine how well the findings translate to people who are not receiving the same sensor provision and visit schedule.
Until those data are available, the CONNECT results support a measured conclusion: CGM use improved HbA1c and time in range over 26 weeks among the enrolled adults with non-insulin-treated type 2 diabetes, while longer-term outcomes and real-world adherence remain uncertain.
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Key Questions
What did the CONNECT trial find?
Over 26 weeks, adults with type 2 diabetes not using insulin who used CGMs had lower mean HbA1c and spent more time in the 70-180 mg/dL glucose range than those receiving routine care.
How much did HbA1c change?
Mean HbA1c fell from 8.8% to 7.2% in the CGM group and from 8.7% to 8.0% in routine care. The adjusted difference between groups at week 26 was -0.9 percentage points.
Did the study report serious safety events?
No cases of severe hypoglycemia or hyperglycemia-related serious adverse events were observed during the trial. Three sensor-related adverse events were reported in the CGM group, including bleeding at insertion sites and an event during sensor removal.
Do the results prove CGMs will work the same way in routine care?
No. The researchers cautioned that sensors were provided and visits took place during the study, which may have contributed to high device use. Adherence and glucose benefits could be lower outside the trial.
What happens next?
A 26-week extension is underway to examine continued CGM use and whether the observed glucose effects last beyond the initial study period.
Source: rss
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