SAN FRANCISCO -- Patients with diabetes who use continuous glucose monitoring (CGM) systems should stay in the recommended range for around three-quarters of the day, according to an international consensus presented here.
For individuals with type 1 and type 2 diabetes, more than 16.8 hours of the day (70%) should be spent between the target range of 70 and 180 mg/dL, corresponding with a 7% hemoglobin A1c, stated Tadej Battelino, MD, PhD, of the University Children's Hospital in Ljubljana, Slovenia, and colleagues in .
Those with type 1 diabetes should spend fewer than 1 hour per day (4%) below or 6 hours (25%) above the recommended range, he said at the American Diabetes Association (ADA) annual meeting.
Furthermore, those with type 2 diabetes should avoid spending more than 15 minutes (1%) below 54 mg/dL or 1.2 hours (5%) above 250 mg/dL, according to the guidelines, which were endorsed by the ADA along with several other professional organizations, including the American Association of Clinical Endocrinologists.
"Randomized controlled trials with CGM clearly showed the benefits -- glycosylated hemoglobin went down, timing range went up, and hyperglycemia was reduced in different trials -- but when you look at the compared to 10 years ago, the outcomes are worse," Battelino told 鶹ý. "We thought that maybe there was a disconnect between what we know about [CGM] and what everyone should know about it."
However, Battelino emphasized that these time-in-range targets are intended to complement HbA1c measures and that even small increases in the amount of time spent in-range are beneficial.
"Both clinicians, healthcare professionals, and people with diabetes have used glycosylated hemoglobin for 30 years, so we don't want to replace it, we want to complement it," he said.
The recommendations come 2 years after the ADA released the , which defined the target range for patients using these systems. This new consensus suggests the duration that should be spent within these thresholds.
CGM has become more widely available, but its successful utilization remains low. It was necessary to update the guidelines so that patients could determine when they may be at risk for diabetic complications in real time, the consensus authors noted.
On the other hand, it may ease patient anxiety to know that just a few minutes or hours spent below or above the target range will not necessarily be detrimental to their overall levels, Battelino said.
The consensus was developed by dozens of physicians, researchers, and CGM technology experts at the .
Their analysis was based on several studies validating the use of this time-in-range measurement, including that linked each 10% reduction in time-in-range with a 64% increased risk of retinopathy progression. referenced tied higher rates of advanced diabetic retinopathy with significantly less time spent in the designated range.
The authors also looked at studies examining the relationship between time-in-range and HbA1c measures and found that 70% of time spent in range corresponded to an HbA1c of about 7%. Meanwhile, spending half of the day in range aligned with an HbA1c of 8%, according to an analysis of more than a dozen trials.
For certain populations, the ideal range needs to be adjusted to reflect access to care or other comorbidities. For example, the standard target may be used for children, adolescents, and adults ages ≤25 who have access to comprehensive care, but patients unable to access insulins, or who cannot regularly check glucose, may require a higher target of around 60%, the authors stated.
For pregnant women with type 1 diabetes or gestational diabetes, the target range is defined as between 62 and 140 mg/dL because glucose levels vary physiologically in pregnancy, the authors reported. With this in mind, Battelino and colleagues recommended that pregnant women with type 1 diabetes spend the same amount of time per day (>70% or 16.8 hours) in range, <1 hour per day (4%) below range, and <6 hours per day (25%) above range.
The panel did not reach a consensus regarding the ideal time-in-range for pregnant women with type 2 diabetes, Battelino said, although the 63-140 mg/dL target range still applies, according to the consensus.
For medically frail patients with type 1 or type 2 diabetes, the panelists determined a less stringent window was necessary to spend in the designated range, as this population may have comorbidities that make it more difficult to achieve ambitious glucose levels, Battelino said. As such, the guidelines recommend more than half of the day be spent between 70 and 180 mg/dL, <15 minutes (1%) below, and <2.4 hours (10%) above.
Battelino said he hopes the recommendations are widely followed so that efficacy can be further evaluated. "Now that we've agreed as a consensus, let's hope that in 5 years we can have completely evidence-based recommendations," he said.
Disclosures
The recommendations were supported by Abbott Diabetes Care, AstraZeneca, Dexcom, Eli Lilly, Insulet, Medtronic, Novo Nordisk, Roche Diabetes Care, and Sanofi.
Battelino disclosed relevant relationships with Novo Nordisk, Sanofi, Eli Lilly, Boehringer, Medtronic, Roche, Bayer Health Care, and DreaMed Diabetes. Co-authors disclosed multiple relevant relationships with industry.
Primary Source
Diabetes Care
Battelino T, et al "Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range" Diabetes Care 2019; DOI: 10.2337/dci19-0028