Real-world MiniMed data in line with trial findings
medwireNews: Patients using the MiniMed 670G hybrid closed-loop system in the real world achieve similar glycemic control to patients who used it in the pivotal clinical trial, researchers have reported.
This also applied to patients who switched to the system directly from multiple daily injections; patients in the clinical trial had already been on insulin pump therapy for at least 6 months.
Scott Lee (Loma Linda University Medical Center, Los Angeles, California, USA) presented data from 30,337 patients with over 3 million days’ use of the MiniMed 670G (Medtronic, Northridge, California, USA), which recently had its FDA approval extended to include children as young as 7 years.
“What we know with real-world data and big datasets is you’re able to get a very heterogeneous population of patients across wide variation and practice styles with people who are actually managing the system,” he said, contrasting it to the homogenous populations that tend to be enrolled to clinical trials.
When patients were using the system in manual mode, which offers suspension of insulin in the case of impending hypoglycemia but is otherwise under the control of the user, the average time in sensor glucose range (70–180 mg/dL) was 62.1%. This improved to 70.5% when patients used the system in closed-loop mode, which makes incremental adjustments to basal insulin to achieve a target glucose level of 120 mg/dL.
Lee told delegates at the ADA’s 78th Scientific Sessions in Orlando, Florida, USA, that this was “consistent with the pivotal trial,” in which patients had a manual and closed-loop time in range of 67.1% and 72.4%, respectively. Time at less than 70 mg/dL in closed-loop mode was 3.0% and 2.1% in the clinical trial and the real-world users, respectively.
The findings were similar for a subgroup of 241 patients who had switched to the MiniMed 670G system directly from multiple daily injections, rather than from an insulin pump. Their time in range was 65.3% in manual mode and 73.1% in closed-loop mode, and their time in hypoglycemia in closed-loop mode was 1.8%.
Lee noted that patients switching directly from injections have less “luggage” than those already using monitoring and pump technology in terms of wanting to try and control every aspect of their blood glucose levels “and for them, in some ways, it’s easier to make that transition than patients who are already on pump therapy [who] have trouble letting go and letting the system automate for its delivery.”
In all groups of patients, the improved time in range was driven mostly by a large fall in the time in hyperglycemia; for example, this fell from 35.4% to 27.3% in the total population of real-world users.
By Eleanor McDermid
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