Closed-loop system tied to better glycemic control vs. standard therapy in type 2 diabetes
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Key takeaways:
- Adults with type 2 diabetes had a higher time in range with fully closed-loop insulin delivery than conventional therapy.
- No difference in adverse events was observed between the two regimens.
Adults with type 2 diabetes using a fully closed-loop automated insulin delivery system have a higher time in range than those receiving conventional insulin therapy, according to findings published in Diabetic Medicine.
“Our meta-analysis suggests that fully closed-loop automated insulin delivery may provide better glycemic control than conventional therapy in patients with type 2 diabetes, including those requiring dialysis or nutritional support,” Basma Ehab Amer, BMed, an MBBCH candidate and undergraduate researcher in the Medical Research Group of Egypt at Negida Academy in Arlington, Massachusetts, and in the faculty of medicine at Benha University in Egypt, and colleagues wrote. “Until higher quality evidence is developed, hospitals should provide comprehensive training for both patients and health care staff to make them ready for this technology.”
Researchers conducted a systematic review and meta-analysis of randomized controlled trials comparing adults with type 2 diabetes using fully closed-loop automated insulin delivery with standard insulin therapy. The Cochrane Central, Scopus, Web of Science and PubMed databases were searched from inception until April 26. The primary outcome of interest was time spent in target glucose range of 100 mg/dL to 180 mg/dL. Studies that did not use that range used a time in range of 70 mg/dL to 180 mg/dL or 70 mg/dL to 145 mg/dL. Secondary outcomes included time spent in hyperglycemia, time spent in hypoglycemia, total daily insulin dose, mean glucose, glucose variability and safety.
There were seven randomized controlled trials with 390 total participants included in the meta-analysis. All of the included studies were conducted in Switzerland or the United Kingdom. Four were parallel-group trials and three had a crossover design.
Adults using a fully closed-loop system spent an additional 18 minutes in glucose range per 24 hours compared with adults receiving standard therapy (P < .01), with 5 additional minutes coming overnight and 13 additional minutes during the day. Time in hypoglycemia did not differ between the fully closed-loop and control groups. Adults receiving fully closed-loop automated insulin delivery spent 15 fewer minutes in hyperglycemia compared with standard insulin therapy (P < .01), though no difference was observed when daytime and overnight time in hyperglycemia were analyzed separately.
“Our results corroborate the hypothesis that fully closed-loop systems may improve glycemic control not only for patients with type 1 diabetes but also for those with type 2 diabetes,” the researchers wrote. “The insignificant difference in both daytime and overnight time spent in hyperglycemia can be attributed to the small number of studies in these subgroups, each of which contains only two studies.”
Adults in the fully closed-loop group had a 11.34 mg/dL lower standard deviation of glucose compared with controls. Coefficient of variation in glucose level was lower in the closed-loop group compared with controls during overnight hours, but not overall or during daytime hours. There were no differences in total daily insulin dose between the groups. Mean glucose was 15.48 mg/dL lower with fully closed-loop insulin delivery compared with standard insulin therapy (P < .01).
Adults receiving fully closed-loop automated insulin delivery had a higher risk for device deficiencies than those receiving standard therapy (RR = 3.77; 95% CI, 2.03-6.98; P < .01). There were no differences in adverse events or serious adverse events between the two groups.
“We recommend further high-quality, well-designed randomized controlled trials to include more participants from different countries and with different races,” the researchers wrote. “We also recommend that future randomized controlled trials provide sufficient information about the participating hospitals’ glycemic management protocols. Therefore, we can evaluate the efficacy of fully closed-loop automated insulin delivery in larger populations, compare its efficacy across different races, and generalize the evidence to a wider range of patients with type 2 diabetes.”
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