1. In this randomized controlled trial, closed-loop insulin delivery was more effective than standard care in keeping blood glucose levels within target for children aged two to six with type 1 diabetes.
2. Closed-loop insulin delivery was also superior to standard care regarding the percentage of time in the hyperglycemic/hypoglycemic range, mean glucose levels, and hemoglobin A1C levels.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Achieving appropriate blood sugar control in young children with type 1 diabetes is exceedingly difficult for various reasons, including those relating to their physiology, developmental abilities, unpredictable nature of their exercise levels, and dietary intake. Closed-loop insulin systems, also sometimes referred to as an ‘artificial pancreas’, are devices that employ frequent blood glucose checks to deliver automated, periodic insulin correction doses as feedback when required. This study was a randomized, unblinded, controlled trial which aimed to compare the efficacy and safety of closed-loop systems against standard care for children between two and six years old. The primary outcome was the proportion of time that the children’s blood glucose levels were within target range. Secondary outcomes included safety, as well as the proportion of time in hyperglycemia, hypoglycemia, and mean blood glucose levels. Results of the study found that the closed-loop systems were more effective at controlling blood glucose than standard care across both the primary outcomes of interest and secondary outcomes. However, there were higher rates of adverse events within the closed-loop system, many of which were linked to infusion-set failure. Although closed-loop systems may effectively overcome historical challenges in maintaining glucose control for young children, further studies focused on clarifying the risk of closed-loop systems are needed.
Click to read the study in NEJM
In-Depth [randomized controlled trial]: This study was an unblinded, randomized, controlled trial comparing the safety and efficacy of a closed-looped insulin delivery system against standard care for children between two to six years old with type 1 diabetes. Participants meeting the age requirement were included if they were diagnosed with T1D and were treated with insulin for a minimum daily insulin dose of at least five units at least six months prior to being enrolled and weighed at least 20 pounds. Participants were excluded if they already used a hybrid closed-loop insulin delivery system. After applying the inclusion and exclusion criteria, 102 children were randomized in a 2:1 ratio to the closed loop group (n=68) or standard care (n=34). The primary endpoint was the proportion of time that glucose was within the target range of 70 to 180 mg per deciliter in (%). Results of the study found that the proportion of time that blood glucose was within the target range was significantly greater for the closed-loop group than for the standard care group (mean adjusted difference 12.4%; 95% Confidence Interval [CI], 9.5 to 15.3; p<0.001). Notably, the closed-loop group had a significantly higher risk of adverse events than the standard care group (p=0.001). Further, the closed-loop group had two cases of severe hypoglycemia (compared to one case in the standard care group) and one case of diabetic ketoacidosis due to infusion-set failure. The closed-loop group also had 51 cases of hyperglycemia with or without ketosis, most of which were associated with infusion-set failures. Comparatively, only eight cases of hyperglycemia with or without ketosis were reported in the standard care group. Overall, this study demonstrated that closed-loop systems were more effective than standard care in maximizing the time that blood glucose was within the target range.
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