1. Amongst patients with type 1 diabetes (T1D), a bionic pancreas caused a reduction in glycated hemoglobin levels over a 13-week period.
2. In comparison to the bionic pancreas group, semi-automated insulin delivery systems did not change glycated hemoglobin levels amongst patients with T1D.
Evidence Rating Level: 1 (Excellent)
Study Rundown: T1D is an autoimmune disease that results in the destruction of insulin-producing cells in the pancreas, leading to persistently high levels of sugar in the blood and an inability of body tissues to use them. If uncontrolled, T1D can cause significant damage to arteries and nerves, even posing a risk of death. As such, maintaining good control of blood sugars is a key priority for persons with T1D. Towards this end, partially automated insulin-delivery systems have grown in popularity over the past decade. These typically describe methods of regulating blood sugars through continuous monitoring of blood glucose levels in combination with calculations of basal rates, carbohydrate intakes, and additional metrics involved in initiation. A newer system of insulin delivery, the iLet bionic pancreas, is a fully automated means of insulin delivery that bypasses several elements of the partially automated insulin delivery systems. The current study was a randomized trial comparing semi-automated insulin delivery systems against the iLet bionic pancreas amongst adults and children with T1D. The primary goal was to investigate the difference in change in glycated hemoglobin levels within the blood after 13 weeks of use. At the last follow-up, the bionic pancreas was able to reduce glycated hemoglobin levels amongst its users without causing significantly different rates of hypoglycemic episodes. In comparison, semi-automated insulin delivery systems did not result in a significant reduction in glycated hemoglobin levels. Further studies with longer follow-up and detailed assessments of whether the bionic pancreas can reduce the risk of hypoglycemia, hyperglycemia, and ketosis will be helpful in better understanding its potential for widespread use.
In-Depth [randomized controlled trial]: The current study was a parallel group, unblinded, multicenter, randomized trial comparing the iLet bionic pancreas against semi-automated insulin delivery systems amongst persons aged 6-79 years old with T1D. Standard care was determined to be any method of insulin delivery that utilized unblinded continuous glucose monitoring tools. Participants (n=219) were randomly assigned to the iLet bionic pancreas group or the standard care group in a 2:1 ratio. The primary endpoint was a change in glycated hemoglobin levels at 13 weeks of follow-up. Secondary endpoints included percentage of time glucose levels were in pre-determined ranges (i.e., <54mg/dL, <70mg/dL, 70-180mg/dL, >180mg/dL, and >250mg/dL), and safety outcomes such as diabetic ketoacidosis, and episodes of severe hypoglycemia. At 13 weeks, the bionic pancreas reduced glycated hemoglobin levels in comparison to standard care (-0.5 percentage points; 95% Confidence Interval [CI], -0.6 to -0.3). The bionic pancreas group and standard care group did not show significant differences in the percentage of time that glucose was below 54mg/dL as measured through real-time continuous glucose monitoring (0.0 percentage points; 95% CI, -0.1 to 0.0). Notably, the bionic pancreas group reported 214 episodes of hyperglycemia (primarily due to infusion-set failure) compared to two in the standard-care group. However, neither group reported any episodes of diabetic ketoacidosis. Although further investigations into the safety profile of the bionic pancreas in comparison to standard care are needed, this study provided evidence of the potential of the bionic pancreas to enhance glucose control amongst persons with T1D.
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