1. Introduction
MDI-treated, hypoglycemic, Diabetes, CSII-treated, diabetes
DIABETES, TYPE 1 DIABETES, JUVENILE DIABETES, DIABETES
These authors contributed equally to this work.Background: Continuous glucose monitoring (CGM) users are encouraged to consider trend arrows before injecting a meal bolus. We evaluated the efficacy and safety of two different algorithms for trend-informed bolus adjustments, the Diabetes Research in Children Network/Juvenile Diabetes Research Foundation (DirectNet/JDRF) and the Ziegler algorithm, in type 1 diabetes. Methods: We conducted a cross-over study of type 1 diabetes patients using Dexcom G6. Participants were randomly assigned to either the DirectNet/JDRF or the Ziegler algorithm for two weeks. After a 7-day wash-out period with no trend-informed bolus adjustments, they crossed to the alternative algorithm. Results: Twenty patients, with an average age of 36 ± 10 years, completed this study. Compared to the baseline and the DirectNet/JDRF algorithm, the Ziegler algorithm was associated with a significantly higher time in range (TIR) and lower time above range and mean glucose. A separate analysis of patients on CSII and MDI revealed that the Ziegler algorithm provides better glucose control and variability than DirectNet/JDRF in CSII-treated patients. The two algorithms were equally effective in increasing TIR in MDI-treated patients. No severe hypoglycemic or hyperglycemic episode occurred during the study. Conclusions: The Ziegler algorithm is safe and may provide better glucose control and variability than the DirectNet/JDRF over a two-week period, especially in patients treated with CSII.In the last two decades, continuous glucose monitoring (CGM) revolutionized the self-management of diabetes by providing users with near real-time information on their current glucose levels [One of the benefits of CGM is the prediction of future glucose levels with the so-called trend arrows, which indicate both the direction and the rate of change (ROC) of glucose at any given time. However, the meaning of the different arrows may vary depending on the manufacturer [Interpreting trend arrows is a fundamental skill a patient should learn when using CGM. In clinical practice, people with diabetes are told to look at the trend arrows alongside current glucose values before physical activity, driving, bedtime, and before each meal to increase or reduce the calculated meal bolus [Within the last decade, a number of algorithms have been proposed to determine appropriate dose adjustments based on the trend arrows. However, there is still no consensus due to the lack of robust clinical trials. In two remarkable studies on type 1 diabetes, the Juvenile Diabetes Research Foundation (JDRF) Continuous Glucose Monitoring study and the Diabetes Research in Children Network (DirecNet) Applied Treatment Algorithm study, the ‘10%/20% rule’ for adjusting bolus insulin dose was evaluated for the first time [Taking into consideration the role of the ROC as expressed by the trend arrow before calculating the meal bolus, we designed our research to evaluate the short-term efficacy and safety of two different algorithms for bolus adjustments, namely the earlier and simpler DirectNet/JDRF algorithm and the novel (at the time when this study was conducted) and more sophisticated Ziegler algorithm, in a sample of patients with type 1 diabetes using a CGM device.