2.1. Study Design
diabetes
TYPE 1 DIABETES, DIABETES
The current research study is an exploratory single-arm, cross-over study. It was approved by the local Ethical Committee, and performed at the diabetes care center of the University Hospital affiliate of the University Magna Graecia, Catanzaro, Italy. Consecutive patients with type 1 diabetes using the Dexcom G6 (Dexcom, Inc., San Diego, CA, USA) CGM system and regularly attending the center were assessed for eligibility. Those who met the inclusion/exclusion criteria (The study consisted of two 2-week-long intervention phases to evaluate two different algorithms for adjusting the meal bolus based on trend arrows and a 7-day wash-out period with no trend-informed bolus adjustments between the two phases. Algorithm 1 was the simple DirectNet/JDRF, which suggests increasing or reducing the meal bolus, as was previously calculated according to the insulin:carbohydrates ratio (ICR) and ISF, by 10% in the case of a 1–2 mg/dL/min rise or fall in sensor glucose levels and by 20% in the case of a >2 mg/dL/min rise or fall in sensor glucose levels, respectively [In the two weeks before the study initiation, basal insulin doses, ICR, and ISF were optimized. The sequence of Algorithms 1 and 2 was randomly assigned to each participant. All patients received detailed instructions about the study’s protocol and a scorecard with the proposed adjustments. Patients on multiple daily injections (MDI) therapy were suggested to round the final dose to the lower unit for safety reasons. Participants were also invited not to change their lifestyle throughout the study period and to take three meals without snacks when possible. A follow-up phone call on day 3 of both phases was scheduled to ensure that participants were accurately following the study protocol. 