Measurements
Diabetes
DIABETES
At screening, participants already wore and actively used a FGM/CGM system (Abbott Freestyle Libre 1, Chicago, IL, USA; Abbott Freestyle Libre 2, Chicago, IL, USA; Dexcom G4, San Diego, CA, USA; Dexcom G5, San Diego, CA, USA; Dexcom G6, San Diego, CA, USA; Medtronic Guardian 3, Minneapolis, MN, USA) according to standard of care, at least 3 months prior to baseline. All participants were trained on the use of FGM/CGM system by our medical staff in order to provide a complete 14-day glucose monitoring at each study visit, when they underwent anthropometric evaluation and blood testing including fasting glycaemia (mg/dL, hexokinase) and HbA1c (% and mmol/mol; HPLC). At enrollment and end-of-study visit, body composition was assessed through a tetrapolar single frequency (50 kHz) bioelectrical impedance analyzer (Akern BIA 101 BIVA, Pontassieve, FI, Italy). Data obtained from bioimpedance were analyzed with the software BodyGram Plus. With this method we could estimate fat-free mass (FFM) and fat mass (FM).Baseline demographic and clinical characteristics, including sex, age, organ transplantation receipt, percent predicted forced expiratory volume in one second (ppFEV1), assessed at the last pulmonary function tests, and daily insulin requirements (IU/kg of body weight/day) were recorded.Data from FGM/CGM were downloaded using the dedicated software (Medtronic Carelink, Minneapolis, MN, USA; Abbott Libreview, Chicago, IL, USA, Dexcom Clarity, San Diego, CA, USA). Glucose control was evaluated using the following metrics: mean glucose levels (mg/dL), time in range (TIR, %), assuming a 70-180 mg/dlL range according to the American Diabetes Association Standards of Medical Care 2022 (Insulin pumps (Medtronic MiniMed 640G, Minneapolis, MN, USA; Medtronic MiniMed 670G, Minneapolis, MN, USA; Tandem T:slim X2, San Diego, CA, USA; Roche Accu Chek Insight, Basel, CH; Roche Accu Chek Solo, Basel, CH; Insulet Omnipod, Acton, MA, USA; Ypsomed Ypsopump, Burgdorf, CH) and glucose monitors were chosen among the devices currently available in Italy for SAP therapy according to standard of care and individuals everyday life needs.