Design
CF, CFRD, Diabetes
RENAL DISEASE, DIABETES
We conducted a non-randomized clinical trial including adult (>18 years) individuals with CFRD on insulin treatment and with HbA1c ≥ 5% (31 mmol/mol). Exclusion criteria were: pregnancy, advanced renal disease, defined by estimated glomerular filtration rate < 30 mL/min/1.73 mFrom November 2020 to November 2021, 82 people with CF attending the Diabetes Unit of the Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico in Milano were evaluated for eligibility.At the screening visit, all subjects were on MDI insulin therapy and, after 2-week run-in period, they underwent an enrollment visit which included clinical, anthropometric and biochemical assessments. Glucose profiles were evaluated with data downloaded from flash glucose monitoring (FGM)/CGM devices. All participants were proposed to participate in a structured preparatory educational program (training to SAP therapy and carbohydrates counting), structured in 4 face-to-face meetings and performed by a multidisciplinary staff (i.e. nutritionist, diabetologist and nurse). After completing the training, all participants were offered to switch from MDI to SAP therapy. Participants who agreed switched to SAP therapy and those who refused continued MDI-scheme insulin therapy. Subjects from both groups had outpatient visits every 3 months according to standard of care. Protocol visits were performed 6, 12 and 24 months after enrollment.The study complies with the Declaration of Helsinki. The research protocol was approved by the Ethics Committee of the Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Ca’ Granda Ospedale Maggiore Policlinico (study number 4166, ID 89006) and has been registered on ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT04379726). A written informed consent was provided by each participant.Study flow chart is reported in Study flow chart. CGM, continuous glucose monitoring; CHO, carbohydrates; FGM, flash glucose monitoring; BIA, bio-impedance analysis; SAP, sensor-augmented pump; CHO, carbohydrates.