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Background and Aims: Several treatment modalities are available for type 1 diabetes (T1D), including continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) with MDI, sensor-augmented pumps with predictive low-glucose suspend function (SAP-PLGS) and hybrid closed-loop systems (HCL). The aim of the study was to evaluate the real-world benefits obtained with these treatment modalities., Methods and Results: A cross-sectional study was performed, selecting 4 groups of T1D subjects, regarding their treatment modalities, paired by age, sex and diabetes duration. A comparison was performed, concerning time in different glucose ranges in 2-week sensor downloads. Estimated HbA1c, glycaemic variability measures and sensor use were also compared. 302 T1D people were included (age: 39 ± 12 years, 47% male, diabetes duration: 21 ± 10 years, estimated HbA1c: 7.28 ± 0.84% (56 ± 9 mmol/mol), baseline HbA1c: 7.4 ± 1.0% (57 ± 11 mmol/mol), length of use of the device 8 [3-21] months). Group 1 (CGM + MDI) and 2 (FGM + MDI) showed no differences in time in different glucose ranges. Group 4 (HCL) showed a higher time 70-180 mg/dl and a lower time in hypoglycaemia than group 3 (SAP-PLGS). Group 1 and 2 showed lower time 70-180 mg/dl, higher time in hyperglycaemia and higher glycaemic variability measures than group 3. Group 4 was superior to groups 1 and 2 in all the outcomes., Conclusion: Real-life achievements in glycaemic control and glycaemic variability are described. HCL offer the maximum benefit in terms of time in range and hypoglycaemia protection, compared to CGM + MDI, FGM + MDI and SAP-PLGS., Competing Interests: Declaration of competing interest The authors declare no conflict of interest., (Copyright © 2021 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)

Background: Automatization of insulin delivery by closed-loop systems represents a major step in type 1 diabetes management. The aim of this study was to analyze the effect of the commercialized hybrid closed-loop system, the MiniMed 670G system, on glycemic control, glycemic variability, and patient satisfaction. Methods: A prospective study, including type 1 diabetes patients consecutively starting on the 670G system in one adult and two pediatric hospitals, was performed. Baseline and 3-month visits were documented. Two weeks of data from the system were downloaded. Glycemic variability measures were calculated. Adults and adolescents completed a set of questionnaires (Gold and Clarke scores, Hypoglycemia Fear Survey, Diabetes Quality of Life [DQoL], Diabetes Treatment Satisfaction [DTS], Diabetes Distress Scale, Pittsburgh Sleep Quality Index). Results: Fifty-eight patients were included (age: 28 ± 15 years [7-63], <18 years old: 38% [ n  = 22], 59% [ n  = 34] females, previous use of SAP-PLGS [predictive low-glucose suspend]: 60% [ n  = 35]). HbA1c was reduced from 57 ± 10 to 53 ± 7 mmol/L (7.4% ± 0.9% to 7.0% ± 0.6%) ( P  < 0.001) and time in range 70-180 mg/dL was increased from 63.0% ± 11.4% to 72.7% ± 8.7% ( P  < 0.001). In patients with high baseline hypoglycemia risk, time <54 and <70 mg/dL were reduced from 0.9% ± 1.1% to 0.45% ± 0.7% ( P  = 0.021) and from 3.3% ± 2.8% to 2.1% ± 2.1% ( P  = 0.019), respectively. Glycemic variability measures improved. Time in auto mode was 85% ± 17%, the number of auto mode exits was 0.6 ± 0.3 per day, and the number of alarms was 8.5 ± 3.7 per day. Fear of hypoglycemia, DQoL, DTS, and diabetes distress improved, while the percentage of patients with poor sleep quality was reduced. The discontinuation rate was 3%. Conclusion: The commercialized hybrid closed-loop system improves glycemic control and glycemic variability in children and adults, reducing the burden of living with type 1 diabetes.

Aim: To analyse the real-life outcomes of two sensor-augmented pumps (SAP) with predictive low glucose suspend (PLGS) function, Medtronic Minimed 640G™ with SmartGuard (MM640G) and Tandem T Slim X2™ with Basal-IQ™ (TTSX2), in Type 1 Diabetes Mellitus (T1DM) patients.Methods: Observational cross-sectional study using data obtained from computerized clinical records. All T1DM patients on TTSX2 therapy were compared (1:1) with MM640G treated patients selected through stratified sampling. Primary efficacy outcome was to describe time in rage (TIR, 70-180 mg/dL, 3.9-10 mmol/L) interstitial glucose differences according to a non-inferiority hypothesis with TTSX2 compared to MM640G.Results: Forty-four patients were analyzed (female 66%). Mean age was 38.9 yrs. (range 23-59 yrs.) and mean diabetes duration was 23.4 ± 9.2 yrs. Patients treated with TTSX2 showed a numerically slightly lower, but non-statistically significantly different, TIR from the MM640G pump group (64.9 ± 16.4% vs. 72.4 ± 17.0%, P = 0.108). Similarly, we did no find differences in HbA1c between T1D patients treated with TTSX2 and MM640G (6.8 ± 1.0% vs. 7.0 ± 0.9%, 51 ± 11 mmol/mol vs. 53 ± 10 mmol/mol, P = 0.312). Moreover, rest of evaluated glycemic outcomes were similar between both treatment groups.Conclusions: Patients using two different SAP with PLGS automatic function showed similar glycaemic control in a real-world scenario. NCT04741685. [ABSTRACT FROM AUTHOR]