Long-term outcomes of an advanced hybrid closed-loop system: A focus on different subpopulations.

BACKGROUND: The long-term benefit provided by advanced hybrid closed-loop (AHCL) systems needs to be assessed in general populations and specific subpopulations. METHODS: A prospective evaluation of subjects initiating the AHCL system 780G was performed. Time in range (70-180 mg/dl) (TIR), <70 mg/dl, <54 mg/dl, >180 mg/dl and >250 mg/dl were compared, at baseline and after one year, in different subpopulations, according to previous treatment (pump vs MDI), age (> or ≤25 years old) and hypoglycaemia risk at baseline. RESULTS: 135 subjects were included (age: 35 ± 15 years, 64 % females, diabetes duration: 21 ± 12 years). An increase in TIR was found, from 67.26 ± 11.80 % at baseline to 77.41 ± 8.85 % after one year (p < 0.001). All the subgroups showed a significant improvement in TIR, time > 180 mg/dl and >250 mg/dl. At the 1-year evaluation, no significant differences were found, between previous pump users and MDI subjects. Children and young adults had a lower time < 70 mg/dl than adults. Subjects with a high risk of hypoglycaemia at baseline had a higher time spent at <70 mg/dl and <54 mg/dl than low-risk individuals. CONCLUSION: The initial benefit provided by the AHCL system is sustained in the long term. MDI subjects obtain the same outcomes as subjects with pump experience.

Spanish Translation and Linguistic Validation of the Glucose Monitoring Experiences Questionnaire (GME-Q) in Continuous Glucose Monitoring Users.

BACKGROUND AND AIMS: The use of continuous glucose monitoring (CGM) has become standard practice in people with type 1 diabetes. The evaluation of user satisfaction is crucial. The Glucose Monitoring Experiences questionnaire (GME-Q) includes 23 items with a 5-point Likert scale to produce a total satisfaction score and three subscale scores. The study aimed to translate the GME-Q from English into Spanish and to validate its use in Spanish-speaking CGM users with type 1 diabetes. METHODS: The linguistic translation and validation process of the GME-Q was established. T1D CGM users were asked to complete the produced Spanish version of the GME-Q and interviewed about difficulties or misunderstandings. Total satisfaction, effectiveness, convenience and intrusiveness subscales and internal consistency reliability were computed. RESULTS: Forward and backward translations and cognitive debriefing produced a final version of the GME-Q in Spanish. Ninety-eight subjects with type 1 diabetes were selected (age: 40 ± 12 years, 63% females, Hb1c: 7.2 ± 0.9% (55 ± 10 mmol/l), pump users: 78%, CGM use: 3.7 ± 2.6 years). The completion rate was 99% and the Cronbach's alpha coefficient was 0.8. The total satisfaction score was 3.9 ± 0.4 (effectiveness: 4.1 ± 0.6, convenience: 3.8 ± 0.6, intrusiveness: 2.2 ± 0.7). CONCLUSION: The GME-Q was translated into Spanish and validated for Spanish-speaking CGM users with type 1 diabetes.

Amelioration of user experiences and glycaemic outcomes with an Advanced Hybrid Closed Loop System in a real-world clinical setting.

AIMS: Automation in diabetes technology is rapidly evolving. The aim was to evaluate the real-world glycemic outcomes and user acceptance after 3 months of using the Medtronic 780G Advanced Hybrid Closed-Loop (AHCL) system. METHODS: A prospective analysis was performed. A glucose target of 100 mg/dl and an active insulin time of 2 h were set. Capillary HbA1c, 2-week of pump and sensor data and several satisfaction questionnaire scores were compared at baseline and after 3 months of using the AHCL system. RESULTS: 52 subjects were selected (age: 43 ±â€¯12 years, sex: 73% female, diabetes duration: 27 ±â€¯11 years, higher education: 31%). Time in range (TIR) 70-180 mg/dl increased from 67.3 ±â€¯13.6% to 80.1 ±â€¯7.5% and time >180 mg/dl and >250 mg/dl were reduced (16.8 ±â€¯8.4 vs 29.4 ±â€¯15.1%, 2.7 ±â€¯3.0% vs 6.9 ±â€¯7.8%, respectively) (all p < 0.001), while time in hypoglycaemia remained below recommended targets. Time in Auto-Mode and sensor use were 94 ±â€¯10% and 90 ±â€¯11%, respectively. Auto-correction boluses represented 29 ±â€¯12% of bolus insulin. Fear of hypoglycaemia, diabetes quality of life, sleep quality and satisfaction with the monitoring system improved after 3 months. CONCLUSION: The real-world use of the AHCL system Medtronic 780G provides an 80.1% TIR 70-180 mg/dl with minimal hypoglycaemia and an increased level of patient satisfaction.

Real-world outcomes with different technology modalities in type 1 diabetes.

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.

Rapid Improvement in Time in Range After the Implementation of an Advanced Hybrid Closed-Loop System in Adolescents and Adults with Type 1 Diabetes.

Background: Advanced hybrid closed-loop (AHCL) systems represent the next step of automation intended to maximize normoglycemia in people with type 1 diabetes (T1D). In the AHCL MiniMed 780G system, different algorithm glucose targets for insulin infusion are available and autocorrection boluses are delivered. The aim was to prospectively evaluate the impact of the implementation of this AHCL system in a clinical setting. Materials and Methods: T1D subjects using a sensor-augmented pump with predictive low-glucose suspend (SAP-PLGS) were upgraded to AHCL. Baseline, every 3 days, 2-week and 1-month sensor and pump data were downloaded. Glucose target was set to 100 mg/dL and active insulin time to 2 h for all the subjects. Time in different glucose ranges was compared. Results: Fifty-two T1D subjects were included (age: 43 ± 12 years, 73% females, diabetes duration: 27 ± 11 years, HbA1c: 7.2% ± 0.9%, time in SAP-PLGS: 5 ± 2 years). Time in range (TIR) 70-180 mg/dL increased from 67.3% ± 13.6% at baseline to 79.6% ± 7.9% at 1 month (P = 0.001). Time in hyperglycemia >180 and >250 mg/dL decreased from 29.4% ± 15.1% to 17.3% ± 8.6% and from 6.9% ± 7.8% to 2.5% ± 2.4%, respectively (P = 0.001). No differences in time in hypoglycemia <70 or <54 mg/dL were found. Time in Auto Mode was 97% ± 4%, and autocorrection insulin was 31% ± 14% of bolus insulin. Four hours postprandial glucose was improved from 162 ± 26 mg/dL at baseline to 142 ± 16 mg/dL at 1 month (P = 0.001). No severe hypoglycemia or diabetic ketoacidosis episodes occurred. Conclusion: AHCL systems allow well-controlled T1D patients to rapidly increase their TIR. The most aggressive settings allow optimal outcomes in TIR, without increasing hypoglycemia frequency.