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.

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.

Prospective Analysis of the Impact of Commercialized Hybrid Closed-Loop System on Glycemic Control, Glycemic Variability, and Patient-Related Outcomes in Children and Adults: A Focus on Superiority Over Predictive Low-Glucose Suspend Technology.

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.

Impact of Sensor-Augmented Pump Therapy with Predictive Low-Glucose Suspend Function on Glycemic Control and Patient Satisfaction in Adults and Children with Type 1 Diabetes.

AIMS: The aim was to evaluate the effectiveness of sensor-augmented pump therapy with predictive low-glucose suspend function (SAP-PLGS) in real-world use in children and adults with type 1 diabetes (T1D). METHODS: Patients with T1D treated with the MiniMed 640G® pump with PLGS function at three referral hospitals were retrospectively evaluated. HbA1c at baseline and at 6, 12, 18, and 24 months was analyzed. Two weeks of data from pumps, sensors, and/or glucose meters were downloaded. Patients completed satisfaction questionnaires at the last follow-up visit. RESULTS: A total of 162 patients were included. Mean age was 32 ± 17 years, 28% were (n = 46) children, and 29% (n = 47) were with a history of severe hypoglycemia. Median follow-up was 12 months (6-18). HbA1c was reduced from 55 ± 9 to 54 ± 8 mmol/mol (7.2% ± 0.8% to 7.1% ± 0.7%) at 12 months (P < 0.03, n = 100). In patients with suboptimal control, there was a reduction in HbA1c from 66% ± 7% to 61 ± 10 mmol/mol (8.2% ± 0.6% to 7.7% ± 0.9%) at the end of follow-up (n = 26, P < 0.01). Three percent (n = 5) of the patients experienced severe hypoglycemia during follow-up. A reduction in the percentage of self-monitoring of blood glucose values <70 mg/dL was achieved (10% ± 7% to 6% ± 5%, P = 0.001, n = 144). Time in range 70-180 mg/dL was 67% ± 13% at the end of follow-up and predictors of a higher time in range were identified. The use of sensors was high (86%) and 73% of the patients showed high satisfaction. In patients using sensors at baseline (n = 54), the time spent at <54 and <70 mg/dL was reduced. CONCLUSION: SAP-PLGS reduces hypoglycemia frequency while maintaining glycemic control in adults and children under real-life conditions.

The DATAC study: a new growth database. Description of the epidemiology, diagnosis and therapeutic attitude in a group of Spanish children with short stature.

BACKGROUND: Recombinant human growth hormone (rhGH) availability has allowed the treatment of a greater number of growth disorders. It is important to get an insight into the clinical characteristics of the paediatric population before rhGH treatment. METHODS: An observational, retrospective and multicentre study was conducted to evaluate the patients' baseline characteristics prior to rhGH therapy. RESULTS: A total of 1404 patients (53.8% males) aged 0.5-17.3 years were included. Clinical conditions were as follows: GH deficiency (GHD), 66.0%; small for gestational age (SGA), 29.7%; and Turner syndrome (TS), 4.3%. Male gender was predominant in most growth disorders; age at diagnosis was higher in GHD patients; therapy with rhGH started at lower chronological age in SGA and TS groups. CONCLUSION: The baseline characteristics of the population to be treated with rhGH were similar to those reported in other growth databases. Delayed age at treatment initiation should increase the awareness of these disorders among general paediatricians and entice them to refer children suspected of having these disorders to a specialist.