A Multicenter Prospective Evaluation of the Benefits of Two Advanced Hybrid Closed-Loop Systems in Glucose Control and Patient-Reported Outcomes in a Real-world Setting.

OBJECTIVE: Advanced hybrid closed-loop systems (AHCL) have been shown to improve glycemic control and patient-reported outcomes in type 1 diabetes. The aim was to analyze the outcomes of two commercially available AHCL in real life. RESEARCH DESIGN AND METHODS: A prospective study was performed, including adolescents and adults with type 1 diabetes, AHCL naïve, from 14 centers, who initiated the use of MM780G with SmartGuard or Tandem t:slimX2 with Control-IQ. Baseline and 3-month evaluations were performed, assessing HbA1c, time in different glycemic ranges, and patient-reported outcomes. The primary outcome was the between-group time in range 70-180 mg/dL difference from beginning to end of follow-up. RESULTS: One hundred fifty participants were included, with 75 initiating each system (age: 39.9 ± 11.4 years [16-72]; 64% female; diabetes duration: 21.6 ± 11.9 years). Time in range increased from 61.53 ± 14.01% to 76.17 ± 9.48% (P < 0.001), with no between-group differences (P = 0.591). HbA1c decreased by 0.56% (95% CI 0.44%, 0.68%) (6 mmol/mol, 95% CI 5, 7) (P < 0.001), from 7.43 ± 1.07% to 6.88 ± 0.60% (58 ± 12 to 52 ± 7 mmol/mol) in the MM780G group, and from 7.14 ± 0.70% to 6.56 ± 0.53% (55 ± 8 to 48 ± 6 mmol/mol) in the Control-IQ group (both P < 0.001 to baseline, P = 0.819 between groups). No superiority of one AHCL over the other regarding fear of hypoglycemia or quality of life was found. Improvement in diabetes-related distress was higher in Control-IQ users (P = 0.012). Sleep quality was improved (PSQI: from 6.94 ± 4.06 to 6.06 ± 4.05, P = 0.004), without differences between systems. Experience with AHCL, evaluated by the INSPIRE measures, exceeded the expectations. CONCLUSIONS: The two AHCL provide significant improvement in glucose control and satisfaction, with no superiority of one AHCL over the other.

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.

Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Mellitus Patients: Results from the Spanish National Registry.

Aim: To analyze the clinical effect of continuous subcutaneous insulin infusion (CSII) in type 1 diabetes mellitus (T1D) patients in the Spanish real-world scenario. Methods: All T1D patients on CSII registered in the SPAnish Insulin Pump (SPAIP) registry were included. The primary efficacy outcome was change in HbA1c during follow-up. Secondary efficacy outcomes included: insulin pump indications, diabetes complication rates, insulin and pump use, and continuous glucose monitoring (CGM) glycometrics. Patient data were typed through the web-based SPAIP registry. Results: Data from 2979 T1D patients treated with CSII were analyzed. The median age was 44 years (interquartile range [IQR] 34-52 years), and T1D duration was 27 years (IQR 18-35 years). The median duration of CSII therapy was 6 years (IQR 3-10 years). The main indications for treatment were suboptimal glycemic control (33.8%), hypoglycemia (22.1%), and increased glycemic variability (18.8%). Glycated hemoglobin decreased by 6 mmol/mol (95% CI, -5 to -6 mmol/mol, P < 0.001) [-0.5%, 95% CI, -0.4 to -0.5, P < 0.001] during the follow-up. The percentage of patients with severe hypoglycemia decreased from 14.9% to 0.9% (P < 0.001). We observed an inverse correlation between final HbA1c levels and CGM adherence (R = -0.24, P < 0.001) or percentage of time with active hybrid closed-loop functions (R = -0.25, P < 0.001). Conclusions: CSII treatment was associated with a sustained improvement in glycemic control in the Spanish population. This benefit was greater among patients with higher CGM or active hybrid closed-loop functions adherence. The protocol was publicly registered at ClinicalTrials.gov (NCT04761094).

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.

RETRACTED: No deleterious effect of lockdown due to COVID-19 pandemic on glycaemic control, measured by glucose monitoring, in adults with type 1 diabetes.

The Editor of Diabetes Technology & Therapeutics is officially retracting the article entitled, "No Deleterious Effect of Lockdown Due to COVID-19 Pandemic on Glycaemic Control, Measured by Glucose Monitoring, in Adults with Type 1 Diabetes," by Beato-Vibora PI. Diabetes Technol Ther 2020; epub DOI: 10.1089/dia.2020.0184. After the Instant Online publication of the article, the journal editor received correspondence indicating that some portions of the paper may have been plagiarized. An internal investigation was launched into the accusation, and though the charge of plagiarism was not found to be compelling, it was discovered that the author's Institutional Review Board approval statements for the paper were secured after submission and publication of the article, and only after the publisher requested said documentation. The author explained that IRB approval was not secured due to her institution's closure because of the COVID-19 pandemic. Despite these unusual circumstances, it is a clear violation of proper and standard protocols for studies containing human subjects, and therefore the Journal officially retracts the paper. Diabetes Technology & Therapeutics, its editors, and its publisher are committed to upholding the strictest standards of the scientific record and the community it serves and will not tolerate any improprieties or violations of proper scientific publishing conventions.

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.

Hábitos de vida, de alimentación y evaluación nutricional en personal sanitario del hospital de Mérida / Life style, dietary habits and nutritional evaluation of hospital de Mérida health professionals

Introducción y objetivos: Se estudiaron hábitos de vida y diversos aspectos nutricionales y la relación entre ellos en personal sanitario del Hospital de Mérida del Servicio Extremeño de Salud (SES). Método: Se contó con la participación voluntaria de 43 trabajadores en activo los cuales autorrealizaron un cuestionario de datos personales, estilos de vida y un registro alimentario de siete días. Además se les midieron una serie de datos antropométricos. Resultados: Los hombres practicaban más actividad física, eran más sedentarios, fumaban menos y bebían más alcohol que las mujeres. Los sujetos con normopeso practicaban más horas de actividad física que los sujetos con sobrepeso y que los obesos y paradójicamente los sujetos con normopeso pasaban más horas sentados a la semana que los obesos. La media de kcal/día fue superior en hombres que en mujeres y en estas se observa un aumento significativo en el consumo de proteínas con respecto a los hombres, así mismo, la ingesta de lípidos y colesterol se encontró elevada en ambos casos. La media de kcal/día fue inferior en los sujetos obesos que en los sujetos con normopeso y sobrepeso. El IMC (índice de masa corporal) se acompañó de un aumento del perímetro cintura, de la cadera, de la masa grasa y del % grasa corporal. Conclusión: La mayor parte de los sujetos estudiados presenta hábitos de vida y alimentación saludables. La ingesta de proteínas, lípidos y colesterol está ligeramente elevada mientras que la ingesta de hidratos de carbono esta disminuida con respecto a los valores recomendados (AU)

Introduction and aims: Living habits, several nutritional aspects and the relationship between them were studied at Hospital de Mérida health professionals in the Extremadura Health Service. Methods: Forty-three employed workers voluntary participated in this project by submitting a questionnaire about personal details and life style, and a seven-day food intake diary. Finally, their anthropometric data were also measured. Results: Men tended to do more physical activities than women. They also were more sedentary. They used to smoke less than women, but they drank more alcohol. Normoweight subjects tried to practice sport during more time than overweight and obese ones. However, they also remained sitting for longer periods on a weekly basis. The average daily intakes of kilocalories were higher in men, but protein intakes were higher in women. Fat intake was increased in both sexes. The average daily intake of kilocalories was lower in obese subjects than overweight and normoweight ones. An increase in the body mass index was accompanied by a bigger waist perimeter, waist to hip ratio, fat mass and body fat percentage. Conclusion: The majority of people interviewed in the survey have healthy living and dietary habits. Protein and fat daily intake is slightly higher than the values recommended by the WHO. Carbohydrate intake, by contrast, is lower (AU)

[Life style, dietary habits and nutritional evaluation of Hospital de Mérida health professionals]. / Hábitos de vida, de alimentación y evaluación nutricional en personal sanitario del hospital de Mérida.

INTRODUCTION AND OBJECTIVES: Living habits, several nutritional aspects and relationship between them were studied of Hospital de Mérida health professional of the Extremadura Health Service (SES). METHODS: Forty-three employed workers participates voluntary in this project by submitting a questionary about personal details and life style, and a seven-days-food-intake-dietary. Finally, their anthropometric data were also measured. RESULTS: Men tend to play more physical activities than women. They also were more sedentary. They use to smoke less than women, but they do drink more. Normal-weight subjects tried to practice sport during more time than overweight and obese ones. However, they also remained sitting for longer periods on a weekly basis. The average daily intakes of kilocalories were higher in men, but protein intakes were higher in women. Fat intake was increased in both sexes. The average daily intake of kilocalories was lower in obese subjects than over and normal-weights ones. An increase in the body mass index was accompanied by a bigger waist perimeter, waist to hip ratio, fat mass and body fat percentage. CONCLUSION: The majority of people interviewed in the survey have healthy living and dietary habits. Protein and fat daily intake is slightly higher than the values recommended by the WHO. Carbohydrates intake, by contrast, is lower.

INTRODUCCIÓN Y OBJETIVOS: Se estudiaron hábitos de vida y diversos aspectos nutricionales y la relación entre ellos en personal sanitario del Hospital de Mérida del Servicio Extremeño de Salud (SES). MÉTODO: Se contó con la participación voluntaria de 43 trabajadores en activo los cuales autorrealizaron un cuestionario de datos personales, estilos de vida y un registro alimentario de siete días. Además se les midieron una serie de datos antropométricos. RESULTADOS: Los hombres practicaban más actividad física, eran más sedentarios, fumaban menos y bebían más alcohol que las mujeres. Los sujetos con normopeso practicaban más horas de actividad física que los sujetos con sobrepeso y que los obesos y paradójicamente los sujetos con normopeso pasaban más horas sentados a la semana que los obesos. La media de kcal/día fue superior en hombres que en mujeres y en estas se observa un aumento significativo en el consumo de proteínas con respecto a los hombres, así mismo, la ingesta de lípidos y colesterol se encontró elevada en ambos casos. La media de kcal/día fue inferior en los sujetos obesos que en los sujetos con normopeso y sobrepeso. El IMC (índice de masa corporal) se acompañó de un aumento del perímetro cintura, de la cadera, de la masa grasa y del % grasa corporal. CONCLUSIÓN: La mayor parte de los sujetos estudiados presenta hábitos de vida y alimentación saludables. La ingesta de proteínas, lípidos y colesterol está ligeramente elevada mientras que la ingesta de hidratos de carbono esta disminuida con respecto a los valores recomendados.

Glycemic control and insulin requirements in type 1 diabetic patients depending on the clinical characteristics at diabetes onset.

INTRODUCTION: The long-term prognosis of type 1 diabetes (T1DM) was evaluated in relation to the clinical characteristics at the time of diabetes onset. PATIENTS AND METHODS: We examined retrospectively the clinical and laboratory characteristics present at the time of diagnosis in 301 adult patients (187 men) consecutively admitted to hospital with T1DM onset and evaluated the clinical outcome of T1DM during 6 ± 4.8 years following diagnosis. RESULTS: Women needed a greater insulin dose per kg of body weight over the first 2 years following diagnosis. Younger patients at diagnosis had greater insulin requirements during follow-up. Patients with at least one positive pancreatic antibody needed a greater insulin dose 2 years after diagnosis and developed poorer glycemic control during follow-up than patients with no detectable pancreatic antibodies at onset. Diabetic ketoacidosis at onset was associated with greater insulin requirements over the first 2 years of follow-up and with poorer glycemic control during the course of the illness. C-peptide levels at diagnosis correlated with insulin requirements during the first 2 years of follow-up. Patients with higher HbA1c levels at diagnosis had greater insulin requirements in the first year of follow-up. A correlation was found between the HbA1c levels at the consecutive years of follow-up. CONCLUSIONS: Female sex, younger age, humoral pancreatic autoimmunity, diabetic ketoacidosis, lower pancreatic reserve and higher HbA1c levels at onset could predict a poor long-term clinical outcome of T1DM in terms of insulin requirements and glycemic control.