Dietary determinants of postprandial blood glucose control in adults with type 1 diabetes on a hybrid closed-loop system.

AIMS/HYPOTHESIS: The aim of this work was to assess the relationship between meal nutrients and postprandial blood glucose response (PGR) in individuals with type 1 diabetes on a hybrid closed-loop system (HCLS). METHODS: The dietary composition of 1264 meals (398 breakfasts, 441 lunches and 425 dinners) was assessed by 7-day food records completed by 25 individuals with type 1 diabetes on HCLSs (12 men/13 women, mean ± SD age 40 ± 12 years, mean ± SD HbA1c 51 ± 10 mmol/mol [6.9 ± 0.2%]). For each meal, PGR (continuous glucose monitoring metrics, glucose incremental AUCs) and insulin doses (pre-meal boluses, post-meal microboluses automatically delivered by the pump and adjustment boluses) over 6 h were evaluated. RESULTS: Breakfast, lunch and dinner significantly differed with respect to energy and nutrient intake and insulin doses. The blood glucose postprandial profile showed an earlier peak after breakfast and a slow increase until 4 h after lunch and dinner (p < 0.001). Mean ± SD postprandial time in range (TIR) was better at breakfast (79.3 ± 22.2%) than at lunch (71.3 ± 23.9%) or dinner (70.0 ± 25.9%) (p < 0.001). Significant negative predictors of TIR at breakfast were total energy intake, per cent intake of total protein and monounsaturated fatty acids, glycaemic load and absolute amounts of cholesterol, carbohydrates and simple sugars consumed (p < 0.05 for all). No significant predictors were detected for TIR at lunch. For TIR at dinner, a significant positive predictor was the per cent intake of plant proteins, while negative predictors were glycaemic load and intake amounts of simple sugars and carbohydrate (p < 0.05 for all). CONCLUSIONS/INTERPRETATION: This study shows that nutritional factors other than the amount of carbohydrate significantly influence postprandial blood glucose control. These nutritional determinants vary between breakfast, lunch and dinner, with differing effects on postprandial blood glucose profile and insulin requirements, thus remaining a challenge to HCLSs.

First year on commercial hybrid closed-loop system-experience on 111 children and adolescents with type 1 diabetes.

OBJECTIVE: The hybrid close-loop system (HCL) is a rapidly emerging treatment method for type 1 diabetes (T1D), but the long-term effectiveness of the system remains unclear. This study investigates the influence of the HCL on glycemic control in children and adolescents with T1D in a real-life setting during the first year on HCL. RESEARCH DESIGN AND METHODS: This retrospective study included all the patients (n = 111) aged 3 to 16 years with T1D who initiated the HCL system between 1st of December 2018 and 1st of December 2019 in the Helsinki University Hospital. Time in range (TIR), HbA1c, mean sensor glucose (SG) value, time below range (TBR), and SG coefficient of variance (CV) were measured at 0, 1, 3, 6, and 12 month. The changes over time were analyzed with a repeated mixed model adjusted with baseline glycemic control. RESULTS: After the initiation of HCL, all measures of glycemic control, except HbA1c, improved and the effect lasted throughout the study period. Between 0 and 12 month, TIR increased (ß = -2.5 [95%CI: -3.6 - (-1.3)], p < 0.001), whereas mean SG values (ß = -0.7 [95%CI: -0.9 - (-0.4)]), TBR (ß = -2.5 [95%CI: -3.6 - (-1.3)]), and SG CV (ß = -4.5 [95%CI: -6.3 - [-2.8]) decreased significantly (p < 0.001). Importantly, the changes occurred regardless of the age of the patient. CONCLUSIONS: Measurements of glycemic control, except HbA1c, improved significantly after the initiation of the HCL system and the favorable effect lasted throughout the follow-up. These results support the view that HCL is an efficacious treatment modality for children and adolescents with T1D of all ages.

Efficacy of automated insulin delivery in pregnant women with type 1 diabetes: a meta-analysis and trial sequential analysis of randomized controlled trials.

BACKGROUND: Automated insulin delivery (AID) devices have shown to be a promising treatment to improve glycemic control in patients with type 1 diabetes mellitus (T1DM). However, its efficacy in pregnant women with T1DM remains uncertain. METHODS: PubMed, Scopus, Cochrane Central and ClinicalTrials.gov were systematically searched for randomized controlled trials (RCTs) comparing AID to standard care (SC), defined as use of sensor-augmented pump and multiple daily insulin injections. Outcomes included time in range (TIR), nocturnal TIR, time in hypoglycemic and hyperglycemic ranges, among others. Sensitivity and trial sequential analyses (TSA) were performed. PROSPERO ID: CRD42023474398. RESULTS: We included five RCTs with a total of 236 pregnant women, of whom 117 (50.6%) received AID. There was a significant increase in nocturnal TIR (mean difference [MD] 12.69%; 95% CI 8.74-16.64; p < 0.01; I2 = 0%) and a decrease in glucose variability (standard deviation of glucose; MD -2.91; 95% CI -5.13 to -0.69; p = 0.01; I2 = 0%). No significant differences were observed for TIR, HBGI, LGBI, mean glucose and time spent in hyperglycemia and hypoglycemia. Regarding TSA, the statistical significance obtained in nocturnal TIR was conclusive and with minimal risk of a type I error. CONCLUSION: Our findings suggest that AID systems can significantly improve nocturnal glycemic control and potentially reduce glycemic variability in pregnant women with T1DM, with no effect in the risk of hypoglycemia and hyperglycemia compared with current insulin treatments.

Use of Advanced Hybrid Closed-Loop System during Pregnancy: Strengths and Limitations of Achieving a Tight Glycemic Control.

Background: Pregnant women with type 1 diabetes mellitus (T1DM) face an elevated risk of complications for both themselves and their newborns. Experts recommend strict glycemic control. The advanced hybrid closed-loop (AHCL) system, though not officially approved for pregnant T1DM patients, is promising for optimal glycemic control. Methods: We collected CGM metrics, HbA1c levels, insulin pump settings, and doses from a 33-year-old pregnant woman with 23-year history of T1DM from the 6th week of gestation to birth. She was initially on continuous insulin pump therapy with CGM and switched to the AHCL system (MiniMedTM 780G, Medtronic, Northridge, CA, USA) between weeks 13 and 14. Results: The AHCL system improved glycemic control from weeks 14 to 26, achieving international guidelines with TIR = 72%, TAR = 24%, TBR = 4%. At week 30, TIR was 66%, TAR 31%. By altering diet and adding 'fake carbohydrates', she maintained TIR ≥ 70%, TBR ≤ 4%, TAR ≤ 26% from week 34 to birth. A healthy 4 kg, 53 cm baby boy was born at week 38. Conclusions: The use of the AHCL system holds significant promise for improving glycemic control in pregnancy. Optimal glycemic control with MiniMedTM 780G in pregnancy requires accurate carbohydrate counting, specific timing of insulin doses in relation to meal consumption and dietary choices that reduce the glycemic load of meals continue to be crucial factors in achieving optimal glycemic control during pregnancy using the MiniMedTM 780G system. Further research and clinical studies are needed to explore the full potential of these advanced systems in managing T1DM during pregnancy and optimizing maternal and neonatal outcomes.

Advanced Hybrid Closed-Loop System Achieves and Maintains Recommended Time in Range Levels for Up To 2 Years: Predictors of Best Efficacy.

Aim: To evaluate the long-term efficacy, up to 2 years, of an advanced hybrid closed-loop (AHCL) system and to assess predictors of best results of the therapy. Methods: We retrospectively evaluated 296 adults with type 1 diabetes mellitus [mean age 42.8 ± 16.5 years, men 42.9%, duration of diabetes 22.5 ± 12.8 years, body mass index 24.9 ± 4.7 kg/m2, baseline glycated hemoglobin (HbA1c) 63.4 ± 12.2 mmol/mol (8.0 ± 1.1%) ] who used the MiniMed™ 780G system. Demographic and clinical data were recorded. Continuous glucose monitoring (CGM)-derived metrics and insulin requirement were analyzed from the 4 weeks before and from every quarter after the switch to the AHCL system. Results: In the first quarter of AHCL treatment, all CGM metrics improved. Time in range (TIR) increased from 58.1 ± 17.5% to 70.3 ± 9.5% (P < 0.0001). The improvement lasted for up to 2 years of observation regardless of previous insulin therapies. Throughout the period of observation, 53.4% of participants achieved mean TIR >70%, 92.6% mean time below range <4%, and 46% mean glucose management indicator <53 mmol/mol (7.0%). At univariable logistic regression older age, lower baseline HbA1c and insulin requirement were associated with mean TIR >70%. At multivariable analysis, lower HbA1c remained independently associated with a better glycemic control. However, mean TIR increased more in participants with a higher baseline HbA1c. Conclusions: Switching to an AHCL leads to a rapid improvement in glycemic control lasting for up to 24 months along with a low risk for hypoglycemia, confirming the safety of the system. Lower baseline HbA1c was the main predictor of better efficacy of therapy, although higher baseline HbA1c was associated with the greatest improvement in mean TIR.

Postprandial Glucose Control With Different Hybrid Closed-Loop Systems According to Type of Meal in Adults With Type 1 Diabetes.

BACKGROUND: Hybrid Closed-Loop Systems (HCLs) may not perform optimally on postprandial glucose control. We evaluated how first-generation and advanced HCLs manage meals varying in carbohydrates, fat, and protein. METHOD: According to a cross-sectional design, seven-day food records and HCLs reports from 120 adults with type 1 diabetes (MiniMed670G: n = 40, MiniMed780G: n = 49, Control-IQ [C-IQ]: n = 31) were analyzed. Breakfasts (n = 570), lunches (n = 658), and dinners (n = 619) were divided according to the median of their carbohydrate (g)/fat (g) plus protein (g) ratio (C/FP). After breakfast (4-hour), lunch (6-hour), and dinner (6-hour), continuous glucose monitoring (CGM) metrics and early and late glucose incremental area under the curves (iAUCs) and delivered insulin doses were evaluated. The association of C/FP and HCLs with postprandial glucose and insulin patterns was analyzed by univariate analysis of variance (ANOVA) with a two-factor design. RESULTS: Postprandial glucose time-in-range 70 to 180 mg/dL was optimal after breakfast (78.3 ± 26.9%), lunch (72.7 ± 26.1%), and dinner (70.8 ± 27.3%), with no significant differences between HCLs. Independent of C/FP, late glucose-iAUC after lunch was significantly lower in C-IQ users than 670G and 780G (P < .05), with no significant differences at breakfast and dinner. Postprandial insulin pattern (Ins3-6h minus Ins0-3h) differed by type of HCLs at lunch (P = .026) and dinner (P < .001), being the early insulin dose (Ins0-3h) higher than the late dose (Ins3-6h) in 670G and 780G users with an opposite pattern in C-IQ users. CONCLUSIONS: Independent of different proportions of dietary carbohydrates, fat, and protein, postprandial glucose response was similar in users of different HCLs, although obtained through different automatic insulin delivery patterns.

Glycemic control in children with type 1 diabetes treated with the advanced hybrid closed loop system 2-year prospective, observational, two-center study.

Background and aims: MiniMed 780G is the first Advanced Hybrid Closed Loop (AHCL) system in Poland, approved in the EU in 2020. To date, observations of glycemic control up to 12 months have been published. This study aimed to analyze glycemic control and anthropometric parameters in children and adolescents with type 1 diabetes (T1D) after two years of using the AHCL system. Materials and methods: We prospectively collected anthropometric data, pump, and continuous glucose records of fifty T1D children (9.9 ± 2.4 years, 24 (48%) boys, T1D for 3.9 ± 2.56 years) using an AHCL system. We compared the two-week AHCL records obtained after AHCL enrollment with data 6, 12, and 24 months after starting AHCL. Results: Time in range (70-180 mg/dl) and BMI z-score did not change during the 2 years of observation (p>0.05). The percentage of autocorrection in total daily insulin increased significantly (p<0.005). Conclusion: Glycemic control in the investigated group of children with T1D treated with the AHCL system for 2 years remained stable. Children in this group maintained weight and optimal metabolic control, most likely due to autocorrection boluses.

The Cost-Effectiveness of an Advanced Hybrid Closed-Loop System Compared to Standard Management of Type 1 Diabetes in a Singapore Setting.

Background: Despite advances in technology, glycemic outcomes in people with type 1 diabetes (T1D) remain suboptimal. The MiniMed 780G (MM780G) advanced hybrid closed-loop (AHCL) system is the latest technology for T1D management with established safety and efficacy. This study explores the cost-effectiveness of MM780G AHCL compared against multiple daily injections (MDI) plus intermittently scanned continuous glucose monitor (isCGM). Methods: A cost-utility analysis was conducted, simulating lifetime outcomes for 1000 T1D individuals, with baseline hemoglobin A1c of 8.4%, using the IQVIA Core Diabetes Model (CDM) v9.5. A Singapore health care payer perspective was taken with 2023 costs applied. Treatment effects were taken from the ADAPT study and treatment-related events from a combination of sources. T1D complication costs were derived from local literature, and health state utilities and disutilities from published literature. Scenario analyses and probabilistic sensitivity analyses (PSAs) explored uncertainty. Cost-effectiveness was assessed based on willingness-to-pay (WTP) thresholds set to Singapore Dollars (SGD) 45,000 (United States Dollars [USD] 33,087) per quality-adjusted life year (QALY) and Singapore's gross domestic product (GDP) per capita of SGD 114,165 (USD 83,941) per QALY. Results: A switch from MDI plus isCGM to MM780G resulted in expected gains in life-years (+0.78) and QALYs (+1.45). Cost savings through reduction in T1D complications (SGD 25,465; USD 18,723) partially offset the higher treatment costs in the AHCL arm (+SGD 74,538; +USD 54,805), resulting in an estimated incremental cost-effectiveness ratio of SGD 33,797 (USD 24,850) per QALY gained. Findings were robust, with PSA outputs indicating 81% and 99% probabilities of cost-effectiveness at the stated WTP thresholds. Conclusion: MM780G is a cost-effective option for people with T1D managed in a Singapore setting.

The Hybrid Closed-Loop System Tandem t:slim X2™ with Control-IQ Technology: Expert Recommendations for Better Management and Optimization.

Technological advances in the management of diabetes, especially type 1 diabetes (T1D), have played a main role in significantly improving glycemic control of these patients in recent years. Undoubtedly, the most important advance has been the commercialization of hybrid closed-loop systems (HCL). Their effectiveness places them in the different guidelines from scientific societies as the gold standard for the treatment of people with T1D. However, obtaining the maximum performance from these systems requires a degree of expertise from the professionals who care for these patients. Specifically, the Tandem X2:slim with Control-IQ technology system, due to its features and configuration options and adjustments, allows T1D patients to better adapt the management of diabetes to multiple circumstances in their day-to-day life. It is necessary, however, to follow a systematic process to start the system and also for the subsequent follow-up, which allows its optimization in the shortest possible time. This expert recommendation reviews the main features of this HCL system, suggesting how to implement it and optimize its use after gaining experience treating many patients.

Safety and performance of a hybrid closed-loop insulin delivery system with carbohydrate suggestion in adults with type 1 diabetes prone to hypoglycemia.

AIMS: To evaluate the safety and performance of a hybrid closed-loop (HCL) system with automatic carbohydrate suggestion in adults with type 1 diabetes (T1D) prone to hypoglycemia. METHODS: A 32-hour in-hospital pilot study, including a night period, 4 meals and 2 vigorous unannounced 45-minute aerobic sessions, was conducted in 11 adults with T1D prone to hypoglycemia. The primary outcome was the percentage of time in range 70-180 mg/dL (TIR). Main secondary outcomes were time below range < 70 mg/dL (TBR < 70) and < 54 (TBR < 54). Data are presented as median (10th-90th percentile ranges). RESULTS: The participants, 6 (54.5%) men, were 24 (22-48) years old, and had 22 (9-32) years of T1D duration. All of them regularly used an insulin pump and a continuous glucose monitoring system. The median TIR was 78.7% (75.6-91.2): 92.7% (68.2-100.0) during exercise and recovery period, 79.3% (34.9-100.0) during postprandial period, and 95.4% (66.4-100.0) during overnight period. The TBR < 70 and TBR < 54 were 0.0% (0.0-6.6) and 0.0% (0.0-1.2), respectively. A total of 4 (3-9) 15-g carbohydrate suggestions were administered per person. No severe acute complications occurred during the study. CONCLUSIONS: The HCL system with automatic carbohydrate suggestion performed well and was safe in this population during challenging conditions in a hospital setting.

Safety Event Outcomes and Glycemic Control with a Hybrid Closed-Loop System Used by Chinese Adolescents and Adults with Type 1 Diabetes Mellitus.

Background: While evidence supports glycemic control benefits for individuals with type 1 diabetes mellitus (T1DM) using hybrid closed-loop (HCL) systems, HCL automated insulin delivery therapy in China has not been assessed. This study evaluated safety events and effectiveness during HCL system use by Chinese adolescents and adults with T1DM. Methods: Sixty-two participants (n = 12 adolescents with a mean ± standard deviation [SD] of 15.5 ± 1.1 years and n = 50 adults [mean ± SD of 37.6 ± 11.1 years]) with T1DM and baseline A1C of 7.1% ± 1.0% underwent a run-in period (∼2 weeks) using open-loop Manual Mode (sensor-augmented pump) insulin delivery with the MiniMed™ 770G system with the Guardian™ Sensor (3) glucose sensor, followed by a study period (4 weeks) with HCL Auto Mode enabled. Analyses compared continuous glucose monitoring data and insulin delivered during the run-in versus study period (Wilcoxon signed-rank test or t-test). Safety events included rates of severe hypoglycemia and diabetic ketoacidosis (DKA). Results: Compared to baseline run-in, overall Auto Mode use increased time in range (TIR, 70-180 mg/dL) from 75.3% to 80.9% (P < 0.001) and reduced time below range (TBR, <70 mg/dL) from 4.7% to 2.2% (P < 0.001). Subgroup analysis demonstrated that participants (n = 29) with baseline A1C <7.0% had TBR that reduced from 5.6% to 2.0%, while participants (n = 21) with baseline A1C ≥7.5% had time above range (TAR, >180 mg/dL) that reduced from 31.6% to 20.8%. Auto Mode use also increased the percentage achieving combined recommendations for time at sensor glucose ranges (i.e., TIR of >70%, TBR of <4% and TAR of <25%) from 24.2% at baseline to 77.4% at study end. Total daily insulin dose reduced from 42.8 ± 19.8 to 40.7 ± 18.9 U (P = 0.013). There were no severe hypoglycemic, DKA, or serious adverse events. Conclusions: Chinese adolescents and adults, some of whom met target A1C at baseline, safely achieved significantly improved glycemia with 1 month of MiniMed 770G system use when compared to open-loop insulin delivery. ClinicalTrials.gov ID: NCT04663295.

MiniMedTM 780G Advanced Hybrid Closed-Loop System Study in Pregnant Women with Type 1 Diabetes.

Background: Evaluate the impact of the MiniMed™ 780G advanced hybrid closed-loop (AHCL) system on the glucose profile of pregnant women with type 1 diabetes (T1D) and maternal-neonatal complications. Methods: From April 2021 to September 2022, pregnant women with T1D treated with the AHCL system were included in an observational multicenter retrospective study. Continuous glucose monitoring parameters were analyzed monthly during pregnancy as well as maternal-neonatal complications. Results: Thirteen pregnant women, including a twin pregnancy (age: 33 ± 3 years, hemoglobin A1c [HbA1c]: 7.3% ± 0.7%, insulin doses: 0.72 ± 0.21 U/kg/day) were analyzed. At delivery, gestational age was 37 ± 2 weeks. During first 2 weeks of pregnancy, time in range (TIR, 63-140 mg/dL) was 46% (34-55) and increased to 54% (51-59) (P < 0.01), 64% (48-68) (P < 0.01), and 66% (60-70) (P < 0.001) during the first, second, and third trimester, respectively. During the night, TIR (63-140 mg/dL) was >70% throughout pregnancy. Time below the range <63 mg/dL increased from 0.5% (0-2) to 1.3% (0.7-2.2), 2% (1.2-3.5) (P < 0.05), and 1.3% (1.31-3) (P < 0.05) during the first, second, and third trimester, respectively. At delivery, insulin doses increased to 0.89 ± 0.35 IU/kg/day (P < 0.01), and HbA1c decreased to 6.4% ± 0.6% (P = 0.005). The reported carbohydrate amount increased from 167 ± 363 g/d during early pregnancy to 243 ± 106 g/d (P < 0.01) at delivery. The birthweight was 3134 ± 711 g, with 5/14 macrosomia and 2/14 neonatal hypoglycemia. Moreover, 5/13 patients had a preeclampsia and 9/13 a cesarean section, including three cases of scarred uterus. The Clinical Trial Registration number is: CE-2022-55. Conclusion: The AHCL system provided good glucose control during pregnancy and recommendation targets were reached during the nocturnal period only. The maternal and neonatal complications remained high.

One-Year Follow-Up of Advanced Hybrid Closed-Loop System in Adults with Type 1 Diabetes Previously Naive to Diabetes Technology: The Effect of Switching to a Calibration-Free Sensor.

The aim of this study was to observe the 1-year clinical outcomes of people with type 1 diabetes who switched from multiple daily injection + blood glucose meter to an advanced hybrid closed-loop (AHCL) system (Medtronic MiniMed™ 780G system [MM 780G]). In addition, the effect of changing at month 6 to a calibration-free sensor (Guardian™ 4 Sensor [G4S]) was evaluated. Eighteen participants (10 men, age 40.9 ± 7.6 years) completed 1 year of MM 780G use. Time in range (TIR; 70-180 mg/dL) remained stable and ranged from 83.2% in month 9 to 84.8% in month 3. There was no difference between TIR at 3 months before switching versus 3 months after switching to G4S (P = 0.614). AHCL system in adults significantly improves glycemic outcomes. This improved glycemic control was maintained over the 12 months. Switching to a calibration-free sensor (G4S) did not affect outcomes but required less patient involvement.

MiniMed 780GTM in children with type 1 diabetes under seven years of age: Prospective open-label, single-arm, double-center, follow-up study.

BACKGROUND: Given the steadily rising incidence of type 1 diabetes (T1D), particularly among the youngest preschool children, coupled with well-documented challenges of achieving and maintaining optimal metabolic control in this age group, there is a growing need for advanced technological devices. OBJECTIVE: To evaluate glycaemic control in children below the age of seven with type 1 diabetes (T1D) and assess the safety of the advanced hybrid closed loop (AHCL) system in comparison to the previous treatment method, a sensor-augmented pump with predictive low-glucose suspend (SAP-PLGS). METHOD: Data from 10 children (aged 2.60-6.98 years) with T1D who transitioned to the AHCL system from SAP-PLGS were analysed. SAP-PLGS records from two weeks prior to the initiation of AHCL were compared with records from the initial four weeks post-switch (excluding the training period). These data were examined at two 2-week intervals and compared with records from two weeks post six-month usage of the AHCL. RESULTS: A significant decrease in the average nighttime glucose concentration was observed compared to pre-AHCL values (p= 0.001, concordance W = 0.53). The Glucose Management Indicator (GMI) value significantly decreased from 6.88 ± 0.37% to 6.52 ± 0.32% (p= 0.018, rbc = 0.93) immediately following the device switch and stabilized at 6.50 ± 0.28% (p= 0.001, W = 0.53) and 6.55 ± 0.41% (p= 0.001, W = 0.53) at subsequent stages of the study. An improvement was also observed in mean glucose values for time spent < 54 mg/dl, while the proportion of time within this range was maintained, both during the day (p< 0.001, W = 0.58) and at night (p= 0.002, W = 0.83). CONCLUSION: The AHCL MiniMed 780GTM system improved glycaemic control in the studied group of children under seven years of age with T1D compared to previous SAP-PLGS therapy. It proved to be safe for delivering insulin in this age group.

Quality of life in the course of a one-year use of an advanced hybrid closed-loop system in adults with type 1 diabetes previously naïve to advanced diabetes technology.

Aim: To evaluate the effect of a one-year use of an advanced hybrid closed-loop (AHCL) system on the quality of life, level of anxiety, and level of self-efficacy in adults with type 1 diabetes (T1D) previously treated with multiple daily injections (MDI) and naïve to advanced diabetes technology. Methods: A total of 18 participants of a previously published 3-month randomized trial (10 men, 8 women; age 40.9 ± 7.6 years) who were switched directly from MDI/BMG to AHCL completed 12 months of MiniMed 780G™system use (a 3-month randomized trial followed by a 9-month follow-up phase). At month 6 of the study, patients were switched from the sensor GS3 (Continuous Glucose Monitoring) system, powered by Guardian™ Sensor 3) to GS4. Quality of life was assessed using the Polish validated version of the 'QoL-Q Diabetes' questionnaire. The level of anxiety was evaluated with the use of the State-Trait Anxiety Inventory (STAI). Self-efficacy was assessed with the General Self-Efficacy Scale (GSES). Results were obtained at baseline and at the end of the study. Results: Significant increase in QoL was reported in the global score (p=0.02, Cohen d=0.61) and in as many as 11 out of 23 analyzed areas of life: being physically active (p=0.02, Cohen d = 0.71); feeling well (p<.01, Cohen d = 0.73); feeling in control of my body (p<.01, Cohen d = 0.72); looking good (p<.01, Cohen d = 1.07); working (p<.01, Cohen d = 1.12); sleeping (p=0.01, Cohen d = 0.66); eating as I would like (p<.01, Cohen d = 0.79); looking after or being useful to others (p= 0.02, Cohen d = 0.65); being active with pets/animals (p<.01, Cohen d = 0.95); being spontaneous (p=0.02, Cohen d = 0.67); and doing "normal" things (p=0.02, Cohen d = 0.67). Both state (p=0.04, Cohen d = 0.56) and trait (p=0.02, Cohen d = 0.60) anxiety decreased while the general self-efficacy increased (p=0.03, Cohen d = 0.76). No participant stopped the use of the pump. Conclusion: Adult patients with T1D previously treated with MDI and naïve to modern technologies experienced significant improvement in their psychological well-being after transitioning to the AHCL system after 12 months of treatment.

The Advanced Hybrid Closed Loop Improves Glycemia Risk Index, Continuous Glucose Monitoring Index, and Time in Range in Children with Type 1 Diabetes: Real-World Data from a Single Center Study.

Introduction: The Glycemia Risk Index (GRI) and Continuous Glucose Monitoring Index (COGI) are newly defined composite metric parameters derived from continuous glucose monitoring (CGM) data. GRI is divided into five separate risk zones (from lowest to highest: A-E). In this study, the effect of the advanced hybrid closed loop (AHCL) system on GRI and COGI in children with type 1 diabetes was evaluated. Materials and Methods: Forty-five children who had started using the AHCL and whose baseline and sixth-month CGM data were available were analyzed in terms of achievement of CGM consensus goals and changes in GRI scores and zones. The paired t-test was used for the analyses. Results: The mean age and duration of diabetes of the participants were 10.95 ± 3.41 and 3.85 ± 2.67 years, respectively. The mean GRI score significantly decreased from 35.66 ± 17.46 at baseline to 22.83 ± 9.08 at 6 months (P < 0.001). Although the proportion of those in the A zone was 20% at baseline, it increased to 42% at 6 months. AHCL also improved COGI from 72.59 ± 12.44 to 82.90 ± 7.72 (P < 0.001). Time in range (TIR) increased significantly from 70.54% to 80.51% (P < 0.001) at 6 months. Conclusion: AHCL provides not only an improvement in TIR but also a significant improvement in both GRI and COGI at 6 months. The incorporation of GRI and COGI alongside TIR may enhance the assessment of the glycemic profile by providing a more comprehensive and in-depth analysis.

Glucose control during Ramadan in a pediatric cohort with type 1 diabetes on MiniMed standard and advanced hybrid closed­loop systems: A pilot study.

BACKGROUND: Hybrid closed-loop (HCL) systems have revolutionized the treatment of diabetes, enabling doctors to cope with challenging conditions that were previously almost impossible to manage or were very risky and difficult. AIMS: To assess the efficacy and safety of a hybrid closed-loop (HCL) system during Ramadan fasting in a pediatric cohort with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: Glucose control outcomes in older children and adolescents aged 8-16 years with automated insulin delivery for T1D were analyzed during Ramadan and 1 month before Ramadan. Participants on MiniMed standard HCL (670G) or advanced HCL (780G) systems of Medtronic were categorized as fasting or nonfasting. RESULTS: The average age of the 19 participants (8 and 11 were on standard and advanced HCL systems, respectively) was 11.35 ± 2 years. Eleven patients fasted during Ramadan. Pump setup and sensor statistics were the same during Ramadan and the month before; no significant difference was found between the two groups in terms of insulin and glucose control metrics, with practically the same coefficient of variation, time in range (TIR) and time spent in hypoglycemia, maintained within the international recommended targets. Total daily doses were paradoxically higher in patients who fasted during Ramadan (p = 0.01), without repercussions on glucose control metrics. CONCLUSIONS: Standard and advanced HCL use during Ramadan were safe and were associated with a maintained optimum TIR (>70 %) and no significant hypoglycemia in adolescents and older children with T1D.

Daytime hypoglycemic episodes during the use of an advanced hybrid closed loop system.

AIMS: The use of advanced hybrid closed loop systems is spreading due to the beneficial effects on glycometabolic control obtained in patients with type 1 diabetes. However, hypoglycemic episodes can be sometimes a matter of concern. We aim to compare the hypoglycemic risk of an advanced hybrid closed loop system and a predictive low glucose suspend sensor augmented pump. METHODS: In this retrospective three months observational study, we included 30 patients using Medtronic Minimed™ 780G advanced hybrid closed loop system and 30 patients using a Medtronic Minimed™ predictive low glucose suspend sensor augmented pump. RESULTS: The advanced hybrid closed loop system reduced the time spent above 180 mg/dL threshold and increased the time in range as compared to the predictive low glucose suspend. No severe hypoglycemia occurred in both groups and no differences were observed in the percentage of time spent below 70 mg/dl and 54 mg/dl glucose threshold. Nevertheless, more hypoglycemic episodes were recorded during daytime, but not in nighttime, with the use of the advanced hybrid closed loop system. CONCLUSIONS: Our results confirmed the general improvement of glycemic outcomes obtained with the advanced hybrid closed loop system; however more hypoglycemic episodes during daytime were evident.

Switching to an advanced hybrid closed-loop system in real-world practice improves hypoglycemia awareness and metabolic control in adults with type 1 diabetes, particularly in those with impaired perception of hypoglycemia symptoms.

AIMS: To evaluate the efficacy of an advance closed-loop (AHCL) system in restoring awareness of hypoglycemia in patients with type 1 diabetes (T1D). METHODS: We conducted a prospective study including 46 subjects with T1D flash glucose monitoring (FGM) or continuous glucose monitoring (CGM) switching to a Minimed 780G® system. Patients were classified in three groups according to the therapy used before switching to Minimed® 780G: multiple dose insulin (MDI) therapy + FGM (n = 6), continuous subcutaneous insulin infusion + FGM (n = 21), and sensor-augmented pump with predictive low-glucose suspend (n = 19). FGM/CGM data were analyzed at baseline, after 2 and 6 months on AHCL. Clarke's score of hypoglycemia awareness was compared at baseline and 6 months recordings. We also compared the efficacy of the AHCL system in improving A1c among patients with appropriate perception of symptoms of hypoglycemia compared to those presenting with impaired awareness of hypoglycemia (IAH). RESULTS: Participants had a mean age of 37 ± 15 and a diabetes duration of 20 ± 10 years. At baseline, 12 patients (27%) showed IAH as defined by a Clarke's score ≥ 3. Patients with IAH were older and had lower estimated glomerular filtration rate (eGFR) compared with those who did not have IAH; with no differences in baseline CGM metrics or A1c. An overall decrease in A1c was observed after 6 months on AHCL system (from 6.9 ± 0.5% to 6.7 ± 0.6%, P < 0.001), regardless of prior insulin therapy. The improvement in metabolic control was greater in patients with IAH, showing a reduction in A1c from 6.9 ± 0.5 to 6.4 ± 0.4% vs 6.9 ± 0.5 to 6.8 ± 0.6% (P = 0.003), showing a parallel increase in total daily boluses of insulin and automatic bolus correction administered by the AHCL system. In patients with IAH Clarke's score decreased from 3.6 ± 0.8 at baseline to 1.9 ± 1.6 after 6 months (P < 0.001). After 6 months on AHCL system, only 3 patients (7%) presented with a Clarke's score ≥ 3, resulting in an absolute risk reduction of 20% (95% confidence interval: 7-32) of having IAH. CONCLUSIONS: Switching from any type of insulin administration to AHCL system improves restoration of hypoglycemia awareness and metabolic control in patients with T1D, particularly in adults with impaired perception of hypoglycemia symptoms. TRIAL REGISTRATION: ClinicalTrial.gov ID NCT04900636.

Real-World User and Clinician Perspective and Experience with MiniMed™ 780G Advanced Hybrid Closed Loop System.

INTRODUCTION: The advanced hybrid closed loop (AHCL) MiniMed™ 780G system changes basal insulin delivery every 5 min and auto bolus in response to sensor glucose values. We assessed the performance of the AHCL system in real-world settings for individuals with type 1 diabetes (T1DM) as well as user and clinician perspectives and satisfaction. METHODS: We held two peer group discussions: one having adults with T1DM/parents of children and adolescents with T1DM to understand their experiences with the AHCL system and another with healthcare providers (HCPs). Responses from the discussions were analyzed and categorized into themes by two independent researchers, with any inconsistencies resolved by consensus. We also analyzed data from the system uploaded to CareLink personal software. Glycemic outcomes, including time in range (TIR), time below range (TBR), time above range (TAR), mean sensor glucose (SG) levels, glucose management indicator (GMI), sensor use, and percentage of time spent in AHCL, were determined. RESULTS: The peer group discussions revealed numerous key themes and issues for each group, such as the significance of setting reasonable expectations, carbohydrate counting and bolus dosing, technical difficulties, and overall user experience. The users (n = 25; T1DM; 17 female; age 13.8 ± 7.49 years; A1C 6.54 ± 0.45%; duration of diabetes 6 ± 6.78 years) were very satisfied with the system. Most users experienced consistent blood glucose values with very few hypoglycemic episodes. However, there were a few limitations reported, such as hyperglycemic episodes caused by inaccuracies in carb counting, issues with sensor connectivity, and cannula blockages or kinking for those using insulin Fiasp. Users achieved a mean GMI of 6.4 ± 0.26%, TIR of 83.0 ± 8.12%, TBR (54-70 mg/dL) of 2.0 ± 0.81%, TBR* (< 54 mg/dL) of 0%. All of the users achieved a TIR of > 70%. CONCLUSION: The use of the AHCL system in T1DM resulted in robust glycemic control, minimizing hypoglycemia. Providing training to both users and HCPs can help them use the system effectively.