Hybrid Closed-loop Research Articles (Page 1)

Background and Aims: The management of very young children with type 1 diabetes (T1D) presents a considerable challenge for health care teams and the families from glycemic and psychosocial perspectives. The aim of this study was to evaluate the impact of hybrid closed-loop (HCL) system on glycemic control, with a particular focus on the patterns of glycemic parameters throughout the day. Methods: Seventy-two children under the age of six diagnosed with T1D (diabetes duration ≥6 months) who transitioned to CamAPS-FX-HCL were included. Data were collected prior to (pre-HCL) and at 1, 3, 9, and 12 months following HCL initiation. Pre-HCL and post-HCL periods were compared using linear mixed models. Results: Time in range (TIR70-180) increased by 11% ± 8% from the pre-HCL to 1 month post-HCL (P < 0.001), with a concomitant decrease in target above range (TAR180) of 13% ± 9% (P < 0.001). The improvement in glycemic control was sustained through 12 months, with the greatest differences observed overnight (P < 0.001). Hypoglycemic metrics (TBR70/TBR54) remained similar before and after HCL (all P > 0.05). However, hourly glycemic patterns indicated that the late-morning period after HCL initiation was a high-risk period for hypoglycemia with TBR70 peaking at 11% ± 9% between 11 AM and 1 PM. This elevated risk of hypoglycemia persisted after 1 year. Conclusions: In real-life setting, HCL was associated with increased TIR and reduced TAR in very young children with T1D from the first month of use. The present study suggests that late morning is a high-risk window for hypoglycemia in this age group. This finding highlights the importance of optimizing HCL therapy settings and educating parents about specific times of the day that carry a higher risk of glycemic instability.

To evaluate the effectiveness and safety of a hybrid closed-loop (HCL) insulin infusion system in treating adult and adolescent patients with type 1 diabetes (T1D). A total of 126 participants (22 adolescents and 104 adults) underwent a 2-week initial treatment phase followed by a 2-week run-in phase with the Equil® S HCL insulin pump system MTM-Z in Manual Mode with calibration-free continuous glucose monitoring (CGM) System G7, followed by a 12-week study phase with HCL Auto Mode enabled. The primary outcome was the overall mean change in CGM time in range (TIR; 70-180 mg/dL). Safety endpoints included rates of severe hypoglycaemia, hyperglycaemia and diabetic ketoacidosis (DKA). Compared with the baseline run-in, Auto Mode increased TIR from 69.11% to 76.72% (p < 0.001) and reduced time below range (<70 mg/dL) from 3.92% to 2.73% (p < 0.001). The mean sensor glucose (SG) decreased from 151 ± 28 to 144 ± 19 mg/dL. The proportion of achieving TIR of >70% increased from 56.03% to 77.59%. The standard deviation (SD: -5.90 mg/dL) and coefficient of variation (CV: -2.49%) reduced significantly. The greatest change in TIR (mean 20.55%), mean SG (estimated treatment difference [ETD]: -30.13, 95% confidence interval [CI]: -41.84, -18.41; p = 0.001) and SD of SG (ETD: -14.21, 95% CI: -21.17, -6.71; p = 0.004) was observed in participants with a baseline glycosylated haemoglobin A1c (HbA1c) value of >8.0%. The percentage of achieving combined recommendations for time at SG ranges increased from 25.86% to 56.90%. No severe hypoglycaemia, DKA or adverse events were observed. HCL therapy is safe in Chinese adolescent and adult patients with T1D. The 12-week application of the Equil® S HCL insulin pump system MTM-Z with Auto Mode increased TIR and reduced HbA1c, hyperglycaemia and hypoglycaemia.

Exploring the Potential of the CamAPS FX Advanced Hybrid Closed-Loop (AHCL) System in the Hospital Setting: From Pregnancy to a Postpartum Complicated by Infective Endocarditis of the Tricuspid Valve

Purpose: It has been previously described that some women with type 1 diabetes (T1D) may experience changes in glucose levels in relation to their menstrual cycle. However, whether an advanced hybrid closed-loop system (AHCL) can mitigate these cycle-dependent changes is yet to be determined. Methods: This study is a prospective analysis of a cohort of premenopausal women with T1D with spontaneous menstrual cycles who are users of an AHCL system 780G Medtronic®. Three consecutive cycles were analyzed for each patient, and each cycle was divided into three phases (menstrual, luteal, and rest of cycle phase). Results: Fifteen subjects were included. Mean age was 38 ± 7.6 years, HbA1c was 7.12 ± 0.7%, and diabetes duration was 21 ± 13.7 years. Mean glucose was higher in the luteal phase compared to the menstrual period (p = 0.029 luteal vs. menstrual) and the rest of the cycle (p = 0.018 luteal vs. rest of cycle). The time in range (TIR) was lower in the luteal phase compared to the rest of cycle phase (p = 0.015 luteal vs. rest of cycle). The time below range (TBR) was significantly higher in the menstrual compared to the luteal phase (p = 0.007 luteal vs. menstrual). Daily insulin requirements were higher in luteal phase compared to rest of cycle (p = 0.017 luteal vs. rest of cycle). Conclusions: A higher mean glucose and lower TIR, despite a higher total insulin dose, was observed in the luteal phase. A higher TBR was observed in the menstrual phase. However, AHCL with 780G Medtronic® achieves a TIR of almost 70% in all cycle phases.

Precise control of flue gas oxygen content is essential for stable and efficient operation in municipal solid waste incineration (MSWI) systems. However, the strong nonlinearity and time-varying characteristics of combustion processes often lead to poor performance of conventional proportional–integral–derivative (PID) and open-loop model-based control schemes. To overcome these limitations, this study proposes a hybrid intelligent closed-loop control framework that integrates the firefly algorithm (FA) and whale optimization algorithm (WOA) for adaptive tuning of control parameters under dynamic operating conditions. The proposed system comprises four coordinated modules—preset, oxygen content prediction, predictive compensation, and feedback compensation—forming an adaptive multi-layer control loop. Experimental validation was performed using real operational data from 2 × 600 t/d MSWI plant. When the operating conditions changed from stable to variable, the proposed method maintained the flue gas oxygen content at 7.78%, with an overshoot of 1.53%, a relative error of –0.094%, and a settling time of 90 s. In comparison, the MPC-based control achieved 7.75%, with an overshoot of 2.10%, relative error of –0.529%, and settling time of 100 s, while the existing plant control method achieved 7.85%, with an overshoot of 2.35%, relative error of 0.835%, and settling time of 180 s. These results indicate that the proposed FA–WOA hybrid control framework effectively improves response speed by 50%, reduces overshoot by 34.9%, and enhances control accuracy by over 80% compared with the conventional method. Moreover, the system eliminates manual adjustment and achieves stable combustion performance under fluctuating conditions, demonstrating its potential for intelligent oxygen control and automation in large-scale MSWI plants.

IntroductionCystic fibrosis-related diabetes (CFRD) is one of the most clinically impactful comorbidities associated with cystic fibrosis (CF). Current recommended management with insulin therapy is challenging due to variable daily insulin requirements and adds to the significant burden of self-management. This study aims to determine if hybrid closed-loop insulin delivery can improve glucose outcomes compared with standard insulin therapy with continuous glucose monitoring (CGM) in young people (≥16 years) and adults with CFRD.Methods and analysisThis open-label, multicentre, randomised, two-arm, single-period parallel design study aims to randomise 114 young people (≥16 years) and adults with CFRD. Following a 2–3 weeks’ run-in period, during which time participants use a masked CGM, participants with time in target glucose range (3.9–10.0 mmol/L) <80% will be randomised to 26 weeks with hybrid closed-loop insulin delivery or standard insulin therapy with CGM. The primary outcome is the between-group difference in time in target glucose range (3.9–10.0 mmol/L) based on CGM levels during the 26-week study phase. Analyses will be conducted on an intention-to-treat basis. Key secondary outcomes are time above target glucose range (>10.0 mmol/L), mean glucose and HbA1c. Other secondary efficacy outcomes include glucose and insulin metrics, change in forced expiratory volume in 1 s and body mass index. Safety, utility, participant experiences and participant-reported outcome measures will also be evaluated. The trial is funded by the National Institute for Health and Care Research.Ethics and disseminationEthics approval has been obtained from East of England–Cambridge South Research Ethics Committee. Results will be disseminated by peer-reviewed publications and conference presentations, and findings will be shared with people living with CF, healthcare providers and relevant stakeholders.Trial registration numberNCT05562492.

Disclosure: P.K. Patel: None. A. Saif: None. P.R. Schroeder: None. P.A. Sack: None.Introduction: Concentrated regular U-500 insulin (U-500R) is typically prescribed for patients with Type 2 diabetes mellitus (T2DM) who are very insulin-resistant requiring more than 200 units of insulin per day. U-500R can reduce the number of daily injections, lower the volume of injections, and enhance cost-effectiveness. Clinical trials have demonstrated improvements in glycemic control without an increased risk of hypoglycemia with the use of U-500R for continuous subcutaneous insulin infusion (CSII). However, automated insulin delivery (AID) systems, including hybrid closed-loop systems, have not yet been formally studied in T2DM patients using U-500R.Case: We present the case of a 39-year-old female with very insulin resistant T2DM who was initially treated with insulin lispro U100, using 100 units/day via the pump, which resulted in frequent pod changes every 1 to 1.5 days. In addition to the insulin she received from her pump, she also required ∼140 units of subcutaneous Basaglar daily. Her U100 lispro insulin, used via the pump, was switched to U-500R while continuing to use the automated mode and her Basaglar was discontinued. We maintained a 24-hour blood glucose target of 110 mg/dL and increased her active insulin time from 3 hours to 6 hours to better reflect the kinetics of U-500R. After four weeks, her average glucose level was 164 mg/dL. The distribution of her blood glucose (BG) readings was 1% <54 mg/dL, 1% < 70 mg/dL, 61% 70-180 mg/dL, 29% >180 mg/dL, and 8% > 250 mg/dL. The pump remained in auto mode 100% of the time. She was getting ∼38 units x 5 per day, or a total of 190 units. Of her total insulin usage, 59% was basal insulin and 41% was bolus insulin. Her insulin pod now lasts for 3 days. The HgA1C improved to 7.3 from 8.8 after two-month use of U500R in the Omnipod 5 AID system. She did not report any overt symptoms of hypoglycemia throughout this period, despite setting the BG target at the lowest possible level of 110. The rare episodes of hypoglycemia seemed to be mostly overnight. Conclusion: U-500R proved to be safe and effective with Omnipod 5 AID. Further research is required to adapt the automated dosing algorithm to U-500R to reduce the risk of nocturnal hypoglycemia.Presentation: Monday, July 14, 2025

Disclosure: R.A. Vigersky: Medtronic Minimed. T. Cordero: Medtronic Diabetes. A. Arrieta: Medtronic Diabetes. M. Liu: Medtronic Diabetes. B. Grosman: Medtronic Diabetes. J. Shin: Medtronic Diabetes.Introduction: AID therapy is recognized as the standard of care for managing glycemia in children and adults with T1D by professional societies and health ministries, globally (ADA- 2025. doi:10.2337/dc25-S007; ISPAD- 2024. doi:10.1159/000543034; UK NICE- https://www.nice.org.uk/guidance/TA943). There are, currently, six commercialized AID therapies (MiniMed™ 780G [MM780G], CamAPS FX, Insulet Omnipod™ 5, Tandem Control™ IQ, Beta Bionics iLet™ and Diabeloop DBLG1 systems) in various countries each having different algorithmic approaches to managing glucose. Real-world data demonstrating the effectiveness of these systems comes from single centers, single countries, or multiple countries within a region. We hypothesized that the MM780G, an advanced hybrid closed-loop system with an algorithm that provides automated basal and correction insulin doses up to every 5 minutes and several glucose target (GT) and active insulin time (AIT) settings, could mitigate regional, cultural and dietary differences in glycemic outcomes in people with T1D and provide similar time in range (TIR, 70-180mg/dL), time above range (TAR 180mg/dL), time below range (TBR 70mg/dL) and glucose management indicator (GMI) and percentage of users reaching international consensus glycemic targets, across the globe. We also studied whether using the recommended optimal settings (ROS, 100mg/dL GT and 2hrs AIT ≥95% of the time) further narrows those differences. Methods: CareLink™ data of consenting MM780G users (any age, with ≥10 days of CGM use) that were uploaded since commercial availability in the following regions; Europe, Middle East and Africa (EMEA) (median 356 days of use), United States (US) (174.7 days), Asia-Pacific (APAC) (245 days), Latin America (LATAM) (213 days) and Canada (CAN) (261.9 days) were de-identified, aggregated and analyzed. The number of users in each region was >10,000 (>8,000 for CAN). Results: During overall settings use, mean %TIR and GMI were 72.1% and 6.9% (EMEA), 73.1% and 7.0% (US), 70.7% and 7.0% (APAC), and 74.0% and 6.8% (LATAM) and 72.6% and 7.0% (CAN). For all regions, mean %TAR was 23-27%, %TBR was ≤2.6% and 40-50% met consensus-recommended targets for all four metrics. In the 10-30% using the ROS, the %TIR and GMI were 77.6% and 6.8% in the EMEA, 78.0% and 6.8% in US, 76.3% and 6.8% in APAC, 78.1% and 6.7% in LATAM, and 78.3% and 6.7% in CAN. Mean %TAR was reduced to <21% and %TBR was ≤2.6% across regions. ROS use allowed 60-70% of users to meet targets. The trends in glycemic outcomes and rates meeting glycemic targets were observed for a majority of countries within the regions. Conclusion: The data show similar glycemic outcomes in real-world MM780G users across the world suggesting the algorithmic approach employed by the MM780G may be democratizing the management of T1D across cultures. The use of ROS increased the percentage reaching consensus-recommended targets by ∼20%.Presentation: Saturday, July 12, 2025

Disclosure: B.S. bohlega: None. S. Inam: None. L.S. AlRasheed: None. H. Al-kubedan: None. A. Mai: None. I. Alghofaili: None. A. Aljohani: None. A. Robert: None. A. Alanazi: None.Background: Maternal antenatal hyperglycemia is a risk factor for both maternal and fetal complications. The use of continuous glucose monitoring in pregnancy is associated with improved glucose control and neonatal outcomes. However optimal glucose control remains difficult. In a recent randomized control trial, Automated Insulin Delivery using a hybrid closed- loop insulin pump (HCLP) in pregnant women with type 1 diabetes resulted in a 10.5 percentage increase in time that glucose levels were within the pregnancy-specific target range (TIR) with low risk of hypoglycemia. Methods: We collected the data of 13 pregnancies that were complicated by type 1 diabetes who were started on HCLP in pregnancy. Collected parameters included demographic data, blood sugar control before and after starting therapy, all reported maternal and fetal complications and therapy safety outcomes. Results: The mean age of women was 26.6 ± 4.82 years with an average of 15.2 ± 4.9 years of diabetes and a mean HBA1C of 8.36 ± 0.64 prior to pregnancy. Mean gestational age at staring pump was 16.69 Weeks . 30.7 % of women had known complications prior to pregnancy namely retinopathy and nephropathy. Indications for HCLP were severe recurrent hypoglycemia, hypoglycemia unawareness, high risk pregnancy and poor control. Prior to starting HCLP TIR was 47.5% this increased to up to 80.3% after starting therapy. Time spent below and above pregnancy-specific target range reduced from 7.9% and 37.6% to 3% and 20% respectively. Diabetes related pregnancy complications occurred in 4 out of 13 patients, emergency CS was needed in 8 women. Neonatal complications occurred in 8 out of 13 patients. One patient developed diabetic ketoacidosis after starting HCLP. Conclusions: The use of HCLP in pregnancies complicated with type 1 diabetes improved glycemic control with an improvement in time that glucose levels were within the pregnancy-specific target range by 32.8 % with reduced risk of hypoglycemia. Better outcomes are expected with earlier use and pregnancy specific HLCPsPresentation: Sunday, July 13, 2025

Disclosure: P. Ratan: None. S. Kodalak: None. L. Saldarriaga: None. A.D. Andrade: None. R. Nunes Lamounier: None. T. Trevisan: None.Introduction: People with type 1 diabetes (T1D) are living longer; however, elderly individuals remain underrepresented in clinical trials. The evidence supporting the use of hybrid closed-loop systems (HCLS) in this population is still limited. We conducted a systematic review and meta-analysis to evaluate the safety and efficacy of HCLS compared to sensor-augmented pump (SAP) therapy in older adults with T1D. Methods: A systematic search of PubMed, Embase, Web of Science, Cochrane Library, and clinicaltrials.gov identified randomized crossover trials comparing HCLS and SAP in individuals aged 60 years or older with T1D. Mean differences (MD) with 95% confidence intervals (CIs) were calculated using a random-effects model. Higgins’ I² statistic assessed heterogeneity, and statistical analyses were performed using Review Manager 5.4.1. Results: Three studies involving a total of 149 participants were included, contributing 292 observations from both HCLS and SAP treatment periods. The median duration of diabetes was 38 years, and the mean time in range (TIR; 70-180 mg/dL) at baseline was 68.4±14.4%. Approximately 90% of participants had previously used insulin pumps. During the HCLS period, TIR increased by 7.9% (95% CI: 6.14 to 9.66; p < 0.001), while time above range (TAR; >180 mg/dL) decreased by 7.14% (95% CI: 6.09 to 8.20; p < 0.001) compared to SAP. TIR was extended by an average of 118 minutes with HCLS, while TAR was reduced by 107 minutes. No significant difference in time below range (TBR; <70 mg/dL) was found between groups (MD -0.59%; 95% CI: -1.20 to 0.01; p = 0.06). Glycated hemoglobin levels decreased by 0.2% (95% CI: 0.13 to 0.27; p < 0.001) with HCLS, and glucose variability, as measured by the coefficient of variation, significantly decreased by 1.96% (95% CI: 1.39 to 2.53; p < 0.001). Conclusion: Hybrid closed-loop systems in older adults with long-duration T1D improved glycemic control without increasing the risk of hypoglycemia when compared to SAP therapy. Further research is warranted to address the unique challenges faced by this population.Presentation: Sunday, July 13, 2025

Hybrid closed-loop (HCL) systems have transformed outpatient diabetes management, yet their application in complex inpatient and hospital-based scenarios remains underexplored. This article examines the utilization of HCL systems in three challenging clinical contexts: the perioperative period, dialysis (hemodialysis and peritoneal dialysis), and during glucocorticoid therapy. Our article and case series examples provide an overview of the current available literature, preliminary data, and practical guidance for clinicians on HCL systems in these settings. Further research is urgently needed to establish the evidence base in this high-risk cohort.

Hybrid closed-loop (HCL) therapy helps reaching efficacy and safety glucose targets (ESGT+) in persons with type 1 diabetes (PwT1D). We analyzed here the glycemia risk index (GRI) in PwT1D at HCL initiation (M0) and at 12 months (M12) and determined whether M0GRI value and/or M0GRI zone (A-B-C-D-E) could identify people reaching M12ESGT+. This was a retrospective study. Consecutive PwT1D who started HCL in a CIRDIA center were included after written consent. Glucose parameters were manually extracted from platforms at M0 and M12. ESGT+ meant reaching time in range (TIR) > 70% and glucose management indicator < 7% and time below range (TBR)<70 < 4% and TBR<54< 1%. Glycemia risk index was calculated and receiver-operating characteristic (ROC) analyses were performed to study the relation between M0GRI and M12ESGT+/M12ESGT-. M12 data were available for 128 PwT1D. M0GRI predicted M12ESGT mostly for low and high M0GRI values. An M0GRI < 41 had a 90% specificity, a 36% sensitivity, and a 74% positive predictive value for M12ESGT+. Sensitivity increased to 80% but specificity dropped to 56% for M0GRI < 61 and M0GRI ≥ 61 had a 78% negative predictive value. All PwT1D with M0GRI 0 to 20 (zone A) reached M12ESGT+. Then, the percentage of M12ESGT+ people dropped about 25% per M0GRI zone (A-B-C-D) and to 11% for zone E. M0GRI was significantly associated with M12ESGT status but mostly when in zones A-B or D-E. Hybrid closed-loop training should focus on PwT1D with M0GRI ≥ 41 (90% of M12ESGT- persons), but reaching M12ESGT+ is possible with M0GRI in zones C-D-E (64% of M12ESGT+ persons) and even D-E (20% of M12ESGT+ persons).

The development of closed-loop systems represents an evolutionary advance in the management of patients with type 1 diabetes (T1D). This study aimed to analyze the impact of the Control-IQ advanced hybrid closed-loop (AHCL) system on glucometric outcomes in a pediatric and adolescent population with T1D, comparing results with baseline values and assessing the influence of baseline Time in Range (TIR) on glycemic control in children under 6 years old over a 12-month period. A 12-month prospective analysis was conducted in 26 patients with T1D (aged 2-15 years) initiating the Control-IQ system. Glucometric variables were assessed at baseline (before system implementation) and at 1, 3, 6, and 12 months post-implementation. A subgroup analysis was performed in patients under 6 years old (n = 13), to evaluate the relationship between basal TIR and glucometric outcomes during the follow-up. TIR increased significantly from 62.04% at baseline to 72.50% at one month (from 57.58% to 66.18% in patients under 6 years), with this improvement sustained throughout follow-up. Time in hyperglycemia 180-250 mg/dL (TAR1) also showed significant improvement (26.84% to 17.40% at one month; 28.66% to 20.09% in patients under 6 years), with significant reductions maintained at all timepoints. Stratification according to the proportion of patients meeting consensus targets revealed significant improvements in TIR and TAR2 at 1 and 12 months in the overall cohort, though not in the under-6 subgroup. Significant differences in TIR and coefficient of variation (CV) were observed based on baseline TIR categorization (<70% vs. ≥70%). Our study revealed a significant enhancement in TIR and time spent in hyperglycemia from the first month after the implementation of the closed-loop system, which was maintained at 12 months, in both the overall cohort and the subgroup under 6 years old. In this younger subgroup, baseline TIR predicted subsequent glycemic control, with higher baseline TIR associated with better long-term outcomes in both TIR and CV.

To provide an updated analysis of the performance of different hybrid closed loop (HCL) systems in randomised controlled trials (RCTs) on subjects with type 1 diabetes. We conducted a systematic review with meta-analysis. We searched four online databases and performed hand-searching of conference proceedings to find studies from inception to 18 April 2025. We included RCTs enrolling subjects with type 1 diabetes, evaluating commercial HCL systems against other insulin therapy regimens, with a duration of intervention ≥2 weeks, and reporting time in range (TIR) as an outcome. Studies involving pregnant women were excluded. A total of 37 studies evaluating seven different HCL systems (CamAPS Fx, Control IQ, DBLG1, iLet BP, MiniMed 670G, MiniMed 780G, and Omnipod 5) were included. In studies with a mean age < 18 years, mean TIR was 64.1% (95% CI: 61-67.2), ranging from 59.3% (95% CI: 49.6-69.1) with MiniMed 780G to 68% (95% CI: 65.8-70.3) with Control IQ, and end-of-study HbA1c was 7.4% (95% CI: 7-7.7), ranging from 6.7% (95% CI: 6.6-6.9) with CamAPS Fx to 7.9% (95% CI: 6.9-9) with MiniMed 780G. In studies with a mean age ≥ 18 years, mean TIR was 70.8% (95% CI: 68.6-73), ranging from 63.1% (95% CI: 59.4-66.8) with Omnipod 5 to 74.4% (95% CI: 69.7-79.1) with MiniMed 780G, and end-of-study HbA1c was 7.1% (95% CI: 7-7.3), ranging from 7.0% (95% CI: 6.9-7.1) with Control IQ to 7.2% (95% CI: 7-7.5) with MiniMed 670G. In RCTs, commercial HCL systems show different achievements of CGM metrics and HbA1c in people with type 1 diabetes.

Objective: To compare maternal glucose metrics and pregnancy outcomes of three advanced hybrid closed-loop (aHCL) systems (MiniMed 780G®, CamAPS® FX, and Tandem Control-IQ) in a real-world, multicenter cohort of pregnant women with type 1 diabetes. Research Design and Methods: Cohort study including 137 pregnant women with type 1 diabetes using aHCL from 27 hospitals in Spain. Participants were grouped according to the aHCL system used: 85 MiniMed 780G (62%), 38 CamAPS FX (27.7%), and 14 Control-IQ (10.2%). Maternal glucose metrics (HbA1c and time spent within [TIRp], below [TBRp], and above [TARp] the pregnancy-specific glucose range 3.5-7.8 mmol/L), as well as pregnancy outcomes, were analyzed. Adjusted models were applied to account for potential confounding factors. Results: No between-group differences in HbA1c levels were observed at baseline. By the third trimester, CamAPS FX and Control-IQ users had significantly lower HbA1c levels compared with the MiniMed 780G group (βadjusted -4.77 mmol/mol, 95% confidence interval [CI] -7.40 to -2.13; and βadjusted -4.79, 95% CI -8.53 to -1.06; respectively). In the second trimester, CamAPS FX was associated with a higher percentage of time in range (βadjusted +5.88%, 95% CI 1.09 to 10.67) and a lower percentage of time above range (βadjusted -6.36%, 95% CI -11.46 to -1.26) compared with MiniMed 780G, with no other significant differences observed in other trimesters. Both CamAPS FX and Control-IQ were associated with lower odds of large-for-gestational-age (LGA) infants (CamAPS FX: ORadjusted 0.25, 95% CI 0.08 to 0.77; Control-IQ: ORadjusted 0.10, 95% CI 0.01 to 0.99) compared with MiniMed 780G. Conclusions: In this multicenter observational study, CamAPS FX and Control-IQ users achieved better glycemic metrics and lower odds of delivering LGA infants compared with those using MiniMed 780G. These findings warrant investigation to confirm associations and inform individualized clinical decision-making in pregnant women with type 1 diabetes.

Abstract This paper tackles the challenge of achieving Input-to-state stable (ISS) synchronization in actuator-saturated sampled-data control (SDC) networks for Markovian jump (MJ) Lur’e networks. We investigate the impacts of actuator saturation on system performance and stability, proposing a control strategy that ensures synchronization in the presence of external disturbances. Our analysis employs a Wirtinger-based integral inequality alongside a modified free matrix-based integral inequality (MFMBII), providing a framework for examining Lur’e networks. Initially, we create an MFMBII that combines the dynamics of MJ Lur’e networks and takes into consideration time-varying delays. Second, we formulate two sufficient conditions for the SDC design that ensure mean-square ISS error of specification for the hybrid closed-loop system. We do this by combining the MFMBII method with the Lyapunov-Krasovskii functional (LKF). Through a systematic methodology, we demonstrate that the proposed method maintains bounded state responses and converges to a common trajectory at an exponential rate. The results highlight the effectiveness of integrating ISS with SDC in managing complex dynamical networks. Finally, the proposed ISS method is validated through a numerical example, confirming its efficacy.

Background: There is limited evidence regarding the safety and efficacy of advanced hybrid closed-loop (AHCL) systems during the perioperative period. Specific management guidelines for these systems are lacking. Objective: To describe glycemic control metrics in patients with AHCL system during the intraoperative and postoperative periods. Methods: Analytical study based on a prospective cohort of adults with type 1 diabetes (T1D) or type 2 diabetes who are treated with AHCL system (MiniMed™780G, Medtronic, USA) and are undergoing surgical procedures. The study compared time in range (%TIR) between 70 and 180 mg/dL, time below range (%TBR) <70 and <54 mg/dL, time above range (%TAR) >180 and >250 mg/dL, and time in normoglycemia range (%TINR) between 70 and 140 mg/dL during the intraoperative, immediate postoperative, and late postoperative periods, with baseline measurements. Results: The analysis included 15 patients (86% T1D; 55.4 ± 16.3 years) and 17 surgical procedures (70% elective; mean duration 65.3 ± 36.3 min). Baseline data obtained 24 h prior to the admission: %TIR 78.4 ± 17.5%, %TINR 58.6 ± 22.9%, and %TBR <70 mg/dL 3.7 ± 4.2%. During the intraoperative period, %TIR increased to 99.6 ± 1.5% (P < 0.001), and %TBR <70 mg/dL decreased to 0 (P < 0.001). %TAR >180 mg/dL decreased from 17.8 ± 16.8% to 0.1 ± 1.5% (P < 0.001). No hypoglycemic events <70 mg/dL or <54 mg/dL were documented in the intraoperative and immediate postoperative periods. No severe adverse events related to device use were recorded. Conclusions: During the perioperative period, continuing insulin infusion using AHCL system is feasible, maintaining high levels of %TIR and %TINR, without hypoglycemia or serious adverse events. Randomized clinical trials are needed to compare the use of this technology with usual care.

Objective: Qualitative meal size estimation (QMSE) could be an interesting alternative to precise carbohydrates counting (PCC) for patients equipped with hybrid closed-loop systems (HCL). The aim is to compare postprandial glycemic control following meals declared by QMSE of the DBLG1 system with PCC. Methods: We randomly selected a 20% sample of patients from the commercial database of type 1 diabetes patients equipped with the DBLG1 system in Europe. We assumed that when the carbohydrates (CHO) amount was identical to the predefined average meal value (small, medium, or large meal), the patient used the semiquantitative method, and the corresponding meals were assigned to the QMSE group. The others were assigned to the PCC group. The glucose metrics of the meals were computed during the postprandial period, defined as [tmeal; tmeal + 4 h], provided that there was no other meal during this 4-h period or during the previous 4 h. Results: A total of 1959 patients from seven Western European countries were included (mean HbA1c 7.6% ± 1.2%; mean age 43.9 ± 14.7 years). Overall, 287,000 meals (47%) were declared with PCC and 327,819 (53%) with QMSE and the mean meal size was 47.2 ± 32.5 g and 48.4 ± 28.6 g, respectively. The postprandial TIR was 62.39% ± 30.86% with QMSE and 63.21% ± 30.62% with PCC. The mean TIR difference of 0.81% was statistically significant but not clinically relevant. Time below range (TBR) was low for both methods of declaration (TBR < 70 mg/dL of 1.4% ± 5.0% with QMSE and 1.4% ± 4.8% with PCC). Conclusion: The semi-quantitative CHO declaration achieves similar glycemic results as CHO counting in this retrospective study. This method could help to reduce the burden of diabetes and offers an alternative to patients reluctant to use CHO counting.

Objective: To determine the impact of age at diagnosis and insulin delivery modality on free-living glycemia in type 1 diabetes overall and during common periods of dysglycemia (sleep, post-prandially, exercise). Research Design and Methods: Retrospective analysis of 4 weeks' free-living data from 423 people with type 1 diabetes duration >5 years within the T1DEXI Study. Participants were divided into putative age at diagnosis endotype groups: AgeDx<7 (diagnosed <7 years old); AgeDx7-12 (7-12 years); AgeDx13-30 (13-30 years); and AgeDx>30 (>30 years). Mixed-effects linear regression, fitted with a random effect for individuals and fixed effects for age at diagnosis groups, insulin delivery modality, and duration of diabetes, was used to analyze percentage time in different glycemic states over 24 h, during sleep/exercise, and for the 2 h post-prandially. Results: Participants using hybrid closed-loop systems spent more time in range (TIR: 70-180 mg/dL) than those using continuous subcutaneous insulin infusion alone (P < 0.001) or multiple daily injections (P < 0.001). TIR correlated positively with age at diagnosis and increased incrementally between diagnostic age groups overall (mean ± standard deviation, AgeDx<7: 71.4 ± 16.0%, AgeDx13-30: 73.0 ± 13.9%; AgeDx>30 78.3 ± 14.1%), during exercise, while sleeping and post-prandially. Linear effects modeling confirmed higher TIR in AgeDx>30 compared with AgeDx<7 overall (12.3%, 95% confidence interval [CI] 4.9%-19.8%, P = 0.0002), during exercise (13.7%, 95% CI 5.3%-22.0%, P = 0.0002), while sleeping (11.0%, 95% CI 3.5%-17.0%, P = 0.0043) and post-prandially (14.9%, 95% CI 5.9 to 23.9%, P = 0.0001). AgeDx13-30 spent more TIR than AgeDx<7 during exercise (8.3%, 95% CI 1.9%-14.7%, P = 0.0050). Conclusions: In addition to insulin modality, age at type 1 diabetes diagnosis independently impacts on glycemia in adults and should be factored into personalized care planning.

Objective: Multiple daily injections therapy in older adults with diabetes can negatively impact glycemic control and comorbidities. This issue may be overcome with advanced diabetes technology that reduces hypoglycemia and hyperglycemia. The present study evaluated real-world glycemic outcomes of a United States (US) cohort ≥65 years using the MiniMed™ 780G (MM780G) advanced hybrid closed-loop system. Methods: CareLink™ personal data as of December 18, 2024, for U.S. MM780G system users ≥65 years, were de-identified and analyzed. Metrics, including time in range (TIR 70-180 mg/dL), time in tight range (TITR 70-140 mg/dL), time below range 70 mg/dL (TBR70), and time above range 180 mg/dL and 250 mg/dL (TAR180 and TAR250, respectively), with and without recommended optimal settings (ROS, 100 mg/dL glucose target with 2 h active insulin time) were determined. Subanalyses based on age group (≥75 years) and type 1 diabetes (T1D) or type 2 diabetes (T2D) were, also, conducted. Results: The overall cohort (n = 8542) had a mean TIR, TITR, TBR70, TAR180, and TAR250 of 78.4%, 51.4%, 0.9%, 20.7%, and 3.6%, respectively, with a 6.8% glucose management indicator. For ROS users (n = 2753), TIR and TITR were higher (81.9% and 55.9%, respectively, P < 0.001), and TAR180 and TAR250 were lower (17.2% and 2.5%, respectively, P < 0.001). Data trended similarly among the population aged ≥75 years, and no differences were observed between T1D and T2D. Conclusions: In a real-world setting, a U.S. cohort aged ≥65 years using the MM780G system achieved consensus-recommended glycemic targets. Use of ROS enabled more users to achieve an even higher level of glycemic control.