Insulin Delivery System Research Articles

Time With Rapid Change of Glucose.

A variety of metrics are used to describe glycemic variation, some of which may be difficult to comprehend or require complex strategies for smoothing of the glucose curve. We aimed to describe a new metric named time with rapid change of glucose (TRC), which is presented as percentage of time, similar to time above range (TAR), time in range (TIR), and time below range (TBR). We downloaded glucose data for 90 days from 159 persons with type 1 diabetes using the Abbott Freestyle Libre version 1. We defined TRC as the proportion of time (%) with an absolute rate of change of glucose > 1.5 mmol/L/15 minutes (1.8mg/dL/min) corresponding to a minimum rate of change for glucose in the 3.9-10.0 mmol/L (70-180 mg/dL) range within 1 hour. TRC is related to the other glucose variability metrics: CV within day (CVw) and mean amplitude of glycemic excursion (MAGE). The more than 1.27 million glucose rates were t-location scale distributed with SD 0.91 mmol/L/15 min (1.1 mg/dL/15 min). The median TRC was 6.9% (IQR 4.5%-9.5%). The proportion of TRC with positive slope was 3.9% (2.6%-5.3%) and significantly higher than the proportion with negative slope 2.8% (1.5%-4.4%) P < .001. TRC correlated with CVw and MAGE (Spearman's correlation coefficient .56 and .65, respectively, P < .001). TRC is proposed as an easily perceived metric to compare the performance of hybrid or fully automated closed-loop insulin delivery systems to obtain glucose homeostasis.

Time In Tight Range in children and adolescents with type 1 diabetes: A cross-sectional observational single centre study evaluating efficacy of new advanced technologies.

Early and tight glycaemic control is crucial to prevent long-term complications of Type 1 Diabetes (T1D). The aim of our study was to compare glucose metrics, including Time In Tight Range (TITR), in a real-world setting. We performed a single-centre cross-sectional study in 534 children and adolescents with T1D. Participants were divided into four groups (multiple daily injections+real-time Continuous glucose monitoring (CGM), multiple daily injections+intermittently scanned CGM, sensor augmented pump (SAP), and Advanced Hybrid Closed-Loop (AHCL). Demographical and clinical data were collected and analysed. The group with AHCL showed significantly higher Time In Range (TIR) (71.31%±10.88) than SAP (57.82%±14.98; p<0.001), MDI+rtCGM (54.56%±17.04; p<0.001) and MDI+isCGM (52.17%±19.36; p<0.001) groups with a lower Time Above Range (p<0.001). The group with AHCL also showed lower Time Below Range than MDI+isCGM and SAP groups (p<0.01). The overall TITR was 37%±14 with 19% of participants who reached a TITR ≥50% with a mean TIR of 81%. AHCL had significantly higher TITR (45.46%±11.77) than SAP (36.25%±13.53; p<0.001), MDI+rtCGM (34.03%±13.89; p<0.001) and MDI+isCGM (33.37%±15.84; p<0.001) groups with a lower Coefficient of Variation (p<0.001). Our study indicates that AHCL ensures a better glycaemic control with an improvement in both TIR and TITR, along with a reduction in CV. Implementation of automated insulin delivery systems should be considered in the treatment of children and adolescents with T1D.

Retrospective observational study on real world use of the Minimed™ 780G automated insulin delivery system: Impact of the settings on autocorrection and omitted meal boluses

IntroductionThe Medtronic MiniMed™ 780G (MM780G) system uses an algorithm that includes autocorrection bolus (AB) delivery. This study evaluates the impact of omitted meal boluses and the system settings, glucose target and active insulin time (AIT), on the AB. MethodRetrospective observational study on data uploaded by all MiniMed 780G users in our healthcare area, obtained through the remote monitoring platform Care Connect, from April to August 2023. Downloads with a sensor usage time <95% were excluded. Results235 downloads belonging to 235 users were analysed. AB delivery was significantly higher at 2 h AIT (36.08 ± 13.17%) compared to the rest of settings (2.25–4 h) (26.43 ± 13.2%) (p < 0.001). AB differences based on the glucose target were not found.Patients with <3 meal boluses per day had higher AB delivery (46.91 ± 19.00% vs 27.53 ± 11.54%) (p < 0.001) and had more unfavourable glucometric parameters (GMI 7.12 ± 0.45%, TIR 67.46 ± 12.89% vs GMI 6.78 ± 0.3%, TIR 76.51 ± 8.37%) (p < 0.001). However, the 2-h AIT group presented similar TAR, TIR and GMI regardless of the number of meal boluses. ConclusionThe fewer user-initiated boluses, the greater the autocorrection received. The active insulin time of 2 h entails a more active autocorrection pattern that makes it possible to more effectively compensate for the omission of meal boluses without increasing hypoglycaemias.

Navigating the Digital Landscape of Diabetes Care: Current State of the Art and Future Directions

Diabetes mellitus remains a global health challenge, requiring innovative solutions for effective disease management. This paper offers a thorough analysis of diabetes technologies, highlighting their various roles in diabetes care. Through a thorough review of the literature and analysis of emerging trends, we explore the multifaceted impact of technology on diabetes care. We investigate the key role of continuous glucose monitoring systems, insulin pumps and smart insulin pens in achieving optimal glycaemic control. The paper also evaluates the integration of artificial intelligence and machine learning algorithms in predictive modelling for early detection of glucose fluctuations, ultimately preventing diabetes-related complications. Additionally, studies the potential of telemedicine and mobile applications in enhancing patient engagement and self-management. Moreover, the review covers advancements in closed-loop insulin delivery systems, offering insights into their clinical effectiveness and potential to revolutionize diabetes care. Ethical and privacy considerations related to the use of patient data in these technologies are discussed, emphasizing the importance of striking a balance between technological innovation and patient security. This paper's evidence synthesis underscores the increasing influence of diabetes technologies on patient outcomes, quality of life, and healthcare systems. It underscores the need for multidisciplinary collaboration between healthcare professionals, researchers and technology developers to ensure the seamless integration and accessibility of these tools to patients living with diabetes. This study serves as a valuable resource for clinicians, researchers, and policymakers, providing a comprehensive view of evolving diabetes technologies and their potential in the field.

Preparation and Characterization of Chitosan Nanofiber: Kinetic Studies and Enhancement of Insulin Delivery System.

Insulin-loaded nanofibers were prepared using chitosan as a natural polymer. The loaded insulin with polyethylene oxide was used for preparing monolayer batch S1. Nanofiber S1 was coated by seven layers of film on both sides to form batch S2 as a sandwich containing Layer A (CS, PEG and PEO) and Layer B (PEG and PEO) using electrospinning apparatus. SEM, TEM and FT-IR techniques were used to confirm the drug loading within the composite nanofibers. The in vitro activity that provided a sustained and controlled release of the drug from the nanofiber batch was studied at different pH values spectrophotometrically using a dialysis method. In batches S1 and S2, the release of insulin from nanofiber proceeds via burst release necessary to produce the desired therapeutic activity, followed by slow step. The rate and the percentage release of insulin in batch S2 are found to be higher at all pH values.

Closed-loop insulin delivery systems in patients with pancreatitis or pancreatectomy-induced diabetes: A case series

Pancreatic diabetes is associated with glycemic variability, poor metabolic control, and reduced quality of life. Though hybrid closed-loop (HCL) insulin delivery systems were not originally developed for these types of diabetes, they could address the therapeutic challenge. We aimed to evaluate long-term metabolic control in ten adult patients (mean ± SD age: 59 ± 12) treated with HCL insulin delivery systems for pancreatitis or pancreatectomy-induced diabetes. After a median of 346 days (range 64 - 631) with HCL insulin delivery, continuous glucose monitoring showed 59±19 % time-in-range [70–180 mg/dl] (versus 49±24 % before HCL insulin delivery, P = 0. 049) and 0.8 ± 1.0 % time-below-range [< 70 mg/dl] (versus 2.2 ± 2.6 %, P = 0.142), with the coefficient of glucose variability at 35.4 ± 7.6 (versus 37.8 ± 7.1, P = 0.047). HbA1c decreased from 8.5 ± 1.7 % to 7.7 ± 1.3 % [69±18 to 60±14 mmol/mol] (P = 0.076). No patient experienced an acute adverse metabolic event.

Automated Insulin Delivery Systems in Pediatric Type 1 Diabetes: A Narrative Review.

This narrative review assesses the use of automated insulin delivery (AID) systems in managing persons with type 1 diabetes (PWD) in the pediatric population. It outlines current research, the differences between various AID systems currently on the market and the challenges faced, and discusses potential opportunities for further advancements within this field. Furthermore, the narrative review includes various expert opinions on how different AID systems can be used in the event of challenges with rapidly changing insulin requirements. These include examples, such as during illness with increased or decreased insulin requirements and during physical activity of different intensities or durations. Case descriptions give examples of scenarios with added user-initiated actions depending on the type of AID system used. The authors also discuss how another AID system could have been used in these situations.

Intensive glucose control and the clinical paradox of transient progression of diabetic retinopathy: Prioritising the relevance of eye screening intervals.

The paradoxical early worsening of diabetic retinopathy with optimisation of glycaemic control is well recognised. Patients with type 2 diabetes mellitus with R0M0 grading at eye screening with enhanced glycaemic control and progression of diabetic retinopathy may get missed with just biennial monitoring as per the changes to national diabetes eye screening programme guidelines. However, from the perspective of patients with type 1 diabetes mellitus being offered newer hybrid closed-loop systems for insulin delivery, very recent guidance allows for this recommendation of a 24-month screening interval to be adjusted. There is an override option within the screening software to enable an additional 12-month screen following the initiation of the closed-loop system. More frequent screening during pregnancy when glycaemic control is tightened, was established several years ago. Interestingly, no such guidance is currently available for patients being treated with GLP-1RA for T2DM, or in patients following bariatric surgery despite the well-recognised impact that has been observed. With newer incretin mimetic treatments in the horizon, this warrants a review and needs a re-appraisal.

Enhancing equity in access to automated insulin delivery systems in an ethnically and socioeconomically diverse group of children with type 1 diabetes

IntroductionManufacturer-supported didactic teaching programmes offer effective automated insulin delivery (AID) systems onboarding in children and young people (CYP) with type 1 diabetes (T1D). However, this approach has limited flexibility to...

Supervised and Unsupervised Approaches for the Real-Time Detection of Undesired Insulin Suspension Caused by Malfunctions.

Automated insulin delivery (AID) systems, permit improved treatment of type 1 diabetes (T1D). Unfortunately, malfunctioning in the insulin pump or in the infusion set can prevent insulin from being administered, reducing the AID efficacy and posing the patient at risk. Different data-driven methods available in the literature can be used to deal with the problem of automatically detecting complete insulin suspension in real-time. This article investigates both supervised and unsupervised strategies and proposes a fair comparison under either population or personalized settings. Several algorithms are compared using data generated through the UVA/Padova T1D simulator, a computer simulator widely used to test control strategies in silico and accepted by the Food and Drugs Administration (FDA) as a substitute to animal pre-clinical trials. Two synthetic data sets, each consisting of 100 virtual subjects monitored for 1 month, were generated. Occasional faults of the insulin pump are simulated as complete occlusions by suspending the therapy administration. Personalized algorithms are investigated with unsupervised approaches only, since personalized labels are hardly available. In the population scenario, the supervised approach outperforms the unsupervised strategy. In particular, logistic regression and random forest achieves a recall of 72% and 82%, with 0.12 and 0.21 false positives (FP) per day, respectively. In the personalized setting scenario, the unsupervised algorithms are tailored on each patient and outperform the population ones, in particular isolation forest achieves a recall 80% and 0.06 FPs per day. This article suggests that unsupervised personalized approach, by addressing the large variability in glucose response among individuals with T1D, is superior to other one-fits-all approaches in detecting insulin suspensions caused by malfunctioning. Population methodologies can be effectively used while waiting to collect sufficient patient data, when the system is installed on a new patient.

Mitigating Severe Hypoglycemia in Users of Advanced Diabetes Technologies: Impaired Awareness of Hypoglycemia and Unhelpful Hypoglycemia Beliefs as Targets for Interventions.

Objective: A subgroup analysis of the Hypoglycemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycemia persisting despite optimized care (HARPdoc) trial was conducted to explore the impact of Blood Glucose Awareness Training (BGAT, a hypoglycemia awareness training program) and the HARPdoc (a psychoeducation addressing unhelpful hypoglycemia beliefs) in reducing severe hypoglycemia (SH) in individuals using advanced diabetes technologies (ADTs). Methods: Data from trial participants who utilized ADTs, including continuous glucose monitors or automated insulin delivery systems, were extracted. Generalized linear mixed-effects models with Poisson distribution or linear mixed-effects models were used to evaluate SH incidence, and Gold questionnaire, Attitudes to Awareness of Hypoglycemia (A2A), Problem Areas in Diabetes (PAID), Hospital Anxiety and Depress Scale (HADS)-anxiety, and HADS-depression scores as measures of hypoglycemia awareness, unhelpful hypoglycemia beliefs, diabetes distress, and anxiety and depression symptoms, respectively. Results: In the 45 participants using ADTs, the BGAT and HARPdoc interventions both reduced SH incidence by more than 50% (P < 0.0001) and yielded improvements in hypoglycemia awareness (P < 0.05). HARPdoc outperformed BGAT in reducing SH at month 24 (P = 0.01). HARPdoc also mitigated unhelpful hypoglycemia beliefs (P < 0.0001), diabetes distress (P < 0.05), and anxiety symptoms (P < 0.05); BGAT demonstrated no significant impacts in these respects. Neither HARPdoc nor BGAT had significant effects on depression symptoms. Conclusion: Psychoeducation (BGAT and HARPdoc) was effective in reducing SH in people using ADTs. HARPdoc may also provide greater long-term SH reduction and improves psychological well-being in this patient group.

Predicting Blood Glucose Levels with Organic Neuromorphic Micro-Networks.

Accurate glucose prediction is vital for diabetes management. Artificial intelligence and artificial neural networks (ANNs) are showing promising results for reliable glucose predictions, offering timely warnings for glucose fluctuations. The translation of these software-based ANNs into dedicated computing hardware opens a route toward automated insulin delivery systems ultimately enhancing the quality of life for diabetic patients. ANNs are transforming this field, potentially leading to implantable smart prediction devices and ultimately to a fully artificial pancreas. However, this transition presents several challenges, including the need for specialized, compact, lightweight, and low-power hardware. Organic polymer-based electronics are a promising solution as they have the ability to implement the behavior of neural networks, operate at low voltage, and possess key attributes like flexibility, stretchability, and biocompatibility. Here, the study focuses on implementing software-based neural networks for glucose prediction into hardware systems. How to minimize network requirements, downscale the architecture, and integrate the neural network with electrochemical neuromorphic organic devices, meeting the strict demands of smart implants for in-body computation of glucose prediction is investigated.

Development of a hydroxypropyl methyl cellulose/polyacrylic acid interpolymer complex formulated buccal mucosa adhesive film to facilitate the delivery of insulin for diabetes treatment

Buccal mucosa administration is a promising method for insulin (INS) delivery with good compliance. However, buccal mucosa delivery systems still face challenges of long-term mucosal adhesion, sustained drug release, and mucosal drug penetration. To address these issues, a double-layer film consisting of a hydroxypropyl methylcellulose/polyacrylic acid interpolymer complex (IPC)-formulated mucoadhesive layer and an ethylcellulose (EC)-formulated waterproof backing layer (IPC/EC film) was designed. Protamine (PTM) and INS were co-loaded in the mucoadhesive layer of the IPC/EC film (PTM-INS-IPC/EC film). In ex vivo studies with porcine buccal mucosa, this film exhibited robust adhesion, with an adhesion force of 120.2 ± 20.3 N/m2 and an adhesion duration of 491 ± 45 min. PTM has been shown to facilitate INS mucosal transfer. Pharmacokinetic studies indicated that the PTM-INS-IPC/EC film significantly improved the absorption of INS, exhibiting a 1.45 and 2.24-fold increase in the area under the concentration-time curve (AUC0-∞) compared to the INS-IPC/EC film and free INS, respectively. Moreover, the PTM-INS-IPC/EC film effectively stabilized the blood glucose levels of type 1 diabetes mellitus (T1DM) rats with post oral glucose administration, maintaining lower glucose levels for approximately 8 h. Hence, the PTM-INS-IPC/EC film provides a promising noninvasive INS delivery system for diabetes treatment.

Technology for the Management of Type 1 Diabetes Mellitus in Saudi Arabia and MENA Region: A Systematic Review.

Diabetes technology in the form of digital health or medical devices holds a promise for improving the quality of life and glycemic outcomes. A comprehensive insight into diabetes technology and its impact in Saudi Arabia and the MENA region may improve type 1 diabetes mellitus (T1DM) management. This study aimed to assess the impact of different DM-specific technologies: insulin pump therapy, continuous glucose monitoring (CGM), and automated insulin delivery system in terms of glycemic control and QoL among T1DM patients in Saudi Arabia and the MENA region. A systematic literature search was performed in PubMed and Scopus from 2005 until August 2023. The search was based on the PICO strategy, focusing on T1DM patients, diabetes technology, and QoL. The inclusion criteria were studies illustrating the effect of diabetes technologies on glycemic control or quality of life or both among T1DM patients. Systematic reviews, books, letters, or studies, including type 2 diabetes mellitus, were excluded. From 101 articles, eighteen studies were duplicated, and thirty-three studies were excluded after reading the title and abstract. Of the 50 articles analyzed, twenty-five articles did not meet the inclusion criteria. Therefore, 25 articles involving a total of 3088 participants were enrolled in the study. It was shown that a continuous glucose monitoring system and continuous subcutaneous insulin infusion improved the glycemic control and the QoL of T1DM patients. There was a positive impact of insulin pumps, continuous glucose monitoring (CGM) systems, and telemedicine in achieving optimal glucose control and better QoL. Further studies are recommended to clarify the significant role of advanced diabetes technologies.

Sustained insulin treatment restoring metabolic status, body weight, and cognition in an anorexia nervosa-like animal model in mice

IntroductionAnorexia Nervosa (AN) is a psycho-socio-biological disease characterized by severe weight loss as result of dieting and hyperactivity. Effective treatments are scarce, despite its significant prevalence and mortality. AN patients show lower basal insulin levels and increased metabolic clearance, leading to weight loss, cognitive deficits, and hormonal imbalances. Low-dose polymer insulin could potentially reverse these effects by restoring brain function, reducing fear of weight gain, encouraging food intake, and restoring fat depots. This study evaluates an insulin delivery system designed for sustained release and AN treatment. MethodsAN-like model was established through dietary restriction (DR). On days 1–25, mice were on DR, and on days 26–31 they were on ad libitum regimen. An insulin-loaded delivery system was administered subcutaneously (1% w/w insulin). The impact of insulin treatment on gene expression in the hippocampus (cognition, regulation of stress, neurogenesis) and hypothalamus (eating behavior, mood) was assessed. Behavioral assays were conducted to evaluate motor activity and cognitive function. ResultsThe delivery system demonstrated sustained insulin release, maintaining therapeutic plasma levels. Diet restriction mice treated with the insulin delivery system showed body weight restoration. Gene expression analysis revealed enhanced expression of CB1 and CB2 genes associated with improved eating behavior and cognition, while POMC expression was reduced. Insulin-polymer treatment restored cognitive function and decreased hyperactivity in the AN-like model. ConclusionThe PSA-RA-based insulin delivery system effectively restores metabolic balance, body weight, and cognitive function in the AN model. Its ability to steadily release insulin makes it a promising candidate for AN treatment."

Comparison between a tubeless, on-body automated insulin delivery system and a tubeless, on-body sensor-augmented pump in type 1 diabetes: a multicentre randomised controlled trial.

This study compares the efficacy and safety of a tubeless, on-body automated insulin delivery (AID) system with that of a tubeless, on-body sensor-augmented pump (SAP). This multicentre, parallel-group, RCT was conducted at 13 tertiary medical centres in South Korea. Adults aged 19-69 years with type 1 diabetes who had HbA1c levels of <85.8 mmol/mol (<10.0%) were eligible. The participants were assigned at a 1:1 ratio to receive a tubeless, on-body AID system (intervention group) or a tubeless, on-body SAP (control group) for 12 weeks. Stratified block randomisation was conducted by an independent statistician. Blinding was not possible due to the nature of the intervention. The primary outcome was the percentage of time in range (TIR), blood glucose between 3.9 and 10.0 mmol/l, as measured by continuous glucose monitoring. ANCOVAs were conducted with baseline values and study centres as covariates. A total of 104 participants underwent randomisation, with 53 in the intervention group and 51 in the control group. The mean (±SD) age of the participants was 40±11 years. The mean (±SD) TIR increased from 62.1±17.1% at baseline to 71.5±10.7% over the 12 week trial period in the intervention group and from 64.7±17.0% to 66.9±15.0% in the control group (difference between the adjusted means: 6.5% [95% CI 3.6%, 9.4%], p<0.001). Time below range, time above range, CV and mean glucose levels were also significantly better in the intervention group compared with the control group. HbA1c decreased from 50.9±9.9 mmol/mol (6.8±0.9%) at baseline to 45.9±7.4 mmol/mol (6.4±0.7%) after 12 weeks in the intervention group and from 48.7±9.1 mmol/mol (6.6±0.8%) to 45.7±7.5 mmol/mol (6.3±0.7%) in the control group (difference between the adjusted means: -0.7 mmol/mol [95% CI -2.0, 0.8 mmol/mol] (-0.1% [95% CI -0.2%, 0.1%]), p=0.366). No diabetic ketoacidosis or severe hypoglycaemia events occurred in either group. The use of a tubeless, on-body AID system was safe and associated with superior glycaemic profiles, including TIR, time below range, time above range and CV, than the use of a tubeless, on-body SAP. Clinical Research Information Service (CRIS) KCT0008398 FUNDING: The study was funded by a grant from the Korea Medical Device Development Fund supported by the Ministry of Science and ICT; the Ministry of Trade, Industry and Energy; the Ministry of Health and Welfare; and the Ministry of Food and Drug Safety (grant number: RS-2020-KD000056).

Polyester Nanoparticles with Controlled Topography for Peroral Drug Delivery Using Insulin as a Model Protein.

Receptor-mediated polyester drug delivery systems have tremendous potential for improving the clinical performance of existing pharmaceutical drugs. Despite significant progress made in this area, it remains unclear how and to what extent the polyester nanoparticle surface topography would affect the in vitro, ex vivo and in vivo performance of a drug, and if there exists a correlation between in vitro and in vivo, as well as healthy versus pathophysiological states. Herein, we report a systematic investigation of the interactions between ligands and receptors as a function of the linker length, two-carbon (2C) versus four-carbon (4C). The in vitro, ex vivo and in vivo in healthy models validate the hypothesis that 4C has better reach and binding to the receptors. The results indicate that 4C offered better performance over 2C in vivo in improving the oral bioavailability of insulin (INS) by 1.1-fold (3.5-fold compared to unfunctionalized nanoparticles) in a healthy rat model. Similar observations were made in pathophysiological models; however, the effects were less prominent compared to those in healthy models. Throughout, ligand decorated nanoparticles outperformed unfunctionalized nanoparticles. Finally, a semimechanistic pharmacokinetic and pharmacodynamic (PKPD) model was developed using the experimental data sets to quantitatively evaluate the effect of P2Ns-GA on oral bioavailability and efficacy of insulin. The study presents a sophisticated oral delivery system for INS or hydrophilic therapeutic cargo, highlighting the significant impact on bioavailability that minor adjustments to the surface chemistry can have.

Efficacy of the hybrid closedloop insulin delivery system in children and adolescents with type 1 diabetes: a meta-analysis with trial sequential analysis.

The aim of this study was to assess the efficacy and safety of hybrid closed-loop (HCL) systems for insulin delivery in children and adolescents with type 1 diabetes (T1D). We searched Embase, PubMed, and Cochrane Library for randomized controlled trials (RCTs) published until March 2023 comparing the HCL therapy with control therapies for children and adolescents with T1D. We computed weighted mean differences (WMDs) for continuous outcomes and risk ratios (RRs) with 95% confidence intervals (CIs) for binary endpoints. Four RCTs and 501 patients were included, of whom 323 were randomized to HCL therapy. Compared with control therapies, HCL significantly improved the period during which glucose level was 70-180 mg/dL (WMD 10.89%, 95% CI 8.22-13.56%) and the number of participants with glycated hemoglobin (HbA1c) level < 7% (RR 2.61, 95% CI 1.29-5.28). Also, HCL significantly reduced the time during which glucoselevel was > 180 mg/dL (WMD-10.46%, 95% CI-13.99 to-6.93%) and the mean levels of glucose (WMD-16.67 mg/dL, 95% CI-22.25 to-11.09 mg/dL) and HbA1c (WMD-0.50%, 95% CI-0.68 to-0.31). There were no significant differences between therapies regarding time during which glucose level was < 70 mg/dL or <54 mg/dL or number of episodes of ketoacidosis, hyperglycemia, and hypoglycemia. In this meta-analysis, HCL compared with control therapies was associated with improved time in range and HbA1c control in children and adolescents with T1D and a similar profile of side effects. These findings support the efficacy of HCL in the treatment of T1D in this population.

Automated Insulin Delivery in Adults With Type 1 Diabetes and Suboptimal HbA1c During Prior Use of Insulin Pump and Continuous Glucose Monitoring: A Randomized Controlled Trial.

Automated insulin delivery (AID) systems offer promise in improving glycemic outcomes for individuals with type 1 diabetes. However, data on those who struggle with suboptimal glycemic levels despite insulin pump and continuous glucose monitoring (CGM) are limited. We conducted a randomized controlled trial to assess the effects of an AID system in this population. Participants with hemoglobin A1c (HbA1c) ≥ 58 mmol/mol (7.5%) were allocated 1:1 to 14 weeks of treatment with the MiniMed 780G system (AID) or continuation of usual care (UC). The primary endpoint was change in time in range (TIR: 3·9-10·0 mmol/L) from baseline to week 14. After this trial period, the UC group switched to AID treatment while the AID group continued using the system. Both groups were monitored for a total of 28 weeks. Forty adults (mean ± SD: age 52 ± 11 years, HbA1c 67 ± 7 mmol/mol [8.3% ± 0.6%], diabetes duration 29 ±13 years) were included. After 14 weeks, TIR increased by 18.7% (95% confidence interval [CI] = 14.5, 22.9%) in the AID group and remained unchanged in the UC group (P < .0001). Hemoglobin A1c decreased by 10.0 mmol/mol (95% CI = 7.0, 13.0 mmol/mol) (0.9% [95% CI = 0.6%, 1.2%]) in the AID group but remained unchanged in the UC group (P < .0001). The glycemic benefits of AID treatment were reproduced after the 14-week extension phase. There were no episodes of severe hypoglycemia or diabetic ketoacidosis during the study. For adults with type 1 diabetes not meeting glycemic targets despite use of insulin pump and CGM, transitioning to an AID system confers considerable glycemic benefits.

Extended Bolus Is No More Needed for Risotto Meal in Children With Type 1 Diabetes Using Automated Insulin Delivery System: A Cohort Study.

Extended Bolus Is No More Needed for Risotto Meal in Children With Type 1 Diabetes Using Automated Insulin Delivery System: A Cohort Study.