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Aims: The present analysis estimated the cost‐effectiveness of treatment with the Tandem t: slim X2 insulin pump with Control IQ technology (CIQ) in children with type 1 diabetes in Sweden. Methods: A four‐state Markov model and probabilistic sensitivity analyses (PSA) were used to assess the cost‐effectiveness of CIQ use compared with treatment with multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII) in conjunction with CGM. Data sources included clinical input data from a recent retrospective, observational study, cost data from local diabetes supply companies and government agencies, and published literature. Outcomes measures were quality adjusted life years (QALYs) at 10, 20 and 30‐year time horizons based on cost per QALY and incremental cost‐effectiveness ratio (ICER). Results: A total of 84 type 1 diabetes children were included (CIQ, n = 37; MDI, n = 19; CSII, n = 28). For all time horizons, the use of CIQ was a dominant strategy (e.g. more effective and less costly) compared with MDI or CSII use: 10‐year ICER, SEK ‐88,010.37 and SEK ‐91,723.92; 20‐year ICER, SEK −72,095.33 and SEK −87,707.79; and 30‐year ICER, SEK −65,573.01 and SEK ‐85,495.68, respectively. PSA confirmed that CIQ use was less costly compared with MDI and CSII. Conclusions: Initiation of CIQ use in children with type 1 diabetes is cost‐saving, besides previously shown improved glycaemic control, and increased quality of life. Further investigations are needed to more fully elucidate the cost‐effectiveness of these technologies in different countries with existing differences in payment models. [ABSTRACT FROM AUTHOR]

Neonatal diabetes mellitus is a rare disorder of glucose metabolism with onset within the first 6 months of life. The initial treatment is based on insulin infusion. The technologies for diabetes treatment can be very helpful, even if guidelines are still lacking. The current study aimed to provide a comprehensive review of the literature about the safety and efficacy of insulin treatment with technology for diabetes to support clinicians in the management of infants with neonatal diabetes mellitus. A total of 22 papers were included, most of them case reports or case series. The first infants with neonatal diabetes mellitus treated with insulin pumps were described nearly two decades ago. Over the years, continuous glucose monitoring systems were added to treat these individuals, allowing for a better customization of insulin administration. Insulin was diluted in some cases to further minimize the doses. Improvement in technology for diabetes prompted clinicians to use new devices and algorithms for insulin delivery in infants with neonatal diabetes as well. These systems are safe and effective, may shorten hospital stay, and help clinicians weaning insulin during the remission phase in the transient forms or switching from insulin to sulfonylurea when suggested by the molecular diagnosis. New technologies for insulin delivery in infants with neonatal diabetes can be used safely and closed-loop algorithms can work properly in these situations, optimizing blood glucose control. [ABSTRACT FROM AUTHOR]

Aim: To establish trust in real‐world evidence (RWE) derived from CareLink Personal (CP), Medtronic's data management system for MiniMed system users, we show that this database and its analyses strictly adhere to the principles of RWE. Methods: The methodology is applicable to all MiniMed iterations. We described every step from raw data to predefined outcomes. In addition, we showed CP's fitness‐for‐research by the below metrics (using last year's MiniMed 780G system data as a case study): representative population, relevant endpoints, appropriate granularity, high data completeness, high data representativity and consistency in results. Results: The process from raw data to outcomes has been validated, and metrics/logics adhere to established definitions. Over 95% of users have a CP account; with 96% providing consent, this allows the use of >91% of the census population. There is no rationale for an over‐representation of a specific phenotype among users not included. CP includes >50 endpoints, including 'International Consensus on Time in Range' based metrics. Data are recorded at 5‐min intervals (maximum 288 per day), and on average there were 263 data points per person per day. Ninety‐nine per cent of uploads were automated. For the last year, only 1 in 6 users had a data gap >1 day, and 1 in 50 had a gap >1 week. The time in range from in‐silico studies was similar to that of real‐world studies from different geographies and with ever growing populations. Conclusion: RWE from CP adheres to the principles of RWE and can serve as robust evidence on the performance and safety of MiniMed systems. [ABSTRACT FROM AUTHOR]

Diabetes treatment options have improved dramatically over the last 100 years, however, close to 2 million individuals in the U.S. alone live with type 1 diabetes (T1D) and are still dependent on multiple daily insulin injections and/or continuous insulin infusion with a pump to stay alive and no oral medications are available. After decades of focusing on immunosuppressive/immunomodulatory approaches for T1D, it has now become apparent that at least after disease onset, this by itself may not be sufficient, and in order to be effective, therapies need to also address beta cell health. This Perspective article discusses the emergence of such a beta cell-targeting, novel class of oral T1D drugs targeting thioredoxin-interacting protein (TXNIP) and some very recent advances in this field that start to address this unmet medical need. It thereby focuses on repurposing of the antihypertensive drug, verapamil found to nonspecifically inhibit TXNIP and on TIX100, a new chemical entity specifically developed as an oral anti-diabetic drug to inhibit TXNIP. Both have shown striking anti-diabetic effects in preclinical studies. Verapamil has also proven to be beneficial in adults and children with recent onset T1D, while TIX100 has just been cleared by the U.S. Food and Drug Administration (FDA) to proceed to clinical trials. Taken together, we propose that such non-immunosuppressive, adjunctive therapies to insulin, alone or in combination with immune modulatory approaches, are critical in order to achieve effective and durable diseasemodifying treatments for T1D. [ABSTRACT FROM AUTHOR]

Abstract\nKey pointsBackground: Diabetes patients’ quality of life can be severely impacted by diabetic muscle atrophy.Aim: This study aimed to explore the impact of high-intensity exercise (HIE) alongside insulin treatment on muscle atrophy in a rat model of type 1 diabetes mellitus (T1DM).Methodology: Fifty rats were allocated into five groups; Group 1, control sedentary (CS), T1DM was elicited in the rest of the groups by giving them Streptozotocin (STZ) (60 mg/kg), where group 2 (DS) remained sedentary, while groups 3,4,5 were treated with insulin after induction of diabetes. Group 4 (DI+MIE) and 5 (DI+ HIE) underwent moderate and high-intensity exercise, respectively.Results: HIE for 14 days combined with insulin treatment significantly restored muscle strength and mass with a significant modification in the mitophagy-related proteins and fibroblast growth factor 21 (FGF 21) compared to other treated groups.Conclusion: This study concluded that there is a therapeutic role for HIE with insulin against T1DM-induced muscle atrophy.T1DM induces loss of skeletal muscle mass and strength.T1DM enhances muscle atrophy-related genes (MAFbx and MuRF1) and impairs mitochondrial function.HIE alongside insulin treatment restores muscle mass, strength, and histological architecture in T1DM-induced muscle atrophy model.HIE alongside insulin treatment over MIE moderated the mitochondrial dysfunction via modulation of the mitophagy-related mediators (BNIP3, Parkin, P62, and LC3II/LC3I) and FGF 21 expression.T1DM induces loss of skeletal muscle mass and strength.T1DM enhances muscle atrophy-related genes (MAFbx and MuRF1) and impairs mitochondrial function.HIE alongside insulin treatment restores muscle mass, strength, and histological architecture in T1DM-induced muscle atrophy model.HIE alongside insulin treatment over MIE moderated the mitochondrial dysfunction via modulation of the mitophagy-related mediators (BNIP3, Parkin, P62, and LC3II/LC3I) and FGF 21 expression. [ABSTRACT FROM AUTHOR]

Background: Poorly controlled adolescents living with type 1 diabetes (T1D) and pump failure of insulin delivery leading to diabetic ketoacidosis (DKA) are still challenging in the western world. Aim: To investigate the effect of a combination modality of long-acting insulin for basal coverage and a pump for boluses, on the incidence of DKA and glycemic parameters in pediatric and young adults with poorly controlled T1D. Methods: This multicenter, observational retrospective study included 55 patients (age range 3–25 years, 52.7% males) who were treated with the combination modality for a median of 18 months [(IQR)12,47], as part of their clinical care. Data were retrieved at initiation of the combined modality, after 6 months, and at last visit. Results: Cohort's median age at combination modality initiation was 14.5 years [IQR12.4,17.3], and its median HbA1c level was 9.2% [IQR 8.2,10.2]. The main reasons for combination modality initiation were: (a) concern about sustained hyperglycemia on current management in 41.8%, (b) previous DKA episodes in 30.8%, and (c) refusal to wear a pump continuously in 14.6%. The percent of patients experiencing DKA who used the modality till end decreased from 25.4 to 8.8%. The frequency of DKA events per patient month decreased after 6 months from 0.073 (min 0, max 0.5) to 0.020 (min 0, max 0.5), p = 0.01, and at end to 0.016 (min 0, max 0.25), p = 0.007. Conclusions: The combination modality of once-daily long-acting insulin and pump for boluses is safe, feasible, and effective in preventing DKA among poorly controlled young people living with T1D, unable or un-willing to use advanced closed pumps. [ABSTRACT FROM AUTHOR]

Aim: To evaluate associations between social disadvantage and insulin pump use among adults with type 1 diabetes (T1D) in the context of a universal publicly funded insulin pump programme in Ontario, Canada, and to ascertain whether social disparities in insulin pump programme enrolment have decreased over time. Methods: Population‐based cross‐sectional studies were conducted using administrative healthcare data in Ontario, Canada. First, among adults aged older than 18 years diagnosed with T1D before 31 March 2021, logistic regression was used to assess the association between neighbourhood social disadvantage (Ontario marginalization index quintiles) and insulin pump use. Second, among all paediatric and adult applicants to the insulin pump programme from 1 September 2006 to 31 March 2022, ordinal logistic regression was used to evaluate associations between year of insulin pump initiation and social disadvantage. Results: Among 27 453 adults with T1D, 60% used insulin pumps. Greater social disadvantage was associated with lower odds of insulin pump use (adjusted odds ratio [OR] 0.44 [95% confidence interval {CI} 0.39‐0.48] for greatest vs. lowest social disadvantage quintile). Among 21 002 paediatric and adult applicants to the insulin pump programme, social disparities in pump use decreased in the first 3 years of the programme, plateaued until 2020, then increased from 2020 to 2022, with no change in the odds of being in a higher social deprivation quintile for 2022 relative to 2007 (OR 1.09 [95% CI 0.83‐1.44]). Conclusions: Despite a universal pump programme for individuals with T1D, disparities by social disadvantage persist. Residual financial and non‐financial barriers must be addressed to promote equitable insulin pump uptake. [ABSTRACT FROM AUTHOR]

Aims Materials and Methods Results Conclusions This study investigates the influence of the automated insulin delivery system (AID) on glycaemic control in children and adolescents with type 1 diabetes (T1D) who do not reach optimal glycaemic control with traditional treatment options.All the patients aged 7 to 16 years with T1D who initiated the AID system between 24 October 2020 and 5 January 2022 in the Helsinki University Hospital and had haemoglobin A1C (HbA1c) levels above 53 mmol/mol/7.0% (N = 79) were included. Time in tight range (TITR), time in range (TIR), HbA1c, mean sensor glucose (SG) value, time below range (TBR) and SG coefficient of variance (CV) were measured at 0, 3, 12 and 24 months. The changes in the outcome measures between the time points were included in the analyses, and statistically significant level was p‐value <0.01.After the initiation of AID, glycaemic control improved, and the effect lasted throughout the study period. Between 0 and 3 months, TITR and TIR increased (mean 11.7% [10.6], mean 18.1% [standard deviation [SD] 13.7], p < 0.001), whereas HbA1c and mean SG values decreased significantly (−8.3 mmol/mol [8.7]/−2.9% [2.9], p < 0.001, −1.8 mmol/L [1.7], p < 0.001). These effects were sustainable and were still visible at 12 and 24 months.Glycaemic control in patients not reaching treatment goals improved significantly after the initiation of the AID system, and the favourable effect lasted throughout the follow‐up. AID treatment could be an option for also those paediatric patients with T1D who do not have good skills in diabetes management. [ABSTRACT FROM AUTHOR]

Many patients with diabetes struggle with post-meal high blood glucose due to missed or untimely meal-related insulin doses. To address this challenge, our research aims to: (1) study mealtime patterns in patients with type 1 diabetes using wearable insulin pump data, and (2) develop personalized models for predicting future mealtimes to support timely insulin dose administration. Using two independent datasets with over 45,000 meal logs from 82 patients with diabetes, we find that the majority of people (∼ 60%) have irregular and inconsistent mealtime patterns that change notably through the course of each day and across months in their own historical data. We also show the feasibility of predicting future mealtimes with personalized LSTM-based models that achieve an average F1 score of > 95% with less than 0.25 false positives per day. Our research lays the groundwork for developing a meal prediction system that can nudge patients with diabetes to administer bolus insulin doses before meal consumption to reduce the occurrence of post-meal high blood glucose. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the safety and explore the efficacy of use of ultra-rapid lispro (URLi, Lyumjev) insulin in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 technology in children, teenagers, and adults living with type 1 diabetes (T1D). Methods: At 14 U.S. diabetes centers, youth and adults with T1D completed a 16-day lead-in period using lispro in a t:slim X2 insulin pump with Control-IQ 1.5 technology, followed by a 13-week period in which URLi insulin was used in the pump. Results: The trial included 179 individuals with T1D (age 6–75 years). With URLi, 1.7% (3 participants) had a severe hypoglycemia event over 13 weeks attributed to override boluses or a missed meal. No diabetic ketoacidosis events occurred. Two participants stopped URLi use because of infusion-site discomfort, and one stopped after developing a rash. Mean time 70–180 mg/dL increased from 65% ± 15% with lispro to 67% ± 13% with URLi (P = 0.004). Mean insulin treatment satisfaction questionnaire score improved from 75 ± 13 at screening to 80 ± 11 after 13 weeks of URLi use (mean difference = 6; 95% confidence interval 4–8; P < 0.001), with the greatest improvement reported for confidence avoiding symptoms of high blood sugar. Mean treatment-related impact measure-diabetes score improved from 74 ± 12 to 80 ± 12 (P < 0.001), and mean TRIM-Diabetes Device (score improved from 82 ± 11 to 86 ± 12 (P < 0.001). Conclusions: URLi use in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 technology was safe for adult and pediatric participants with T1D, with quality-of-life benefits of URLi use perceived by the study participants. Clinicaltrials.gov registration: NCT05403502. [ABSTRACT FROM AUTHOR]

Introduction: Sodium glucose cotransporter inhibitors may increase beta-hydroxybutyrate (BHB) in insulin-requiring patients. We determined factors associated with BHB changes from baseline (ΔBHB) and diabetic ketoacidosis (DKA) in patients with type 1 diabetes (T1D) receiving sotagliflozin as an insulin adjunct. Research Design and Methods: This post hoc analysis compared ΔBHB levels in adults with T1D receiving sotagliflozin 400 mg or placebo for 6 months. We evaluated clinical and metabolic factors associated with ΔBHB and used logistic regression models to determine predictors associated with BHB values >0.6 and >1.5 mmol/L (inTandem3 population; N = 1402) or with DKA events in a pooled analysis (inTandem1–3; N = 2453). Results: From baseline (median, 0.13 mmol/L), median fasting BHB increased by 0.04 mmol/L (95% confidence interval, 0.03–0.05; P < 0.001) at 24 weeks with sotagliflozin versus placebo; 67% of patients had no or minimal changes in BHB over time. Factors associated with on-treatment BHB >0.6 or >1.5 mmol/L included baseline BHB and sotagliflozin use. Age, insulin pump use, sotagliflozin use, baseline BHB, and ΔBHB were significantly associated with DKA episodes. Independent of treatment, DKA risk increased by 18% with each 0.1-mmol/L increase in baseline BHB and by 8% with each 0.1-mmol/L increase from baseline. Conclusion: Incremental increases in baseline BHB and ΔBHB were associated with a higher DKA risk independent of treatment. Adding sotagliflozin to insulin increased median BHB over 24 weeks in patients with T1D and was associated with increased DKA events. These results highlight the importance of BHB testing and monitoring and individualizing patient education on DKA risk, mitigation, identification, and treatment. [ABSTRACT FROM AUTHOR]

This article discusses a study comparing the effectiveness of advanced hybrid closed-loop (AHCL) pump therapy and multiple daily injection therapy (MDI) in children with newly diagnosed type 1 diabetes. The study found that AHCL systems had positive effects on glucose control and psychological outcomes, achieving recommended glycemic outcomes and reducing the frequency of hypoglycemia. The research was conducted in a real-world setting and included data on glucose metrics, glycated hemoglobin (HbA1c), and quality of life. The results suggest that AHCL systems may be a beneficial treatment option for pediatric type 1 diabetes. Another study mentioned in the text examined glucose management in individuals with type 1 diabetes. The study showed improvements in glucose management over time, with participants experiencing lower average glucose levels and spending more time in the target range. However, there were also increases in time above range and time below range at certain time intervals. The study concludes that AHCL therapy is a better option for pediatric patients with newly diagnosed type 1 diabetes, leading to better glucose control and improved quality of life. [Extracted from the article]

In recent years, diabetes technologies have revolutionized the care of people with type 1 diabetes (T1D). Emerging evidence suggests that people with type 2 diabetes (T2D) can experience similar benefits from these advances in technology. While glycaemic outcomes are often a primary focus, the lived experience of the person with diabetes is equally important. In this review, we describe the impact of diabetes technologies on patient‐reported outcome measures (PROMs). We highlight that most of the published studies investigated PROMs as secondary outcomes. Continuous glucose monitoring systems may have an important role in improving PROMs in individuals with T1D, which may be driven by the prevention or proactive management of hypoglycaemia. In people with T2D, continuous glucose monitoring may also have an important role in improving PROMs, particularly in those treated with insulin therapy. The impact of insulin pumps on PROMs seems positive in T1D, while there is limited evidence in T2D. Studies of hybrid closed‐loop therapies suggest increased treatment satisfaction, improved quality of life and decreased diabetes‐related distress in T1D, but it is unclear whether these benefits are because of a ‘class‐effect’ or individual systems. We conclude that PROMs deserve a more central role in trials and clinical practice, and we discuss directions for future research. [ABSTRACT FROM AUTHOR]

Background: Multiple clinician adjustable parameters impact upon glycemia in people with type 1 diabetes (T1D) using Medtronic Mini Med 780G (MM780G) AHCL. These include glucose targets, carbohydrate ratios (CR), and active insulin time (AIT). Algorithm-based decision support advising upon potential settings adjustments may enhance clinical decision-making. Methods: Single-arm, two-phase exploratory study developing decision support to commence and sustain AHCL. Participants commenced investigational MM780G, then 8 weeks Phase 1-initial optimization tool evaluation, involving algorithm-based decision support with weekly AIT and CR recommendations. Clinicians approved or rejected CR and AIT recommendations based on perceived safety per protocol. Co-design resulted in a refined algorithm evaluated in a further identically configured Phase 2. Phase 2 participants also transitioned to commercial MM780G following "Quick Start" (algorithm-derived tool determining initial AHCL settings using daily insulin dose and weight). We assessed efficacy, safety, and acceptability of decision support using glycemic metrics, and the proportion of accepted CR and AIT settings per phase. Results: Fifty three participants commenced Phase 1 (mean age 24.4; Hba1c 61.5mmol/7.7%). The proportion of CR and AIT accepted by clinicians increased between Phases 1 and 2 respectively: CR 89.2% vs. 98.6%, p < 0.01; AIT 95.2% vs. 99.3%, p < 0.01. Between Phases, mean glucose percentage time < 3.9mmol (< 70mg/dl) reduced (2.1% vs. 1.4%, p = 0.04); change in mean TIR 3.9-10mmol/L (70-180mg/dl) was not statistically significant: 72.9% ± 7.8 and 73.5% ± 8.6. Quick start resulted in stable TIR, and glycemic metrics compared to international guidelines. Conclusion: The co-designed decision support tools were able to deliver safe and effective therapy. They can potentially reduce the burden of diabetes management related decision making for both health care practitioners and patients. Trial registration: Prospectively registered with Australia/New Zealand Clinical Trials Registry(ANZCTR) on 30th March 2021 as study ACTRN12621000360819. [ABSTRACT FROM AUTHOR]

Background: Several studies were performed on transdermal (TD) insulin delivery in vitro and in vivo, and recently, the study groups included a clinical trial in humans. Therefore, this systematic review was conducted to get summary information about the effectiveness, safety, and preferability of TD insulin in comparison with subcutaneous insulin delivery. Methods: We conducted a thorough search to find studies in the databases Cochrane Library, MEDLINE via PubMed, Web of Science Core Collection, EMBASE, Scopus, Hinari, Medlib, and Magiran until January 2024. We included 18 randomized clinical trials. Results: Although there are various types of TD delivery methods, the TD insulin delivery methods that have undergone clinical trials are the TD patch, micro needle TD insulin delivery, and TD insulin jet injector. Eighteen studies were conducted on TD insulin delivery, which showed either superior or comparable effectiveness, safety, and preferability of TD insulin in comparison with SC insulin. About eleven out of eighteen studies (61.1%) showed more effective blood glucose control than SC delivery, and the remaining seven studies showed comparable effectiveness with SC delivery. Eleven studies (61.1%) showed equal tolerability of TD insulin versus SC insulin, and seven studies (38.9%) showed more tolerability of TD insulin over SC insulin. In most studies, eleven out of eighteen (61.1%) showed a higher preference for TD insulin delivery over traditional SC delivery; sixth out of eighteen (33.3%) showed equal preferability for TD insulin versus SC insulin; and only one study (5.6%) showed that TD insulin delivery was less preferable than SC insulin. Conclusion: The review revealed that clinical trials have demonstrated the effectiveness of TD insulin delivery methods such as TD patches, MN-based insulin delivery, and insulin jet injectors compared to traditional SC routes of administration. The studies showed the superior or comparable effectiveness of TD insulin in controlling blood glucose levels. Additionally, TD insulin delivery was found to be equally or more tolerable than SC insulin delivery in all studies. Overall, the majority of studies favored TD insulin delivery over traditional SC delivery methods, highlighting its potential as a preferred option for insulin administration. [ABSTRACT FROM AUTHOR]

Objective This study investigated the onset and the choice of treatment in children with very early onset of type 1 diabetes mellitus (T1D). Methods The study included 5,763 patients from the German Diabetes Patient Follow-up registry with onset of T1D in the first 4 years of life from January 2010 – June 2022. The analysis included diabetes-specific parameters, anthropometric data, and mode of treatment at onset, within the first and second year of T1D. Three groups were compared according to age at onset (G1: 223 patients 6–<12 months, G2: 1519 patients 12–<24 months, G3: 4001 patients 24–48 months). Results In 12.3% of all cases in childhood and adolescence, the incidence of diabetes in the first 4 years of life was rare. At the onset, clinical status was worse and diabetic ketoacidosis (DKA) rates were higher in G1 and G2 (52.3% and 46.5%, respectively) compared to G3 (27.3% (p<0.001)). G1 and G2 were significantly more likely to be treated with insulin pump therapy (CSII) 2 years after onset (98.1% and 94.1%, respectively)) compared to G3 (85.8%, p<0.001). Median HbA1c after 2 years did not differ between groups (G1: 7.27% (56.0 mmol/mol), G2: 7.34% (56.7 mmol/mol) and G3: 7.27% (56.0 mmol/mol)) or when comparing CSII vs MDI. The rate of severe hypoglycemia (SH) and DKA during the first 2 years of treatment did not differ among the three groups, ranging from 1.83–2.63/100 patient-years (PY) for DKA and 9.37–24.2/100 PY for SH. Children with T1D under 4 years of age are more likely to be diagnosed with celiac disease but less likely to have thyroiditis than older children with T1DM. Conclusions Young children with T1D had high rates of DKA at onset and were predominantly treated with insulin pump therapy during the first 2 years. The median HbA1c for all three groups was<7.5% (58 mmol/mol) without increased risk of SH or DKA. The use of continuous glucose monitoring (CGM) was not associated with lower HbA1c in children under 48 months. [ABSTRACT FROM AUTHOR]

Background: Inpatient use of insulin pump therapy has been increasing due to greater availability of this technology, however there is a paucity of research that investigates glycemic control of inpatient insulin pump users. Objective: To compare the glycemic control of hospitalized patients with type 1 diabetes (T1D) who used insulin pump vs. multiple daily injections (MDI). Design: Retrospective chart review. Participants: Patients with T1D who were hospitalized between January 1, 2017, and December 31, 2019, in an academic medical center in the New York metropolitan area. Main Measures: Patients were categorized into three groups based on their method of insulin administration: "pump only" group used insulin pump exclusively, "MDI only" group used MDI only, and "intermittent pump" group used a combination of both methods. The primary endpoints are mean blood glucose, rates of hypoglycemic events (blood glucose < 70 mg/dL), and rates of hyperglycemic events (blood glucose > 250 mg/dL). Separate multivariable Poisson regressions were performed to determine the association between the type of insulin administration and rate outcomes (i.e., rate of hypoglycemic events and rate of hyperglycemic events). Results: The study included 78 patients with a mean age of 51, who were mostly male (54%), and white (72%). The average proportion of glucose measurements that were hyperglycemic for the "pump only", "MDI only", and "intermittent pump" groups were 0.11 (SD = 0.11), 0.25 (SD = 0.19), and 0.24 (SD = 0.25), respectively. The "pump only" group has a significantly lower proportion of hyperglycemic events as compared to the "MDI only" group (p = 0.0227). Conclusions: In this sample, patients who exclusively used their insulin pump while inpatient had a lower rate of hyperglycemic events than patients who used MDI only; suggesting that select patients can safely continue their insulin pump therapy in the inpatient setting. [ABSTRACT FROM AUTHOR]

Aim: To evaluate gastric emptying (GE) and the glycaemic response to a 75‐g oral glucose load in newly diagnosed, treatment‐naïve Han Chinese with type 2 diabetes (T2D) before insulin pump therapy, after 4 weeks of insulin pump therapy, and 12–15 months after insulin pump therapy. Materials and Methods: Twenty participants with T2D (baseline glycated haemoglobin [± SD] 10.7% [± 1.2%] 93 [± 10] mmol/mol) ingested a 75‐g glucose drink containing 150 mg 13C‐acetate, to determine the gastric half‐emptying time, and underwent assessment of plasma glucose and serum insulin, C‐peptide and glucagon‐like peptide‐1 (GLP‐1) over 180 min before and after 4 weeks of insulin pump therapy (discontinued for 48 h before re‐assessment). Data were compared to those in 19 healthy participants matched for sex and age. After 12–15 months, GE was re‐measured in 14 of the T2D participants. Results: At baseline, participants with T2D exhibited substantially augmented fasting and post‐glucose glycaemia, diminished insulin secretion, and more rapid GE (p < 0.05 each), but comparable GLP‐1, compared to healthy participants. Following insulin pump therapy, insulin secretion increased, GLP‐1 secretion was attenuated, fasting and post‐glucose glycaemia were lower, and GE was slowed (p < 0.05 each). The slowing of GE in T2D participants was sustained over 12–15 months of follow‐up. Conclusions: In newly diagnosed Han Chinese with T2D, GE is often accelerated despite poor glycaemic control and is slowed by short‐term insulin pump therapy. The effect on GE is maintained for at least 12 months. [ABSTRACT FROM AUTHOR]

Aims: Time in Tight Range (TITR) is a novel glycaemic metric in monitoring type 1 diabetes (T1D) management. The aim of this study was to assess the attainability of the TITR target in children and adolescents using the advanced hybrid closed loop (AHCL). Methods: The 2128‐day CGM data from 56 children and adolescents with T1D using AHCL (Minimed‐780G) were analysed. Time in Range (TIR) (3.9–10 mmol/L), TITR (3.9–7.7 mmol/L), and other glycaemic parameters were separately analysed in terms of whole day, daytime (06.00–23:59), and nighttime (00.00–05.59) results. The participants were divided into two groups by autocorrection rate where Group 1 had a rate of <30% and Group 2 had a rate of ≥30. Results: All glycaemic parameters indicated a better glycaemic outcome in the nighttime with higher TIR and TITR values compared with daytime (for TIR 87.5 ± 9.5% vs. 78.8 ± 8%, p < 0.001, and TITR 68.2 ± 13.5% vs. 57.5 ± 8.8%, p < 0.001). The rates of TITR >50% and >60% were 87% and 52%, respectively. When those with TITR >60% (n: 29) and those without (n: 27) were evaluated in terms of hypoglycaemia, no statistically significant difference was found in time below range (TBR) 3–3.9 mmol/L (0.3% vs. 2.1%, p: 0.084) and TBR < 3 mmol/L (0.47% vs. 0.3%, p: 0.298). Group 1 had a significantly higher TIR and TITR compared to Group 2 (82.6 ± 6.1% vs. 75.6 ± 8.6%, p: 0.008 and 62.1 ± 7.5% vs. 53.8 ± 7.5%, p: 0.002, respectively). Conclusions: Most children and adolescents on AHCL achieved the 50% target for TITR whereas more than half achieved the >60% target. A target of >50% for TITR seems realistic in children with T1D using AHCL. [ABSTRACT FROM AUTHOR]

Background: Advanced Hybrid Closed-Loop system (AHCL) has profoundly changed type 1 diabetes therapy. This study primarily aimed to assess the impact on Glycemia Risk Index (GRI) and other continuous glucose monitoring (CGM) metrics when switching from one of four insulin strategies to AHCL in type 1 adult patients. Methods: A single-center, retrospective pre/post observational study; 198 patients (age 44.4 ± 12.7 years, 115 females/83 males, diabetes duration 24.7 ± 11.6 years, HbA1c 7.4 ± 1%), treated with different insulin therapies (MDI, CSII, SAP with PLGS, HCL) were assessed before and after switching to an AHCL (MiniMed 780G, Diabeloop Roche, Tandem Control-IQ) at 1, 3, 6, and 12 months. Mixed-effects multivariable regression models were used to estimate the mean pre/post variations at different time points, adjusted for potential confounders. Results: A month after the switch, there was an improvement in CGM metrics and HbA1c for all patients: GRI −10.7, GMI −0.27%, CV −2.1%, TAR>250 −3.7%, TAR180-250 −5.6%, TIR + 9.7%, HbA1c −0.54% (all p < 0.001). This improvement was maintained throughout the observational period (at 3, 6, and 12 months, with all p-values < 0.001). When improvements across the 780, Diabeloop, and Tandem CIQ devices were compared: Diabeloop demonstrated significantly better performance in terms of GRI, GMI, CV, TAR>250 at T1 (for all p < 0.01); 780 recorded highest average decrease in TAR180-250 (p = 0.020), while Tandem achieved the most significant reduction in TBR54-69 (p = 0.004). Conclusions: Adopting an AHCL leads to a rapid and sustained improvement in GRI and other parameters of metabolic control for up to a year, regardless of prior insulin therapies, baseline conditions or brands. [ABSTRACT FROM AUTHOR]

Aim: To provide updated efficacy and safety information for teplizumab in the treatment of Stage 3 type 1 diabetes mellitus (T1DM). Materials and Methods: The PubMed, Embase and Cochrane databases were searched for randomized controlled trials (RCTs) comparing teplizumab to placebo for T1DM that reported any of the following outcomes: (1) C‐peptide area under the curve (AUC); (2) glycated haemoglobin (HbA1c) levels; (3) insulin requirements; and (4) adverse events. Heterogeneity was examined with I2 statistics. p values <0.05 were taken to indicate statistical significance. The continuous endpoints were compared through the pooled mean difference (MD) and binary endpoints were assessed using risk ratios, both with 95% confidence intervals (CIs). Statistical analyses were performed using Review Manager Web software. Results: Eight RCTs with 1052 patients (754 receiving teplizumab) were included. Teplizumab significantly increased the AUC of C‐peptide levels at 6 (MD 0.10 nmol/L, 95% CI 0.05, 0.16), 12 (MD 0.13 nmol/L, 95% CI 0.06, 0.20), 18 (MD 0.18 nmol/L, 95% CI 0.09, 0.27) and 24 months (MD 0.16 nmol/L, 95% CI 0.02, 0.31), significantly reduced HbA1c levels at 6 (MD −0.57%, 95% CI −1.07, −0.08) and 12 months (MD −0.31%, 95% CI −0.59, −0.02), and significantly reduced insulin requirements at 6 (MD −0.12 U/kg, 95% CI −0.16, −0.08), 12 (MD −0.11 U/kg, 95% CI −0.15, −0.07), 18 (MD −0.17 U/kg, 95% CI −0.26, −0.09) and 24 months (MD −0.11 U/kg, 95% CI −0.22, −0.01). Conclusion: Teplizumab increases AUC of C‐peptide levels and decreases HbA1c levels and insulin use, without raising serious adverse event risk. [ABSTRACT FROM AUTHOR]

OBJECTIVE Little is known about the influence of residual islet function on glycemic control in type 1 diabetes (T1D). We investigated the associations between residual β-cell function and metrics of continuous glucose monitoring (CGM) in individuals with T1D. RESEARCH DESIGN AND METHODS In this cross-sectional cohort comprising 489 individuals (64% female, age 41.0 ± 14.0 years), T1D duration was 15.0 (interquartile range [IQR] 6.0-29.0) years. Individuals had a time in range (TIR) of 66% (IQR 52-80%) and a urinary C-peptide-to-creatinine ratio (UCPCR) of 0.01 (IQR 0.00-0.41) nmol/mmol. To assess β-cell function, we measured UCPCR (detectable >0.01 nmol/mmol), and to assess α-cell function, fasting plasma glucagon/glucose ratios were measured. CGM was used to record TIR (3.9-10 mmol/L), time below range (TBR) (<3.9 mmol/L), time above range (TAR) (>10 mmol/L), and glucose coefficient of variance (CV). For CGM, 74.7% used FreeStyle Libre 2, 13.8% Medtronic Guardian, and 11.5% Dexcom G6 as their device. RESULTS The percentage of patients with T1D who had a detectable UCPCR was 49.4%. A higher UCPCR correlated with higher TIR (r = 0.330, P < 0.05), lower TBR (r = -0.237, P < 0.05), lower TAR (r = -0.302, P < 0.05), and lower glucose CV (r = -0.356, P < 0.05). A higher UCPCR correlated negatively with HbA1c levels (r = -0.183, P < 0.05) and total daily insulin dose (r = -0.183, P < 0.05). Glucagon/glucose ratios correlated with longer TIR (r = 0.234, P < 0.05). CONCLUSIONS Significantly longer TIR, shorter TBR and TAR, and lower CV were observed in individuals with greater UCPCR-assessed β-cell function. Therefore, better CGM-derived metrics in individuals with preserved β-cell function may be a contributor to a lower risk of developing long-term complications. [ABSTRACT FROM AUTHOR]

Although continuous glucose monitoring (CGM) devices are now considered the standard of care for people with type 1 diabetes mellitus, the uptake among people with type 2 diabetes mellitus (T2DM) has been slower and is focused on those receiving intensive insulin therapy. However, increasing evidence now supports the inclusion of CGM in the routine care of people with T2DM who are on basal insulin-only regimens or are managed with other medications. Expanding CGM to these groups could minimize hypoglycaemia while allowing efficient adaptation and escalation of therapies. Increasing evidence from randomized controlled trials and observational studies indicates that CGM is of clinical value in people with T2DM on non-intensive treatment regimens. If further studies confirm this finding, CGM could soon become a part of routine care for T2DM. In this Perspective we explore the potential benefits of widening the application of CGM in T2DM, along with the challenges that must be overcome for the evidence-based benefits of this technology to be delivered for all people with T2DM. Continuous glucose monitoring (CGM) is an effective tool in the management of diabetes mellitus. This Perspective discusses the potential benefits of widespread adoption of CGM in people with type 2 diabetes mellitus at different stages of disease progression and treatment intensification. [ABSTRACT FROM AUTHOR]

Aims: Hyperglycaemia aversion in type 1 diabetes can be associated with severe hypoglycaemia and impaired awareness of hypoglycaemia but is not routinely assessed clinically. This study aimed to undertake the first psychometric validation of the UK version of the Hyperglycaemia Avoidance Scale (HAS‐UK). Methods: The HAS‐UK was completed by adults with type 1 diabetes in three separate research studies. Psychometric properties were evaluated, using exploratory factor analysis, internal consistency, and convergent validity. Results: Of the 431 participants who completed the HAS‐UK in the three studies, mean age was 49.5 years, and 58.0% were women. Mean duration of diabetes was 29 years, with 192 (44.5%) using multiple daily injections and 229 (53.1%) using an insulin pump. Five participants were excluded from analyses due to incomplete HAS‐UK responses. Exploratory factor analysis revealed a 3‐factor solution, with acceptable internal consistency for 'worry' and 'blood glucose decisions' factors. HAS‐UK total score was higher in those using insulin pumps versus multiple daily injections, and 'blood glucose decisions' score was higher in those using a continuous blood glucose sensor versus a meter. Conclusions: The HAS‐UK is a reliable measure with acceptable structural validity and is likely to be useful for evaluating hyperglycaemia aversion in people with type 1 diabetes. Future research would benefit from investigating further psychometric properties including test–retest reliability, sensitivity to change, and clinical significance of scores. [ABSTRACT FROM AUTHOR]

Aim: To summarise, in a narrative review, published data on hypoglycaemia occurrence with basal insulin therapy in adults with type 1 diabetes treated with basal‐bolus insulin regimens in treat‐to‐target randomised controlled trials. Methods: Data were included from 21 eligible trials, which mainly used self‐measured blood glucose or plasma glucose to detect hypoglycaemia. Results: All‐day self‐measured blood glucose or plasma glucose level 2 (glucose threshold of 3.1 or 3.0 mmol/L) and level 3 (severe, requiring assistance) hypoglycaemic events were reported, respectively, by a range of 69.0%–97.5% and 0%–13.4% adults when receiving basal‐bolus insulin therapy, with rates of 10.6–68.1 and 0.0–0.4 events per patient‐year of exposure, respectively. Hypoglycaemia rates measured using continuous glucose monitoring (three studies) were numerically, yet consistently, higher than with either other method, except when limiting to symptomatic events. Nocturnal hypoglycaemia rates were generally less than 30% of the equivalent all‐day rates. Conclusions: Differences across the studies in design (e.g., titration targets) and participant characteristics hindered comparison of hypoglycaemia rates by insulin formulation. Consequently, few trends were identified by insulin formulation, study methodology or individuals' characteristics, suggesting that further research is required to identify treatment strategies that facilitate development of individualised recommendations to lower hypoglycaemia risk. These findings are useful to understand hypoglycaemia risk with available basal insulin therapies when used in a multiple daily injection regimen, as well as to provide context for the results of ongoing and future clinical trials, including those for two once‐weekly basal insulins, insulin icodec and basal insulin Fc. [ABSTRACT FROM AUTHOR]

The growing prevalence of type 2 diabetes (T2D) remains a leading health concern in the US. Despite new medications and technologies, glycemic control in this population remains suboptimal, which increases the risk of poor outcomes, increased healthcare resource utilization, and associated costs. This article reviews the clinical and economic impacts of suboptimal glycemic control in patients on basal-bolus insulin or multiple daily injections (MDI) and discusses how new technologies, such as tubeless insulin delivery devices, referred to as "patch pumps", have the potential to improve outcomes in patients with T2D. [ABSTRACT FROM AUTHOR]

Objective: Insulin bolus doses derive from glucose levels and planned carbohydrate intake, although fat and protein impact glycemic excursions. We examined the impact of macronutrients and number of daily meals/snacks on glycemic outcomes in youth with type 1 diabetes. Methods: Youth (N = 136, ages 8–17) with type 1 diabetes completed 3-day food records, wore 3-day masked continuous glucose monitoring, and had A1c measurements every 3 months for 1 year. Diet data were analyzed using Nutrition Data System for Research. Longitudinal mixed models assessed effects of macronutrient intake and number of meals/snacks on glycemic outcomes. Results: At baseline, youth (48% male) had mean age of 12.8 ± 2.5 years and diabetes duration of 5.9 ± 3.1 years; 73% used insulin pumps. Baseline A1c was 8.1% ± 1.0%, percent time in range 70–180 mg/dL (%TIR) was 49% ± 17%, % time below range <70 mg/dL (%TBR) was 6% ± 8%, % time above range >180 mg/dL (%TAR) was 44% ± 20%, and glycemic variability as coefficient of variation (CV) was 41% ± 8%; macronutrient intake included 48% ± 5% carbohydrate, 36% ± 5% fat, and 16% ± 2% protein. Most youth (56%) reported 3–4 meals/snacks daily (range 1–9). Over 1 year, greater carbohydrate intake was associated with lower A1c (P = 0.0003), more %TBR (P = 0.0006), less %TAR (P = 0.002), and higher CV (P = 0.03). Greater fat intake was associated with higher A1c (P = 0.006), less %TBR (P = 0.002), and more %TAR (P = 0.005). Greater protein intake was associated with higher A1c (P = 0.01). More daily meals/snacks were associated with lower A1c (P = 0.001), higher %TIR (P = 0.0006), and less %TAR (P = 0.0001). Conclusions: Both fat and protein impact glycemic outcomes. Future automated insulin delivery systems should consider all macronutrients for timely insulin provision. The present research study derived from secondary analysis of the study registered under NCT00999375. [ABSTRACT FROM AUTHOR]

Background Insulin is a mainstay of treatment in diabetic ketoacidosis (DKA) however controversy remains over the optimal dose and administration. An initial bolus dose of insulin prior to a continuous infusion is utilized despite a lack of data showing clinical benefit and potential for complications. Objective This study was designed to evaluate the safety and efficacy of an initial insulin bolus in the treatment of DKA. Methods A retrospective chart review of patients with DKA was conducted. Fifty-nine patients met inclusion for the bolus group and 108 in the no-bolus group. The primary outcome was a composite of interruption of insulin infusion, hypoglycemia (BG <70 mg/dL), or hypokalemia (K+ <3.4 mEq/L) occurring within eight hours of starting insulin. Secondary outcomes included time to discontinuation of insulin infusion, as well as time to discharge from the ICU and the hospital. Results Baseline characteristics were similar between groups. The majority of patients were classified as having mild DKA. The primary outcome occurred significantly more frequently in the bolus group (45.8% vs 25%, P =.003) which was primarily driven by incidence of hypokalemia. Time to anion gap closure (6:39 vs 9:00, P =.063) was shorter with a bolus, although not significantly so. This finding carried forward to non-significant differences in time to stopping insulin infusion as well as ICU and hospital discharge. Conclusion An insulin bolus prior to initiation of an insulin infusion was associated with significantly more adverse effects early in therapy without a corresponding benefit in time to resolution of DKA. [ABSTRACT FROM AUTHOR]

YG1699 is a novel inhibitor of sodium‐glucose cotransporter 1 (SGLT1) and SGLT2. This double‐blind, 3‐way crossover trial compared YG1699 to dapagliflozin as an adjunct to insulin in people with type 1 diabetes (T1D) on insulin pump therapy. Treatment periods included four mixed meal tolerance tests (MMTTs) and insulin withdrawal tests per person. Nineteen adults with T1D were randomized to YG1699 10 mg, YG1699 25 mg, and dapagliflozin 10 mg once daily for 1 week in different orders. The primary end point was the difference in area under the curve (AUC) in plasma glucose (AUC0–120min) after an MMTT between treatment groups. Mean change in plasma glucose after an MMTT (AUC0–120min) was lower for YG1699 10 mg vs. dapagliflozin (89.51% of baseline vs. 102.13%, 90% confidence interval (CI) vs. dapagliflozin, −6% to −16%, P = 0.0003) and for YG1699 25 mg (84.83% vs. 102.13%, 90% CI vs. dapagliflozin −13% to −22%, P < 0.0001). At 120 minutes, mean glucose values on no treatment, dapagliflozin, YG1699 10 mg, and YG1699 25 mg were 149 (SE 7.6), 141 (SE 6.1), 128 (SE 6.9), and 115 (SE 7.8) mg/dL, respectively. Insulin dose requirements were lower for YG1699 10 mg and 25 mg vs. dapagliflozin for bolus insulin, and for YG1699 10 mg vs. dapagliflozin for total daily insulin. Safety profiles were similar between treatment groups. YG1699 reduced post‐prandial glucose more than dapagliflozin in people with T1D on insulin pump therapy. The results were consistent with dual SGLT1/SGLT2 inhibition by YG1699. [ABSTRACT FROM AUTHOR]

Advanced hybrid closed-loop (AHCL) therapy with the Medtronic MiniMed™ 780G system improves glycemia; however, the clinical outcomes in younger children remain less established. This pilot study aimed to explore the continuous glucose monitoring (CGM) metrics in very young children on AHCL. Children between 2 and 7 years of age and on insulin pump therapy were recruited. A 2-week phase in manual mode was followed by a 6-week AHCL phase. CGM metrics were analyzed to review glycemic outcomes. Out of 11 participants enrolled [mean (standard deviation [SD]) age 5.3 (0.8) years], 10 completed the study. Time in closed loop was 96.7 (3.9)%. In AHCL, participants had a mean (SD) time in range of 72.6 (7.4)% and spent 3.0 (1.74)% and 0.63 (0.46)% in time <70 and <54 mg/dL, respectively. AHCL is a feasible option for management of young children with type 1 diabetes. [ABSTRACT FROM AUTHOR]

Artificial intelligence (AI) algorithms and continuous monitoring technologies have the potential to transform the way chronic illnesses are managed. We will also talk about the problems and potential that AI technology presents for CGM in individualised and preventive medicine. Furthermore, we assessed the AHCL system's usefulness in patients with impaired awareness of hypoglycemia (IAH) and those who correctly recognised hypoglycemia symptoms. The participants' ages varied from 37 to 15, and they had received diabetes medication for an average of 20 to 10 years. IAH was seen in 12 individuals (27%) with a Clarke's score of less than 3. Patients with IAH were older than those who did not have IAH. The baseline CGM readings and A1c were the same, but the estimated glomerular filtration rate (eGFR) was lower. Despite prior insulin treatment, the AHCL system resulted in an overall drop in A1c (from 6.9 0.5% to 6.7 0.6%, P 0.001). Only three patients (7%) received Clarke's three scores after six months on the AHCL system, resulting in a 20% absolute risk decrease for IAH (95% confidence interval: 7-32). [ABSTRACT FROM AUTHOR]

This work discusses the physiological processes influencing the dynamics of blood glucose concentration in patients with diabetes mellitus and approaches to mathematical modeling of blood glucose metabolism are proposed to build predictive models as required for automating insulin therapy. Insulin-dependent and non-insulin-dependent processes occurring in the liver, kidneys, and other organs and tissues, the hormones regulating these processes, and enzymes modulating the rates of these processes are considered. A unified scheme is presented which systematizes the interaction of these substances in various processes with indications of localizations. [ABSTRACT FROM AUTHOR]

Background: The management of Type 1 Diabetes Mellitus (T1DM) is a significant clinical challenge. This study evaluated the efficacy of teplizumab, an immunomodulatory drug, in patients with T1DM, using a systematic review and meta‐analysis approach. Methods: We systematically searched multiple databases including Medline, Scopus, and others up to 10 January 2024, without language or regional restrictions. We included randomized controlled trials (RCTs) comparing teplizumab with placebo in T1DM patients. Results: Our analysis incorporated 8 RCTs, predominantly involving participants aged 7–35 years, diagnosed with T1DM and treated with 14‐day courses of teplizumab. The primary outcomes included insulin use, C‐peptide levels, and HbA1c levels. We observed a significant reduction in insulin use in the teplizumab group standardised mean difference of −0.50 (95% Confidence Interval [CI]: −0.76 to −0.23, p < 0.001; I2 = 49%). C‐peptide levels were consistently higher in the teplizumab group, indicating improved endogenous insulin production. However, no significant change was noted in HbA1c levels between the groups. Quality assessment indicated a low risk of bias in most studies. Conclusions: Teplizumab has a significant impact on reducing insulin dependence and enhancing endogenous insulin production in T1DM patients. However, its effect on long‐term glycaemic control, as indicated by HbA1c levels, remains inconclusive. [ABSTRACT FROM AUTHOR]

This meta-analysis explores the effectiveness of the dual-hormone artificial pancreas system (DH-APS) in preventing exercise-induced hypoglycemia in adults with type 1 diabetes. The analysis includes six randomized controlled trials with a total of 114 participants and compares DH-APS with other treatment methods. The results indicate that DH-APS may be successful in reducing the time spent with low glucose levels during and after exercise, as well as the overall number of hypoglycemia episodes. However, DH-APS does not significantly improve time in range or time above range during exercise. This suggests that DH-APS may be a beneficial option for adults with type 1 diabetes during physical activity. [Extracted from the article]

Aims: It is not clear whether there are differences in glycemic control between the Equil patch and the MMT‐712 insulin pump. Our objective was to compare two types of insulin pumps in the treatment of type 2 diabetes mellitus (T2DM), using continuous glucose monitoring (CGM) metrics and profiles. Methods: This was a randomized case‐crossover clinical trial. Participants were hospitalized and randomly allocated to two groups and underwent two types of insulin pump treatments (group A: Equil patch—Medtronic MMT‐712 insulin pump; group B: Medtronic MMT‐712—Equil patch insulin pump) separated by a 1‐day washout period. Glycemic control was achieved after 7–8 days of insulin pump therapy. Each patient received CGM for 5 consecutive days (from day 1 to day 5). On day 3 of CGM performance, the Equil patch insulin pump treatment was switched to Medtronic MMT‐712 insulin pump treatment at the same basal and bolus insulin doses or vice versa. CGM metrics and profiles including glycemic variability (GV), time in range (TIR, 3.9–10.0 mmol/L), time below range (TBR, <3.9 mmol/L), time above range (TAR, >10.0 mmol/L), and postprandial glucose excursions, as well as incidence of hypoglycemia. Results: Forty‐six T2DM patients completed the study. There was no significant difference in parameters of daily GV and postprandial glucose excursions between the Equil patch insulin pump treatment and the Medtronic insulin pump treatment. Similarly, there was no between‐treatment difference in TIR, TBR, and TAR, as well as the incidence of hypoglycemia. Conclusion: The Equil patch insulin pump was similar to the traditional MMT‐712 insulin pump in terms of glycemic control. Equil patch insulin pump is a reliable tool for glycemic management of diabetes mellitus. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To compare demographic, clinical, and therapeutic characteristics of children with type 1 diabetes age <6 years across three international registries: Diabetes Prospective Follow-Up Registry (DPV; Europe), T1D Exchange Quality Improvement Network (T1DX-QI; U.S.), and Australasian Diabetes Data Network (ADDN; Australasia). RESEARCH DESIGN AND METHODS: An analysis was conducted comparing 2019–2021 prospective registry data from 8,004 children. RESULTS: Mean ± SD ages at diabetes diagnosis were 3.2 ± 1.4 (DPV and ADDN) and 3.7 ± 1.8 years (T1DX-QI). Mean ± SD diabetes durations were 1.4 ± 1.3 (DPV), 1.4 ± 1.6 (T1DX-QI), and 1.5 ± 1.3 years (ADDN). BMI z scores were in the overweight range in 36.2% (DPV), 41.8% (T1DX-QI), and 50.0% (ADDN) of participants. Mean ± SD HbA1c varied among registries: DPV 7.3 ± 0.9% (56 ± 10 mmol/mol), T1DX-QI 8.0 ± 1.4% (64 ± 16 mmol/mol), and ADDN 7.7 ± 1.2% (61 ± 13 mmol/mol). Overall, 37.5% of children achieved the target HbA1c of <7.0% (53 mmol/mol): 43.6% in DPV, 25.5% in T1DX-QI, and 27.5% in ADDN. Use of diabetes technologies such as insulin pump (DPV 86.6%, T1DX 46.6%, and ADDN 39.2%) and continuous glucose monitoring (CGM; DPV 85.1%, T1DX-QI 57.6%, and ADDN 70.5%) varied among registries. Use of hybrid closed-loop (HCL) systems was uncommon (from 0.5% [ADDN] to 6.9% [DPV]). CONCLUSIONS: Across three major registries, more than half of children age <6 years did not achieve the target HbA1c of <7.0% (53 mmol/mol). CGM was used by most participants, whereas insulin pump use varied across registries, and HCL system use was rare. The differences seen in glycemia and use of diabetes technologies among registries require further investigation to determine potential contributing factors and areas to target to improve the care of this vulnerable group. [ABSTRACT FROM AUTHOR]

Background. Diabetes is one of the most common chronic and metabolic diseases. This systematic review and meta-analysis study aimed to compare the effects of multiple daily insulin injections against permanent subcutaneous insulin injections on glycated hemoglobin (HbA1C) levels in type 2 diabetic patients. Methods. Studies that compared the impacts of multiple daily insulin injections against permanent subcutaneous insulin injections on HbA1C levels and were published until the end of 2022 in international databases were searched and retrieved (nine randomized clinical trial studies). The Chi-squared test and I2 were used to determine the presence and size of heterogeneity. Results. The results of the analysis demonstrated that compared to the group of multiple daily insulin injections, HbA1C was significantly reduced in the group of permanent subcutaneous insulin injections, so that the standardized mean difference was equal to -0.26 (95% confidence interval: -0.46– -0.06 P=0.025). According to the results of Egger’s (P=0.333) and Begg’s (P=0.667) tests, publication bias was not observed in this study. Conclusion. Based on the available evidence, permanent subcutaneous injection of insulin could be significantly successful in reducing and controlling the level of HbA1C because the patients in the permanent subcutaneous injection group had lower levels of HbA1C. Practical Implications. In patients with type 2 diabetes, insulin treatment with the permanent subcutaneous injection method can better control the level of HbA1C than the multiple daily injection method. [ABSTRACT FROM AUTHOR]

The physical and psychological benefits of exercise are particularly pertinent to people with type 1 diabetes (T1D). The variability in subcutaneous insulin absorption and the delay in offset and onset in glucose lowering action impose limitations, given the rapidly varying insulin requirements with exercise. Simultaneously, there are challenges to glucose monitoring. Consequently, those with T1D are less likely to exercise because of concerns regarding glucose instability. While glucose control with exercise can be enhanced using automated insulin delivery (AID), all commercially available AID systems remain limited by the pharmacokinetics of subcutaneous insulin delivery. Although glycemic responses may vary with exercises of differing intensities and durations, the principles providing the foundation for guidelines include minimization of insulin on board before exercise commencement, judicious and timely carbohydrate supplementation, and when possible, a reduction in insulin delivered in anticipation of planned exercise. There is an increasing body of evidence in support of superior glucose control with AID over manual insulin dosing in people in T1D who wish to exercise. The MiniMed™ 780G AID system varies basal insulin delivery with superimposed automated correction boluses. It incorporates a temporary (elevated glucose) target of 8.3 mmol/L (150 mg/dL) and when it is functioning, the autocorrection boluses are stopped. As the device has recently become commercially available, there are limited data assessing glucose control with the MiniMed™ 780G under exercise conditions. Importantly, when exercise was planned and implemented within consensus guidelines, %time in range and %time below range targets were met. A practical approach to exercising with the device is provided with illustrative case studies. While there are limitations to spontaneity imposed on any AID device due to the pharmacokinetics associated with the subcutaneous delivery of current insulin formulations, the MiniMed™ 780G system provides people with T1D an excellent option for exercising safely if the appropriate strategies are implemented. [ABSTRACT FROM AUTHOR]

Objective To evaluate the impact of temporary insulin pump use during hospitalization on glycemia, postoperative complications, and cost/utilization in perioperative patients with diabetes. Methods Patients (n=159) with type 2 diabetes and hospitalized for elective surgery were recruited from three hospitals. Subjects were categorized into the insulin pump group and the multiple daily subcutaneous insulin injection group according to their treatment therapy. Data were collected at admission, discharge, and 3 months post-discharge. Results Subjects in the CSII group who were still on insulin therapy transitioned from CSII to MDII; however, their daily insulin dosages were lower than those in the MDII group (15.31±10.98 U/d vs. 23.48±17.02 U/d, P=0.015) after discharge. In terms of medical costs, the CSII group had significantly higher hospitalization costs than the MDII group (112.36±103.43 thousand RMB vs. 82.65±77.98 thousand RMB, P=0.043). After 3 months, the CSII group had significantly lower outpatient costs than the MDII group (3.17±0.94 thousand RMB vs. 3.98±1.76 thousand RMB, P ˂ 0.001). In the MDII group, 10 patients reported severe postoperative complications requiring re-hospitalization; there were no similar reports in the CSII group. Conclusion Temporary use of insulin pump therapy for perioperative patients with diabetes results in a reduction in blood glucose and blood glucose fluctuation during hospitalization, HbA1c, and the risk of postoperative complication and readmission, thus significantly decreasing costs in this complex patient cohort. Further work is needed to better understand indications for utilizing pump therapy based on diabetes phenotype and the complexity of planned surgical intervention. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To compare the risk of fetal overgrowth and preterm delivery in pregnant women with type 1 diabetes (T1D) treated with insulin pumps versus multiple daily injections (MDI) and examine whether possible differences were mediated through improved glycemic control or gestational weight gain during pregnancy. RESEARCH DESIGN AND METHODS: The risk of pregnancy and perinatal outcomes were evaluated in a cohort of 2,003 pregnant women with T1D enrolled from 17 countries in a real-world setting during 2013–2018. RESULTS: In total, 723 women were treated with pumps and 1,280 with MDI. At inclusion (median gestational weeks 8.6 [interquartile range 7–10]), pump users had lower mean HbA1c (mean ± SD 50.6 ± 9.8 mmol/mol [6.8 ± 0.9%] vs. 53.6 ± 13.8 mmol/mol [7.1 ± 1.3%], P < 0.001), longer diabetes duration (18.4 ± 7.8 vs. 14.4 ± 8.2 years, P < 0.001), and higher prevalence of retinopathy (35.3% vs. 24.4%, P < 0.001). Proportions of large for gestational age (LGA) offspring and preterm delivery were 59.0% vs. 52.2% (adjusted odds ratio [OR] 1.36 [95% CI 1.09; 1.70], P = 0.007) and 39.6% vs. 32.1% (adjusted OR 1.46 (95% CI 1.17; 1.82), P < 0.001), respectively. The results did not change after adjustment for HbA1c or gestational weight gain. CONCLUSIONS: Insulin pump treatment in pregnant women with T1D, prior to the widespread use of continuous glucose monitoring or automated insulin delivery, was associated with a higher risk of LGA offspring and preterm delivery compared with MDI in crude and adjusted analyses. This association did not appear to be mediated by differences in glycemic control as represented by HbA1c or by gestational weight gain. [ABSTRACT FROM AUTHOR]

Patients with type 2 diabetes using a continuous subcutaneous insulin infusion (CSII) often require large doses of insulin and need to change their insulin administration sets frequently. A proposed solution to this problem is to use concentrated insulin in their insulin pump; however, insulin pumps are programmed to administer U-100 insulin. Therefore, these patients are at greater risk of hypoglycemia and are responsible for adjusting daily doses. The solution for our patient encountering this problem was to administer half of his daily basal insulin via subcutaneous injection and allow the CSII to administer the remainder through automated insulin delivery (AID). When this strategy was initiated, the patient's A1C was > 14%. After 5 months of follow-up, the patient's A1C was 8.3% and he reported improved quality of life. This technique allows patients with high insulin requirements to benefit from AID without the safety risks associated with using concentrated insulin. [ABSTRACT FROM AUTHOR]

Objective: This study investigates the efficacy of using a long-acting insulin analog, along with the infusion of regular insulin, in achieving appropriate glycemic control and correcting lactic acidosis in patients post orthotopic heart transplant who demonstrate severe lactic acidosis and insulin resistance. Methods: This was a retrospective study of two cohorts (IRB FLA 20-003) of patients post orthotopic heart transplant with severe lactic acidosis and insulin resistance who were admitted to a tertiary intensive care unit and treated with (group 1) or without long-acting insulin analog (group 2) within the first 24 h of admission to the intensive care unit. Insulin resistance is defined as the requirement for intravenous regular insulin infusion of more than 20 units/h without the ability to achieve appropriate serum glucose level (120–180 mg /dL). Severe lactic acidosis is defined as arterial lactic acid of more than 10 mmol/L. The following parameters were investigated: time to correct lactic acidosis, duration of postoperative mechanical ventilation, the need for periprocedural mechanical circulatory support, and 28-day mortality. Results: The 28-day mortality was zero in both groups. Two patients required periprocedural mechanical support in group one, and ten patients required mechanical support in group two (RR = 0.224, 95%, confidence interval 0.052–0.95, Z = 2.029, p = 0.042). Three patients required tracheostomy in group one, and four patients required tracheostomy in group two (RR 0.84, 95 confidence interval 0.20–3.48, Z = 0.23, P = 0.81). Wilcoxon rank-sum test was used to compare time to correct lactic acidosis, with lactic acid resolution being faster in group one ( X ¯ 1 = 19.7 h, SD ± 12.6 h X ¯ 2 = 29.3 h, SD ± 19.6 h, Z-value − 2.02, p-value 0.043). The duration of mechanical ventilation was less in group one ( X ¯ 1 = 29 h, SD ± 12.7 h, X ¯ 2 = 55.1 h, SD ± 44.5 h, Z-value: − 1.92, p-value 0.05). Conclusion: Administration of low-dose long-acting insulin glargine led to the resolution of the lactic acidosis, insulin resistance, and decreased requirements for pressor and inotropic support, which led to decreased need for mechanical circulatory support. [ABSTRACT FROM AUTHOR]

With the deepening of aging in China, the prevalence of diabetes in older people has increased noticeably, and standardized diabetes management is critical for improving clinical outcomes of diabetes in older people. In 2021, the National Center of Gerontology, Chinese Society of Geriatrics, and Diabetes Professional Committee of Chinese Aging Well Association organized experts to write the first guideline for diabetes diagnosis and treatment in older people in China, the Guideline for the Management of Diabetes Mellitus in the Elderly in China (2021 Edition). The guideline emphasizes that older patients with diabetes are a highly heterogeneous group requiring comprehensive assessment and stratified and individualized management strategies. The guideline proposes simple treatments and de‐intensified treatment strategies for older patients with diabetes. This edition of the guideline provides clinicians with practical and operable clinical guidance, thus greatly contributing to the comprehensive and full‐cycle standardized management of older patients with diabetes in China and promoting the extensive development of clinical and basic research on diabetes in older people and related fields. In the past 3 years, evidence‐based medicine for older patients with diabetes and related fields has further advanced, and new treatment concepts, drugs, and technologies have been developed. The guideline editorial committee promptly updated the first edition of the guideline and compiled the Guideline for the Management of Diabetes Mellitus in the Elderly in China (2024 Edition). More precise management paths for older patients with diabetes are proposed, for achieving continued standardization of the management of older Chinese patients with diabetes and improving their clinical outcomes. [ABSTRACT FROM AUTHOR]

Aims: The target of metabolic control (HbA1c < 7% or 53 mmol/mol) recommended by the ADA and ISPAD is attained by 30% of children with Type 1 Diabetes (T1D). Advances in technologies for T1D aim to improve metabolic outcomes and reduce complications. This observational study assesses the long-term outcomes of advanced technologies for treatment of T1D compared to conventional approach started at onset in a group of very young children with T1D. Methods: 54 patients with less 4 years old at onset of T1D were enrolled and followed for up to 9 years after diagnosis. 24 subjects started continuous subcutaneous insulin (CSII) treatment and 30 subjects received MDI therapy from onset. Auxological data, HbA1c and total daily insulin dose (TDD/kg) have been collected at admission and every 4 months. HbA1cAUC>6%, rates of acute complications, glycemic variability indices and glucometrics were also recorded. Results: Patients with CSII therapy had significantly lower mean HbA1c values compared to subjects receiving MDI treatment. CSII approach also recorded lower mean HbA1cAUC>6% and TDD/kg than MDI therapy. At the last download data, the time in range (TIR) was higher in patients with CSII and hyperglycemia events were lower. Better glycemic variability indices have been described during CSII therapy, including mean glycemia, standard deviation, coefficient of variation (CV), glycemia risk index (GRI) and high blood glucose index (HBGI). There was no statistically significant difference between frequency of severe hypoglycemia and ketoacidosis episodes between groups. Conclusions: Early initiation of diabetes technologies is safe and able to determine a better long term glycemic control in young children with T1D. It also allows to flatten the trajectory of HbA1c, probably reducing microvascular, macrovascular and neurological complications of diabetes in this very peculiar age group. [ABSTRACT FROM AUTHOR]

This article explores the use of artificial intelligence (AI) in managing insulin therapy for patients with type 2 diabetes. It focuses on the d-Nav® technology, which allows for autonomous insulin titration in patients using insulin injections. The study evaluated the effectiveness of d-Nav® in maintaining glucose levels within the target range and found that users spent nearly 70% of the time in the target range. The article also includes a case study of a woman who has been using basal-bolus insulin therapy for 29 years and provides a table comparing different insulin regimens. [Extracted from the article]

Aims: Among adults with insulin‐ and/or secretagogue‐treated diabetes in the United States, very little is known about the real‐world descriptive epidemiology of iatrogenic severe (level 3) hypoglycaemia. Addressing this gap, we collected primary, longitudinal data to quantify the absolute frequency of events as well as incidence rates and proportions. Materials and Methods: iNPHORM is a US‐wide, 12‐month ambidirectional panel survey (2020‐2021). Adults with type 1 diabetes mellitus (T1DM) or insulin‐ and/or secretagogue‐treated type 2 diabetes mellitus (T2DM) were recruited from a probability‐based internet panel. Participants completing ≥1 follow‐up questionnaire(s) were analysed. Results: Among 978 respondents [T1DM 17%; mean age 51 (SD 14.3) years; male: 49.6%], 63% of level 3 events were treated outside the health care system (e.g. by family/friend/colleague), and <5% required hospitalization. Following the 12‐month prospective period, one‐third of individuals reported ≥1 event(s) [T1DM 44.2% (95% CI 36.8%‐51.8%); T2DM 30.8% (95% CI 28.7%‐35.1%), p =.0404, α = 0.0007]; and the incidence rate was 5.01 (95% CI 4.15‐6.05) events per person‐year (EPPY) [T1DM 3.57 (95% CI 2.49‐5.11) EPPY; T2DM 5.29 (95% CI 4.26‐6.57) EPPY, p =.1352, α = 0.0007]. Level 3 hypoglycaemia requiring non‐transport emergency medical services was more common in T2DM than T1DM (p <.0001, α = 0.0016). In total, >90% of events were experienced by <15% of participants. Conclusions: iNPHORM is one of the first long‐term, prospective US‐based investigations on level 3 hypoglycaemia epidemiology. Our results underscore the importance of participant‐reported data to ascertain its burden. Events were alarmingly frequent, irrespective of diabetes type, and concentrated in a small subsample. [ABSTRACT FROM AUTHOR]

Aims/Introduction: To evaluate the efficacy of sensor‐augmented pump (SAP) for improving obstetric and neonatal outcomes among pregnant women with type 1 diabetes mellitus by comparing it with continuous subcutaneous insulin infusion plus self‐monitoring of blood glucose (continuous subcutaneous insulin infusion [CSII]/SMBG). Materials and Methods: This retrospective cohort study included 40 cases of pregnancy complicated by type 1 diabetes mellitus treated with SAP (SAP group), and 29 cases of pregnancy complicated by type 1 diabetes mellitus treated with CSII/SMBG (CSII/SMBG group). The obstetric and neonatal outcomes were compared between the two groups. Results: The median of the glycoalbumin levels in the first (18.8% vs 20.9%; P < 0.05) and second (15.4% vs 18.0%; P < 0.05) trimesters, the hemoglobin A1c levels in the peripartum period (6.1% vs 6.5%; P < 0.05) and the standard deviation score of birthweights (0.36 vs 1.52; P < 0.05) were significantly lower in the SAP group than in the CSII/SMBG group. The incidence rate of large for gestational age newborns was significantly lower in the SAP group than in the CSII/SMBG group (27.5% vs 65.5%; P < 0.05). No significant differences in the incidence rates of hypertensive disorders of pregnancy, small for gestational age, respiratory distress syndrome, neonatal hypoglycemia, hypervolemia and hyperbilirubinemia were observed between the groups. Conclusion: The present study showed that SAP therapy is more effective in preventing large for gestational age newborns in pregnant women with type 1 diabetes mellitus than CSII/SMBG. [ABSTRACT FROM AUTHOR]

Aims: Blood glucose control is central to the management of diabetes, and continuous glucose monitoring (CGM) improves glycemic control. We aimed to describe the perspectives of people with diabetes using CGM. Materials and methods: We performed a systematic review of qualitative studies. Results: Fifty‐four studies involving 1845 participants were included. Six themes were identified: gaining control and convenience (reducing pain and time, safeguarding against complications, achieving stricter glucose levels, and sharing responsibility with family); motivating self‐management (fostering ownership, and increasing awareness of glycemic control); providing reassurance and freedom (attaining peace of mind, and restoring social participation); developing confidence (encouraged by the endorsement of others, gaining operational skills, customizing settings for ease of use, and trust in the device); burdened with device complexities (bewildered by unfamiliar technology, reluctant to rely on algorithms, overwhelmed by data, frustrated with malfunctioning and inaccuracy, distressed by alerts, and bulkiness of machines interfering with lifestyle); and excluded by barriers to access (constrained by cost, lack of suppliers). Conclusions: CGM can improve self‐management and confidence in patients managing diabetes. However, the technical issues, uncertainty in readings, and cost may limit the uptake. Education and training from the health professionals may help to reduce the practical and psychological burden for better patient outcomes. [ABSTRACT FROM AUTHOR]

BACKGROUND: The glycemic control of automated insulin delivery (AID) systems in outpatient children and adolescents with type 1 diabetes (T1D) has not been systematically evaluated. PURPOSE: To evaluate the efficacy and safety of AID systems in children and adolescents in outpatient settings. DATA SOURCES: PubMed, Embase, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched until 4 May 2023. This study was registered with PROSPERO (2023, CRD42023395252). STUDY SELECTION: Randomized controlled trials that compared AID systems with conventional insulin therapy in outpatient children and adolescents with T1D and reported continuous glucose monitoring outcomes were selected. DATA EXTRACTION: Percent time in range (TIR) (3.9–10 mmol/L), time below range (TBR) (<3.9 mmol/L), and time above range (TAR) (>10 mmol/L) were extracted. Data were summarized as mean differences (MDs) with 95% CIs. DATA SYNTHESIS: Twenty-five trials (1,345 participants) were included in the meta-analysis. AID systems were associated with an increased percentage of TIR (MD, 11.38% [95% CI 9.01–13.76], P < 0.001; high certainty). The favorable effect was consistent whether AID was used over 3 months (10.46% [8.71–12.20]) or 6 months (10.87% [7.11–14.63]). AID systems had a favorable effect on the proportion of TBR (−0.59% [−1.02 to −0.15], P = 0.008; low certainty) or TAR (−12.19% [−14.65 to −9.73], P < 0.001; high certainty) compared with control treatment. LIMITATIONS: Substantial heterogeneity was observed in most analyses. CONCLUSIONS: AID systems are more effective than conventional insulin therapy for children and adolescents with T1D in outpatient settings. The favorable effect is consistent both in the short term and long term. [ABSTRACT FROM AUTHOR]