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Aims Methods Results Conclusions 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.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).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.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]

Aim Methods Results Conclusion 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.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.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.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]

Background Diabetes technology, especially advanced hybrid closed-loop (AHCL) systems, is rapidly advancing, offering improved glycemic control, reduced hypoglycemia, and reduced treatment burden for patients with type 1 diabetes (T1D). This study aimed to evaluate the clinical efficiency of an AHCL system—the Medtronic MiniMed 780G insulin pump combined with continuous glucose monitoring—among individuals with T1D in real-world clinical settings. Methods In an observational retrospective study, we identified a cohort of 41 patients (mean age, 47.1 ± 13.7 years; T1D duration, 23.6 ± 13 years; 73.2% female) previously using an insulin pump or those on multiple daily insulin injections, currently using the AHCL system for at least 6 months. Primary outcomes were the changes of the following parameters, before AHCL initiation and at 6 months after treatment; (1) time in range (TIR): time with glucose levels in the range of 70 to 180 mg/dL, (2) time below range (TBR): time with glucose levels below 70 mg/dL, and (3) time above range (TAR): time with glucose levels above 180 mg/dL. Results Data analysis from 41 patients showed a significant 16.5% ± 13.8% increase in TIR (from 56.6 ± 17.9 to 73.1 ± 10.6%, p < 0.001). Both TBR and TAR decreased by 2.9 ± 4.8% (p = 0.004) and 13.6 ± 16.4% (p < 0.001), respectively. Mean glucose concentration, coefficient of variation, and glucose management indicator significantly improved. Conclusion The AHCL system effectively improved glucose control regarding TIR, TBR, and TAR. Enhanced glycemic control metrics highlight the potential for wider adoption of AHCL technology. [ABSTRACT FROM AUTHOR]

I explore the experience of managing type 1 diabetes with wearable technology. Type 1 diabetes is a chronic illness which requires continuous maintenance to keep the blood glucose levels within range. Using autoethnography, I investigate both the practices of translating information from technology and from senses, and also from health authorities, into practices. I conclude that the management of type 1 diabetes is informed by an urge to control the body, but this situation can be understood otherwise from a logic of care. [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]

The article discusses the Diabetes Control and Complications Trial (DCCT) and its follow-up study, the Epidemiology of Diabetes Interventions and Complications (EDIC). It explains how the DCCT demonstrated that intensive treatment of type 1 diabetes reduced the risk of microvascular complications, such as retinopathy, neuropathy, and albuminuria. However, it also found that intensive treatment had adverse effects, including an increase in severe hypoglycemia. The EDIC study showed that the benefits of intensive treatment persisted over time, leading to reductions in severe complications and mortality. The findings of these studies have greatly influenced diabetes treatment guidelines and improved outcomes for people with type 1 diabetes. [Extracted from the article]

The article offers a comprehensive update on recent advancements in diabetes research and treatments. Topics discussed include the influence of walking speed on the risk of developing type 2 diabetes, emerging evidence linking type 2 diabetes to Alzheimer's disease, and the innovative use of xenotransplantation involving pig organs to address the shortage of human kidneys for transplantation.

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]

Aims Materials and Methods Results Conclusions To conduct a systematic review and meta‐analysis, within the Coordinating Research and Evidence for Medical Devices (CORE‐MD) project, evaluating CE‐marked high‐risk devices for glucose management.We identified interventional and observational studies evaluating the efficacy and safety of eight automated insulin delivery (AID) systems, two implantable insulin pumps, and three implantable continuous glucose monitoring (CGM) devices. We meta‐analysed randomized controlled trials (RCTs) comparing AID systems with other treatments.A total of 182 studies published between 2009 and 2024 were included, comprising 166 studies on AID systems, six on insulin pumps, and 10 on CGM devices; 26% reported industry funding; 18% were pre‐market; 37% had a comparator group. Of the studies identified, 29% were RCTs, 24% were non‐randomized trials, and 47% were observational studies. The median (interquartile range) sample size was 48 (28–102), age 34.8 (14–44.2) years, and study duration 17.5 (12–26) weeks. AID systems lowered glycated haemoglobin by 0.5 percentage points (absolute mean difference [MD] = −0.5; 21 RCTs; I2 = 86%) and increased time in target range for sensor glucose level by 13.4 percentage points (MD = 13.4; 14 RCTs; I2 = 90%). At least one safety outcome was assessed in 71% of studies.High‐risk devices for glucose monitoring or insulin dosing, in particular AID systems, improve glucose control safely, but evidence on diabetes‐related end‐organ damage is lacking due to short study durations. Methodological heterogeneity highlights the need for developing standards for future pre‐ and post‐market investigations of diabetes‐specific high‐risk medical devices. [ABSTRACT FROM AUTHOR]

In type 1 diabetes, high-fat meals require more insulin to prevent hyperglycemia while meals followed by aerobic exercises require less insulin to prevent hypoglycemia, but the adjustments needed vary between individuals. We propose a decision support system with reinforcement learning to personalize insulin doses for high-fat meals and postprandial aerobic exercises. We test this system in a single-arm 16-week study in 15 adults on multiple daily injections therapy (NCT05041621). The primary objective of this study is to assess the feasibility of the novel learning algorithm. This study looks at glucose outcomes and patient reported outcomes. The postprandial incremental area under the glucose curve is improved from the baseline to the evaluation period for high-fat meals (378 ± 222 vs 38 ± 223 mmol/L/min, p = 0.03) and meals followed by exercises (−395 ± 192 vs 132 ± 181 mmol/L/min, p = 0.007). The postprandial time spent below 3.9 mmol/L is reduced after high-fat meals (5.3 ± 1.6 vs 1.8 ± 1.5%, p = 0.003) and meals followed by exercises (5.3 ± 1.2 vs 1.4 ± 1.1%, p = 0.003). Our study shows the feasibility of automatically personalizing insulin doses for high-fat meals and postprandial exercises. Randomized controlled trials are warranted. Individuals with type 1 diabetes face challenges in determining the insulin doses they need before high-fat meals and meals followed by aerobic exercises. Here, the authors show that it is clinically feasible to automatically determine these insulin doses for each individual using a reinforcement learning algorithm. [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]

Background: The purpose of this systematic review and meta-analysis was to synthesize the current literature to determine the safety and efficacy of using subcutaneous insulin compared to an intravenous (IV) insulin infusion in managing diabetic ketoacidosis (DKA). Methods: We searched Ovid-Medline, EMBASE, SCOPUS, BIOSIS and CENTRAL from inception to April 26, 2024. Randomized controlled trials (RCTs) and observational studies that assessed the use of subcutaneous compared to intravenous insulin for the treatment of mild to moderate DKA were included. Data extraction and quality assessment were performed by two independent reviewers and disagreements were resolved through further discussion or by a third reviewer. The Cochrane Risk of Bias tool version 2.0 was used to evaluate the RCTs and the Risk of Bias in Non-randomized Studies of Interventions (ROBINS)-I tool was used to evaluate the observational studies. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. Meta-analyses were conducted using random-effects models. We followed the PRISMA guidelines for reporting our findings. Results: Six RCTs (245 participants) and four observational studies (8444 patients) met our inclusion criteria. Some studies showed a decreased length of stay (Mean Difference [MD] in days: -0.39; 95% CI: -2.83 to 2.08; I2: 0%) among individuals treated with subcutaneous insulin compared to intravenous insulin. There was no difference in the risk of all-cause mortality, time to resolution of DKA (MD in hours: 0.17; 95% confidence interval [CI]: -3.45 to 3.79; I2: 0%) and hypoglycemia (Risk Ratio [RR]: 1.02; 95% CI: 0.88 to 1.19; I2: 0%) between the two groups. Conclusion: Treatment of DKA with subcutaneous insulin may be a safe and effective alternative to IV insulin in selected patients. The limited available evidence underscores the need for further studies to explore optimal dosing, patient selection criteria and long-term outcomes. [ABSTRACT FROM AUTHOR]

Background: Use of Continuous Subcutaneous Insulin Infusion (CSII) has been shown to improve glycemic outcomes in Type 1 Diabetes (T1D), but high costs limit accessibility. To address this issue, an inter-operable, open-source Ultra-Low-Cost Insulin Pump (ULCIP) was developed and previously shown to demonstrate comparable delivery accuracy to commercial models in standardised laboratory tests. This study aims to evaluate the updated ULCIP in-vivo, assessing its viability as an affordable alternative for those who cannot afford commercially available devices. Methods: This first-in-human feasibility study recruited six participants with T1D. During a nine-hour inpatient stay, participants used the ULCIP under clinical supervision. Venous glucose, insulin, and β-Hydroxybutyrate were monitored to assess device performance. Results: Participants displayed expected blood glucose and blood insulin levels in response to programmed basal and bolus insulin dosing. One participant developed mild ketosis, which was treated and did not recur when a new pump reservoir was placed. All other participants maintained β-Hydroxybutyrate < 0.6 mmol/L throughout. Conclusion: The ULCIP safely delivered insulin therapy to users in a supervised inpatient environment. Future work should focus on correcting a pump hardware issue identified in this trial and extending device capabilities for use in closed loop control. Longer-term outpatient studies are warranted. Trial Registration: The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623001288617) on the 11 December 2023. [ABSTRACT FROM AUTHOR]

Background: The Omnipod® 5 Automated Insulin Delivery System was associated with favorable glycemic outcomes for people with type 1 diabetes (T1D) in two pivotal clinical trials. Real-world evidence is needed to explore effectiveness in nonstudy conditions. Methods: A retrospective analysis of the United States Omnipod 5 System users (aged ≥2 years) with T1D and sufficient data (≥90 days of data; ≥75% of days with ≥220 continuous glucose monitor readings/day) available in Insulet Corporation's device and person-reported datasets as of July 2023 was performed. Target glucose setting usage (i.e., 110–150 mg/dL in 10 mg/dL increments) was summarized and glycemic outcomes were examined. Subgroup analyses of those using the lowest average glucose target (110 mg/dL) and stratification by baseline characteristics (e.g., age, prior therapy, health insurance coverage) were conducted. Results: In total, 69,902 users were included. Multiple and higher glucose targets were more commonly used in younger age groups. Median percentage of time in range (TIR; 70–180 mg/dL) was 68.8%, 61.3%, and 53.6% for users with average glucose targets of 110, 120, and 130–150 mg/dL, respectively, with minimal time <70 mg/dL (all median <1.13%). Among those with an average glucose target of 110 mg/dL (n = 37,640), median TIR was 65.0% in children and adolescents (2–17 years) and 69.9% in adults (≥18 years). Subgroup analyses of users transitioning from Omnipod DASH or multiple daily injections and of Medicaid/Medicare users demonstrated favorable glycemic outcomes among these groups. Conclusion: These glycemic outcomes from a large and diverse sample of nearly 70,000 children and adults demonstrate effective use of the Omnipod 5 System under real-world conditions. [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]

• Youth with Type 1 Diabetes are at greater risk of psychological comorbidity. • Fear of hypoglycemia impacts diabetes self-management. • Cognitive behavioral therapy improves psychosocial functioning. • A course of modular cognitive behavioral therapy is demonstrated. Youth diagnosed with Type 1 Diabetes are at higher risk for psychological comorbidities such as anxiety and depression than the general population. Disease-related psychological distress including fear of hypoglycemia contributes to poor adherence to youths' medical regimes and glycemic control. Poorly managed Type 1 Diabetes often leads to adverse health outcomes such as ketoacidosis, vision impairment, and sometimes death. Cognitive-behavioral therapy is a promising method to improve health outcomes and psychological functioning in youth with Type 1 Diabetes. Accordingly, this article offers a brief overview of Type 1 Diabetes as well as examining the role of fear of hypoglycemia and disease-related anxieties in pediatric patients. Additionally, various obstacles to medical adherence and the impact of family conflict are discussed. The clinical sequelae of Type 1 Diabetes in diverse populations and the research supporting cognitive behavioral therapy are delineated. Next, the case description illustrates the challenges for youth with Type 1 Diabetes and their families. This bench-to-bedside translation presents evidence of clinically meaningful improvements from implementing CBT with a Latino male child. Psychoeducation, relaxation training, cognitive restructuring, and behavioral experiments were deployed. Last, additional considerations for treatment were presented. [ABSTRACT FROM AUTHOR]

Context Omnipod DASH Insulin Management System is a tubeless insulin pump that overcomes the physical inconveniences of conventional tubed insulin pump therapy (IPT). Objective We compared treatment satisfaction with Omnipod DASH System to usual care (multiple daily injections [MDIs] or tubed IPT) in adults with type 1 diabetes using self-monitoring blood glucose (SMBG). Methods Adults with type 1 diabetes on MDI (n = 40) or IPT (n = 25) from 4 diabetes centers in Australia were randomly assigned in a 1:1 nonblinded manner to Omnipod DASH System (Omnipod group) or continue usual care (Usual Care group) for 12 weeks, followed by a further 12-week extension during which all participants used the device. The primary outcome was treatment satisfaction assessed by change in Diabetes Technology Questionnaire "current" (ΔDTQ-current) score at 12 weeks (study end). Secondary outcomes included ΔDTQ-current following extension and other participant-reported outcomes (PROs) measuring quality of life, burden of disease treatment, and glycemic and device-related outcomes at 12 weeks (study end) and 24 weeks (end extension). Results Treatment satisfaction improved more in the Omnipod group vs the Usual Care group (ΔDTQ-current score of 16.4 [21.2] vs 0.0 [12.8]; P <.001) at study end. Significantly greater improvements in other PROs and glycated hemoglobin A1c were also observed. Improvements in DTQ-current and other PROs comparing study end and end extension were similar. While percentage in time in range change from baseline did not differ at study end (−2.0 [12.7] %), it was significantly greater at end extension (5.6 [10.9] %; P =.016). Conclusion The Omnipod DASH System resulted in greater treatment satisfaction at 12 weeks in adults with type 1 diabetes using SMBG that was sustained after 24 weeks of device use without compromising sleep quality and fear of hypoglycemia. Improvements in glycemia were also observed. [ABSTRACT FROM AUTHOR]

The T1DCoach mobile application is designed to educate patients—children with type 1 diabetes (T1D) and their caregivers and diabetes educators. The idea behind the mobile application is that its users perform actions that the patient needs to perform in real life. These include measuring blood glucose levels, operating the insulin pump, meal calculation, bolus administration, etc. These in-application activities are performed on the patient's digital twin. To increase user engagement, gamification elements have been implemented in the application. An important element of the T1DCoach mobile application is its interface, which should be adapted to very different groups of users: children, their caregivers and educators. In addition to presenting the T1DCoach application, the paper presents the stage examining the quality of the interface using three research groups: children, their caregivers and educators. The research was conducted using the scenario method, using eye-tracking, recording activities and thinking aloud. After the application testing sessions, surveys were carried out using the System Usability Scale method and focus group interviews were conducted. The research results are presented in the article along with the most important recommendations for improving the application interface. [ABSTRACT FROM AUTHOR]

Individuals with diabetes are at increased risk for psychological, behavioral, and social problems. Comorbid mental illness and diabetes present a unique set of challenges for people with diabetes and their health care providers, particularly in an inpatient setting. Psychiatric symptoms before admission may affect type 1 diabetes management, and mental status and behavior can affect individuals' ability to cooperate with treatment while they are inpatients. This article describes a clinical protocol to manage type 1 diabetes and maximize patient safety in an acute inpatient child psychiatric unit. [ABSTRACT FROM AUTHOR]

Aims/hypothesis: Our study aims to uncover glycaemic phenotype heterogeneity in type 1 diabetes. Methods: In the Study of the French-speaking Society of Type 1 Diabetes (SFDT1), we characterised glycaemic heterogeneity thanks to a set of complementary metrics: HbA1c, time in range (TIR), time below range (TBR), CV, Gold score and glycaemia risk index (GRI). Applying the Discriminative Dimensionality Reduction with Trees (DDRTree) algorithm, we created a phenotypic tree, i.e. a 2D visual mapping. We also carried out a clustering analysis for comparison. Results: We included 618 participants with type 1 diabetes (52.9% men, mean age 40.6 years [SD 14.1]). Our phenotypic tree identified seven glycaemic phenotypes. The 2D phenotypic tree comprised a main branch in the proximal region and glycaemic phenotypes in the distal areas. Dimension 1, the horizontal dimension, was positively associated with GRI (coefficient [95% CI]) (0.54 [0.52, 0.57]), HbA1c (0.39 [0.35, 0.42]), CV (0.24 [0.19, 0.28]) and TBR (0.11 [0.06, 0.15]), and negatively with TIR (−0.52 [−0.54, −0.49]). The vertical dimension was positively associated with TBR (0.41 [0.38, 0.44]), CV (0.40 [0.37, 0.43]), TIR (0.16 [0.12, 0.20]), Gold score (0.10 [0.06, 0.15]) and GRI (0.06 [0.02, 0.11]), and negatively with HbA1c (−0.21 [−0.25, −0.17]). Notably, socioeconomic factors, cardiovascular risk indicators, retinopathy and treatment strategy were significant determinants of glycaemic phenotype diversity. The phenotypic tree enabled more granularity than traditional clustering in revealing clinically relevant subgroups of people with type 1 diabetes. Conclusions/interpretation: Our study advances the current understanding of the complex glycaemic profile in people with type 1 diabetes and suggests that strategies based on isolated glycaemic metrics might not capture the complexity of the glycaemic phenotypes in real life. Relying on these phenotypes could improve patient stratification in type 1 diabetes care and personalise disease management. [ABSTRACT FROM AUTHOR]

Aim Methods Results Conclusions 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.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.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]).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]

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. [ABSTRACT FROM AUTHOR]

Congestive heart failure (CHF) is a fatal disease with progressive severity and no cure; the heart's inability to adequately pump blood leads to fluid accumulation and frequent hospital readmissions after initial treatments. Therefore, it is imperative to continuously monitor CHF patients during its early stages to slow its progression and enable timely medical interventions for optimal treatment. An increase in interstitial fluid pressure (IFP) is indicative of acute CHF exacerbation, making IFP a viable biomarker for predicting upcoming CHF if continuously monitored. In this paper, we present an inductor-capacitor (LC) sensor for subcutaneous wireless and continuous IFP monitoring. The sensor is composed of inexpensive planar copper coils defined by a simple craft cutter, which serves as both the inductor and capacitor. Because of its sensing mechanism, the sensor does not require batteries and can wirelessly transmit pressure information. The sensor has a low-profile form factor for subcutaneous implantation and can communicate with a readout device through 4 layers of skin (12.7 mm thick in total). With a soft silicone rubber as the dielectric material between the copper coils, the sensor demonstrates an average sensitivity as high as –8.03 MHz/mmHg during in vitro simulations. [ABSTRACT FROM AUTHOR]

Aim Materials and Methods Results Conclusion This study aims to provide a comprehensive overview of real‐world evidence pertaining to disparities in the utilization of continuous glucose monitors (CGMs)/insulin pumps to highlight potential evidentiary gaps and discern emerging themes from the literature.A systematic review of published manuscripts and abstracts was conducted from: MEDLINE, EMBASE, Nursing and Allied Health, Web of Science and CINHAL. Attributes related to patients, outcomes, interventions (CGMs/pumps/both) and study type were captured. In addition, factors associated with disparities in device utilization were examined.Thirty‐six studies were included in the final analysis; the studies predominantly focused on people living with type 1 diabetes. Only two studies included individuals with type 2 diabetes. Almost two‐thirds of the studies reported outcomes associated with disparities (e.g. glycated haemoglobin, diabetic ketoacidosis, resource utilization). Most studies highlighted disparities across race, ethnicity and insurance type. Evidentiary gaps were identified, particularly in the evidence for people with type 2 diabetes, the continuation of CGM/pump use and limited studies addressing disparities among Native Americans/American Indians.This study reveals critical disparities in diabetes technology use across race, ethnicity and insurance type, particularly among people with type 1 diabetes. Evidentiary gaps assessing disparities in diabetes technology use persist, particularly concerning people with type 2 diabetes, Native American/American Indian and LGBTQ+ populations, and in outcomes related to continuation of use. Social and digital determinants of health, such as income, transportation, residential location and technological literacy, are crucial to achieving equitable access. Future research should focus on the patient journey to identify opportunities for equitable access to diabetes technology as its use grows. [ABSTRACT FROM AUTHOR]

This article explores the advantages of transitioning from disposable insulin pens to reusable cartridge insulin pens within the UK's National Health Service (NHS). The NHS aims to achieve net zero carbon emissions by 2045, and pharmaceuticals contribute significantly to their emissions. The study reveals that using reusable pens could decrease plastic waste, carbon footprint, and NHS expenses. The analysis demonstrates that reusable pens are often more cost-effective than disposable pens and offer substantial environmental benefits. However, it is important to consider individual dexterity and patient preference when prescribing insulin pen types. The University of Exeter Medical School and the Royal Devon University Healthcare NHS Foundation Trust conducted the study, which suggests that adopting reusable cartridge insulin pens could yield significant cost-efficiency and environmental sustainability advantages. The study compares the environmental and cost implications of using disposable and reusable insulin pens and finds that reusable pens are either cost-neutral or cheaper, while reducing plastic waste by 89% and carbon footprint by 40%. The researchers recommend that reusable cartridge insulin pens should be the default method of insulin delivery for individuals requiring long-term insulin pen prescriptions. [Extracted from the article]

Aims/hypothesis: There is increasing evidence for heterogeneity in type 1 diabetes mellitus (T1D): not only the age of onset and disease progression rate differ, but also the risk of complications varies markedly. Consequently, the presence of different disease endotypes has been suggested. Impaired T and B cell responses have been established in newly diagnosed diabetes patients. We hypothesized that deciphering the immune cell profile in peripheral blood of adults with longstanding T1D may help to understand disease heterogeneity. Methods: Adult patients with longstanding T1D and healthy controls (HC) were recruited, and their blood immune cell profile was determined using multicolour flow cytometry followed by a machine-learning based elastic-net (EN) classification model. Hierarchical clustering was performed to identify patientspecific immune cell profiles. Results were compared to those obtained in matched healthy control subjects. Results: Hierarchical clustering analysis of flow cytometry data revealed three immune cell composition-based distinct subgroups of individuals: HCs, T1Dgroup-A and T1D-group-B. In general, T1D patients, as compared to healthy controls, showed a more active immune profile as demonstrated by a higher percentage and absolute number of neutrophils, monocytes, total B cells and activated CD4+CD25+ T cells, while the abundance of regulatory T cells (Treg) was reduced. Patients belonging to T1D-group-A, as compared to T1D-group-B, revealed a more proinflammatory phenotype characterized by a lower percentage of FOXP3+ Treg, higher proportions of CCR4 expressing CD4 and CD8 T cell subsets, monocyte subsets, a lower Treg/conventional Tcell (Tconv) ratio, an increased proinflammatory cytokine (TNFα, IFNβ) and a decreased antiinflammatory (IL-10) producing potential. Clinically, patients in T1D-group-A had more frequent diabetes-related macrovascular complications. Conclusions: Machine-learning based classification of multiparameter flow cytometry data revealed two distinct immunological profiles in adults with longstanding type 1 diabetes; T1D-group-A and T1D-group-B. T1D-group-A is characterized by a stronger pro-inflammatory profile and is associated with a higher rate of diabetes-related (macro)vascular complications. [ABSTRACT FROM AUTHOR]

Subcutaneous once-weekly (ow) semaglutide is a recent treatment option for type 2 diabetes (T2D) and obesity, but real-world data on weight loss and associated changes in body composition, nutrients intake, and quality of life are still scarce. This observational, prospective clinical study involved all T2D patients starting ow semaglutide according to routine care between December 2021 and February 2022. Clinical information was collected after 6 months (T6) and 12 months (T12) from semaglutide initiation (T0). Bioelectrical Impedance Analysis (BIA) was performed to measure changes in body composition. Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the 36 - items Short Form Health Survey (SF-36) were administered as patient-reported outcomes (PROs). Changes in continuous endpoints (weight, body composition, nutrients intake, other clinical parameters, and PROs) were assessed using mixed models for repeated measurements. Overall, 90 patients (age 63.0 ± 10.0 years; diabetes duration 7.6 ± 5.9 years; 58.9% men; HbA1c 7.7 ± 1.1%; weight 95.4 ± 19.4 Kg, BMI 34.6 ± 6.4 Kg/m2; 36.7% naïve to diabetes treatment, 43.3% on metformin, 10.0% on dual oral therapy, and 10.0% treated with schemes including insulin) were included in the study. After 6 months from semaglutide initiation, body weight significantly decrease by -4.69 Kg (95%CI -6.19;-3.19) (primary endpoint). After 12 months, body weight was further reduced (-5.38 Kg; 95%CI -7.79;-2.97). At BIA, fat mass was significantly reduced by 2.1 Kg after 6 months but only slightly reduced after 12 months vs. baseline; lean mass was also significantly reduced by over 3 Kg both at 6 and 12 months. Intake of all nutrients declined in the first 6 months of therapy, although only lipids reduction reached the statistical significance (-6.73 g; p=0.02). Statistically significant improvements in BMI, waist circumference, glycemic control, blood pressure and lipid profile were documented. Satisfaction with treatment (DTSQ questionnaire) and mental health (MCS score of SF-36 questionnaire) significantly increased during the follow-up. The study documented real-world benefits of semaglutide for treating obesity in T2D subjects, with important changes on clinical and patient-reported outcomes. Loss of lean mass associated with weight loss warrants attention; parallel strategies to preserve skeletal muscle and improve physical function, i.e. nutritional education and structured exercise, are of great importance. [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]

Background and aims: Cystic fibrosis related diabetes (CFRD) is correlated with worsening of nutritional status and greater deterioration of lung function. The role of new technologies for the treatment of CFRD is little explored. The aim of the study was to evaluate the efficacy of Advanced Hybrid Closed Loop (AHCL) systems on glycemic control in CF patients. Methods: A single-center retrospective study on CFRD patients using AHCL systems was performed. Glycated hemoglobin (HbA1c) values and Continuous Glucose Monitoring (CGM) metrics were collected at T0 (AHCL placement), T1 (1-month), T2 (6-months) and T3 (1-year) to evaluate glycemic control. Results: 10 patients were included in the study. Data showed a reduction of HbA1c value (7.31 ± 0.34 to 6.35 ± 1.00; p=0.03), glycemic variability (p=0.05) and insulin requirement (p=0.03). The study population reached American Diabetes Association (ADA) recommended glycemic targets at 1-year. An increase in the Time in Range (TIR) and a reduction in time in hyperglycemia were also observed, although not statistically significant. Conclusions: In patients with CFRD, the use of AHCL leads to an improvement in glycemic control in terms of HbA1c and glycemic variability. The increase in TIR and the reduction of time in hyperglycemia, although not statistically significant, are extremely encouraging from a clinical point of view. Further studies with a larger population and a longer follow-up are needed. The results of this study demonstrate the importance of proposing the use of AHCL even in CF patients, who could benefit from glycemic improvement also in terms of nutritional status and respiratory function. [ABSTRACT FROM AUTHOR]

Introduction: Most continuous subcutaneous insulin infusion (CSII) catheters (KT) are changed every 3 days. This study aims at evaluating whether KT changes impact glucose control while under open-loop (OL) or automated insulin delivery (AID) modes. Methods: We included patients with type 1 diabetes who used Tandem t:slim x2 insulin pump and Dexcom G6 glucose sensor for 20 days in OL, then as AID. CSII and sensor glucose data in OL and for the past 20 days of 3-month AID were retrospectively analyzed. The percentage of time spent with sensor glucose above 180 mg/dL (%TAR180) was compared between the calendar day of KT change (D0), the next day (D1), and 2 days later (D2). Values were adjusted for age, gender, body mass index (BMI), hemoglobin A1c (HbA1c) at inclusion, and %TAR180 for the 2 h before KT change. Results: A total of 1636 KT changes were analyzed in 134 patients: 72 women (54%), age: 35.6 ± 15.7 years, BMI: 25.2 ± 4.7 kg/m2, and HbA1c: 7.5 ± 0.8%. %TAR180 in the 2 h before the KT change was 51.3 ± 37.0% in OL and 33.2 ± 30.0% in AID mode. In OL, significant absolute increases of %TAR180 at D0 versus D1 (+6.9%; P < 0.0001) or versus D2 (+6.8%; P < 0.0001) were observed. In AID, significant absolute increases of %TA180R at D0 versus D1 (+4.8%; P < 0.0001) or versus D2 (+4.2%; P < 0.0001) were also observed. Conclusion: This study shows an increase in time spent in hyperglycemia on the day of the KT change both in OL and AID modes. This additional information should be taken into account to improve current AID algorithms. ClinicalTrials.gov: NCT 04939766. [ABSTRACT FROM AUTHOR]

Aim: To evaluate whether caffeine combined with a moderate amount of glucose reduces the risk for exercise‐related hypoglycaemia compared with glucose alone or control in adult people with type 1 diabetes using ultra‐long‐acting insulin degludec. Materials and Methods: Sixteen participants conducted three aerobic exercise sessions (maximum 75 min) in a randomized, double‐blind, cross‐over design. Thirty minutes before exercise, participants ingested a drink containing either 250 mg of caffeine + 10 g of glucose + aspartame (CAF), 10 g of glucose + aspartame (GLU), or aspartame alone (ASP). The primary outcome was time to hypoglycaemia. Results: There was a significant effect of the condition on time to hypoglycaemia (χ2 = 7.674, p =.0216). Pairwise comparisons revealed an 85.7% risk reduction of hypoglycaemia for CAF compared with ASP (p =.044). No difference was observed between GLU and ASP (p =.104) or between CAF and GLU (p =.77). While CAF increased glucose levels during exercise compared with GLU and ASP (8.3 ± 1.9 mmol/L vs. 7.7 ± 2.2 mmol/L vs. 5.8 ± 1.4 mmol/L; p <.001), peak plasma glucose levels during exercise did not differ between CAF and GLU (9.3 ± 1.4 mmol/L and 9.1 ± 1.6 mmol/L, p =.80), but were higher than in ASP (6.6 ± 1.1 mmol/L; p <.001). The difference in glucose levels between CAF and GLU was largest during the last 15 min of exercise (p =.002). Compared with GLU, CAF lowered perceived exertion (p =.023). Conclusions: Pre‐exercise caffeine ingestion combined with a low dose of glucose reduced exercise‐related hypoglycaemia compared with control while avoiding hyperglycaemia. [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]

Insulin pumps have transformed the way diabetes is managed by providing a more accurate and individualized method of delivering insulin, in contrast to conventional injection routines. This research explores the progression of insulin pumps, following their advancement from initial ideas to advanced contemporary systems. The report proceeds to categorize insulin pumps according to their delivery systems, specifically differentiating between conventional, patch, and implantable pumps. Every category is thoroughly examined, emphasizing its unique characteristics and capabilities. A comparative examination of commercially available pumps is provided to enhance informed decision making. This section provides a thorough analysis of important specifications among various brands and models. Considered factors include basal rate and bolus dosage capabilities, reservoir size, user interface, and compatibility with other diabetes care tools, such as continuous glucose monitoring (CGM) devices and so on. This review seeks to empower healthcare professionals and patients with the essential information to improve diabetes treatment via individualized pump therapy options. It provides a complete assessment of the development, categorization, and full specification comparisons of insulin pumps. [ABSTRACT FROM AUTHOR]

Introduction There are limited data regarding the international travel history and preparation, as well as glycaemic control practices, risk behaviours and experiences of people with type 1 diabetes during travel. Our review aimed to address the research question: 'What are the health practices, behaviours and experiences of people with type 1 diabetes when travelling?' Methods We conducted a mixed-methods narrative review using adapted review methods from the Centre for Reviews and Dissemination and standards developed by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis. MEDLINE, Scopus, PubMed and CINAHL, and the reference lists of all eligible studies were searched. Results Nine records comprising of 11 studies were included, with data heralding from various countries, published between 1990 and 2022. We identified three main themes: travel preparation (type of travel, planning and advice seeking); issues related to air travel (airports and airport security, hypoglycaemia and hyperglycaemia, and insulin) and general travel-related issues (illness and medical treatment, type 1 diabetes management, and major concerns and barriers). Conclusions Our findings highlighted the lack of quality data regarding type 1 diabetes and travel within the extant literature, as well a pressing need for empirical studies to be undertaken and consensus guidelines developed to improve the travel experiences of people with type 1 diabetes. Unless change is made, people with type 1 diabetes will continue to experience preventable risk and harm while travelling. [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]

Objectives: To conduct systematic evaluation of the risk predictors of glycaemic control in children and adolescents with type 1 diabetes mellitus. Methods: Cohort studies on risk predictors of glycaemic control in children and adolescents with type 1 diabetes were retrieved from CNKI, PubMed, Web of Science, Embase databases, etc. from the construction of the repository to 3 February 2023. Literature screening was conducted according to inclusion and exclusion criteria, then data extraction of region, sample size, age, follow‐up time, risk predictors, outcome indicators, etc., and quality evaluation of The Newcastle‐Ottawa Scale were conducted by two researchers while the third researcher makes decisions if there are disagreements. Finally, Revman5.4 and StataMP17 were used for meta‐analysis. Results: A total of 29 studies were included, and the results showed that insulin pump [Weighed mean difference (WMD) = −.48, 95% CI (−.73, −.24), p <.01], high‐frequency sensor monitoring, early use of insulin pumps, prospective follow‐up male, white race, large body mass index‐standardised scoring, conscientiousness, agreeableness of mothers, eicosapentaenoic acid, leucine and protein (p <.05) were beneficial for reducing HbA1c levels in children and adolescents with diabetes. Ketoacidosis [WMD =.39, 95% CI (.28,.50), p <.01], selective admission, higher HbA1c level at one time (p <.01), higher glutamate decarboxylase antibody at 1 month after diagnosis, lower socio‐economic status, non‐living with biological parents, non‐two‐parent family, family disorder, family history of diabetes and high carbohydrate intake (p <.05) increased HbA1c levels in children and adolescents with diabetes. Conclusion: For children and adolescents with type 1 diabetes mellitus, the use of insulin pump, high‐frequency sensor monitoring, prospective follow‐up, good family support and reasonable diet are conducive to blood glucose control, while selective admission and DKA are not. Disease characteristics and demographic characteristics of children are closely related to subsequent blood glucose control, and the relationship between diagnosis age and blood glucose control needs to be further explored. [ABSTRACT FROM AUTHOR]

Health innovation is mainly envisioned in direct connection to medical research institutions or pharmaceutical and technology companies. Yet, these types of innovation often do not meet the needs and expectations of individuals affected by health conditions. With the emergence of digital health technologies and social media, we can observe a shift, which involves people living with illness modifying and improving medical and health devices outside of the formal research and development sector, figuring both as users and innovators. This patient‐led innovation has been celebrated in innovation studies and economics as a "bottom‐up" type of innovation. In this article, we take a closer look at open‐source patient‐led innovation in the context of type 1 diabetes care. In our inquiry, we pay particular attention to the social and ethical dimensions of this innovation, building on empirical material. Upon exploring the notion of patient‐led innovation and its socio‐political context through the lens of intersectional and global health justice, we argue that a proactive strategy is needed to ensure that open‐source patient‐led innovation will be more globally accessible, center the health needs of the most underserved populations, as well as facilitate equitable and just health benefits. To support this aim, we provide a range of examples of different initiatives addressing the persistent inequalities that have so far inhibited patient‐led innovation from more fully materializing its innovative potential. [ABSTRACT FROM AUTHOR]

Use of medical devices (MDs), that is, glucose sensors and insulin pumps, in patients with Type 1 diabetes mellitus (T1D) has proven an enormous advantage for disease control. Adverse skin reactions from these MDs may however hamper compliance. The objective of this study was to systematically review and analyse studies assessing the prevalence and incidence of dermatitis, including allergic contact dermatitis (ACD) related to MDs used in patients with T1D and to compare referral routes and the clinical investigation routines between clinics being part of the European Environmental and Contact Dermatitis Research Group (EECDRG). A systematic search of PubMed, EMBASE, CINAHL and Cochrane databases of full‐text studies reporting incidence and prevalence of dermatitis in persons with T1D using MDs was conducted until December 2021. The Newcastle–Ottawa Scale was used to assess study quality. The inventory performed at EECRDG clinics focused on referral routes, patient numbers and the diagnostic process. Among the 3145 screened abstracts, 39 studies fulfilled the inclusion criteria. Sixteen studies included data on children only, 14 studies were on adults and nine studies reported data on both children and adults. Participants were exposed to a broad range of devices. Skin reactions were rarely specified. It was found that both the diagnostic process and referral routes differ in different centres. Further data on the prevalence of skin reactions related to MDs in individuals with T1D is needed and particularly studies where the skin reactions are correctly diagnosed. A correct diagnosis is delayed or hampered by the fact that, at present, the actual substances within the MDs are not declared, are changed without notice and the commercially available test materials are not adequately updated. Within Europe, routines for referral should be made more standardized to improve the diagnostic procedure when investigating patients with possible ACD from MDs. [ABSTRACT FROM AUTHOR]

Background: Type 1 diabetes is one of the most common chronic diseases in children. Wearable technology (insulin pumps and continuous glucose monitoring devices) that makes diabetes management relatively simple, in addition to education and follow-ups, enhances the quality of life and health of individuals with diabetes. Aims: To evaluate the impact of wearable technology on metabolic management and the quality of life in children and adolescents with type 1 diabetes. Study Design: Systematic review and meta-analysis. Methods: The Preferred Reporting System for Systematic Reviews and Meta-Analyses was used to conduct a systematic review and metaanalysis. PubMed, Web of Science, MEDLINE, Cochrane Library, EBSCO, Ulakbim and Google Scholar were searched in July 2022 and July 2023 using predetermined keywords. The methodological quality of the studies was evaluated using the Joanna Briggs Institute's Critical Appraisal Checklists for randomized controlled experimental and cross-sectional studies. The meta-analysis method was used to pool the data. Results: Eleven studies published between 2011 and 2022 were included. The total sample size of the included studies was 1,853. The metaanalysis revealed that the decrease in hemoglobin A1C (HbA1c) level in those using wearable technology was statistically significant [mean difference (MD): -0.33, Z = 2.54, p = 0.01]. However, the technology had no effect on the quality of life [standardized mean difference (SMD): 0.44, Z = 1.72, p = 0.09]. The subgroup analyses revealed that the decrease in the HbA1c level occurred in the cross-sectional studies (MD: -0.49, Z = 2.54, p = 0.01) and the 12-19 (MD = 0.59, Z = 4.40, p < 0.001) and 4-18 age groups (MD: -0.31, Z = 2.56, p = 0.01). The subgroup analyses regarding the quality of life revealed that there was no difference according to the research design. However, the quality of life was higher in the wearable technology group than in the control group in the 8-12 and 4-18 age groups (SMD: 1.32, Z = 2.31, p = 0.02 and SMD: 1.00, Z = 5.76, p < 0.001, respectively). Conclusion: Wearable technology effectively reduces the HbA1c levels in children and adolescents with type 1 diabetes in some age groups. However, it does not affect the quality of life. [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]

Continuous glucose monitoring (CGM) technology is a valuable tool for managing diabetes. It provides more comprehensive information about glucose levels compared to traditional methods. CGM systems use sensors to measure glucose levels under the skin and provide insights into glucose profiles and variability. CGM has been shown to improve glycemic control and reduce hypoglycemia. However, there are challenges to widespread adoption, such as cost and accuracy limitations. Despite these challenges, CGM technology continues to improve and has shown benefits in diabetes care. [Extracted from the article]

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]

Objective: To examine the cross‐sectional associations between diabetes distress, BMI (zBMI; BMI z‐score), objectively measured mean daily blood glucose readings and insulin boluses administered, and A1C in adolescents with type 1 diabetes (T1D) using insulin pumps. Methods: T1D self‐management behaviour data were downloaded from adolescents' (N = 79) devices and mean daily frequency of blood glucose readings and insulin boluses were calculated. Diabetes distress was measured (Problem Areas in Diabetes–Teen questionnaire [PAID‐T]), A1C collected, and zBMI calculated from height and weight. Three multiple linear regressions were performed with blood glucose readings, insulin boluses, and A1C as the three dependent variables and covariates (age, T1D duration), zBMI, diabetes distress, and the diabetes distress x zBMI interaction as independent variables. Results: Participants (55.7% female) were 14.9 ± 1.9 years old with T1D for 6.6 ± 3.4 years. zBMI moderated the relationship between diabetes distress and mean daily insulin boluses administered (b = −0.02, p = 0.02); those with higher zBMI and higher diabetes distress administered fewer daily insulin boluses. zBMI was not a moderator of the association between diabetes distress and blood glucose readings (b = −0.01, p = 0.29) or A1C (b = 0.002, p = 0.81). Conclusions: Using objective behavioural data is useful for identifying how adolescent diabetes distress and zBMI affect daily bolusing behaviour amongst adolescent insulin pump users. Although distinct interventions exist to improve T1D self‐management or diabetes distress, none addresses them together while considering zBMI. Decreasing diabetes distress could be especially important for youth with high zBMI. [ABSTRACT FROM AUTHOR]