Search

The growing incidence of type 2 diabetes (T2D) is a significant health concern, representing 90% of diabetes cases worldwide. As the disease progresses, resultant insulin deficiency and hyperglycaemia necessitates insulin therapy in many cases. It has been recognized that a significant number of people who have a clinical requirement for insulin therapy, as well as their healthcare professionals, are reluctant to intensify treatment with insulin due to fear of hypoglycaemia, poor understanding of treatment regimens or lack of engagement, and are therefore at higher risk of developing complications from poor glycaemic control. Over the past decade, the rise of diabetes technologies, including dosing advisors, continuous glucose monitoring systems, insulin pumps and automated insulin delivery systems, has led to great improvements in the therapies available, particularly to those requiring insulin. Although the focus has largely been on delivering these therapies to the type 1 diabetes population, it is becoming increasingly recognized that people with T2D face similar challenges to achieve recommended glycaemic standards and also have the potential to benefit from these advances. In this review, we discuss diabetes technologies that are currently available for people with T2D and the evidence supporting their use, as well as future prospects. We conclude that there is a clinical need to extend the use of these technologies to the T2D population to curb the consequences of suboptimal disease management in this group. [ABSTRACT FROM AUTHOR]

Background: Clinicians mediate access to closed-loop technology for people with diabetes. Consequently, their attitudes regarding appropriate levels of closed-loop usage will play a key role in future adoption processes. This study aimed to explore clinician attitudes toward future mainstream closed-loop usage in England. Materials and Methods: We conducted 36 semistructured interviews with clinicians from a range of professional backgrounds working in outpatient clinics in England. Interview topics included clinicians' views on future pathways for closed-loop use and attitudes toward the predictability of users' technology experiences, a key factor in eligibility decision making. We analyzed transcripts using thematic and framework approaches. Results: Clinicians exhibited a range of opinions regarding future eligibility for closed-loop technology. We identified three key strands of clinician opinion, envisaging (1) tighter access for closed loop (n = 10), citing funding challenges and issues arising from user overconfidence or negative technology attitudes; (2) similar access to closed loop as for current diabetes technologies (n = 15), on the grounds that future funding and access pathways will be similar to current arrangements; and (3) wider access for closed-loop technologies (n = 9), given the potential for significant and widespread benefits arising from closed-loop usage, including downstream cost savings alongside improved glycemic control. Conclusions: Clinicians expressed a range of opinions encompassing continuity with current diabetes technologies, while others envisaged either tighter or more liberal access for closed-loop systems. To optimize technology adoption and equitable uptake, future implementation pathways should consider clinician attitudes toward technology use and access. [ABSTRACT FROM AUTHOR]

Type 1 diabetes mellitus (T1DM) represents 5-10% of diabetes cases worldwide. The incidence of T1DM is increasing, and there is no immediate prospect of a cure. As such, lifelong management is required, the burden of which is being eased by novel treatment modalities, particularly from the field of diabetes technologies. Continuous glucose monitoring has become the standard of care and includes factory-calibrated subcutaneous glucose monitoring and long-term implantable glucose sensing. In addition, considerable progress has been made in technology-enabled glucose-responsive insulin delivery. The first hybrid insulin-only closed-loop system has been commercialized, and other closed-loop systems are under development, including dual-hormone glucose control systems. This Review focuses on well-established diabetes technologies, including glucose sensing, pen-based insulin delivery, data management and data analytics. We also cover insulin pump therapy, threshold-based suspend, predictive low-glucose suspend and single-hormone and dual-hormone closed-loop systems. Clinical practice recommendations for insulin pump therapy and continuous glucose monitoring are presented, and ongoing research and future prospects are highlighted. We conclude that the management of T1DM is improved by diabetes technology for the benefit of the majority of people with T1DM, their caregivers and guardians and health-care professionals treating patients with T1DM. [ABSTRACT FROM AUTHOR]

The management of postprandial glucose excursions in type 1 diabetes has a major impact on overall glycaemic control. In this work, we propose and evaluate various mechanistic models to characterize the disposal of meal-attributable glucose. Sixteen young volunteers with type 1 diabetes were subject to a variable-target clamp which replicated glucose profiles observed after a high-glycaemic-load ([Formula: see text]) or a low-glycaemic-load ([Formula: see text]) evening meal. [6,6-[Formula: see text]] and [U-[Formula: see text];1,2,3,4,5,6,6-[Formula: see text]] glucose tracers were infused to, respectively, mimic: (a) the expected post-meal suppression of endogenous glucose production and (b) the appearance of glucose due to a standard meal. Six compartmental models (all a priori identifiable) were proposed to investigate the remote effect of circulating plasma insulin on the disposal of those glucose tracers from the non-accessible compartments, representing e.g. interstitium. An iterative population-based parameter fitting was employed. Models were evaluated attending to physiological plausibility, posterior identifiability of their parameter estimates, accuracy-via weighted fitting residuals-and information criteria (i.e. parsimony). The most plausible model, best representing our experimental data, comprised: (1) a remote effect x of insulin active above a threshold [Formula: see text] = 1.74 (0.81-2.50) [Formula: see text] min[Formula: see text] [median (inter-quartile range)], with parameter [Formula: see text] having a satisfactory support: coefficient of variation CV = 42.33 (31.34-65.34) %, and (2) steady-state conditions at the onset of the experiment ([Formula: see text]) for the compartment representing the remote effect, but not for the masses of the tracer that mimicked endogenous glucose production. Consequently, our mechanistic model suggests non-homogeneous changes in the disposal rates for meal-attributable glucose in relation to plasma insulin. The model can be applied to the in silico simulation of meals for the optimization of postprandial insulin infusion regimes in type 1 diabetes. [ABSTRACT FROM AUTHOR]

We consider situations, which are common in medical statistics, where we have a number of sets of response data, from different individuals, say, potentially under different conditions. A parametric model is defined for each set of data, giving rise to a set of random effects. Our goal here is to efficiently explore a range of possible 'population' models for the random effects, to select the most appropriate model. The range of possible models is potentially vast, because the random effects may depend on observed covariates, and there may be multiple credible ways of partitioning their variability. Here, we consider pharmacokinetic (PK) data on insulin aspart, a fast acting insulin analogue used in the treatment of diabetes. PK models are typically nonlinear (in their parameters), often complex and sometimes only available as a set of differential equations, with no closed-form solution. Fitting such a model for just a single individual can be a challenging task. Fitting a joint model for all individuals can be even harder, even without the complication of an overarching model selection objective. We describe a two-stage approach that decouples the population model for the random effects from the PK model applied to the response data but nevertheless fits the full, joint, hierarchical model, accounting fully for uncertainty. This allows us to repeatedly reuse results from a single analysis of the response data to explore various population models for the random effects. This greatly expedites not only model exploration but also cross-validation for the purposes of model criticism. © 2015 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

This letter discusses two studies that examine the relationship between diabetic ketoacidosis (DKA) at the onset of type 1 diabetes (T1D) and glycemic outcomes in young people. The first study, called the Pilot 4T study, found that even with intensive insulin management, individuals with DKA at diagnosis had higher levels of glycated hemoglobin (HbA1c) at 6 and 12 months post-diagnosis compared to those without DKA. The second study, called the CLOuD study, found that young people using a hybrid closed-loop (HCL) insulin delivery system had similar glycemic outcomes at 6, 12, and 24 months regardless of whether they presented with DKA or not. The authors suggest that HCL systems may mitigate the adverse glycemic effects of DKA better than continuous glucose monitoring (CGM) alone. They also note that DKA at diagnosis may be indicative of psycho-social factors and reduced beta-cell function. However, the CLOuD study had a smaller sample size and differences in baseline characteristics compared to the Pilot 4T study. Overall, the authors highlight the contrasting findings of these two studies and emphasize the potential benefits of advanced diabetes technology, particularly the CamAPS FX HCL system, in improving glycemic outcomes for individuals who present with DKA. [Extracted from the article]

OBJECTIVE To evaluate feasibility, safety, and efficacy of overnight closed-loop insulin delivery in free-living youth with type 1 diabetes. RESEARCH DESIGN AND METHODS Overnight closed loop was evaluated at home by 16 pump-treated adolescents with type 1 diabetes aged 12-18 years. Over a 3-week period, overnight insulin delivery was directed by a closed-loop system, and on another 3-week period sensor-augmented therapy was applied. The order of interventions was random. The primary end point was time when adjusted sensor glucose was between 3.9 and 8.0 mmol/L from 2300 to 0700 h. RESULTS Closed loop was constantly applied over at least 4 h on 269 nights (80%); sensor data were collected over at least 4 h on 282 control nights (84%). Closed loop increased time spent with glucose in target by a median 15% (interquartile range 29 to 43; P < 0.001). Mean overnight glucose was reduced by a mean 14 (SD 58) mg/dL (P < 0.001). Time when glucose was <70mg/dL was low in both groups, but nights with glucose <63mg/dL for at least 20min were less frequent during closed loop (10 vs. 17%; P = 0.01). Despite lower total daily insulin doses by a median 2.3 (interquartile range 24.7 to 9.3) units (P = 0.009), overall 24-h glucose was reduced by a mean 9 (SD 41) mg/dL (P = 0.006) during closed loop. CONCLUSIONS Unsupervised home use of overnight closed loop in adolescents with type 1 diabetes is safe and feasible. Glucose control was improved during the day and night with fewer episodes of nocturnal hypoglycemia. [ABSTRACT FROM AUTHOR]

Automated closed-loop insulin delivery, also referred to as the 'artificial pancreas', has been an important but elusive goal of diabetes treatment for many decades. Research milestones include the conception of continuous glucose monitoring in the early 1960s, followed by the production of the first commercial hospital-based artificial pancreas in the late 1970s that combined intravenous glucose sensing and insulin delivery. In the past 10 years, research into the artificial pancreas has gained substantial momentum and focused on the subcutaneous route for glucose measurement and insulin delivery, which reflects technological advances in interstitial glucose monitoring and the increasing use of the continuous subcutaneous insulin infusion. This Review discusses the design of an artificial pancreas, its components and clinical results, as well as the advantages and disadvantages of different types of automated closed-loop systems and potential future advances. The introduction of the artificial pancreas into clinical practice will probably occur gradually, starting with simpler approaches, such as overnight control of blood glucose concentration and temporary pump shut-off, that are adapted to more complex situations, such as glycemic control during meals and exercise. [ABSTRACT FROM AUTHOR]

The article discusses a phase 2 randomised crossover trial which aimed to establish whether closed-loop insulin delivery could control overnight blood glucose in young people. The study involved 19 patients aged 5 to 18 years with type 1 diabetes of duration 6.4 years. Study participants were also masked to plasma and sensor glucose and were studied for 33 closed-loop and 21 continuous infusion nights. The researchers concluded that closed-loop systems have the potential to reduce risk of nocturnal hypogycaemia in children and adolescents with type 1 diabetes.

A new calculation method is proposed to quantify the endogenous glucose production (EGP), the glucose appearance rate due to meal ingestion (Ra meal), and the glucose disposal (Rd) during a three-tracer study design. The method utilizes the maximum likelihood theory combined with a regularization method to achieve a theoretically coherent computational framework. The method uses the two-compartment formulation of the glucose kinetics. Instead of assuming smoothness of unlabeled and labeled glucose concentrations, the method assumes that the EGP, the Ra meal, and the fractional glucose clearance are smooth, increasing plausibility of their individual estimates. The method avoids transformation of the measurement errors, which may skew the estimates of the EGP, Ra meal, and Rd with the traditional approach. Finally, the sequential nature of the calculations is replaced by calculating the EGP, Ra meal, and Rd in "one go" to avoid the propagation of the errors from the EGP and Ra meal into Rd. An example study is shown demonstrating the utility of the approach. A better performance of the new method is demonstrated in a simulation study. [ABSTRACT FROM AUTHOR]

Presents a study which estimated the effect of insulin on glucose distribution/transport, glucose disposal and endogenous production during an intravenous glucose tolerance test (IVGTT). Results of the stable-label two-compartment model; Parameter estimates of the minimal model during an IVGTT; Ways in which insulin temporal action can be represented.

The authors discuss the development and innovations for the various diabetes technologies, such as insulin pumps and continuous glucose monitoring (CGM) sensors, for the continuous improvement of the management of type 1 diabetes. Topics discussed include the complexity in the self-management of insulin therapy despite such innovation, the advantages of closed-loop systems for modulation of insulin delivery, and the effectiveness of hypoglycemia reduction. [ABSTRACT FROM AUTHOR]

Aims: 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. Materials and Methods: 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. Results: 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. Conclusions: 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]

Describes the implementation of the diabetes advisory system (DIAS) network in the form of a special version of dynamic causal probabilistic networks (CPN). Overview of CPN; Information on the DIAS; CPN representing carbohydrate metabolism in subjects with noninsulin-dependent diabetes mellitus (NIDDM).

Describes the surrogate measurement of the whole body leucine transport into and out of cells under steady-state conditions based on a mass-balance model. Viability of the proposed whole body measurement; Observed linear relationship between plasma leucine and leucine transport; Reproducibility of the leucine transport via the proposed method.

Presents information on a study that described the principles of a surrogate measure of leucine transport across across the cell membrane on the whole body level and its application in normal subjects under fasting conditions. Methodology; Results of the study.

Presents information on a study which investigated the reproducibility of fasting hepatic glucose output (HGO) estimates with the use of isotope dilution methodology of stable-label tracers. Reasons for the constant infusion and bolus injection; Assessment of HGO.

Investigates the reproducibility of fasting hepatic glucose output (HGO) estimates by use of isotope dilution methodology of stable-label tracers. Constant infusion of labeled glucose; Reproducibility, comparability and precision of HGO estimates; Plasma glucose, endogenous glucose component, insulin and C-peptide.

OBJECTIVE: We evaluated the effect of long-term intensive metabolic control with hybrid closed-loop (CL) on residual C-peptide secretion and glucose control compared with standard insulin therapy in youth with type 1 diabetes over 48 months. RESEARCH DESIGN AND METHODS: Following the 24-month primary phase of a multicenter, randomized, parallel trial of 96 newly diagnosed youth aged 10 to 16.9 years, participants were invited to an extension phase using treatment allocated at randomization. They continued with hybrid CL using the Cambridge algorithm or standard insulin therapy (control) until 48 months after diagnosis. Analysis was by intention-to-treat. RESULTS: At 24 months after diagnosis, 81 participants (mean ± SD age 14 ± 2 years) continued in the extension phase (47 CL, 34 control). There was no difference in fasting C-peptide corrected for fasting glucose at 48 months between groups (CL: 5 ± 9 vs. control: 6 ± 14 pmol/L per mmol/L; mean adjusted difference −2 [95% CI −7, 4; P = 0.54]). Central laboratory HbA1c remained lower in the CL group by 0.9% (10 mmol/mol [95% CI 0.2, 1.5; 3, 17 mmol/mol); P = 0.009). Time in target range of 3.9 to 10.0 mmol/L was 12 percentage points (95% CI 3, 20; P = 0.008) higher in the CL group compared with control. There were 11 severe hypoglycemic events (6 CL, 5 control) and 7 diabetic ketoacidosis events (3 CL, 4 control) during the extension phase. CONCLUSIONS: Improved glycemic control was sustained over 48 months after diagnosis with CL insulin delivery compared with standard therapy in youth with type 1 diabetes. This did not appear to confer a protective effect on residual C-peptide secretion. [ABSTRACT FROM AUTHOR]

Objective: To evaluate postprandial glucose control when applying (1) faster-acting insulin aspart (Fiasp) compared to insulin aspart and (2) ultra-rapid insulin lispro (Lyumjev) compared to insulin lispro using the CamAPS FX hybrid closed-loop algorithm. Research Design and Methods: We undertook a secondary analysis of postprandial glucose excursions from two double-blind, randomized, crossover hybrid closed-loop studies contrasting Fiasp to standard insulin aspart, and Lyumjev to standard insulin lispro. Endpoints included incremental area under curve (iAUC)-2h, iAUC-4h, 4 h postprandial time in target range, time above range, and time below range. It was approved by independent research ethics committees. Results: Two trials with 8 weeks of data from 51 adults with type 1 diabetes were analyzed and 7137 eligible meals were included. During Lyumjev compared with insulin lispro, iAUC-2h and iAUC-4h were significantly decreased following breakfast (mean difference 92 mmol/L per 2 h (95% confidence interval [CI]: 56 to 127); P < 0.001 and 151 mmol/L per 4 h (95% CI: 74 to 229); P < 0.001, respectively) and the evening meal (P < 0.001 and P = 0.011, respectively). Mean time in target range (3.9–10.0 mmol/L) for 4 h postprandially significantly increased during Lyumjev with a mean difference of 6.7 percentage points (95% CI: 3.3 to 10) and 5.7 percentage points (95% CI: 1.4 to 9.9) for breakfast and evening meal, respectively. In contrast, there were no significant differences in iAUC-2h, iAUC-4h, and the other measures of postprandial glucose control between insulin aspart and Fiasp during breakfast, lunch, and evening meal (P > 0.05). Conclusion: The use of Lyumjev with CamAPS FX closed-loop system improved postprandial glucose excursions compared with insulin lispro, while the use of Fiasp did not provide any advantage compared with insulin aspart. Clinical Trial Registration numbers: NCT04055480, NCT05257460. [ABSTRACT FROM AUTHOR]

Introduction: The Closing the Loop in Adults With Type 1 Diabetes (CLEAR) randomized crossover study compared a novel fully closed-loop insulin delivery system with no carbohydrate entry or mealtime bolusing (CamAPS HX), with standard insulin pump therapy and glucose sensor in adults with type 1 diabetes and suboptimal glycemic outcomes. This qualitative substudy aimed to understand the psychosocial impact of using the fully automated system. Materials and Methods: Adults participating in the CLEAR study were invited to take part in a virtual semistructured interview after they had completed 8 weeks using the fully closed-loop system. Recruitment continued until there was adequate representation and data saturation occurred. Interviews were anonymized and transcribed for in-depth thematic analysis using an inductive-deductive approach. Study participants were also asked to complete questionnaires assessing diabetes distress, hypoglycemia confidence, and closed-loop treatment satisfaction. Results: Eleven participants (eight male and three female; age range 26–66 years) were interviewed. After an initial adjustment period, interviewees reported enjoying a reduction in diabetes burden, freed-up mental capacity, and improved mood. All were happy with overnight glycemic outcomes, with the majority reporting benefits on sleep. Although experiences of postprandial glucose outcomes varied, all found mealtimes easier and less stressful, particularly when eating out. Negatives raised by participants predominantly related to the insulin pump hardware, but some also reported increased snacking and challenges around resuming carbohydrate counting at trial closeout. Conclusions: In adults with type 1 diabetes, use of a fully closed-loop insulin delivery system had significant quality-of-life benefits and provided a welcome break from the day-to-day demands of living with diabetes. Clinical Trial Registration: NCT04977908. [ABSTRACT FROM AUTHOR]

The presence of diabetic ketoacidosis (DKA) at diagnosis of type 1 diabetes (T1D) is associated with higher glycated hemoglobin levels over time. We evaluated whether hybrid-closed loop (HCL) therapy from onset of T1D could prevent the adverse impact of DKA at diagnosis on long-term glycemic outcomes. This was a posthoc analysis from 51 adolescents using HCL from diagnosis of T1D as part of the CLOuD trial (NCT02871089). We compared glycemic and insulin metrics between adolescents with (n = 17) and without (n = 34) DKA at diagnosis. Participants with and without DKA at diagnosis had similar time in target glucose range 3.9–10.0 mmol/L (70–180 mg/dL), time below range (<3.9 mmol/L, <70 mg/dL) and HbA1c at 6, 12, and 24 months. While insulin requirements at 6 months were higher in those with DKA at diagnosis, this was not statistically significant after adjusting for bodyweight. Residual C-peptide secretion was similar between groups. We conclude that HCL therapy may mitigate against the negative glycemic effects of DKA at T1D diagnosis. [ABSTRACT FROM AUTHOR]

A study published in the journal Diabetes, Obesity & Metabolism examined the impact of hybrid closed-loop (HCL) insulin delivery on cardiac rhythm in older adults with type 1 diabetes (T1D). The study found that HCL devices improved glucose control and reduced the risk of low blood sugar, but did not have a significant impact on cardiac rhythm. The study suggests that HCL systems can be beneficial for managing T1D in older adults without negatively affecting cardiac rhythm. However, more research is needed to understand the relationship between glucose control and cardiac rhythm in individuals with T1D. [Extracted from the article]

Introduction: Recent high-profile calls have emphasized that women's experiences should be considered in maternity care provisioning. We explored women's experiences of using closed-loop during type 1 diabetes (T1D) pregnancy to inform decision-making about antenatal rollout and guidance and support given to future users. Methods: We interviewed 23 closed-loop participants in the Automated insulin Delivery Among Pregnant women with T1D (AiDAPT) trial after randomization to closed-loop and ∼20 weeks later. Data were analyzed thematically. Results: Women described how closed-loop lessened the physical and mental demands of diabetes management, enabling them to feel more normal and sleep better. By virtue of spending increased time-in-range, women also worried less about risks to their baby and being judged negatively by health care professionals. Most noted that intensive input and support during early pregnancy had been crucial to adjusting to, and developing confidence in, the technology. Women emphasized that attaining pregnancy glucose targets still required ongoing effort from themselves and the health care team. Women described needing education to help them determine when, and how, to intervene and when to allow the closed-loop to operate without interference. All women reported more enjoyable pregnancy experiences as a result of using closed-loop; some also noted being able to remain longer in paid employment. Conclusions: Study findings endorse closed-loop use in T1D pregnancy by highlighting how the technology can facilitate positive pregnancy experiences. To realize fully the benefits of closed-loop, pregnant women would benefit from initial intensive oversight and support together with closed-loop specific education and training. Clinical Trial Registration number: NCT04938557. [ABSTRACT FROM AUTHOR]

Introduction: To evaluate hybrid closed-loop with ultra-rapid insulin lispro (Lyumjev) compared with hybrid closed-loop with standard insulin lispro in adults with type 1 diabetes. Materials and Methods: In a single-center, double-blind, randomized, crossover study, 28 adults with type 1 diabetes (mean ± standard deviation [SD]: age 44.5 ± 10.7 years, glycated hemoglobin (HbA1c) 7.1 ± 0.9% [54 ± 10 mmol/mol]) underwent two 8-week periods comparing hybrid closed-loop with ultra-rapid insulin lispro and hybrid closed-loop with standard insulin lispro in random order. The same CamAPS FX closed-loop algorithm was used in both periods. Results: In an intention-to-treat analysis, the proportion of time sensor glucose was in target range (3.9–10 mmol/L [70–180 mg/dL]; primary endpoint) was greater with ultra-rapid lispro compared with standard insulin lispro (mean ± SD: 78.7 ± 9.8% vs. 76.2 ± 9.6%; mean difference 2.5 percentage points [95% confidence interval 0.8 to 4.2]; P = 0.005). Mean sensor glucose was lower with ultra-rapid lispro compared with standard insulin lispro (7.9 ± 0.8 mmol/L [142 ± 14 mg/dL] vs. 8.1 ± 0.9 mmol/L [146 ± 16 mg/dL]; P = 0.048). The proportion of time with sensor glucose <3.9 mmol/L [70 mg/dL] was similar between interventions (median [interquartile range] ultra-rapid lispro 2.3% [1.3%–2.7%] vs. standard insulin lispro 2.1% [1.4%–3.3%]; P = 0.33). No severe hypoglycemia or ketoacidosis occurred. Conclusions: The use of ultra-rapid lispro with CamAPS FX hybrid closed-loop increases time in range and reduces mean glucose with no difference in hypoglycemia compared with standard insulin lispro in adults with type 1 diabetes. ClinicalTrials.gov: Trial registration number NCT05257460. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article "Analysis of Continuous Glucose Monitoring Data to Assess Outpatient Closed-Loop Studies: Considerations for Different Sensors" by T.M. Mitre, and colleagues in a 2014 issue.

OBJECTIVE: We evaluated the safety and efficacy of fully closed-loop with ultrarapid insulin lispro in adults with type 1 diabetes and suboptimal glycemic control compared with insulin pump therapy with continuous glucose monitoring (CGM). RESEARCH DESIGN AND METHODS: This single-center, randomized, crossover study enrolled 26 adults with type 1 diabetes using insulin pump therapy with suboptimal glycemic control (mean ± SD, age 41 ± 12 years, HbA1c 9.2 ± 1.1% [77 ± 12 mmol/mol]). Participants underwent two 8-week periods of unrestricted living to compare fully closed-loop with ultrarapid insulin lispro (CamAPS HX system) with insulin pump therapy with CGM in random order. RESULTS: In an intention-to-treat analysis, the proportion of time glucose was in range (primary end point 3.9–10.0 mmol/L) was higher during closed-loop than during pump with CGM (mean ± SD 50.0 ± 9.6% vs. 36.2 ± 12.2%, mean difference 13.2 percentage points [95% CI 9.5, 16.9], P < 0.001). Time with glucose >10.0 mmol/L and mean glucose were lower during closed-loop than during pump with CGM (mean ± SD time >10.0 mmol/L: 49.0 ± 9.9 vs. 62.9 ± 12.6%, mean difference −13.3 percentage points [95% CI −17.2, −9.5], P < 0.001; mean ± SD glucose 10.7 ± 1.1 vs. 12.0 ± 1.6 mmol/L, mean difference −1.2 mmol/L [95% CI −1.8, −0.7], P < 0.001). The proportion of time with glucose <3.9 mmol/L was similar between periods (median [interquartile range (IQR)] closed-loop 0.88% [0.51–1.55] vs. pump with CGM 0.64% [0.28–1.10], P = 0.102). Total daily insulin requirements did not differ (median [IQR] closed-loop 51.9 units/day [35.7–91.2] vs. pump with CGM 50.7 units/day [34.0–70.0], P = 0.704). No severe hypoglycemia or ketoacidosis occurred. CONCLUSIONS: Fully closed-loop insulin delivery with CamAPS HX improved glucose control compared with insulin pump therapy with CGM in adults with type 1 diabetes and suboptimal glycemic control. [ABSTRACT FROM AUTHOR]

BACKGROUND Hybrid closed-loop insulin therapy has shown promise for management of type 1 diabetes during pregnancy; however, its efficacy is unclear. METHODS In this multicenter, controlled trial, we randomly assigned pregnant women with type 1 diabetes and a glycated hemoglobin level of at least 6.5% at nine sites in the United Kingdom to receive standard insulin therapy or hybrid closed-loop therapy, with both groups using continuous glucose monitoring. The primary outcome was the percentage of time in the pregnancy-specific target glucose range (63 to 140 mg per deciliter [3.5 to 7.8 mmol per liter]) as measured by continuous glucose monitoring from 16 weeks' gestation until delivery. Analyses were performed according to the intention-to-treat principle. Key secondary outcomes were the percentage of time spent in a hyperglycemic state (glucose level >140 mg per deciliter), overnight time in the target range, the glycated hemoglobin level, and safety events. RESULTS A total of 124 participants with a mean (±SD) age of 31.1±5.3 years and a mean baseline glycated hemoglobin level of 7.7±1.2% underwent randomization. The mean percentage of time that the maternal glucose level was in the target range was 68.2±10.5% in the closed-loop group and 55.6±12.5% in the standard-care group (mean adjusted difference, 10.5 percentage points; 95% confidence interval [CI], 7.0 to 14.0; PcO.OOl). Results for the secondary outcomes were consistent with those of the primary outcome; participants in the closed-loop group spent less time in a hyperglycemic state than those in the standard-care group (difference, -10.2 percentage points; 95% CI, -13.8 to -6.6); had more overnight time in the target range (difference, 12.3 percentage points; 95% CI, 8.3 to 16.2), and had lower glycated hemoglobin levels (difference, -0.31 percentage points; 95% CI, -0.50 to -0.12). Little time was spent in a hypoglycemic state. No unanticipated safety problems associated with the use of closed-loop therapy during pregnancy occurred (6 instances of severe hypoglycemia, vs. 5 in the standard-care group; 1 instance of diabetic ketoacidosis in each group; and 12 device-related adverse events in the closed-loop group, 7 related to closed-loop therapy). CONCLUSIONS Hybrid closed-loop therapy significantly improved maternal glycemic control during pregnancy complicated by type 1 diabetes. [ABSTRACT FROM AUTHOR]

Insulin replacement therapy is integral to the management of type 1 diabetes, which is characterised by absolute insulin deficiency. Optimal glycaemic control, as assessed by glycated haemoglobin, and avoidance of hyper- and hypoglycaemic excursions have been shown to prevent diabetes-related complications. Insulin pump use has increased considerably over the past decade with beneficial effects on glycaemic control, quality of life and treatment satisfaction. The advent and progress of ambulatory glucose sensor technology has enabled continuous glucose monitoring based on real-time glucose levels to be integrated with insulin therapy. Low glucose and predictive low glucose suspend systems are currently used in clinical practice to mitigate against hypoglycaemia, and provide the first step towards feedback glucose control. The more advanced technology approach, an artificial pancreas or a closed-loop system, gradually increases and decreases insulin delivery in a glucose-responsive fashion to mitigate against hyper- and hypoglycaemia. Randomised outpatient clinical trials over the past 5 years have demonstrated the feasibility, safety and efficacy of the approach, and the recent FDA approval of the first single hormone closed-loop system establishes a new standard of care for people with type 1 diabetes. [ABSTRACT FROM AUTHOR]

Introduction. Parents of children living with type 1 diabetes (T1D) often report short and/or poor quality sleep. The development of closed-loop systems promises to transform the management of T1D. This study compared sleep quality and quantity in caregivers of children using a closed-loop system (CL) or sensor-augmented pump (SAP) therapy. Method. Data from sleep diaries, accelerometers, and questionnaires were provided by forty parents (classified as caregiver 1 (main analyses) or 2 (supplementary analyses) based on their contribution towards treatment management) of 21 very young children aged 1 to 7 years living with T1D (mean age: 4.7 (SD = 1.7)). Assessments were made at a single post-randomisation time point when the child was completing either the 16-week CL arm (n = 10) or the 16-week SAP arm (n = 11) of the main study. Results. Overall, there was a mixed pattern of results and group differences were not statistically significant at the p < 0.05 level. However, when we consider the direction of results and results from caregiver 1, sleep diary data showed that parents of the CL (as compared to the SAP) group reported a shorter sleep duration but better sleep quality, fewer awakenings, and less wake after sleep onset (WASO). Actiwatch data showed that caregiver 1 of the CL (as compared to the SAP) group had a shorter sleep latency; greater sleep efficiency; and less wake after sleep onset. Results from the Pittsburgh Sleep Quality Index also showed better sleep quality for caregiver 1 of the CL group as compared to the SAP group. Conclusions. Results from this study suggest that sleep quality and quantity in parents of children using CL were not significantly different to those using SAP. Considering effect sizes and the direction of the non-significant results, CL treatment could be associated with better sleep quality in the primary caregiver. However, further research is needed to confirm these findings. This trial is registered with NCT05158816. [ABSTRACT FROM AUTHOR]

We evaluated the use of hybrid closed-loop (HCL) insulin delivery with faster insulin aspart (Fiasp) in very young children with type 1 diabetes (T1D). In a double-blind, multicenter, randomized, crossover study, children aged 2–6 years with T1D underwent two 8-week periods of HCL using CamAPS FX with Fiasp and standard insulin aspart (IAsp), in random order. Primary endpoint was between-treatment difference in time in target range 3.9–10.0 mmol/L. We randomized 25 participants: mean (±standard deviation) age 5.1 ± 1.3 years, baseline HbA1c 55 ± 9 mmol/mol. Time in range was not significantly different between interventions (64% ± 9% vs. 65% ± 9% for HCL with Fiasp vs. IAsp; mean difference −0.33% [95% confidence interval: −2.13 to 1.47; P = 0.71]). There was no significant difference in time with glucose <3.9 mmol/L. No post-randomization severe hypoglycemia or diabetic ketoacidosis events occurred. Use of Fiasp with CamAPS FX HCL demonstrated no significant difference in glycemic outcomes compared with IAsp in very young children with T1D. Clinical trials registration: NCT04759144. [ABSTRACT FROM AUTHOR]

Aims: Fully closed‐loop insulin delivery has been shown in clinical trials to be safe and improve glucose control compared with standard insulin therapy in the inpatient setting. We investigated the feasibility of implementing the approved CamAPS HX fully closed‐loop system in a hospital setting. Methods: This implementation project was conducted in a large teaching hospital in Cambridge, UK. Healthcare professional training was multimodal including face‐to‐face workshops, online learning modules and supported by standard operating procedures. Set‐up and maintenance of closed‐loop devices were undertaken by the inpatient diabetes team. Selection of suitable patients was multidisciplinary and prioritised those with more challenging diabetes management. Demographic and clinical data were collected from electronic health records and diabetes data management platforms. Results: In the 12 months since the closed‐loop system was implemented, 32 inpatients (mean ± SD age 61 ± 16 years, 8 females, 24 males) used closed‐loop insulin delivery during their admission, across medical and surgical wards in the hospital with a total of 555 days of closed‐loop glucose control (median [IQR]: 14 [6, 22] days per inpatient). The time spent in target glucose range 3.9–10.0 mmol/L was 53.3 ± 18.3%. Mean glucose was 10.7 ± 1.9 mmol/L with 46.0 ± 18.2% of time spent with glucose >10.0 mmol/L. Time spent with sensor glucose below 3.9 mmol/L was low (median [IQR]: 0.38 [0.00, 0.85]). There were no episodes of severe hypoglycaemia or diabetic ketoacidosis during closed‐loop use. Conclusions: We have demonstrated that the fully closed‐loop system can be safely and effectively implemented by a diabetes outreach team in complex medical and surgical inpatients with challenging glycaemic control. [ABSTRACT FROM AUTHOR]

Background: Rapid progress over the past decade has been made with the development of the 'Artificial Pancreas', also known as the closed-loop system, which emulates the feedback glucose-responsive functionality of the pancreatic beta cell. The recent FDA approval of the first hybrid closed-loop system makes the Artificial Pancreas a realistic therapeutic option for people with type 1 diabetes. In anticipation of its advent into clinical care, we provide a primer and appraisal of this novel therapeutic approach in type 1 diabetes for healthcare professionals and non-specialists in the field.Discussion: Randomised clinical studies in outpatient and home settings have shown improved glycaemic outcomes, reduced risk of hypoglycaemia and positive user attitudes. User input and interaction with existing closed-loop systems, however, are still required. Therefore, management of user expectations, as well as training and support by healthcare providers are key to ensure optimal uptake, satisfaction and acceptance of the technology. An overview of closed-loop technology and its clinical implications are discussed, complemented by our extensive hands-on experience with closed-loop system use during free daily living.Conclusions: The introduction of the artificial pancreas into clinical practice represents a milestone towards the goal of improving the care of people with type 1 diabetes. There remains a need to understand the impact of user interaction with the technology, and its implication on current diabetes management and care. [ABSTRACT FROM AUTHOR]

Background: Interest is growing in how closed‐loop systems can support attainment of within‐target glucose levels amongst pregnant women with type 1 diabetes. We explored healthcare professionals' views about how, and why, pregnant women benefitted from using the CamAPS FX system during the AiDAPT trial. Methods: We interviewed 19 healthcare professionals who supported women using closed‐loop during the trial. Our analysis focused on identifying descriptive and analytical themes relevant to clinical practice. Results: Healthcare professionals highlighted clinical and quality‐of‐life benefits to using closed‐loop in pregnancy; albeit, they attributed some of these to the continuous glucose monitoring component. They emphasised that the closed‐loop was not a panacea and that, to gain maximum benefit, an effective collaboration between themselves, the woman and the closed‐loop was needed. Optimal performance of the technology, as they further noted, also required women to interact with the system sufficiently, but not excessively; a requirement that they felt some women had found challenging. Even where healthcare professionals felt that this balance was not achieved, they suggested that women had still benefitted from using the system. Healthcare professionals reported difficulties predicting how specific women would engage with the technology. In light of their trial experiences, healthcare professionals favoured an inclusive approach to closed‐loop rollout in routine clinical care. Conclusions: Healthcare professionals recommended that closed‐loop systems be offered to all pregnant women with type 1 diabetes in the future. Presenting closed‐loop systems to pregnant women and healthcare teams as one pillar of a three‐party collaboration may help promote optimal use. [ABSTRACT FROM AUTHOR]

Aims: To explore healthcare professionals' views about the training and support needed to rollout closed-loop technology to pregnant women with type 1 diabetes. Methods: We interviewed (n = 19) healthcare professionals who supported pregnant women using CamAPS FX closed-loop during the Automated insulin Delivery Amongst Pregnant women with Type 1 diabetes (AiDAPT) trial. Data were analyzed descriptively. An online workshop involving (n = 15) trial team members was used to inform recommendations. Ethics approvals were obtained in conjunction with those for the wider trial. Results: Interviewees expressed enthusiasm for a national rollout of closed-loop, but anticipated various challenges, some specific to use during pregnancy. These included variations in insulin pump and continuous glucose monitoring expertise and difficulties embedding and retaining key skills, due to the relatively small numbers of pregnant women using closed-loop. Inexperienced staff also highlighted difficulties interpreting data downloads. To support rollout, interviewees recommended providing expert initial advice training, delivered by device manufacturers together with online training resources and specific checklists for different systems. They also highlighted a need for 24 h technical support, especially when supporting technology naive women after first transitioning onto closed-loop in early pregnancy. They further recommended providing case-based meetings and mentorship for inexperienced colleagues, including support interpreting data downloads. Interviewees were optimistic that if healthcare professionals received training and support, their long-term workloads could be reduced because closed-loop lessened women's need for glycemic management input, especially in later pregnancy. Conclusions: Interviewees identified challenges and opportunities to rolling-out closed-loop and provided practical suggestions to upskill inexperienced staff supporting pregnant women using closed-loop. A key priority will be to determine how best to develop mentorship services to support inexperienced staff delivering closed-loop. Clinical Trials Registration: NCT04938557. [ABSTRACT FROM AUTHOR]

Keywords: clinical trial; continuous glucose monitoring; CSII; insulin analogues; insulin pump therapy; insulin therapy EN clinical trial continuous glucose monitoring CSII insulin analogues insulin pump therapy insulin therapy 1121 1124 4 03/08/23 20230401 NES 230401 INTRODUCTION Carbohydrate counting to quantify prandial insulin requirement remains a key aspect of type 1 diabetes self-management.[1] This, however, remains challenging, leading to dysglycaemia and increased burden for many people with type 1 diabetes.[2] Current hybrid closed-loop systems still require manual meal (prandial) bolusing due to the relatively slow action of standard rapid-acting insulin. In conclusion, glucose control using the CamAPS FX closed-loop system under conditions of underestimated and missed meal bolus with faster-acting insulin aspart is comparable with insulin aspart. DISCUSSION Use of faster-acting insulin aspart compared to insulin aspart during closed loop when meal boluses were underestimated and missed led to comparable glycaemic outcomes, with no significant differences in closed-loop algorithm-mediated insulin doses. Comparison of faster-acting aspart with insulin aspart under conditions mimicking underestimation or missed meal boluses in type 1 diabetes using closed-loop insulin delivery. [Extracted from the article]

The central role of pancreas in glucose regulation imposes high demands on perioperative glucose management in patients undergoing pancreatic surgery. In a post-hoc subgroup analysis of a randomized controlled trial, we evaluated the perioperative use of subcutaneous (SC) fully closed-loop (FCL, CamAPS HX) versus usual care (UC) insulin therapy in patients undergoing partial or total pancreatic resection. Glucose control was compared using continuous glucose monitoring (CGM) metrics (% time with CGM values between 5.6 and 10.0mmol/L and more). Over the time of hospitalisation, FCL resulted in better glucose control than UC with more time spent in the target range 5.6-10.0mmol/L (mean (SD) % time in target 77.7±4.6 % and 41.1±19.5 % in FCL vs. UC subjects, respectively; mean difference 36.6 % (95% CI [18.5; 54.8])), without increasing the risk of hypoglycaemia. Findings suggest that an adaptive SC FCL approach effectively accommodated the highly variable insulin needs in patients undergoing pancreatic surgery. [ABSTRACT FROM AUTHOR]

Keywords: randomized trial; type 1 diabetes; insulin pump therapy; continuous glucose monitoring (CGM) EN randomized trial type 1 diabetes insulin pump therapy continuous glucose monitoring (CGM) 889 893 5 02/03/23 20230301 NES 230301 INTRODUCTION Healthy sleep supports general health and well-being.[[1]] Sleep disturbance in type 1 diabetes (T1DM) can be caused by factors including fear of hypoglycaemia and suboptimal glucose control.[3] For example, hypoglycaemia or hyperglycaemia can disturb sleep, through mechanisms including sympathetic activation and neuropathic pain, respectively.[4] Several observational studies have suggested that hybrid closed-loop (HCL) system initiation is associated with improved sleep,[[5]] but these data could be limited by confounding and other biases. Hybrid closed-loop glucose control compared with sensor augmented pump therapy in older adults with type 1 diabetes: an open-label multicentre, multinational, randomised, crossover study. The proportion of participants with self-reported poor sleep quality (PSQI score >5) was nonsignificantly higher during the SAP period compared to the HCL period (40.5 [24.8-57.9]% vs. 29.7 [15.9-47.0]%; I P i = 0.15). Effects of closed-loop insulin delivery on glycemia during sleep and sleep quality in older adults with type 1 diabetes: results from the ORACL trial. [Extracted from the article]

The article focuses on a randomised controlled clinical trial related to closed loop delivery of insulin in adults with the type 1 diabetes. The trial found that closed loop insulin delivery improved overnight glucose control and minimized the risk of nocturnal hypoglycaemia in adults suffering from the said disease. It informs that 24 adults with the type 1 diabetes were examined during the trial. A graph depicting plasma glucose levels during the time of insulin delivery is also presented.

Abstract: Objective: To outline a roadmap to the artificial pancreas (AP) comprising a subcutaneous (sc) glucose monitor, a control algorithm, and an insulin pump delivering sc insulin. Research design and methods: A literature review, personal views, and material from the Juvenile Diabetes Research Foundation have been used to prepare the roadmap. Results: The roadmap identifies sensor reliability but not sensor accuracy as the critical roadblock, which can be addressed by advanced control algorithms combined with safety critical features. It is argued that incremental rather than perfect glucose control should be the objective of the first generation of the AP. Overnight glucose control is more easily achieved than postmeal control and could be the first aim for a commercial AP. Glycated haemoglobin and the risk of hypoglycaemia will remain the primary efficacy and safety measures being accompanied by complementary measures of variability of glucose excursions. Research priorities include the development of AP prototypes incorporating existing glucose monitors with focus on evaluation at home over short- and long-term periods. Conclusions: The AP promises to revolutionise insulin treatment. Building on technological progress in glucose sensing, the true potential of the AP needs to be assessed by building prototypes and evaluations in home settings. [Copyright &y& Elsevier]

Dear Editor, Fully closed-loop insulin delivery has been shown to dramatically improve glycemic control without increasing hypoglycemia in adults with type 2 diabetes (T2D).[1] Exogenous insulin requirements may vary considerably from day to day due to variable oral intake, activity, hormonal, and other factors. Variability of insulin requirements over 12 weeks of closed-loop insulin delivery in adults with type 1 diabetes. [Extracted from the article]

Background: Whether improved glucose control with hybrid closed-loop therapy can preserve C-peptide secretion as compared with standard insulin therapy in persons with new-onset type 1 diabetes is unclear.Methods: In a multicenter, open-label, parallel-group, randomized trial, we assigned youths 10.0 to 16.9 years of age within 21 days after a diagnosis of type 1 diabetes to receive hybrid closed-loop therapy or standard insulin therapy (control) for 24 months. The primary end point was the area under the curve (AUC) for the plasma C-peptide level (after a mixed-meal tolerance test) at 12 months after diagnosis. The analysis was performed on an intention-to-treat basis.Results: A total of 97 participants (mean [±SD] age, 12±2 years) underwent randomization: 51 were assigned to receive closed-loop therapy and 46 to receive control therapy. The AUC for the C-peptide level at 12 months (primary end point) did not differ significantly between the two groups (geometric mean, 0.35 pmol per milliliter [interquartile range, 0.16 to 0.49] with closed-loop therapy and 0.46 pmol per milliliter [interquartile range, 0.22 to 0.69] with control therapy; mean adjusted difference, -0.06 pmol per milliliter [95% confidence interval {CI}, -0.14 to 0.03]). There was not a substantial between-group difference in the AUC for the C-peptide level at 24 months (geometric mean, 0.18 pmol per milliliter [interquartile range, 0.06 to 0.22] with closed-loop therapy and 0.24 pmol per milliliter [interquartile range, 0.05 to 0.30] with control therapy; mean adjusted difference, -0.04 pmol per milliliter [95% CI, -0.14 to 0.06]). The arithmetic mean glycated hemoglobin level was lower in the closed-loop group than in the control group by 4 mmol per mole (0.4 percentage points; 95% CI, 0 to 8 mmol per mole [0.0 to 0.7 percentage points]) at 12 months and by 11 mmol per mole (1.0 percentage points; 95% CI, 7 to 15 mmol per mole [0.5 to 1.5 percentage points]) at 24 months. Five cases of severe hypoglycemia occurred in the closed-loop group (in 3 participants), and one occurred in the control group; one case of diabetic ketoacidosis occurred in the closed-loop group.Conclusions: In youths with new-onset type 1 diabetes, intensive glucose control for 24 months did not appear to prevent the decline in residual C-peptide secretion. (Funded by the National Institute for Health and Care Research and others; CLOuD ClinicalTrials.gov number, NCT02871089.). [ABSTRACT FROM AUTHOR]

Objectives: We explored parents' views about healthcare professionals having remote access to their young child's insulin and glucose data during a clinical trial to inform use of data sharing in routine pediatric diabetes care. Research Design and Methods: Interviews with 33 parents of 30 children (aged 1–7 years) with type 1 diabetes participating in a randomized trial (KidsAP02) comparing hybrid closed‐loop system use with sensor‐augmented pump therapy. Data were analyzed using a qualitative descriptive approach. Results: Parents reported multiple benefits to healthcare professionals being able to remotely access their child's glucose and insulin data during the trial, despite some initial concerns regarding the insights offered into everyday family life. Key benefits included: less work uploading/sharing data; improved consultations; and, better clinical input and support from healthcare professionals between consultations. Parents noted how healthcare professionals' real‐time data access facilitated remote delivery of consultations during the COVID‐19 pandemic, and how these were more suitable for young children than face‐to‐face appointments. Parents endorsed use of real‐time data sharing in routine clinical care, subject to caveats regarding data access, security, and privacy. They also proposed that, if data sharing were used, consultations for closed‐loop system users in routine clinical care could be replaced with needs‐driven, ad‐hoc contact. Conclusions: Real‐time data sharing can offer clinical, logistical, and quality‐of‐life benefits and enhance opportunities for remote consultations, which may be more appropriate for young children. Wider rollout would require consideration of ethical and cybersecurity issues and, given the heightened intrusion on families' privacy, a non‐judgmental, collaborative approach by healthcare professionals. [ABSTRACT FROM AUTHOR]

Objective: Perioperative management of glucose levels remains challenging. We aimed to assess whether fully closed-loop subcutaneous insulin delivery would improve glycemic control compared with standard insulin therapy in insulin-requiring patients undergoing elective surgery.Research Design and Methods: We performed a single-center, open-label, randomized controlled trial. Patients with diabetes (other than type 1) undergoing elective surgery were recruited from various surgical units and randomly assigned using a minimization schedule (stratified by HbA1c and daily insulin dose) to fully closed-loop insulin delivery with fast-acting insulin aspart (closed-loop group) or standard insulin therapy according to local clinical practice (control group). Study treatment was administered from hospital admission to discharge (for a maximum of 20 days). The primary end point was the proportion of time with sensor glucose in the target range (5.6-10.0 mmol/L).Results: Forty-five patients were enrolled and assigned to the closed-loop (n = 23) or the control (n = 22) group. One patient (closed-loop group) withdrew from the study before surgery and was not analyzed. Participants underwent abdominal (57%), vascular (23%), orthopedic (9%), neuro (9%), or thoracic (2%) surgery. The mean proportion of time that sensor glucose was in the target range was 76.7 ± 10.1% in the closed-loop and 54.7 ± 20.8% in the control group (mean difference 22.0 percentage points [95% CI 11.9; 32.0%]; P < 0.001). No episodes of severe hypoglycemia (<3.0 mmol/L) or hyperglycemia with ketonemia or any study-related adverse events occurred in either group.Conclusions: In the context of mixed elective surgery, the use of fully closed-loop subcutaneous insulin delivery improves glucose control without a higher risk of hypoglycemia. [ABSTRACT FROM AUTHOR]

Background: The acute impact of different types of physical activity on glycemic control in type 1 diabetes has not been well quantified. Objectives: Our objective was to estimate the rate of change (RoC) in glucose concentration induced acutely during the performance of structured exercise and at recovery in subjects with type 1 diabetes. Methods: We searched for original articles in the PubMed, MEDLINE, Scopus, and Cochrane databases. Search terms included type 1 diabetes, blood glucose, physical activity, and exercise. Eligible studies (randomized controlled trials and non-randomized experiments) encompassed controlled physical activity sessions (continuous moderate [CONT], intermittent high intensity [IHE], resistance [RESIST], and/or a resting reference [REST]) and reported excursions in glucose concentration during exercise and after its cessation. Data were extracted by graph digitization to compute two RoC measures from population profiles: RoC during exercise and RoC in recovery. Results: Ten eligible studies were found from 540 publications. Meta-analyses of exercise modalities versus rest yielded the following: RoC −4.43 mmol/L h ( p < 0.00001, 95 % confidence interval [CI] −6.06 to −2.79) and RoC +0.70 mmol/L h ( p = 0.46, 95 % CI −1.14 to +2.54) for CONT vs. REST; RoC −5.25 mmol/L·h ( p < 0.00001, 95 % CI −7.02 to −3.48) and RoC +0.72 mmol/L h ( p = 0.71, 95 % CI −3.10 to +4.54) for IHE vs. REST; RoC −2.61 mmol/L h ( p = 0.30, 95 % CI −7.55 to +2.34) and RoC −0.02 mmol/L h ( p = 1.00, 95 % CI −7.58 to +7.53) for RESIST vs. REST. Conclusions: Novel RoC magnitudes RoC, RoC reflected rapid decays of glycemia during CONT exercise and gradual recoveries immediately afterwards. RESIST showed more constrained decays, whereas discrepancies were found for IHE. [ABSTRACT FROM AUTHOR]

Aims: To explore parents' experiences of using remote monitoring technology when caring for a very young child with type 1 diabetes during a clinical trial. Methods: Interviews were conducted with parents of 30 children (aged 1–7 years) participating in a trial (the KidsAP02 study) comparing hybrid closed‐loop insulin delivery with sensor‐augmented pump therapy. In both arms, parents had access to remote monitoring technology. Data analysis focused on identification of descriptive themes. Results: Remote monitoring technology gave parents improved access to data which helped them pre‐empt and manage glucose excursions. Parents observed how, when children were in their own care, they could be more absent while present, as their attention could shift to non‐diabetes‐related activities. Conversely, when children were others' care, remote monitoring enabled parents to be present while absent, by facilitating oversight and collaboration with caregivers. Parents described how remote monitoring made them feel more confident allowing others to care for their children. Parents' confidence increased when using a hybrid closed‐loop system, as less work was required to keep glucose in range. Benefits to children were also highlighted, including being able to play and sleep uninterrupted and attend parties and sleepovers without their parents. While most parents welcomed the increased sense of control remote monitoring offered, some noted downsides, such as lack of respite from caregiving responsibilities. Conclusions: Remote monitoring can offer manifold benefits to both parents and very young children with type 1 diabetes. Some parents, however, may profit from opportunities to take 'time out'. [ABSTRACT FROM AUTHOR]

The authors discuss a study regarding the role of dual-hormone closed-loop delivery system in a randomized controlled outpatient clinical trial. Topics mentioned include the use of simplified meal-bolus strategy based on the sizes of carbohydrate content, the challenge association with postprandial management of diabetes during closed loop, and the questions about the addition of glucagon to closed-loop insulin delivery.

Minimal model analysis of intravenous glucose tolerance test (IVGTT) glucose and insulin concentrations offers a validated approach to measuring insulin sensitivity, but model identification is not always successful. Improvements may be achieved by using alternative settings in the modeling process, although results may differ according to setting, and care must be exercised in combining results. IVGTT data (12 samples, regular test) from 533 men without diabetes was modeled by the traditional nonlinear regression (NLR) approach, using five different permutations of settings. Results were evaluated with reference to the more robust Bayesian hierarchical (BH) approach to model identification and to the proportion of variance they explained in known correlates of insulin sensitivity (age, BMI, blood pressure, fasting glucose and insulin, serum triglyceride, HDL cholesterol, and uric acid concentration). BH analysis was successful in all cases. With NLR analysis, between 17 and 35 IVGTTs were associated with parameter coefficients of variation (PCVs) for minimal model parameters S1 (insulin sensitivity) and SG (glucose effectiveness) of >100%. Systematic use of each different approach in combination reduced this number to five. Mean (interquartile range) SINLR was then 3.14 (2.29–4.63) min-1·mU-1·1 × 10-4 and 2.56 (1.74–3.83) min-1·mU-1·1 × 10-4 for SIBH (correlation 0.86, P < 0.0001). SINLR explained, on average, 10.6% of the variance in known correlates of insulin sensitivity, whereas SIBH explained 8.5%. In a large body of data, which BH analysis demonstrated could be fully identified, use of alternative modeling settings in NLR analysis could substantially reduce the number of analyses with PCVs >100%. SNLR compared favorably with SIBH in the proportion of variance explained in known correlates of insulin sensitivity. [ABSTRACT FROM AUTHOR]