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Introduction: Hybrid closed loop systems are now commercially available for people with type 1 diabetes and are increasingly being adopted into clinical practice. Real-world data reflect both the glycemic and quality of life benefits reported in trials. Areas covered: In this review, we summarize the key clinical efficacy and safety evidence for hybrid closed-loop systems, and the lived experience of users with type 1 diabetes across different age groups and during pregnancy. We comment on recent and emerging advancements addressing performance limitations and user experience, as well as the use of closed-loop systems in other types of diabetes. Expert opinion: Emerging technological developments in closed-loop systems focus on improving performance and increasing automation to further optimize glycemic outcomes and improve quality of life for users. Workforce developments are now urgently required to ensure widespread equitable access to this life-changing technology. Future applications of closed-loop technology are expected to expand into other types of diabetes including type 2 diabetes. [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]

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]

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]

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]

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]

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]

Aims: To identify key gaps in the research evidence base that could help improve how technology supports people with diabetes, and provide recommendations to researchers and research funders on how best to address them. Methods: A research workshop was conducted, bringing together research experts in diabetes, research experts in technology, people living with diabetes and healthcare professionals. Results: The following key areas within this field were identified, and research recommendations for each were developed: Matching the pace of research with that of technology developmentTime in range as a measureHealth inequalities and high‐risk groupsHow to train people to use technology most effectivelyImpact of technology usage on mental health Conclusions: This position statement outlines recommendations through which research could improve how technology is employed to care for and support people living with diabetes, and calls on the research community and funders to address them in future research programmes and strategies. [ABSTRACT FROM AUTHOR]

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]

Type 1 diabetes is a lifelong disease with high management burden. The majority of people with type 1 diabetes fail to achieve glycemic targets. Algorithm-driven automated insulin delivery (closed-loop) systems aim to address these challenges. This review provides an overview of commercial and emerging closed-loop systems. We review safety and efficacy of commercial and emerging hybrid closed-loop systems. A literature search was conducted and clinical trials using day-and-night closed-loop systems during free-living conditions were used to report on safety data. We comment on efficacy where robust randomized controlled trial data for a particular system are available. We highlight similarities and differences between commercial systems. Study data shows that hybrid closed-loop systems are safe and effective, consistently improving glycemic control when compared to standard therapy. While a fully closed-loop system with minimal burden remains the end-goal, these hybrid closed-loop systems have transformative potential in diabetes care. [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]

Objective: This study evaluated a novel diabetes treatment device that combines commercially available continuous glucose monitoring and insulin infusion technology in such a way as to perform insulin delivery and glucose sensing through a single skin insertion site (single-port device). Methods: Ten type 1 diabetes patients used the device for up to six days in their home/work environment for open-loop insulin delivery and glucose sensing. On an additional day, the device was used in combination with an algorithm to perform automated closed-loop glucose control under hospital settings. To assess the performance of the device, capillary blood glucose concentrations were frequently determined and a continuous glucose sensor was additionally worn by the patients. Results: The average mean absolute relative deviation from blood glucose concentrations obtained for the sensor of the device was low (median, 13.0%; interquartile range, 10.5–16.7%; n = 10) and did not differ from that of the additionally worn glucose sensor (versus 13.9%; 11.9–15.3%; P = 0.922). Furthermore, insulin delivery with the single-port device was reliable and safe during home use and, when performed in combination with the control algorithm, was adequate to achieve and maintain near normoglycemia. Conclusion: Our data show the feasibility of open- and closed-loop glucose control in diabetes patients using a device that combines insulin delivery and glucose sensing at a single tissue site. Significance: The reduction in device size and invasiveness achieved by this design may largely increase patient convenience and enhance acceptance of diabetes treatment with continuous glucose monitoring and insulin delivery technology. [ABSTRACT FROM AUTHOR]

Background: Studies have shown that overnight closed-loop insulin delivery can improve glucose control and reduce the risk of hypoglycemia and hence may improve metabolic outcomes and reduce burden for children with type 1 diabetes and their families. However, research so far has not reported insulin levels while comparing closed-loop to open-loop insulin delivery in children. Therefore, in this study we obtained glucose levels as well as plasma insulin levels in children with type 1 diabetes to evaluate the efficacy of a model—based closed-loop algorithm compared to an open-loop administration. Methods: Fifteen children with type 1 diabetes, 6–12 years, participated in this open-label single center study. We used a randomized cross over design in which we compared overnight closed-loop insulin delivery with sensor augmented pump therapy for two nights in both the hospital and at home (i.e., 1 night in-patient stay and at home per treatment condition). Only during the in-patient stay, hourly plasma insulin and blood glucose levels were assessed and are reported in this paper. Results: Results of paired sample t-tests revealed that although plasma insulin levels were significantly lower during the closed-loop than in the open-loop (Mean difference 36.51 pmol/l; t(13) = 2.13, p = .03, effect size d = 0.57), blood glucose levels did not vary between conditions (mean difference 0.76 mmol/l; t(13) = 1.24, p = .12, d = 0.37). The administered dose of insulin was significantly lower during the closed-loop compared with the open-loop (mean difference 0.10 UI; t(12) = 2.45, p = .02, d = 0.68). Conclusions: Lower insulin doses were delivered in the closed-loop, resulting in lower plasma insulin levels, whereby glucose levels were not affected negatively. This suggests that the closed-loop administration is better targeted and hence could be more effective. [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]

Objective: Despite advances in technology, optimal glucose control remains elusive and neonatal complications remain ubiquitous in type 1 diabetes (T1D) pregnancy. Our aim was to examine the safety, efficacy, and longer-term feasibility of day-and-night closed-loop insulin delivery.Research Design and Methods: We recruited 16 pregnant women (mean [SD]: age 32.8 [5.0] years, T1D duration 19.4 [10.2] years, HbA1c 8.0% [1.1], and BMI 26.6 [4.4] kg/m2) to an open-label, randomized, crossover trial. Participants completed 28 days of closed-loop and sensor-augmented pump (SAP) insulin delivery separated by a washout period. Afterward, participants could continue to use the closed-loop system up to 6 weeks postpartum. The primary end point was the proportion of time with glucose levels within the target range (63-140 mg/dL).Results: The proportion of time with glucose levels within target was comparable during closed-loop and SAP insulin delivery (62.3 vs. 60.1% [95% CI -4.1 to 8.3]; P = 0.47). Mean glucose and time spent hyperglycemic >140 mg/dL also did not differ (131.4 vs. 131.4 mg/dL [P = 0.85] and 36.6 vs. 36.1% [P = 0.86], respectively). During closed-loop, fewer hypoglycemic episodes occurred (median 8 [range 1-17] vs. 12.5 [1-53] over 28 days; P = 0.04) and less time at <63 mg/dL (1.6 vs. 2.7%; P = 0.02). Hypoglycemia <50 mg/dL (0.24 vs. 0.47%; P = 0.03) and low blood glucose index (1.0 vs. 1.4; P = 0.01) were lower. Less nocturnal hypoglycemia (2300-0700 h) during closed-loop therapy (1.1 vs. 2.7%; P = 0.008) and a trend toward higher overnight time in target (67.7 vs. 60.6%; P = 0.06) were found.Conclusions: Closed-loop insulin delivery was associated with comparable glucose control and significantly less hypoglycemia than SAP therapy. Larger, longer-duration multicenter trials are now indicated to determine clinical efficacy of closed-loop insulin delivery in T1D pregnancy and the impact on neonatal outcomes. [ABSTRACT FROM AUTHOR]

Measurement of glycated hemoglobin (HbA1c) has been the traditional method for assessing glycemic control. However, it does not reflect intra- and interday glycemic excursions that may lead to acute events (such as hypoglycemia) or postprandial hyperglycemia, which have been linked to both microvascular and macrovascular complications. Continuous glucose monitoring (CGM), either from real-time use (rtCGM) or intermittently viewed (iCGM), addresses many of the limitations inherent in HbA1c testing and self-monitoring of blood glucose. Although both provide the means to move beyond the HbA1c measurement as the sole marker of glycemic control, standardized metrics for analyzing CGM data are lacking. Moreover, clear criteria for matching people with diabetes to the most appropriate glucose monitoring methodologies, as well as standardized advice about how best to use the new information they provide, have yet to be established. In February 2017, the Advanced Technologies & Treatments for Diabetes (ATTD) Congress convened an international panel of physicians, researchers, and individuals with diabetes who are expert in CGM technologies to address these issues. This article summarizes the ATTD consensus recommendations and represents the current understanding of how CGM results can affect outcomes. [ABSTRACT FROM AUTHOR]

Parameters of physiological models of glucose–insulin regulation in type 1 diabetes have previously been estimated using data collected over short periods of time and lack the quantification of day-to-day variability. We developed a new hierarchical model to relate subcutaneous insulin delivery and carbohydrate intake to continuous glucose monitoring over 12 weeks while describing day-to-day variability. Sensor glucose data sampled every 10-min, insulin aspart delivery and meal intake were analyzed from eight adults with type 1 diabetes (male/female 5/3, age \text39.9\,\pm \,\text9.5 years, BMI \text25.4\,\pm \,\text4.4 kg/ m^2, HbA1c \text8.4\,\pm \,\text0.6%) who underwent a 12-week home study of closed-loop insulin delivery. A compartment model comprised of five linear differential equations; model parameters were estimated using the Markov chain Monte Carlo approach within a hierarchical Bayesian model framework. Physiologically, plausible a posteriori distributions of model parameters including insulin sensitivity, time-to-peak insulin action, time-to-peak gut absorption, and carbohydrate bioavailability, and good model fit were observed. Day-to-day variability of model parameters was estimated in the range of 38–79% for insulin sensitivity and 27–48% for time-to-peak of insulin action. In conclusion, a linear Bayesian hierarchical approach is feasible to describe a 12-week glucose–insulin relationship using conventional clinical data. The model may facilitate in silico testing to aid the development of closed-loop insulin delivery systems. [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]

Objective: This study evaluated the feasibility, safety, and efficacy of day-and-night hybrid closed-loop insulin delivery in adolescents with type 1 diabetes under free-living conditions.Research Design and Methods: In an open-label randomized crossover study, 12 suboptimally controlled adolescents on insulin pump therapy (mean ± SD age 14.6 ± 3.1 years; HbA1c 69 ± 8 mmol/mol [8.5 ± 0.7%]; duration of diabetes 7.8 ± 3.5 years) underwent two 21-day periods in which hybrid closed-loop insulin delivery was compared with sensor-augmented insulin pump therapy in random order. During the closed-loop intervention, a model predictive algorithm automatically directed insulin delivery between meals and overnight. Participants used a bolus calculator to administer prandial boluses.Results: The proportion of time that sensor glucose was in the target range (3.9-10 mmol/L; primary end point) was increased during the closed-loop intervention compared with sensor-augmented insulin pump therapy by 18.8 ± 9.8 percentage points (mean ± SD; P < 0.001), the mean sensor glucose level was reduced by 1.8 ± 1.3 mmol/L (P = 0.001), and the time spent above target was reduced by 19.3 ± 11.3 percentage points (P < 0.001). The time spent with sensor glucose levels below 3.9 mmol/L was low and comparable between interventions (median difference 0.4 [interquartile range -2.2 to 1.3] percentage points; P = 0.33). Improved glucose control during closed-loop was associated with increased variability of basal insulin delivery (P < 0.001) and an increase in the total daily insulin dose (53.5 [39.5-72.1] vs. 51.5 [37.6-64.3] units/day; P = 0.006). Participants expressed positive attitudes and experience with the closed-loop system.Conclusions: Free-living home use of day-and-night closed-loop in suboptimally controlled adolescents with type 1 diabetes is safe, feasible, and improves glucose control without increasing the risk of hypoglycemia. Larger and longer studies are warranted. [ABSTRACT FROM AUTHOR]

Research on and commercial development of the artificial pancreas (AP) continue to progress rapidly, and the AP promises to become a part of clinical care. In this report, members of the JDRF Artificial Pancreas Project Consortium in collaboration with the wider AP community 1) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA1c, and 2) identify a short set of basic, easily interpreted outcome measures to be reported in AP studies whenever feasible. Consensus on a broader range of measures remains challenging; therefore, reporting of additional metrics is encouraged as appropriate for individual AP studies or study groups. Greater consistency in reporting of basic outcome measures may facilitate the interpretation of study results by investigators, regulatory bodies, health care providers, payers, and patients themselves, thereby accelerating the widespread adoption of AP technology to improve the lives of people with type 1 diabetes. [ABSTRACT FROM AUTHOR]

Objective: To evaluate feasibility, safety, and efficacy of day-and-night hybrid closed-loop insulin delivery in adolescents with type 1 diabetes under free-living conditions without remote monitoring or supervision.Research Design and Methods: In an open-label, randomized, free-living, crossover study design, 12 adolescents receiving insulin pump therapy (mean [±SD] age 15.4 ± 2.6 years; HbA1c 8.3 ± 0.9%; duration of diabetes 8.2 ± 3.4 years) underwent two 7-day periods of sensor-augmented insulin pump therapy or hybrid closed-loop insulin delivery without supervision or remote monitoring. During the closed-loop insulin delivery, a model predictive algorithm automatically directed insulin delivery between meals and overnight; prandial boluses were administered by participants using a bolus calculator.Results: The proportion of time when the sensor glucose level was in the target range (3.9-10 mmol/L) was increased during closed-loop insulin delivery compared with sensor-augmented pump therapy (72 vs. 53%, P < 0.001; primary end point), the mean glucose concentration was lowered (8.7 vs. 10.1 mmol/L, P = 0.028), and the time spent above the target level was reduced (P = 0.005) without changing the total daily insulin amount (P = 0.55). The time spent in the hypoglycemic range was low and comparable between interventions.Conclusions: Unsupervised day-and-night hybrid closed-loop insulin delivery at home is feasible and safe in young people with type 1 diabetes. Compared with sensor-augmented insulin pump therapy, closed-loop insulin delivery may improve glucose control without increasing the risk of hypoglycemia in adolescents with suboptimally controlled type 1 diabetes. [ABSTRACT FROM AUTHOR]