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Aim: To evaluate the real‐world effectiveness of automated insulin delivery (AID) systems in patients with type 1 diabetes (T1D). Materials and Methods: PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov were searched for studies published up until 2 March 2024. We included pragmatic randomized controlled trials (RCTs), cohort studies, and before–after studies that compared AID systems with conventional insulin therapy in real‐world settings and reported continuous glucose monitoring outcomes. Percent time in range (TIR; 3.9–10 mmol/L), time below range (TBR; <3.9 mmol/L), time above range (TAR; >10 mmol/L), and glycated haemoglobin (HbA1c) level were extracted. Data were summarized as mean differences (MDs) with 95% confidence interval. Results: A total of 23 before–after studies (101 704 participants) were included in the meta‐analysis. AID systems were associated with an increased percentage of TIR (11.61%, 10.47 to 12.76; p < 0.001). The favourable effect of AID systems was consistently observed when used continuously for 6 (11.76%) or 12 months (11.33%), and in both children (12.16%) and adults (11.04%). AID systems also showed favourable effects on TBR (−0.53%, −0.63 to −0.42), TAR (−9.65%, −10.63 to −8.67) and HbA1c level (−0.42%, −0.47 to −0.37) when compared with previous treatments. Conclusions: Similar improvements in glycaemic parameters were observed in real‐world settings in RCTs using AID systems in T1D. AID systems benefit both children and adults by increasing TIR for both short‐ and long‐term interventions. [ABSTRACT FROM AUTHOR]

Type 1 diabetes (T1D) is the most frequent form of diabetes in pediatric age, affecting more than 1.5 million people younger than age 20 years worldwide. Early and intensive control of diabetes provides continued protection against both microvascular and macrovascular complications, enhances growth, and ensures normal pubertal development. In the absence of definitive reversal therapy for this disease, achieving and maintaining the recommended glycemic targets is crucial. In the last 30 years, enormous progress has been made using technology to better treat T1D. In spite of this progress, the majority of children, adolescents and young adults do not reach the recommended targets for glycemic control and assume a considerable burden each day. The development of promising new therapeutic advances, such as more physiologic insulin analogues, pioneering diabetes technology including continuous glucose monitoring and closed loop systems as well as new adjuvant drugs, anticipate a new paradigm in T1D management over the next few years. This review presents insights into current management of T1D in youths.

The integration of technologies such as continuous glucose monitors, insulin pumps, and smart pens into diabetes management has the potential to support the transformation of health care services that provide a higher quality of diabetes care, lower costs and administrative burdens, and greater empowerment for people with diabetes and their caregivers. Among people with diabetes, older adults are a distinct subpopulation in terms of their clinical heterogeneity, care priorities, and technology integration. The scientific evidence and clinical experience with these technologies among older adults are growing but are still modest. In this review, we describe the current knowledge regarding the impact of technology in older adults with diabetes, identify major barriers to the use of existing and emerging technologies, describe areas of care that could be optimized by technology, and identify areas for future research to fulfill the potential promise of evidence-based technology integrated into care for this important population.

Tremendous progress has been made towards achieving tight glycaemic control in individuals with diabetes mellitus through the use of frequent or continuous glucose measurements. However, in patients who require insulin, accurate dosing must consider multiple factors that affect insulin sensitivity and modulate insulin bolus needs. Accordingly, an urgent need exists for frequent and real-time insulin measurements to closely track the dynamic blood concentration of insulin during insulin therapy and guide optimal insulin dosing. Nevertheless, traditional centralized insulin testing cannot offer timely measurements, which are essential to achieving this goal. This Perspective discusses the advances and challenges in moving insulin assays from traditional laboratory-based assays to frequent and continuous measurements in decentralized (point-of-care and home) settings. Technologies that hold promise for insulin testing using disposable test strips, mobile systems and wearable real-time insulin-sensing devices are discussed. We also consider future prospects for continuous insulin monitoring and for fully integrated multisensor-guided closed-loop artificial pancreas systems.

BACKGROUND: We investigated the potential benefits of automated insulin delivery (AID) among individuals with type 1 diabetes (T1D) in sub-populations of baseline device use determined by continuous glucose monitor (CGM) use status and insulin delivery via multiple daily injections (MDI) or insulin pump. MATERIALS AND METHODS: In a six-month randomized, multicenter trial, 168 individuals were assigned to closed-loop control (CLC, Control-IQ, Tandem Diabetes Care), or sensor-augmented pump (SAP) therapy. The trial included a two- to eight-week run-in phase to train participants on study devices. The participants were stratified into four subgroups: insulin pump and CGM (pump+CGM), pump-only, MDI and CGM (MDI+CGM), and MDI users without CGM (MDI-only) users. We compared glycemic outcomes among four subgroups. RESULTS: At baseline, 61% were pump+CGM users, 18% pump-only users, 10% MDI+CGM users, and 11% MDI-only users. Mean time in range 70-180 mg/dL (TIR) improved from baseline in the four subgroups using CLC: pump+CGM, 62% to 73%; pump-only, 61% to 70%; MDI+CGM, 54% to 68%; and MDI-only, 61% to 69%. The reduction in time below 70 mg/dL from baseline was comparable among the four subgroups. No interaction effect was detected with baseline device use for TIR (P = .67) or time below (P = .77). On the System Usability Questionnaire, scores were high at 26 weeks for all subgroups: pump+CGM: 87.2 ± 12.1, pump-only: 89.4 ± 8.2, MDI+CGM 87.2 ± 9.3, MDI: 78.1 ± 15. CONCLUSIONS: There was a consistent benefit in patients with T1D when using CLC, regardless of baseline insulin delivery modality or CGM use. These data suggest that this CLC system can be considered across a wide range of patients.

Aims Methods Results Conclusions There are marked inequities in clinical outcomes and rates of diabetes technology use among youth with type 1 diabetes (T1D). The quantitative data from our mixed methods cohort study identified significant improvements in glycaemia and quality of life in participants. We aimed to use qualitative methods to provide further insight into our quantitative findings in the setting of underlying health disparities.Fifteen publicly insured, insulin pump‐naïve non‐Hispanic Black youth aged 6–21 years with T1D and baseline haemoglobin A1c (HbA1c) ≥86 mmol/mol (10%) and their parents participated in a mixed methods cohort study. Semi‐structured interviews were conducted separately with parents and youth after completion of 6 months of HCL use. Three topic areas were explored: (1) Experience using HCL, (2) barriers to HCL and (3) facilitators to accessing HCL. Semantic content analysis and consensus coding involving two team members were used to generate themes. Thematic saturation was achieved.Youth (Medianage 14.9 years, 67% female) and parents (92% female) were interviewed. Youth and their parents reported that access to HCL provides a new outlook on living with T1D, although managing T1D is still hard. They felt that diabetes technology is most helpful for those struggling with management. Participants experienced barriers to access including misconceptions of HCL systems, clinician bias and systemic racism. They suggested these barriers can be overcome by offering diabetes technology education for all people with T1D, increasing awareness of HCL in the community and providing resources to overcome barriers created by social determinants of health.The voices of historically minoritised youth with suboptimal T1D control and their parents provide important, previously unreported experiences and perspectives on barriers and facilitators to using HCL that will shape interventions to improve equity in access to diabetes technology. [ABSTRACT FROM AUTHOR]

This article discusses the case of a neonate with transient neonatal diabetes mellitus (TNDM) who was successfully treated with the Medtronic MiniMed™ 780G system. TNDM is a rare disease that occurs within the first 6 months of life and can be classified as transient or permanent. The patient in this case had a defect in the 6q24 region and was initially treated with intravenous insulin infusion before transitioning to the MiniMed 780G system. The system allowed for good glucose control and prevented hypoglycemic events. The article highlights the benefits of insulin pump therapy for neonates with diabetes and emphasizes the importance of genetic testing for accurate diagnosis and treatment. [Extracted from the article]

BACKGROUND: Closed-loop control systems of insulin delivery may improve glycemic outcomes in young children with type 1 diabetes. The efficacy and safety of initiating a closed-loop system virtually are unclear. METHODS: In this 13-week, multicenter trial, we randomly assigned, in a 2:1 ratio, children who were at least 2 years of age but younger than 6 years of age who had type 1 diabetes to receive treatment with a closed-loop system of insulin delivery or standard care that included either an insulin pump or multiple daily injections of insulin plus a continuous glucose monitor. The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring. Secondary outcomes included the percentage of time that the glucose level was above 250 mg per deciliter or below 70 mg per deciliter, the mean glucose level, the glycated hemoglobin level, and safety outcomes. RESULTS: A total of 102 children underwent randomization (68 to the closed-loop group and 34 to the standard-care group); the glycated hemoglobin levels at baseline ranged from 5.2 to 11.5%. Initiation of the closed-loop system was virtual in 55 patients (81%). The mean (±SD) percentage of time that the glucose level was within the target range increased from 56.7±18.0% at baseline to 69.3±11.1% during the 13-week follow-up period in the closed-loop group and from 54.9±14.7% to 55.9±12.6% in the standard-care group (mean adjusted difference, 12.4 percentage points [equivalent to approximately 3 hours per day]; 95% confidence interval, 9.5 to 15.3; P

Abstract Aims/Introduction This study evaluated the effects of the Medtronic MiniMed 770G hybrid closed‐loop system on glycemic control and psychological aspects in persons with type 1 diabetes mellitus. Materials and Methods This 3‐month prospective observational study included 22 participants with type 1 diabetes mellitus who used the Medtronic MiniMed 640G predictive low‐glucose suspend system and were switched to the 770G system. Time in the range of 70–180 mg/dL and glycated hemoglobin levels were evaluated; satisfaction, emotional distress and quality of life were assessed using self‐reported questionnaires, including the Diabetes Treatment Satisfaction Questionnaire Status, Problem Area in Diabetes and Diabetes Therapy‐Related Quality of Life. Results Time in the range of 70–180 mg/dL increased (63.5 ± 13.4 to 73.0 ± 10.9% [mean ± standard deviation], P = 0.0010), and time above the range of 181–250 mg/dL decreased (26.9 ± 8.9 to 19.6 ± 7.1%, P

Background and Aims: Carbohydrate counting is a well-established tool for self-management of type 1 diabetes (T1D) and can improve glycemic control and potentially reduce long-term complication risk. However, it can also be burdensome, error-prone, and complicated for the patient. A randomized controlled trial was conducted to investigate glycemic control with carbohydrate counting ("flex") versus simplified meal announcement ("fix") in adolescents with T1D using the MiniMed™ 780G system. The present study reports follow-up data to 12 months. Methods: Adolescents with T1D were randomly assigned 1:1 to use the MiniMed™ 780G system alongside the flex versus fix approaches. Participants were followed for 12 months with outcomes recorded at 3, 6, 9, and 12 months. The primary endpoint was the difference in time-in-range (TIR), and secondary endpoints included glycated hemoglobin (HbA1c) and other glucose and insulin metrics. Results: At 12 months, TIR (proportion of time with sensor glucose 70–180 mg/dL) was significantly lower in the fix versus flex group (72.9% vs. 80.1%, respectively; P = 0.001). There was no significant difference in HbA1c between the fix (6.8% ± 0.5%) and flex groups (6.5% ± 0.5%) at 12 months (P = 0.092), and mean HbA1c was below 7% at all time points in both arms. Conclusions: Glycemic control with simplified meal announcement was maintained over 12 months. On average, the international consensus targets were met in both arms for all time points. The simplified approach represents a viable alternative to carbohydrate counting, particularly in people who find the latter burdensome; however, carbohydrate counting resulted in superior TIR. This study is registered with ClinicalTrials.gov, number NCT05069727. [ABSTRACT FROM AUTHOR]

Aims/Introduction: This study evaluated the effects of the Medtronic MiniMed 770G hybrid closed‐loop system on glycemic control and psychological aspects in persons with type 1 diabetes mellitus. Materials and Methods: This 3‐month prospective observational study included 22 participants with type 1 diabetes mellitus who used the Medtronic MiniMed 640G predictive low‐glucose suspend system and were switched to the 770G system. Time in the range of 70–180 mg/dL and glycated hemoglobin levels were evaluated; satisfaction, emotional distress and quality of life were assessed using self‐reported questionnaires, including the Diabetes Treatment Satisfaction Questionnaire Status, Problem Area in Diabetes and Diabetes Therapy‐Related Quality of Life. Results: Time in the range of 70–180 mg/dL increased (63.5 ± 13.4 to 73.0 ± 10.9% [mean ± standard deviation], P = 0.0010), and time above the range of 181–250 mg/dL decreased (26.9 ± 8.9 to 19.6 ± 7.1%, P < 0.0005). Glycated hemoglobin levels decreased (7.7 ± 1.0 to 7.2 ± 0.8%, P = 0.0021). The percentage of participants with time below the range of 54–69 mg/dL <4% of readings increased from 91% to 100% (P < 0.0005). No significant changes were detected in the satisfaction, emotional distress and quality of life levels, but increased sensor calibration might be related to worsened emotional distress and quality of life. Conclusions: The hybrid closed‐loop system decreased hyperglycemia and minimized hypoglycemia, but did not improve psychological aspects compared with the predictive low‐glucose suspend system, probably because sensor calibration was increased. [ABSTRACT FROM AUTHOR]

Patients with type 1 diabetes mellitus (T1D) require insulin administration at all times to maintain euglycemia and metabolic stability. Insulin administration in the perioperative period is complicated by fasting requirements and perioperative stressors that can change the patient's insulin needs. In addition, many anesthesia providers are not familiar with insulin dosing strategies and technology, such as insulin pumps and continuous glucose monitors (CGMs), that are commonly used by patients with T1D. Errors in perioperative insulin administration can lead to hypoglycemia, hyperglycemia, and diabetic ketoacidosis. This article reviews common errors of associated with the perioperative management of patients with T1D, including failure to assess and coordinate patient care preoperatively; failure to understand diabetes management and technology; failure to monitor blood glucose and recognize dysglycemia; and failure to appropriately administer basal insulin. [ABSTRACT FROM AUTHOR]

Background There are over 2000 pregnancies annually in women with type 1 diabetes in the UK. Despite recent improvements in diabetes technology, most women cannot achieve and maintain the recommended pregnancy glucose targets. Thus, one in two babies experience complications requiring neonatal care unit admission. Recent studies demonstrate that hybrid closed-loop therapy, in which algorithms adjust insulin delivery according to continuous glucose measurements, is effective for managing type 1 diabetes outside of pregnancy, but efficacy during pregnancy is unclear. Objective To examine the clinical efficacy of hybrid closed-loop compared to standard insulin therapy in pregnant women with type 1 diabetes. Design A multicentre, parallel-group, open-label, randomised, controlled trial in pregnant women with type 1 diabetes. Setting Nine antenatal diabetes clinics in England, Scotland and Northern Ireland. Participants Pregnant women with type 1 diabetes and above-target glucose levels, defined as glycated haemoglobin A1c of ≥ 48 mmol/mol (6.5%) in early pregnancy. Interventions A hybrid closed-loop system compared to standard insulin delivery (via insulin pump or multiple daily injections) with continuous glucose monitoring. Outcome measures The primary outcome is the difference between the intervention and control groups in percentage time spent in the pregnancy glucose target range (3.5–7.8 mmol/l) as measured by continuous glucose monitoring from 16 weeks’ gestation until delivery. Secondary outcomes include overnight time in range, time above range (> 7.8 mmol/l), glycated haemoglobin A1c, safety outcomes (diabetic ketoacidosis, severe hypoglycaemia, adverse device events), psychosocial functioning obstetric and neonatal outcomes. Results The percentage of time that maternal glucose levels were within target range was higher with closed-loop than standard insulin therapy: 68.2 ± 10.5 in closed-loop and 55.6 ± 12.5 in the control group (mean‑adjusted difference 10.5 percentage points, 95% confidence interval 7.0 to 14.0; p < 0.001). Results were consistent in secondary outcomes, with less time above range (−10.2%, 95% confidence interval −13.8 to −6.6%; p < 0.001), higher overnight time in range (12.3%, 95% confidence interval 8.3 to 16.2%; p < 0.001) and lower glycated haemoglobin A1c (−0.31%, 95% confidence interval −0.50 to −0.12%; p < 0.002) all favouring closed-loop. The treatment effect was apparent from early pregnancy and consistent across clinical sites, maternal glycated haemoglobin A1c categories and previous insulin regimen. Maternal glucose improvements were achieved with 3.7 kg less gestational weight gain and without additional hypoglycaemia or total daily insulin dose. There were no unanticipated safety problems (six vs. five severe hypoglycaemia cases, one diabetic ketoacidosis per group) and seven device-related adverse events associated with closed-loop. There were no between-group differences in patient-reported outcomes. There was one shoulder dystocia in the closed-loop group and four serious birth injuries, including one neonatal death in the standard care group. Limitations Our results cannot be extrapolated to closed-loop systems with higher glucose targets, and our sample size did not provide definitive data on maternal and neonatal outcomes. Conclusions Hybrid closed-loop therapy significantly improved maternal glycaemia during type 1 diabetes pregnancy. Our results support National Institute for Health and Care Excellence guideline recommendations that hybrid closed-loop therapy should be offered to all pregnant women with type 1 diabetes. Future work Future trials should examine the effectiveness of hybrid closed-loop started before pregnancy, or as soon as possible after pregnancy confirmation. Trial registration This trial is registered as ISRCTN56898625. Funding This award was funded by the National Institute of Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 16/35/01) and is published in full in Efficacy and Mechanism Evaluation; Vol. 11, No. 7. See the NIHR Funding and Awards website for further award information. Dexcom supplied the continuous glucose monitoring systems used by AiDAPT intervention- and control-arm participants at reduced cost. Plain language summary Pregnancy in women with type 1 diabetes is associated with complications for both mother and baby. Recent improvements in diabetes technology have not been sufficient to help most women achieve and maintain recommended pregnancy glucose targets. Hybrid closed-loop technology (an insulin pump, smartphone app and continuous glucose monitor), which automatically adjusts insulin doses according to glucose measurements, is effective in managing type 1 diabetes outside of pregnancy, but its effectiveness during pregnancy was unclear. To examine the effectiveness of hybrid closed-loop therapy compared to standard insulin therapy in pregnant women with type 1 diabetes, we conducted a randomised controlled trial in nine maternity clinics in England, Scotland and Northern Ireland. We enrolled pregnant women with type 1 diabetes and above-target glucose levels, defined as glycated haemoglobin A1c of ≥ 48 mmol/mol, in early pregnancy. Women were randomly assigned to either a hybrid closed-loop system or standard insulin delivery (insulin pump or multiple daily injections) with continuous glucose monitoring. This study found that hybrid closed-loop therapy improved maternal glucose levels during type 1 diabetes pregnancy, resulting in higher time spent in the target glucose range and less time above range. Mothers in the closed-loop group had less weight gain during pregnancy, without additional hypoglycaemia or insulin dose. The benefits of closed-loop were consistent across maternity clinics, maternal glucose levels and previous insulin pump or injection therapy. There were no unanticipated safety problems associated with using closed-loop. However, the study was too small to provide definite information on pregnancy outcomes, and the results cannot be inferred to other closed-loop systems with higher glucose targets. Future trials should examine the effectiveness of closed-loop started before pregnancy or as soon as possible after pregnancy confirmation. Our results support National Institute for Health and Care Excellence guideline recommendations that hybrid closed-loop therapy should be offered to all pregnant women with type 1 diabetes. Scientific summary Background There are over 2000 pregnancies annually in women with type 1 diabetes. These pregnancies are complicated by high and increasing rates of preterm births, large for gestational age birthweight babies and neonatal care unit admissions. Obstetric and neonatal complications are lowest in mothers who achieve target glucose levels, which requires unrelenting attention to diabetes self-management and insulin dose adjustment throughout pregnancy. Despite improvements in diabetes technology, including continuous glucose monitoring (CGM) and insulin pumps, most pregnant women with type 1 diabetes cannot achieve or maintain the pregnancy glucose targets. National audit data confirm that only 15% of women enter pregnancy with the recommended glycated haemoglobin A1c (HbA1c) target of 10 mmol/l). The primary outcome was the percentage of time spent with CGM glucose levels between 3.5 and 7.8 mmol/l between 16 weeks’ gestation and delivery. Safety outcomes included the number and severity of diabetic ketoacidosis (DKA), severe hypoglycaemia (SH) and adverse device events. Patient-reported outcomes were reported at around 34–36 weeks’ gestation using the following validated questionnaires: Insulin Delivery Systems: Perspectives, Ideas, Reflections and Expectations (INSPIRE); EuroQol-5 Dimensions health-related quality-of-life questionnaire (EQ-5D), Diabetes Distress Scale (DDS), hypoglycaemia fear survey II (HFS – worry scale only) and Pittsburgh Sleep Quality Index (PSQI). Maternal and neonatal outcomes were documented at hospital discharge following delivery. Protocol amendments implemented during the COVID-19 pandemic allowed participants the option to continue using CGM with standard or closed-loop insulin delivery as per their initial randomisation for up to 6 months post partum. Outcomes for those who participated in the observational post-partum extension study will be reported separately. Details of the clinical study protocol are published. Primary outcome analysis was by intention-to-treat using a linear mixed-effects regression model adjusted for baseline CGM TIR, insulin delivery and clinical site. Missing primary end-point data were handled using multiple imputation (Rubins and direct likelihood methods) with all randomised participants included. For secondary outcomes, analyses were similar to the primary analysis, without imputation. False discovery rate (FDR)-adjusted p-values were calculated for selected secondary outcomes (overall, overnight, and by-trimester sensor glucose metrics, HbA1c, insulin doses, subgroup analyses, questionnaires) using Benjamini–Hochberg methods. For attainment of sensor glucose targets, a mixed-effects logistic regression model was fitted adjusting for baseline TIR, insulin delivery and clinical site as a random effect. All p-values are two-tailed. Analyses were performed using SAS® 9.4 (SAS Institute Inc., Cary, NC, USA; SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries.® indicates USA registration). Results Participants Between September 2019 and May 2022, 334 participants were assessed for eligibility, with 126 enrolled and 124 randomised: 61 to the closed-loop intervention group and 63 to the standard care control group. Participants were from nine NHS maternity clinics and spanned a range of maternal age, body weight and glycaemic categories. Almost all (98%) were using CGM and approximately half were using insulin pump therapy at enrolment. Participants in the closed-loop group had more previous pregnancies, while those in the standard care group reported more previous DKA events. Two participants switched from their randomised allocation group: one intervention participant for whom lockdown restrictions prevented closed-loop training and one standard care participant who procured closed-loop (CamAPS FX) outside of the trial. Seven participants in each group discontinued their allocated treatment. Despite the impact of the COVID-19 pandemic, the proportion of completed study visits was high (approximately 95%). Participants in the standard care group had more additional clinic visits (1.5 vs. 1.1) and more unscheduled contacts (9.6 vs. 6.1), mostly for pregnancy and diabetes-related reasons. The frequency of sensor use was consistently high: median 97% across both treatment groups. The frequency of closed-loop use was high (median 96%) and remained > 95% throughout pregnancy. Primary efficacy end point The mean (± standard deviation) percentage of time that maternal glucose levels were within the pregnancy target range increased from 47.8 ± 16.4% to 68.2 ± 10.5% in the closed-loop group and from 44.5 ± 14.4% to 55.6 ± 12.5% in the control group [mean‑adjusted difference 10.5 percentage points, 95% confidence interval (CI) 7.0 to 14.0 percentage points; p < 0.001]. Adjustment for potential confounding variables, including previous pregnancies and DKA episodes, did not change the treatment difference. There were no variations in the treatment effect between trial sites and no differential effects across maternal age, HbA1c or insulin delivery categories. The large treatment difference was consistent between intention-to-treat and per-protocol analyses and using multiple imputation methods. Secondary glycaemic outcomes Participants randomised to closed-loop spent less time with glucose levels above target range (mean difference −10.2%, 95% CI −13.8% to −6.6%; p < 0.001). This was accompanied by decreased hyperglycaemia across milder (> 6.7 mmol/l) and more pronounced (> 10.0 mmol/l) categories, as well as lower mean glucose and lower HbA1c (mean difference −0.31%, 95% CI −0.50% to −0.12%; p < 0.002). These changes are notable since participants in both groups spent approximately 70% of time in the near-optimal glucose range of 3.5–10.0 mmol/l at enrolment. Furthermore, in those who started closed-loop therapy during the first trimester, a 5% higher TIR was observed by the end of 12 weeks’ gestation. The effects of the intervention during the overnight period (23.00–07.00) closely followed the 24-hour results (12.3% higher TIR, 95% CI 8.3% to 16.2%; p < 0.001). This was accompanied by less nocturnal hypoglycaemia and fewer nocturnal hypoglycaemic events. Attainment of the sensor glucose target of > 70% time (16 hours 48 minutes) within the pregnancy-specific range was achieved by 28 (47%) closed-loop and 7 (11%) standard care participants. Attainment of the sensor glucose target of 95%) throughout pregnancy, and without apparent safety problems, including among those new to insulin pump therapy. Indeed, participants who continued standard care had more clinic visits and more unscheduled contacts, suggesting that beyond initial training, closed-loop use did not require additional healthcare professional input. Recent trials have demonstrated the benefits of CamAPS FX to those with newly diagnosed type 1 diabetes and young children, and these results further extend the evidence for closed-loop therapy to pregnant women. During pregnancy, women in the closed-loop group increased the percentage of time with near-target glucose levels (3.5–10.0 mmol/l) from 71 to 87%. This is, to the best of our knowledge, the tightest glycaemic control yet achieved through use of closed-loop therapy. Alongside women’s motivation to minimise pregnancy complications, closed-loop use facilitated attainment of 70% time in pregnancy-specific target range throughout gestation. This suggests that tighter glycaemic control could also be feasible outside of pregnancy, when clinically warranted. Given the rapid increases in TIR observed within 1 week of therapy initiation in this trial, and within 1 day in a recent trial, we speculate that further benefits may be obtained from starting closed-loop before pregnancy, or as soon as possible, after pregnancy is confirmed. The current trial participants gained an additional 10% TIR above and beyond the 10% increment achieved by CGM and standard insulin therapy across pregnancy. Previous studies demonstrated that every 5% increased TIR is associated with improved obstetric and neonatal outcomes. Our trial was not powered for pregnancy outcomes, but we infer that this additional 10% time in the pregnancy target range would be expected to have additional health benefits for mothers and their babies. The strengths of our trial include its parallel-group, randomised controlled design, generalisability of our patient population, including those naive to insulin pump therapy and a large proportion who initiated therapy during the first trimester, and a flexible pragmatic trial protocol that facilitated virtual or in-person visits. There was no evidence of increased clinical contacts, frequently observed in investigational device trials. This trial had certain limitations. We did not undertake a health economic evaluation and the current sample size did not provide definitive data on maternal and neonatal health outcomes. Furthermore, our data are applicable only to the CamAPS FX closed-loop system and cannot be extrapolated to systems with higher glucose targets. Closed-loop therapy was effective in type 1 diabetes pregnancy, safely accommodating the marked gestational changes in insulin doses across a range of maternal body weight and glycaemic categories. It gave additional clinical advantage above and beyond that which can be achieved by CGM and standard insulin therapy, supporting NICE guideline recommendations that hybrid closed-loop therapy should be offered to all pregnant women with type 1 diabetes. Trial registration This trial is registered as ISRCTN56898625. Funding This award was funded by the National Institute of Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 16/35/01) and is published in full in Efficacy and Mechanism Evaluation; Vol. 11, No. 7. See the NIHR Funding and Awards website for further award information. Dexcom supplied the continuous glucose monitoring systems used by AiDAPT intervention- and control-arm participants at reduced cost.

BACKGROUND: Currently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine operation. In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting. METHODS: In this 13-week, multicenter, randomized trial, we randomly assigned in a 2:1 ratio persons at least 6 years of age with type 1 diabetes either to receive bionic pancreas treatment with insulin aspart or insulin lispro or to receive standard care (defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring). The primary outcome was the glycated hemoglobin level at 13 weeks. The key secondary outcome was the percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter; the prespecified noninferiority limit for this outcome was 1 percentage point. Safety was also assessed. RESULTS: A total of 219 participants 6 to 79 years of age were assigned to the bionic-pancreas group, and 107 to the standard-care group. The glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic-pancreas group and did not change (was at 7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, -0.5 percentage points; 95% confidence interval [CI], -0.6 to -0.3; P

Background: Automated insulin delivery (AID) systems have proven effective in increasing time-in-range during both clinical trials and real-world use. Further improvements in outcomes for single-hormone (insulin only) AID may be limited by suboptimal insulin delivery settings. Methods: Adults (≥18 years of age) with type 1 diabetes were randomized to either sensor-augmented pump (SAP) (inclusive of predictive low-glucose suspend) or adaptive zone model predictive control AID for 13 weeks, then crossed over to the other arm. Each week, the AID insulin delivery settings were sequentially and automatically updated by an adaptation system running on the study phone. Primary outcome was sensor glucose time-in-range 70-180 mg/dL, with noninferiority in percent time below 54 mg/dL as a hierarchical outcome. Results: Thirty-five participants completed the trial (mean age 39 ± 16 years, HbA1c at enrollment 6.9% ± 1.0%). Mean time-in-range 70-180 mg/dL was 66% with SAP versus 69% with AID (mean adjusted difference +2% [95% confidence interval: -1% to +6%], P = 0.22). Median time

Using a closed-loop system significantly improves time in range (TIR) 70-180 mg/dL in patients with type 1 diabetes (T1D). In a 6-month RCT, 112 subjects were randomly assigned to closed-loop control (Tandem Control-IQ) after obtaining 2 weeks of baseline Continuous glucose monitoring (CGM) data from sensor-augmented pump therapy. We compared glycemic outcomes from baseline to end of study among subgroups classified by baseline HbA1c levels. All HbA1c subgroups showed an improvement in TIR due to reduction of both hyperglycemia and hypoglycemia. Those with HbA1c

BackgroundBlood glucose and insulin exhibit coordinated daily and hourly rhythms in people without diabetes (nonT1D). Although the presence and stability of these rhythms are associated with euglycemia, it is unknown if they (1) are preserved in individuals with type 1 diabetes (T1D) and (2) vary by therapy type. In particular, Hybrid Closed Loop (HCL) systems improve glycemia in T1D compared to Sensor Augmented Pump (SAP) therapies, but the extent to which either recapitulates coupled glucose and insulin rhythmicity is not well described. In HCL systems, more rapid modulation of glucose via automated insulin delivery may result in greater rhythmic coordination and euglycemia. Such precision may not be possible in SAP systems. We hypothesized that HCL users would exhibit fewer hyperglycemic event, superior rhythmicity, and coordination relative to SAP users.MethodsWavelet and coherence analyses were used to compare glucose and insulin delivery rate (IDR) within-day and daily rhythms, and their coordination, in 3 datasets: HCL (n = 150), SAP (n = 89), and nonT1D glucose (n = 16).ResultsGlycemia, correlation between normalized glucose and IDR, daily coherence of glucose and IDR, and amplitude of glucose oscillations differed significantly between SAP and HCL users. Daily glucose rhythms differed significantly between SAP, but not HCL, users and nonT1D individuals.ConclusionsSAP use is associated with greater hyperglycemia, higher amplitude glucose fluctuations, and a less stably coordinated rhythmic phenotype compared to HCL use. Improvements in glucose and IDR rhythmicity may contribute to the overall effectiveness of HCL systems.

IntroductionInsulin pumps and continuous glucose monitors (CGM) have many benefits in the management of type 1 diabetes. Unfortunately disparities in technology access occur in groups with increased risk for adverse effects (eg, low socioeconomic status [SES], public insurance).Research design & methodsUsing 2015 to 2016 data from 4,895 participants from the T1D Exchange Registry, a structural equation model (SEM) was fit to explore the hypothesized direct and indirect relationships between SES, insurance features, access to diabetes technology, and adverse clinical outcomes (diabetic ketoacidosis, hypoglycemia). SEM was estimated using the maximum likelihood method and standardized path coefficients are presented.ResultsHigher SES and more generous insurance coverage were directly associated with CGM use (β = 1.52, SE = 0.12, P < .0001 and β = 1.21, SE = 0.14, P < .0001, respectively). Though SES displayed a small inverse association with pump use (β = -0.11, SE = 0.04, P = .0097), more generous insurance coverage displayed a stronger direct association with pump use (β = 0.88, SE = 0.10, P < .0001). CGM use and pump use were both directly associated with fewer adverse outcomes (β = -0.23, SE = 0.06, P = .0002 and β = -0.15, SE = 0.04, P = .0002, respectively). Both SES and insurance coverage demonstrated significant indirect effects on adverse outcomes that operated through access to diabetes technology (β = -0.33, SE = 0.09, P = .0002 and β = -0.40, SE = 0.09, P < .0001, respectively).ConclusionsThe association between SES and insurance coverage and adverse outcomes was primarily mediated through diabetes technology use, suggesting that disparities in diabetes outcomes have the potential to be mitigated by addressing the upstream disparities in technology use.

Diabetes Technology Society hosted its annual Diabetes Technology Meeting on November 4 to November 6, 2021. This meeting brought together speakers to discuss various developments within the field of diabetes technology. Meeting topics included blood glucose monitoring, continuous glucose monitoring, novel sensors, direct-to-consumer telehealth, metrics for glycemia, software for diabetes, regulation of diabetes technology, diabetes data science, artificial pancreas, novel insulins, insulin delivery, skin trauma, metabesity, precision diabetes, diversity in diabetes technology, use of diabetes technology in pregnancy, and green diabetes. A live demonstration on a mobile app to monitor diabetic foot wounds was presented.

BACKGROUND: Highly variable insulin sensitivity, susceptibility to hypoglycemia and inability to effectively communicate hypoglycemic symptoms pose significant challenges for young children with type 1 diabetes (T1D). Herein, outcomes during clinical MiniMed™ 670G system use were evaluated in children aged 2-6 years with T1D. METHODS: Participants (N = 46, aged 4.6 ± 1.4 years) at seven investigational centers used the MiniMed™ 670G system in Manual Mode during a two-week run-in period followed by Auto Mode during a three-month study phase. Safety events, mean A1C, sensor glucose (SG), and percentage of time spent in (TIR, 70-180 mg/dl), below (TBR, 180 mg/dl) range were assessed for the run-in and study phase and compared using a paired t-test or Wilcoxon signed-rank test. RESULTS: From run-in to end of study (median 87.1% time in auto mode), mean A1C and SG changed from 8.0 ± 0.9% to 7.5 ± 0.6% (p

Continuous subcutaneous insulin infusion (CSII) therapy is becoming increasingly popular. CSII provides convenient insulin delivery, precise dosing, easy adjustments for physical activity, stress, or illness, and integration with continuous glucose monitors in hybrid or other closed-loop systems. However, even as insulin pump hardware and software have advanced, technology for insulin infusion sets (IISs) has stayed relatively stagnant over time and is often referred to as the "Achilles heel" of CSII. To discuss barriers to insulin pump therapy and present information about advancements in, and results from clinical trials of extended wear IISs, Diabetes Technology Society virtually hosted the "Improving the Patient Experience with Longer Wear Infusion Sets Symposium" on December 1, 2021. The symposium featured experts in the field of IISs, including representatives from Steno Diabetes Center Copenhagen, University of California San Francisco, Stanford University, Medtronic Diabetes, and Science Consulting in Diabetes. The webinar's seven speakers covered (1) advancements in insulin pump therapy, (2) efficacy of longer wear infusion sets, and (3) innovations to reduce plastics and insulin waste.

With the first commercially available smart insulin pens, the predominant insulin delivery device for millions of people living with diabetes is now coming into the digital age. Smart insulin pens (SIPs) have the potential to reshape a connected diabetes care ecosystem for patients, providers, and health systems. Existing SIPs are enhanced with real-time wireless connectivity, digital dose capture, and integration with personalized dosing decision support. Automatic dose capture can promote effective retrospective review of insulin dose data, particularly when paired with glucose data. Patients, providers, and diabetes care teams will be able to make increasingly data-driven decisions and recommendations, in real time, during scheduled visits, and in a more continuous, asynchronous care model. As SIPs continue to progress along the path of digital transformation, we can expect additional benefits: iteratively improving software, machine learning, and advanced decision support. Both these technological advances, and future care delivery models with asynchronous interactions, will depend on easy, open, and continuous data exchange between the growing number of diabetes devices. SIPs have a key role in modernizing diabetes care for a large population of people living with diabetes.

Current guidelines support the use of continuous glucose monitoring devices and insulin pumps in minor surgical procedures for pediatric patients with type 1 diabetes mellitus. However, there are few reported cases of using hybrid closed loop technology in the perioperative period. This retrospective case series presents seven pediatric patients with type 1 diabetes who underwent eight surgical procedures with maintenance of hybrid closed loop systems. This paper also provides considerations for future use of hybrid closed loop systems perioperatively. [ABSTRACT FROM AUTHOR]

Closed-loop insulin delivery systems are fast becoming the standard of care in the management of type 1 diabetes and have led to significant improvements in diabetes management. Nevertheless, there is still room for improvement for the closed-loop systems to optimize treatment and meet target glycemic control. Adjunct treatments have been introduced as an alternative method to insulin-only treatment methods to overcome diabetes treatment challenges and improve clinical and patient reported outcomes during closed-loop treatment. The adjunct treatment agents mostly consist of medications that are already approved for type 2 diabetes treatment and aim to complete the missing physiologic factors, such as the entero-endocrine system, that regulate glycemia in addition to insulin. This paper will review many of these adjunct therapies, including the basic mechanisms of action, potential benefits, side effects, and the evidence supporting their use during closed-loop treatment.

BackgroundThe introduction of insulin pumps with bolus calculators (BCs) has improved glycemic outcomes and quality of life for those with type 1 diabetes. Despite the increased reliance on BCs, the formulas used to derive recommended boluses are not standardized. Our objective was to examine whether recommendations from different pump BCs vary significantly for identical clinical scenarios.MethodsThree commercially available insulin pump BCs were programmed with identical settings and then presented with combinations of blood glucose (BG) and carbohydrates (CHOs) to generate a 4-unit bolus. At one- and two-hour time points, while there was insulin-on-board (IOB) present, we simulated various BG and CHO scenarios in order to compare BC-recommended doses.ResultsDifferences in suggested doses were noted between BCs, as well as within the same brand. The greatest variation was apparent when BG was below target. Doses suggested by one BC varied depending on whether the IOB resulted from a previous dose given for BG or CHO, while the other two BCs adjusted for total IOB regardless of the source.ConclusionsIn this simulation study, there were large differences in recommended doses between BCs due to the unique way each manufacturer incorporates IOB into their formulas as well as the pharmacokinetics used to derive the IOB amount. Providers should be aware that identical pump settings will result in a different dose recommendation for each pump brand and advise patients accordingly.

With the expanding use of continuous glucose monitoring (CGM) and insulin pumps worldwide, several international guidelines dedicated to diabetes technology have been developed. Recently, the Korean Diabetes Association released a new version of their clinical practice guidelines including substantial changes in recommendations on the use of CGM and insulin pumps. Of note, continuous use of realtime CGM is now recommended to all people with diabetes using insulin, including people with type 2 diabetes using once daily basal insulin. Convincing evidence from recent automated insulin delivery (AID) trials supports the recommendation of AID as standard therapy in type 1 diabetes. This review summarizes the results of recent clinical studies on CGM and AID and their influence on the new clinical recommendations. [ABSTRACT FROM AUTHOR]

A few people with type 1 diabetes undergo multiple hospital admissions for acute glycaemic events. We report on a series of five such 'frequent flyers' who were provided with continuous subcutaneous insulin infusion (CSII) therapy. Mean HbA1c decreased from 9.7 ± 2.5% (83 ± 27 mmol/mol) to 7.9 ± 0.4% (63 ± 4.7 mmol/mol) after 2–4 months. Frequency of admissions for acute glycaemic events reduced in three but increased in two patients within 6 months. Total insulin dose and body mass index decreased in some patients and satisfaction was anecdotally higher. Some, but not all, 'frequent flyers' benefited from a trial of CSII. [ABSTRACT FROM AUTHOR]

Aims: To compare the time required for perioperative glucose management using fully automated closed‐loop versus standard insulin therapy. Methods: We performed a time–motion study to quantify the time requirements for perioperative glucose management with fully closed‐loop (FCL) and standard insulin therapy applied to theoretical scenarios. Following an analysis of workflows in different periods of perioperative care in elective surgery patients receiving FCL or standard insulin therapy upon hospital admission (pre‐ and intra‐operatively, at the intermediate care unit and general wards), the time of process‐specific tasks was measured by shadowing hospital staff. Each task was measured 20 times and its average duration in combination with its frequency according to guidelines was used to calculate the cumulative staff time required for blood glucose management. Cumulative time was calculated for theoretical scenarios consisting of elective minor and major abdominal surgeries (pancreatic surgery and sleeve gastrectomy, respectively) to account for the different care settings and lengths of stay. Results: The FCL insulin therapy reduced the time required for perioperative glucose management compared to standard insulin therapy, across all assessed care periods and for both perioperative pathways (range 2.1–4.5). For a major abdominal surgery, total time required was 248.5 min using FCL versus 753.9 min using standard insulin therapy. For a minor abdominal surgery, total time required was 68.6 min and 133.2 min for FCL and standard insulin therapy, respectively. Conclusions: The use of fully automated closed‐loop insulin delivery for inpatient glucose management has the potential to alleviate the workload of diabetes management in an environment with adequately trained staff. [ABSTRACT FROM AUTHOR]

BACKGROUND: Computerized insulin infusion protocols have demonstrated higher staff satisfaction, better compliance with protocols, and increased time with glucose in range compared to paper protocols. At University of California San Diego Health (UCSDH), we implemented an insulin infusion computer calculator (IICC) and transitioned it from a web-based platform directly into the electronic medication administration record (eMAR) of our primary electronic health record (EHR). METHODS: This is a retrospective analysis of 6306 adult patients at UCSDH receiving intravenous (IV) insulin infusion from March 7, 2013 to May 30, 2019. We created three periods of the study-(1) the pre-eMAR integration period; (2) the eMAR integration period; and (3) the post-eMAR integration period-and looked at the percentage of readings within goal range (90-150 mg/dL for intensive care unit [ICU], 90-180 mg/dL for non-ICU) in patients with and without hyperglycemic emergencies. As our safety endpoints, we elected to look at incidence of blood glucose (BG) readings

OBJECTIVE: To further evaluate the safety and efficacy of the Control-IQ closed-loop control (CLC) system in children with type 1 diabetes. RESEARCH DESIGN AND METHODS: After a 16-week randomized clinical trial (RCT) comparing CLC with sensor-augmented pump (SAP) therapy in 101 children 6-13 years old with type 1 diabetes, 22 participants in the SAP group initiated use of the CLC system (referred to as SAP-CLC cohort), and 78 participants in the CLC group continued use of CLC (CLC-CLC cohort) for 12 weeks. RESULTS: In the SAP-CLC cohort, mean percentage of time in range 70-180 mg/dL (TIR) increased from 55 ± 13% using SAP during the RCT to 65 ± 10% using CLC (P < 0.001), with 36% of the cohort achieving TIR >70% plus time

Introduction: The objective of this systematic literature review was to evaluate the available literature concerning the clinical, economic, and patient-reported benefits of insulin pen platforms, including connected insulin pens/caps/sleeves and insulin platforms, as well as mobile apps capable of receiving near real-time insulin dosing information. Methods: Medline and Embase databases and the Cochrane Library were searched for published literature between January 2015 and May 2021, and manual searches for conference abstracts from 2018 to May 2021 were performed. These searches were supplemented by internet searches for relevant literature and clinical trials. Study selection involved the population, intervention, comparator, outcomes, time frame, and study design outline. Included studies investigated connected insulin systems or connected caps/sleeves enabling pens to be connected, or apps able to connect to these systems, in individuals of all ages with type 1 or type 2 diabetes mellitus. Results: Searches identified a total of 26 publications (mostly observational studies and conference abstracts) for inclusion, representing ten unique, predominantly small studies. Evidence in this field is still in its early stages, and only two randomized controlled trials met our inclusion criteria. Available results showed that connected insulin pens and their systems potentially helped reduce suboptimal insulin use and may therefore improve glycemic control. Satisfaction of people with diabetes with the technologies used was high, and economic benefits were noted. Features of effective connected insulin pen devices include simplicity of use and data upload/sharing, useful "point-of-care" alerts, and simple and understandable data presentation to facilitate more effective consultations. Conclusions: Connected insulin pen systems could be increasingly considered as part of routine clinical care for insulin-treated persons with diabetes who must manage the complexity of their daily insulin routine. Future research focusing on the way data obtained from these devices can be most effectively used alongside other information is urgently needed. Plain Language Summary: Digital health tools, like text message reminders and mobile apps, are being used more often to help people with diabetes improve their health in a way that works for them. For people who take insulin to treat their diabetes, what has been missing is a way to track insulin doses alongside other diabetes information in an app. Connected insulin pens, also called smart pens, are able to do this. In this article we have looked at the evidence available on the benefits of connected insulin pens. We found that while information on connected insulin pens is limited at the moment, what there is shows that using a connected insulin pen can help people remember to take their insulin and give themselves the right dose and that those who have used a connected insulin pen or related technology are happy with it. Useful features of connected insulin pens include being easy to use, having an alert function, and being able to share the insulin information with the user's doctor. Connected insulin pens may also reduce diabetes-related costs. Connected insulin pens are likely to become more common for people with diabetes who take insulin, but there is a need for more research on how best to use them to improve the treatment of people with diabetes. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Limited information is available about glycemic outcomes with a closed-loop control (CLC) system compared with a predictive low-glucose suspend (PLGS) system. RESEARCH DESIGN AND METHODS: After 6 months of use of a CLC system in a randomized trial, 109 participants with type 1 diabetes (age range, 14-72 years; mean HbA1c, 7.1% [54 mmol/mol]) were randomly assigned to CLC (N = 54, Control-IQ) or PLGS (N = 55, Basal-IQ) groups for 3 months. The primary outcome was continuous glucose monitor (CGM)-measured time in range (TIR) for 70-180 mg/dL. Baseline CGM metrics were computed from the last 3 months of the preceding study. RESULTS: All 109 participants completed the study. Mean ± SD TIR was 71.1 ± 11.2% at baseline and 67.6 ± 12.6% using intention-to-treat analysis (69.1 ± 12.2% using per-protocol analysis excluding periods of study-wide suspension of device use) over 13 weeks on CLC vs. 70.0 ± 13.6% and 60.4 ± 17.1% on PLGS (difference = 5.9%; 95% CI 3.6%, 8.3%; P < 0.001). Time >180 mg/dL was lower in the CLC group than PLGS group (difference = -6.0%; 95% CI -8.4%, -3.7%; P < 0.001) while time

AimTo assess the associations between demographic and clinical characteristics and sensor glucose metrics in young children with type 1 diabetes, using masked, continuous glucose monitoring data from children aged 2 to < 8 years.Research design and methodsThe analysis included 143 children across 14 sites in the USA, enrolled in a separate clinical trial. Eligibility criteria were: age 2 to 10.0 mmol/l) and a median of ~1 h/day in hypoglycaemia (

BackgroundModern therapy for type 1 diabetes (T1D) increasingly utilizes technology such as insulin pumps and continuous glucose monitors (CGMs). Prior analyses suggest that T1D costs are driven by preventable hospitalizations, but recent escalations in insulin prices and use of technology may have changed the cost landscape.MethodsWe conducted a retrospective analysis of T1D medical costs from 2012 to 2016 using the OptumLabs Data Warehouse, a comprehensive database of deidentified administrative claims for commercial insurance enrollees. Our study population included 9445 individuals aged ≤18 years with T1D and ≥13 months of continuous enrollment. Costs were categorized into ambulatory care, hospital care, insulin, diabetes technology, and diabetes supplies. Mean costs for each category in each year were adjusted for inflation, as well as patient-level covariates including age, sex, race, census region, and mental health comorbidity.ResultsMean annual cost of T1D care increased from $11 178 in 2012 to $17 060 in 2016, driven primarily by growth in the cost of insulin ($3285 to $6255) and cost of diabetes technology ($1747 to $4581).ConclusionsOur findings suggest that the cost of T1D care is now driven by mounting insulin prices and growing utilization and cost of diabetes technology. Given the positive effects of pumps and CGMs on T1D health outcomes, it is possible that short-term costs are offset by future savings. Long-term cost-effectiveness analyses should be undertaken to inform providers, payers, and policy-makers about how to support optimal T1D care in an era of increasing reliance on therapeutic technology.

OBJECTIVE: Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system. RESEARCH DESIGN AND METHODS: This protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ≥14 years, and baseline HbA1c

BACKGROUND: We tested the safety and performance of the insulin-only configuration of the bionic pancreas (BP) closed-loop blood-glucose control system in a home-use setting to assess glycemic outcomes using different static and dynamic glucose set-points. METHOD: This is an open-label non-randomized study with three consecutive intervention periods. Participants had consecutive weeks of usual care followed by the insulin-only BP with (1) an individualized static set-point of 115 or 130 mg/dL and (2) a dynamic set-point that automatically varied within 110 to 130 mg/dL, depending on hypoglycemic risk. Human factors (HF) testing was conducted using validated surveys. The last five days of each study arm were used for data analysis. RESULTS: Thirteen participants were enrolled with a mean age of 28 years, mean A1c of 7.2%, and mean daily insulin dose of 0.6 U/kg (0.4-1.0 U/kg). The usual care arm had an average glucose of 145 ± 20 mg/dL, which increased in the static set-point arm (159 ± 8 mg/dL, P = .004) but not in the dynamic set-point arm (154 ± 10 mg/dL, P = ns). There was no significant difference in time spent in range (70-180 mg/dL) among the three study arms. There was less time

This study evaluated the safety and efficacy of tubeless patch pump called EOPatch in patients with well-controlled type 1 diabetes mellitus (T1DM). This 4-week, two-center, open-label, single-arm study enrolled 10 adult patients diagnosed with T1DM with glycosylated hemoglobin less than 7.5%. The co-primary end points were patch pump usage time for one attachment and number of serious adverse events related to the patch pump. The secondary end points were total amount of insulin injected per patch and changes in glycemic parameters including continuous glucose monitoring data compared to those at study entry. The median usage time per patch was 84.00 hours (interquartile range, 64.50 to 92.50). Serious adverse events did not occur during the trial. Four weeks later, time in range 70 to 180 mg/dL was significantly improved (70.71%±17.14 % vs. 82.96%±9.14%, P=0.01). The times spent below range (180 mg/dL) also improved (All P

OBJECTIVE: Artificial pancreas (AP) systems have been shown to improve glycemic control throughout the day and night in adults, adolescents, and children. However, AP testing remains limited during intense and prolonged exercise in adolescents and children. We present the performance of the Tandem Control-IQ AP system in adolescents and children during a winter ski camp study, where high altitude, low temperature, prolonged intense activity, and stress challenged glycemic control. METHODS: In a randomized controlled trial, 24 adolescents (ages 13-18 years) and 24 school-aged children (6-12 years) with Type 1 diabetes (T1D) participated in a 48 hours ski camp (∼5 hours skiing/day) at three sites: Wintergreen, VA; Kirkwood, and Breckenridge, CO. Study participants were randomized 1:1 at each site. The control group used remote monitored sensor-augmented pump (RM-SAP), and the experimental group used the t: slim X2 with Control-IQ Technology AP system. All subjects were remotely monitored 24 hours per day by study staff. RESULTS: The Control-IQ system improved percent time within range (70-180 mg/dL) over the entire camp duration: 66.4 ± 16.4 vs 53.9 ± 24.8%; P = .01 in both children and adolescents. The AP system was associated with a significantly lower average glucose based on continuous glucose monitor data: 161 ± 29.9 vs 176.8 ± 36.5 mg/dL; P = .023. There were no differences between groups for hypoglycemia exposure or carbohydrate interventions. There were no adverse events. CONCLUSIONS: The use of the Control-IQ AP improved glycemic control and safely reduced exposure to hyperglycemia relative to RM-SAP in pediatric patients with T1D during prolonged intensive winter sport activities.

Using a continuous glucose monitor (CGM) improves glycemic control in patients with type 1 diabetes. The ambulatory glucose profile (AGP) has been recommended as a standard method for reporting CGM data. However, in recently developed automated insulin delivery (AID) systems, a standard format for reporting data has not yet been developed. Instead, reports are specific to each system being used. Currently, the only FDA approved AID system is a hybrid closed-loop insulin pump. In these systems, the patient is still required to announce a meal, respond to alerts, and keep the system in automated insulin delivery. The integrated pump and sensor information provides insights into how the system is performing, and how to make changes to tunable parameters, such as carbohydrate to insulin ratios. The reports also offer a window into human behavior related to performing diabetes tasks, responding to alarms, reasons for exiting HCL, and how glycemic goals are being met. This article reviews the pump and CGM data provided by several of the current closed-loop systems with a focus on systems that are currently approved in the United States (MiniMed™ 670G, Tandem Basal:IQ) and those used by patients using do-it-yourself systems. A step-wise approach to reviewing the nuances of these systems is provided. The comparison may reinforce the importance of the continued need for streamlining a standard report for providers to be able to interpret the CGM data of these systems.

Semi-crystalline thermoplastics are an important class of biomaterials with applications in creating extracorporeal and implantable medical devices. In situ release of nitric oxide (NO) from medical devices can enhance their performance via NO's potent anti-thrombotic, bactericidal, anti-inflammatory, and angiogenic activity. However, NO-releasing semi-crystalline thermoplastic systems are limited and the relationship between polymer crystallinity and NO release profile is unknown. In this paper, the functionalization of poly(ether-block-amide) (PEBA), Nylon 12, and polyurethane tubes, as examples of semi-crystalline polymers, with the NO donor S-nitroso-N-acetylpenicillamine (SNAP) within, is demonstrated via a polymer swelling method. The degree of crystallinity of the polymer plays a crucial role in both SNAP impregnation and NO release. Nylon 12, which has a relatively high degree of crystallinity, exhibits an unprecedented NO release duration of over 5 months at a low NO level, while PEBA tubing exhibits NO release over days to weeks. As a new biomedical application of NO, the NO-releasing PEBA tubing is examined as a cannula for continuous subcutaneous insulin infusion. The released NO is shown to enhance insulin absorption into the bloodstream probably by suppressing the tissue inflammatory response, and thereby could benefit insulin pump therapy for diabetes management.

In contrast to Europe and the United States (US), conventional insulin pumps have not been widely used in East Asia, even among people with type 1 diabetes. Clinical experiences in Europe and the US indicate that automated insulin delivery (AID) can successfully improve the quality of glucose control even in people with type 1 diabetes who do not have experience with conventional insulin pumps. Therefore, prior use of a conventional insulin pump was not a requirement for successful introduction of AID. However, use of AID still requires full understanding of conventional insulin pump management, and AID-specific education as well. Besides basic information on continuous glucose monitoring and conventional insulin pumps, people with type 1 diabetes starting AID should understand the difference between closed-loop and open-loop insulin delivery, should have reasonable expectations for AID, and should be motivated to engage in clinical follow-up to prevent discontinuation of the use of AID devices. Failure to provide AID-specific education before and after the introduction of AID would result in discontinuation of the use of AID devices, which would in turn result in suboptimal glucose control. In this review, I summarize lessons from clinical experience where AID is already in clinical use, and discuss what preparations should be made for successful introduction of AID in Korean clinical practice. [ABSTRACT FROM AUTHOR]

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Objectives: Diabetic ketoacidosis (DKA) in type 1 diabetes (T1D) can occur during both insulin pump therapy (continuous subcutaneous insulin infusion, CSII) and insulin injection therapy (multiple daily injections, MDI). The primary aim of this study was to compare CSII and MDI regarding DKA frequency. A secondary aim was to compare metabolic derangement between CSII and MDI at hospital admission for DKA. Research Design and methods: Children 0–17.99 years with established T1D admitted for DKA in Sweden from February 1, 2015 to January 31, 2017 were invited to participate. Data regarding demographics, laboratory data, CSII or MDI, and access to ketone meters and CGM were provided through questionnaires and medical records. The Swedish National Diabetes Registry (SWEDIABKIDS) was used to compare the distribution of CSII and MDI in the national population with the population admitted for DKA, using the chi‐square goodness‐of‐fit test. Distribution of CSII and MDI was then categorized in clinical severity grades for mild (pH 7.20–7.29), moderate (pH 7.10–7.29) and severe DKA (pH <7.10). Results: The distribution of CSII at DKA admission was significantly larger than in the national pediatric population with T1D (74.7% vs. 59.7%, p = 0.002). CSII was overrepresented in mild DKA (85.2% vs. with CSII, p < 0.001), but not in moderate/severe DKA (57.9% with CSII, p = 0.82). Mean HbA1c at hospital admission was 73.9 mmol/mol with CSII and 102.7 mmol/mol with MDI. Conclusions: CSII was associated with higher risk of mild DKA than MDI. MDI was associated with markedly higher HbA1c levels than CSII at hospital admission for DKA. [ABSTRACT FROM AUTHOR]

Background: Among the treatments for type 1 diabetes mellitus (T1DM), Continuous Subcutaneous Insulin Infusion (CSII) is a device that infuses insulin through the subcutaneous tissue in an uninterrupted manner and that comes closest to the physiological secretion of insulin. The use of CSII can provide the family with greater security and children and adolescents have more autonomy in relation to the treatment of T1DM. There is a lack of reviews that systematically gather the mounting evidence about the use of CSII in children and adolescents with T1DM. Therefore, the aim of this review was to group and describe primary and secondary studies on the use of CSII in children and adolescents with T1DM. Methods: A systematic mapping review was performed based on searches in the following databases: PubMed, Embase, CINAHL, Lilacs and PsycINFO, using a combination of descriptors and keywords. The screening of the studies was carried out with the aid of the Rayyan software and reading in full was conducted independently by two reviewers. The data extraction of the studies was performed using an extraction tool adapted and validated by researchers specialized in diabetes. The data were analyzed according to the content analysis technique. The map from geocoding of the studies was produced using the ArcGis 10.5 software. Results: A total of 113 studies were included in the review, including primary studies, literature reviews and gray literature publications. The content analysis of the results of the studies allowed for the identification of four categories: 1) metabolic control; 2) support networks; 3) benefits of using CSII; and 4) challenges of using CSII, each category having its respective subcategories. The review also made it possible to conduct a rigorous mapping of the literature on the use of CSII considering the location of development and the design of the studies. Conclusions: The use of CSII should be indicated by health professionals able to prepare children, adolescents, and their families for the treatment of T1DM, and, despite being a technological device, it may not be suitable for the entire pediatric population. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the efficacy and safety of a dual‐hormone artificial pancreas (DH) in type 1 diabetes. Material and Methods: PubMed, Embase, the Cochrane Library and ClinicalTrials.gov were searched for studies published up to February 16, 2022. We included randomized controlled trials that compared DH with single-hormone artificial pancreas (SH), continuous subcutaneous insulin infusion (CSII) or sensor‐augmented pumps (SAP), and predictive low glucose suspend systems (PLGS) in type 1 diabetes. The primary outcome was percent time in target (3.9‐10 mmol/L [70‐180 mg/dL]). Data were summarized as mean differences (MDs) or risk differences (RDs). Results: A total of 17 randomized crossover trials (438 participants) were included. There were nine trials of DH versus SH, 13 trials of DH versus SAP/CSII, and two trials of DH versus PLGS. For time in target, DH showed no significant difference in time in target compared with SH (MD 2.69%, 95% confidence interval [CI] −0.38 to 5.76) but resulted in 16.05% (95% CI 12.06 to 20.05) and 6.89% (95% CI 2.63 to 11.14) more time in target range compared with SAP/CSII and PLGS, respectively. DH slightly reduced time in hypoglycaemia (MD −1.20%, 95% CI −1.85 to −0.56) but increased the risk of gastrointestinal symptoms (RD 0.18, 95% CI 0.08 to 0.27) compared with SH. Conclusions: The results of this study suggest that DH has a comparable effect on time in target compared with SH, but is associated with a longer time in target range compared with SAP/CSII and PLGS. The DH slightly reduced time in hypoglycaemia but may increase the risk of gastrointestinal symptoms compared with the SH. PROSPERO registration number: CRD42022314015. [ABSTRACT FROM AUTHOR]

Abstract Background Among the treatments for type 1 diabetes mellitus (T1DM), Continuous Subcutaneous Insulin Infusion (CSII) is a device that infuses insulin through the subcutaneous tissue in an uninterrupted manner and that comes closest to the physiological secretion of insulin. The use of CSII can provide the family with greater security and children and adolescents have more autonomy in relation to the treatment of T1DM. There is a lack of reviews that systematically gather the mounting evidence about the use of CSII in children and adolescents with T1DM. Therefore, the aim of this review was to group and describe primary and secondary studies on the use of CSII in children and adolescents with T1DM. Methods A systematic mapping review was performed based on searches in the following databases: PubMed, Embase, CINAHL, Lilacs and PsycINFO, using a combination of descriptors and keywords. The screening of the studies was carried out with the aid of the Rayyan software and reading in full was conducted independently by two reviewers. The data extraction of the studies was performed using an extraction tool adapted and validated by researchers specialized in diabetes. The data were analyzed according to the content analysis technique. The map from geocoding of the studies was produced using the ArcGis 10.5 software. Results A total of 113 studies were included in the review, including primary studies, literature reviews and gray literature publications. The content analysis of the results of the studies allowed for the identification of four categories: 1) metabolic control; 2) support networks; 3) benefits of using CSII; and 4) challenges of using CSII, each category having its respective subcategories. The review also made it possible to conduct a rigorous mapping of the literature on the use of CSII considering the location of development and the design of the studies. Conclusions The use of CSII should be indicated by health professionals able to prepare children, adolescents, and their families for the treatment of T1DM, and, despite being a technological device, it may not be suitable for the entire pediatric population.