Use of a decision support tool and quick start onboarding tool in individuals with type 1 diabetes using advanced automated insulin delivery: a single-arm multi-phase intervention study.

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

Glucose and Psychosocial Outcomes 12 Months Following Transition from Multiple Daily Injections to Advanced Hybrid Closed Loop in Youth with Type 1 Diabetes and Suboptimal Glycemia.

Objective: To investigate 12-month glycemic and psychosocial changes following transition from multiple daily injections (MDI) to advanced hybrid closed-loop (AHCL) therapy in youth (aged 13-25 years) with type 1 diabetes and suboptimal glycemia (glycated hemoglobin [HbA1c] ≥8.5% [69 mmol/mol]). Research Design and Methods: Prospective, single arm, dual-center study in 20 participants. Extension phase outcomes reported after 12 months, including HbA1c, time in glycemic ranges, AHCL system performance, and psychosocial questionnaires assessing quality of life, diabetes treatment, and sleep. Results: After 12 months, 19 out of 20 participants continued to use AHCL. Average time-in-range 70-180 mg/dL (3.9-10.0 mmol/L) improved from 27.6% ± 13.2% to 62.5% ± 11.4%. This translated to an average 2.5 percentage-point (27.1 mmol/mol) improvement in HbA1c from 10.5% ± 2.1% (91.2 mmol/mol) at baseline to 8.0% ± 0.9% (64.1 mmol/mol) at 12 months. Psychosocial questionnaires and very high HbA1c at study entry indicated significant diabetes-associated burden for both individuals and parents. After 12 months, improvements were observed in general and diabetes-specific health-related quality of life, as well as in diabetes treatment satisfaction. Safety data were reassuring with a diabetic ketoacidosis rate of 0.15 per participant-year after 12 months of AHCL (compared to 0.25 per participant-year in the 12 months before the study). Conclusions: After 12 months of AHCL usage, this study highlights the potential for substantial and sustained glycemic and psychosocial improvements among individuals experiencing considerable diabetes burden and suboptimal glycemia, following their switch from MDI to AHCL.

User experiences during the transition to calibration-free sensors with remote monitoring while using automated insulin delivery - a qualitative study.

Introduction: To evaluate the experiences of patients with type 1 diabetes following transition from a calibration-requiring to a calibration-free sensor and remote monitoring in the context of using automated insulin delivery (AID). Research design and methods: Fifteen participants aged 7-65 years with type 1 diabetes participating in a longitudinal study used a Medtronic® advanced hybrid closed loop (AHCL) device with initially calibration-requiring then calibration-free sensors. Qualitative interviews were conducted ≥20 weeks following use of the calibration-requiring and ≥4 weeks after use of the calibration-free sensors/remote monitoring. Thematic analysis was used to identify key themes and subthemes. Results: At baseline, mean diabetes duration was 14.5 years ( ± 10.9), mean Hba1c 54.8 mmol/mol ( ± 10.2) (7.2 ± 0.9%) and Time in range 75.4% ( ± 11.6). Participants reported a progressive improvement in digital and lifestyle integration, and device trust following transition to calibration-free sensors with remote monitoring potential. They also reported a reduced need for capillary glucose, increased device satisfaction and trust, and reduced burden of diabetes care. Negative aspects reported included periodic early sensor loss, and for some, impaired integration with mobile devices. Conclusion: Transitioning to calibration-free sensors with remote monitoring while using AHCL was associated with better user experience, including perceptions of improved quality of life and a reduced burden of diabetes care. Appropriate expectation setting, training, and ongoing support allow for the optimal user experience while using AHCL. Clinical trial registration: https://www.anzctr.org.au, identifier ACTRN12621000360819.

Managing intractable pain with neuraxial infusion at home.

A case study of a 9-year-old child with complex pain secondary to metastatic liver cancer, who eventually required intrathecal drug delivery (ITDD) of analgesia. Multi-modal symptom control strategies were deployed to achieve the child's and parental wishes for end-of-life care (EoLC) at home using ITDD. The following recommendations are made for nursing practice in paediatric palliative care (PPC); rigorous risk assessment, exemplary communication with the identification of a coordinating team, timely training needs assessment and the delivery of training from hospital based experts in ITDD practice, comprehensive symptom management plan and 24/7 access to specialist palliative care teams were essential for safe nursing practice. In this case, robust risk assessment and mitigations enabled challenges to be safely addressed with a successful outcome, extending the boundaries of PPC home care.

Interviews with Indigenous Maori with type 1 diabetes using open-source automated insulin delivery in the CREATE randomised trial.

Purpose: Open-source automated insulin delivery (AID) is used by thousands of people with type 1 diabetes (T1D), but has unknown generalisability to marginalised ethnic groups. This study explored experiences of Indigenous Maori participants in the CREATE trial with use of an open-source AID system to identify enablers/barriers to health equity. Methods: The CREATE randomised trial compared open-source AID (OpenAPS algorithm on an Android phone with a Bluetooth-connected pump) to sensor-augmented pump therapy. Kaupapa Maori Research methodology was used in this sub-study. Ten semi-structured interviews with Maori participants (5 children, 5 adults) and whanau (extended family) were completed. Interviews were recorded and transcribed, and data were analysed thematically. NVivo was used for descriptive and pattern coding. Results: Enablers/barriers to equity aligned with four themes: access (to diabetes technologies), training/support, operation (of open-source AID), and outcomes. Participants described a sense of empowerment, and improved quality of life, wellbeing, and glycaemia. Parents felt reassured by the system's ability to control glucose, and children were granted greater independence. Participants were able to use the open-source AID system with ease to suit whanau needs, and technical problems were manageable with healthcare professional support. All participants identified structures in the health system precluding equitable utilisation of diabetes technologies for Maori. Conclusion: Maori experienced open-source AID positively, and aspired to use this therapy; however, structural and socio-economic barriers to equity were identified. This research proposes strength-based solutions which should be considered in the redesign of diabetes services to improve health outcomes for Maori with T1D.Trial Registration: The CREATE trial, encompassing this qualitative sub-study, was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000034932p) on the 20th January 2020. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-023-01215-3.

Extended Use of an Open-Source Automated Insulin Delivery System in Children and Adults with Type 1 Diabetes: The 24-Week Continuation Phase Following the CREATE Randomized Controlled Trial.

Aim: To assess long-term efficacy and safety of open-source automated insulin delivery (AID) in children and adults (7-70 years) with type 1 diabetes. Methods: Both arms of a 24-week randomized controlled trial comparing open-source AID (OpenAPS algorithm within a modified version of AndroidAPS, preproduction DANA-i™ insulin pump, Dexcom G6 continuous glucose monitor) with sensor-augmented pump therapy (SAPT), entered a 24-week continuation phase where the SAPT arm (termed SAPT-AID) crossed over to join the open-source AID arm (termed AID-AID). Most participants (69/94) used a preproduction YpsoPump® insulin pump during the continuation phase. Analyses incorporated all 52 weeks of data, and combined between-group and within-subject differences to calculate an overall "treatment effect" of AID versus SAPT. Results: Mean time in range (TIR; 3.9-10 mmol/L [70-180 mg/dL]) was 12.2% higher with AID than SAPT (95% confidence interval [CI] 10.4 to 14.1; P < 0.001). TIR was 56.9% (95% CI 54.2 to 59.6) with SAPT and 69.1% (95% CI 67.1 to 71.1) with AID. The treatment effect did not differ by age (P = 0.39) or insulin pump type (P = 0.37). HbA1c was 5.1 mmol/mol lower [0.5%] with AID (95% CI -6.6 to -3.6; P < 0.001). There were no episodes of diabetic ketoacidosis or severe hypoglycemia with either treatment over the 48 weeks. Six participants (all in SAPT-AID) withdrew: three with hardware issues, two preferred SAPT, and one with infusion-site skin irritation. Conclusion: Further evaluation of the community derived automated insulin delivery (CREATE) trial to 48 weeks confirms that open-source AID is efficacious and safe with different insulin pumps, and demonstrates sustained glycemic improvements without additional safety concerns.

Impact of Advanced Hybrid Closed Loop on Youth With High-Risk Type 1 Diabetes Using Multiple Daily Injections.

OBJECTIVE: To evaluate glycemic outcomes in youth (aged 13-25 years) with type 1 diabetes and high-risk glycemic control (HbA1c ≥8.5% [69 mmol/mol]) on multiple daily injection (MDI) therapy after transitioning to advanced hybrid closed loop (AHCL) therapy. RESEARCH DESIGN AND METHODS: This prospective, 3-month, single-arm, dual-center study enrolled 20 participants, and all completed the study. RESULTS: HbA1c decreased from 10.5 ± 2.1% (91.2 ± 22.8 mmol/mol) at baseline to 7.6 ± 1.1% (59.7 ± 11.9 mmol/mol), and time spent in target range 70-180 mg/dL (3.9-10.0 mmol/L) increased from 27.6 ± 13.2% at baseline to 66.5 ± 9.8% after 3 months of AHCL. Two episodes of diabetic ketoacidosis attributed to infusion set failure occurred. CONCLUSIONS: AHCL has the potential to improve suboptimal glycemia in youth with type 1 diabetes previously on MDI therapy.

Open-Source Automated Insulin Delivery in Type 1 Diabetes.

BACKGROUND: Open-source automated insulin delivery (AID) systems are used by many patients with type 1 diabetes. Data are needed on the efficacy and safety of an open-source AID system. METHODS: In this multicenter, open-label, randomized, controlled trial, we assigned patients with type 1 diabetes in a 1:1 ratio to use an open-source AID system or a sensor-augmented insulin pump (control). The patients included both children (defined as 7 to 15 years of age) and adults (defined as 16 to 70 years of age). The AID system was a modified version of AndroidAPS 2.8 (with a standard OpenAPS 0.7.0 algorithm) paired with a preproduction DANA-i insulin pump and Dexcom G6 CGM, which has an Android smartphone application as the user interface. The primary outcome was the percentage of time in the target glucose range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter) between days 155 and 168 (the final 2 weeks of the trial). RESULTS: A total of 97 patients (48 children and 49 adults) underwent randomization (44 to open-source AID and 53 to the control group). At 24 weeks, the mean (±SD) time in the target range increased from 61.2±12.3% to 71.2±12.1% in the AID group and decreased from 57.7±14.3% to 54.5±16.0% in the control group (adjusted difference, 14 percentage points; 95% confidence interval, 9.2 to 18.8; P<0.001), with no treatment effect according to age (P = 0.56). Patients in the AID group spent 3 hours 21 minutes more in the target range per day than those in the control group. No severe hypoglycemia or diabetic ketoacidosis occurred in either group. Two patients in the AID group withdrew from the trial owing to connectivity issues. CONCLUSIONS: In children and adults with type 1 diabetes, the use of an open-source AID system resulted in a significantly higher percentage of time in the target glucose range than the use of a sensor-augmented insulin pump at 24 weeks. (Supported by the Health Research Council of New Zealand; Australian New Zealand Clinical Trials Registry number, ACTRN12620000034932.).

Improved technology satisfaction and sleep quality with Medtronic MiniMed® Advanced Hybrid Closed-Loop delivery compared to predictive low glucose suspend in people with Type 1 Diabetes in a randomized crossover trial.

BACKGROUND: Automated insulin delivery aims to lower treatment burden and improve quality of life as well as glycemic outcomes. METHODS: We present sub-study data from a dual-center, randomized, open-label, two-sequence crossover study in automated insulin delivery naïve users, comparing Medtronic MiniMed® Advanced Hybrid Closed-Loop (AHCL) to Sensor Augmented Pump therapy with Predictive Low Glucose Management (SAP + PLGM). At the end of each 4-week intervention, impacts on quality of life, sleep and treatment satisfaction were compared using seven age-appropriate validated questionnaires given to patients or caregivers. RESULTS: 59/60 people completed the study (mean age 23.3 ± 14.4yrs). Statistically significant differences favoring AHCL were demonstrated in several scales (data shown as mean ± SE). In adults (≥ 18yrs), technology satisfaction favored AHCL over PLGM as shown by a higher score in the DTSQs during AHCL (n = 28) vs SAP + PLGM (n = 29) (30.9 ± 0.7 vs 27.9 ± 0.7, p = 0.004) and DTSQc AHCL (n = 29) vs SAP + PLGM (n = 30) (11.7 ± 0.9 vs 9.2 ± 0.8, p = 0.032). Adolescents (aged 13-17yrs) also showed a higher DTSQc score during AHCL (n = 16) versus SAP + PLGM (n = 15) (14.8 ± 0.7 vs 12.1 ± 0.8, p = 0.024). The DTQ "change" score (n = 59) favored AHCL over SAP + PLGM (3.5 ± 0.0 vs 3.3 ± 0.0, p < 0.001). PSQI was completed in those > 16 years (n = 36) and demonstrated improved sleep quality during AHCL vs SAP + PLGM (4.8 ± 0.3 vs 5.7 ± 0.3, p = 0.048) with a total score > 5 indicating poor quality sleep. CONCLUSION: These data suggest that AHCL compared to SAP + PLGM mode has the potential to increase treatment satisfaction and improve subjective sleep quality in adolescents and adults with T1D.

Parental experiences of short term supported use of a do-it-yourself continuous glucose monitor (DIYrtCGM): A qualitative study.

AIMS: To investigate the experiences of parents caring for young children with type 1 diabetes type 1 diabetes using a do-it-yourself continuous glucose monitor (DIYrtCGM) in a supported setting. METHODS: Exit interviews were conducted with parents from 11 families at the end of the MiaoMiao study: a randomised cross-over trial focusing on parental fear of hypoglycaemia. Technical support was provided to participants while using DIYrtCGM during the trial. A convenience sampling approach was used to recruit parents. An in-depth, semi-structured interview approach was used. Thematic analysis was used to identify key themes and subthemes. RESULTS: Parents identified that remote monitoring enabled proactive management and that overall alarms/glucose alerts were useful. Some parents reported reductions in anxiety, increased independence for their child, and improvements in the child-parent relationship. However, parents also reported regular signal loss with DIYrtCGM, along with complicated apps and challenges troubleshooting technical problems. Despite this, nine of the 11 families continued to use the system after the end of the trial. CONCLUSIONS: Do-it-yourself continuous glucose monitoring (CGM) was on balance beneficial for the parents interviewed. However, while access to CGM shifted the burden of care experienced by parents, burden did not significantly reduce for all parents, as the improved glycaemic control that they achieved was accompanied with the responsibility for continually monitoring their child's data. Supported use of do-it-yourself CGM may be an achievable, cost-effective option for parents caring for children with type 1 diabetes in countries without funded access to CGM.

Learning challenges of healthcare professionals supporting open-source automated insulin delivery.

BACKGROUND: Open-source automated insulin delivery (AID) is a user-driven treatment modality used by thousands globally. Healthcare professionals' (HCPs) ability to support users of this technology is limited by a lack of knowledge of these systems. AIMS: To describe the challenges experienced by HCPs supporting participants' use of open-source automated insulin delivery in the Community deRivEd AuTomatEd insulin delivery (CREATE) study. METHODS: Data were collected prospectively from the study team's fortnightly meetings and Slack Workspace (Slack Technologies, Ltd. 2018) during the first 4 months of the trial. Key topics were identified from minutes of meetings. Slack conversations were categorised by topic, with the number of posts per conversation, number of sites per conversation and involvement of experts in open-source AID being recorded. RESULTS: In the first 4 months of the trial, there were 254 conversations in Slack with a mean of 5.2 (±4.25) posts per conversation. The most frequent learning challenge was insulin pump and cannula problems relating to the DANA-iTM insulin pump, which totalled 24.0% of all conversations. Experts on open-source AID use were involved in 83.3% of conversations. CONCLUSIONS: A significant proportion of challenges related to specific devices, rather than AID. Challenges relating to the functioning of open-source AID were more likely to involve input from experts in open-source AID. This is the first report of challenges experienced by a multidisciplinary team in a supported open-source environment that may inform expectations in routine clinical care.

Study protocol: Safety and efficacy of smart watch integrated do-it-yourself continuous glucose monitoring in adults with Type 1 diabetes, a randomised controlled trial.

PURPOSE: Type 1 diabetes (T1D) management requires regular monitoring of glucose levels and judicious therapeutic administration of insulin to prevent both microvascular and macrovascular complications. Few people with diabetes are able to sustain the self-monitored blood glucose measurements needed for optimal care, and those that do, typically experience significant diabetes-related distress. Both intermittently scanned continuous glucose monitoring (isCGM) and continuous glucose monitoring (CGM) offer alternatives to reduce the overall burden, but both still have limitations. Given the expense of CGM, smart watch integrated do-it-yourself (DIY)-CGM has been developed as an alternative to commercial isCGM and CGM technologies. This study has been designed to evaluate the clinical efficacy of smart watch integrated DIY-CGM compared with isCGM in adults with T1D. METHODS: This multicentre, randomised, crossover study will be conducted in New Zealand and aims to recruit 60 adults with established T1D who currently use isCGM. DIY-CGM will be compared to usual care with isCGM. Participants will be randomised to either arm of the study for 8 weeks followed by a 4-week washout period before crossing over to the other study arm for a further 8 weeks. The primary endpoint is glucose time in range (TIR) defined as percentage of time interstitial glucose is spent between 3.9 to 10 mmol/L for the entire intervention period. Secondary endpoints include diabetes-related quality of life, distress, and sleep quality in participants and their partners. DISCUSSION: The results of this study will provide clinical trial data regarding smart watch integrated DIY-CGM versus isCGM for improving glycaemic control in adults with T1D, and also report a variety of key secondary outcomes, including changes in subjective outcome measures for both people with diabetes and their partners. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12621000648820,31 May 2021); World Health Organisation International Clinical Trial Registry Platform (U1111-1262-2784, 3rd December 2020).

Unilateral pulmonary edema and acute severe mitral regurgitation associated with operatively repaired aortic coarctation.

Cardiogenic pulmonary edema classically presents bilaterally and with a symmetric distribution. Occasionally, cardiogenic pulmonary edema can present unilaterally, which carries an independent risk for mortality, possibly due to the delayed diagnosis. The most common cardiogenic cause of unilateral pulmonary edema is acute mitral regurgitation, frequently described in the setting of acute coronary syndrome. Here we describe a case of unilateral pulmonary edema caused by acute mitral regurgitation outside the setting of acute coronary syndrome.

Improved Glycemic Outcomes With Medtronic MiniMed Advanced Hybrid Closed-Loop Delivery: Results From a Randomized Crossover Trial Comparing Automated Insulin Delivery With Predictive Low Glucose Suspend in People With Type 1 Diabetes.

OBJECTIVE: To study the MiniMed Advanced Hybrid Closed-Loop (AHCL) system, which includes an algorithm with individualized basal target set points, automated correction bolus function, and improved Auto Mode stability. RESEARCH DESIGN AND METHODS: This dual-center, randomized, open-label, two-sequence crossover study in automated-insulin-delivery-naive participants with type 1 diabetes (aged 7-80 years) compared AHCL to sensor-augmented pump therapy with predictive low glucose management (SAP + PLGM). Each study phase was 4 weeks, preceded by a 2- to 4-week run-in and separated by a 2-week washout. RESULTS: The study was completed by 59 of 60 people (mean age 23.3 ± 14.4 years). Time in target range (TIR) 3.9-10 mmol/L (70-180 mg/dL) favored AHCL over SAP + PLGM (70.4 ± 8.1% vs. 57.9 ± 11.7%) by 12.5 ± 8.5% (P < 0.001), with greater improvement overnight (18.8 ± 12.9%, P < 0.001). All age-groups (children [7-13 years], adolescents [14-21 years], and adults [>22 years]) demonstrated improvement, with adolescents showing the largest improvement (14.4 ± 8.4%). Mean sensor glucose (SG) at run-in was 9.3 ± 0.9 mmol/L (167 ± 16.2 mg/dL) and improved with AHCL (8.5 ± 0.7 mmol/L [153 ± 12.6 mg/dL], P < 0.001), but deteriorated during PLGM (9.5 ± 1.1 mmol/L [17 ± 19.8 mg/dL], P < 0.001). TIR was optimal when the algorithm set point was 5.6 mmol/L (100 mg/dL) compared with 6.7 mmol/L (120 mg/dL), 72.0 ± 7.9% vs. 64.6 ± 6.9%, respectively, with no additional hypoglycemia. Auto Mode was active 96.4 ± 4.0% of the time. The percentage of hypoglycemia at baseline (<3.9 mmol/L [70 mg/dL] and ≤3.0 mmol/L [54 mg/dL]) was 3.1 ± 2.1% and 0.5 ± 0.6%, respectively. During AHCL, the percentage time at <3.9 mmol/L (70 mg/dL) improved to 2.1 ± 1.4% (P = 0.034) and was statistically but not clinically reduced for ≤3.0 mmol/L (54 mg/dL) (0.5 ± 0.5%; P = 0.025). There was one episode of mild diabetic ketoacidosis attributed to an infusion set failure in combination with an intercurrent illness, which occurred during the SAP + PLGM arm. CONCLUSIONS: AHCL with automated correction bolus demonstrated significant improvement in glucose control compared with SAP + PLGM. A lower algorithm SG set point during AHCL resulted in greater TIR, with no increase in hypoglycemia.

Serum anti-Müllerian hormone levels in women are unstable in the postpartum period but return to normal within 5 months: a longitudinal study.

PURPOSE: Anti-Müllerian hormone (AMH) levels fall during pregnancy but the amount of time required for AMH levels to return to normal has not been accurately determined. We have previously shown that AMH levels have yet to return to normal in some women at 3-months postpartum. In this study, AMH levels were examined at 1- and 5-months postpartum to examine whether AMH levels had returned to normal within this interval. METHODS: Longitudinal study involving 38 pregnant women, with serum samples taken in the first trimester, third trimester, 1-month postpartum, 5-months postpartum and 4-6 years postpartum. Participants were recruited from a tertiary maternity clinic (single centre). All women in the study were intending to breastfeed exclusively for at least 5 months, with all 38 participants achieving this at 1-month postpartum and 36/38 after 5 months. RESULTS: Serum AMH concentrations had not returned to expected non-pregnant levels by 1-month postpartum. At 5-months postpartum, mean AMH concentrations were similar to expected non-pregnant levels but the rank order of AMH concentrations was still dissimilar to the non-pregnant state. CONCLUSIONS: The regulation of AMH secretion appears to be distinctly different in non-pregnant, pregnant and postpartum populations. This may affect the conclusions that can be drawn from AMH measurements in women during pregnancy and the postpartum period.

Impact of Inappropriate Antibiotic Therapy in Vancomycin-Resistant Enterococcus Bacteremia.

BACKGROUND: Vancomycin-resistant Enterococcus (VRE) bacteremia has significant morbidity and mortality. Empiric antibiotic regimens for treating patients with risk factors for multidrug-resistant organisms may not have medications directed at treating VRE. STUDY QUESTION: To evaluate the impact of antibiotic therapy (and other risk factors) on mortality in VRE bacteremia. STUDY DESIGN: We identified 146 patients with VRE bacteremia, admitted at our institution over an 11 years period (2004-2014). All inpatients with an initial positive VRE blood culture were included only once in the analysis. Eighteen patients were excluded from the study because of inability to retrieve medical information regarding one or more important study variables. The retrospectively collected data from electronic medical records of 128 patients were analyzed. RESULTS: The inpatient, 30-day, and 1-year mortality rates from VRE bacteremia were 23%, 31%, and 59%, respectively. Only 19% patients were discharged home. Inappropriate antibiotics were prescribed in 19% patients. Appropriate antibiotics were prescribed in 81% patients (62% daptomycin and 37% linezolid); however, only 58% patients received appropriate antibiotics within 24 hours of the reported positive blood cultures. The 30-day and 1-year mortality rates for patients treated with inappropriate antibiotics were 54% and 67% compared with 26% and 50%, respectively, for those treated with appropriate antibiotics. The median survival rate for patients treated with inappropriate antibiotics was 1 month (95% confidence interval: 0.0-1.0) compared with 11 months (95% confidence interval: 4.0-13.0) for those treated with appropriate antibiotics. The advanced patient age (median age 75 years vs. 63 years) was a significant risk factor for inappropriate antibiotic therapy (P value = 0.02). The multivariate Cox regression model revealed inappropriate antibiotic therapy (P value = 0.003), septic shock (P value = 0.0004), albumin (P value = 0.04), and dementia (P value = 0.003) to be associated with 30-day mortality. CONCLUSIONS: Our study highlights the detrimental effect of inappropriate antibiotic therapy and other risk factors on morbidity and mortality associated with VRE bacteremia.

The MiaoMiao study: can do-it-yourself continuous glucose monitoring technology improve fear of hypoglycaemia in parents of children affected by type 1 diabetes?

PURPOSE: Type 1 diabetes (T1D) is one of the most common chronic diseases of childhood and comes with considerable management and psychological burden for children and their families. Fear of hypoglycaemia (FOH), particularly nocturnal hypoglycaemia, is a common worry. Continuous glucose monitoring (CGM) is a tool that may help reduce FOH, as well as reduce overall diabetes burden. However, CGM systems are expensive and often not publicly funded or subsidised. MiaoMiao (MM) is a novel relatively affordable third-party add-on technology to intermittently scanned CGM (isCGM). MM allows users to convert their isCGM to a form of "Do-it-yourself" (DIY)-CGM. Our hypothesis is that MM-CGM will result in significant reduction in parental fear from hypoglycaemia. The primary objective is to determine the impact of real-time DIY-CGM on parental fear of hypoglycaemia using Hypoglycaemia Fear Survey (HFS). METHODS: This is a multisite randomised cross-over study of 55 New Zealand children (ages 2-13 years) with established T1D and current users of isCGM (Abbott FreeStyle Libre). DIY-CGM will be compared to usual care with isCGM. Participants will be randomised to either arm of the study for 6 weeks followed by a 4-week wash-out period before crossing over to the other study arm for a further 6 weeks. DISCUSSION: The results of this study will provide much needed clinical trial data regarding DIY-CGM effectiveness in reducing parental FOH, as measured by HFS, as well as various other secondary outcomes including traditional glycaemic metrics, and child and caregiver sleep. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN 12619001551189) on 18 November 2019, and the World Health Organisation International Clinical Trial Registry Platform (Universal Trial Number U1111-1236-9189).

Pleural tuberculosis.

A 35-year-old woman with previously untreated latent tuberculosis was admitted to the hospital for management of a right-sided empyema. After a prolonged hospitalization and several interventions, including chest tubes, bronchoscopy with bronchoalveolar lavage, and a video-assisted thoracoscopic surgery, positive acid-fast bacilli cultures on the initial thoracentesis ultimately led to the diagnosis of pleural tuberculosis. This case highlights the importance of utilizing a combination of diagnostic tests to diagnose pleural tuberculosis, especially in the setting of a negative pleural adenosine deaminase level.

Factors influencing the community integration of patients following traumatic spinal cord injury: a systematic review.

BACKGROUND: Spinal cord injury (SCI) is a high-cost disabling condition, which brings a huge number of changes in individual's life. The emphasis of rehabilitation has moved from medical administration to issues that affect quality of life and community integration. This systematic review was conducted to identify the factors associated with community reintegration of patients with spinal cord injury. . METHODS: Google Scholar, PEDro, Pakmedinet, AMED, BIOMED central, Cochrane Library, MEDLINE, PsychoINFO, PUBMED, ScienceDIRECT, Scirus and Wiley Online Library databses were searched by using key words 'Spinal cord injury' 'Paraplegia' or 'Spinal Cord Lesion' or Tetraplegia. They were cross-linked with 'Community reintegration', 'Community participation' and 'Community access'. The methodological quality of the studies included was analysed by using McMaster University Tool and Thomas Tool. The data extracted included sample size, intervention, duration, results, outcome measures, and follow-up period. RESULTS: A total of 11 relevant studies were located. The evidence extracted was classified into four groups; health-related barriers or facilitators, environment-related barriers or facilitators, psychological barriers and social barriers that are associated with community reintegration of such individuals. CONCLUSIONS: The review revealed that there were more barriers in the form of health-related issues, personal and environmental, psychological and social issues that hinder the community reintegration of individuals with spinal cord injury compared to facilitators. Most studies identified special challenges related to environment in the sense of accessibility of home and public buildings and transportation. Removing barriers related to health, environment, and psychological and social factors can enhance community reintegration of such patients.

Massive hemoptysis: an unusual presentation of papillary thyroid carcinoma due to tracheal invasion.

A 67-year-man presented to the emergency department with massive hemoptysis, coughing up about 250 mL frank blood in 2-3 hours. Physical examination was significant for tachycardia, tachypnea and blood around the mouth. A CT of the chest did not reveal any aetiology of hemoptysis. Flexible fiberoptic bronchoscopy was remarkable for an actively oozing 1×1 cm sessile subglottic polyp on the anterior tracheal wall. CT neck revealed a 2.5×2.4 cm pretracheal soft tissue mass, bulging into the subglottic trachea. Fine needle aspiration confirmed papillary thyroid carcinoma with BRAF mutation. The patient underwent radical resection and surgical pathology confirmed a 2.5 cm papillary thyroid carcinoma with extensive extra-thyroid extension into the tracheal mucosa. Invasion of the trachea and surrounding structures like larynx and oesophagus is not usual for papillary thyroid carcinoma and may be associated with aggressive cancer behaviour and relatively poor outcome and prognosis.