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.).

Associations between type 1 diabetes and educational outcomes: an Aotearoa/New Zealand nationwide birth cohort study using the Integrated Data Infrastructure.

AIMS/HYPOTHESIS: Type 1 diabetes is one of the most common chronic diseases of childhood. It is hypothesised that the metabolic and psychosocial consequences of type 1 diabetes may affect educational outcomes; however, existing literature presents conflicting results. This study aimed to assess whether educational outcomes differ for young people with and without type 1 diabetes in Aotearoa/New Zealand (NZ). METHODS: This was a nationwide 9 year birth cohort study of all people born in NZ from 1993 to 2001 using linked administrative data held within the Integrated Data Infrastructure, a national research database containing linked health and non-health data. Educational outcomes of high school attainment, high school attendance and university enrolment were measured from age 13 years until 20 years. Generalised linear regression models with log link and Gaussian distributions were used to compare educational outcomes between those with and those without type 1 diabetes, adjusting for sociodemographic and maternal characteristics. RESULTS: Of the 442,320 children in the birth cohort, type 1 diabetes was identified in 2058 (0.47%) (mean [SD] age of type 1 diabetes diagnosis 7.7 [3.4] years). Educational outcomes were significantly lower for children with type 1 diabetes than for those without type 1 diabetes, including for any high school qualification (RR 0.97 [95% CI 0.95, 0.99]), university entrance-level high school attainment (RR 0.88 [95% CI 0.84, 0.92]), regular high school attendance (RR 0.91 [95% CI 0.85, 0.97]) and university enrolment (RR 0.93 [95% CI 0.88, 0.98]), even after adjusting for sociodemographic and maternal factors. In addition, educational outcomes were substantially lower for those with post type 1 diabetes diagnosis hospitalisations for diabetic ketoacidosis and hypoglycaemia. CONCLUSIONS/INTERPRETATION: In this whole NZ birth cohort study, type 1 diabetes was associated with lower educational outcomes spanning secondary school and into university enrolment. Ongoing efforts to support students with type 1 diabetes are needed, particularly for those with a greater risk profile.

Do-it-yourself continuous glucose monitoring in people aged 16 to 69 years with type 1 diabetes: A qualitative study.

AIMS: In many countries, real-time continuous glucose monitoring (rt-CGM) is not funded, and cost presents a barrier to access. A do-it-yourself conversion of intermittently scanned CGM (DIY-CGM) is a cheaper alternative. This qualitative study aimed to explore user experiences with DIY-CGM in people aged 16 to 69 years with type 1 diabetes (T1D). METHODS: Convenience sampling was used to recruit participants for semi-structured virtual interviews exploring experiences of DIY-CGM use. Participants were recruited after completing the intervention arm of a crossover randomised controlled trial that evaluated DIY-CGM versus intermittently scanned CGM (isCGM). Participants were previously naive to DIY-CGM and rt-CGM but not isCGM. The DIY-CGM intervention consisted of a Bluetooth bridge connected to isCGM, adding rt-CGM functionality over 8 weeks. Interviews were transcribed, then thematic analysis was performed. RESULTS: Interviews were with 12 people aged 16 to 65 years, with T1D: mean age ± SD 43 ± 14 years; baseline mean HbA1c ± SD 60 mmol/mol ± 9.9 (7.6 ± 0.9%) and time in range 59.8% ± 14.8%. Participants perceived that using DIY-CGM improved both glycaemic control and aspects of quality of life. Alarm and trend functionality allowed participants to perceive reduced glycaemic variability overnight and following meals. The addition of a smartwatch increased discrete access to glucose information. There was a high degree of trust in DIY-CGM. Challenges while using DIY-CGM included signal loss during vigorous exercise, alarm fatigue and short battery life. CONCLUSIONS: This study suggests that for users, DIY-CGM appears to be an acceptable alternative method of rt-CGM.

Real time continuous glucose monitoring in high-risk people with insulin-requiring type 2 diabetes: A randomised controlled trial.

AIMS: To investigate the impact of real-time continuous glucose monitoring (rtCGM) on glycaemia in a predominantly indigenous (Maori) population of adults with insulin-requiring type 2 diabetes (T2D) in New Zealand. METHODS: Twelve-week, multicentre randomised controlled trial (RCT) of adults with T2D using ≥0.2 units/kg/day of insulin and elevated glycated haemoglobin (HbA1c) ≥64 mmol/mol (8.0%). Following a 2-week blinded CGM run-in phase, participants were randomised to rtCGM or control (self-monitoring blood glucose [SMBG]). The primary outcome was time in the target glucose range (3.9-10 mmol/L; TIR) during weeks 10-12, with data collected by blinded rtCGM in the control group. RESULTS: Sixty-seven participants entered the RCT phase (54% Maori, 57% female), median age 53 (range 16-70 years), HbA1c 85 (IQR 74, 94) mmol/mol (9.9 [IQR 8.9, 10.8]%), body mass index (36.7 ± 7.7 kg/m2). Mean (±SD) TIR increased from 37 (24)% to 53 (24)% [Δ 13%; 95% CI 4.2 to 22; P = 0.007] in the rtCGM group but did not change in the SMBG group [45 (21)% to 45 (25)%, Δ 2.5%, 95% CI -6.1 to 11, P = 0.84]. Baseline-adjusted between-group difference in TIR was 10.4% [95% CI -0.9 to 21.7; P = 0.070]. Mean HbA1c (±SD) decreased in both groups from 85 (18) mmol/mol (10.0 [1.7]%) to 64 (16) mmol/mol (8.0 [1.4]%) in the rtCGM arm and from 81 (12) mmol/mol (9.6 [1.1]%) to 65 (13) mmol/mol (8.1 [1.2]%) in the SMBG arm (P < 0.001 for both). There were no severe hypoglycaemic or ketoacidosis events in either group. CONCLUSIONS: Real-time CGM use in a supportive treat-to-target model of care likely improves glycaemia in a population with insulin-treated T2D and elevated HbA1c.

Children and adolescents with type 1 diabetes in Aotearoa New Zealand: An online survey of workforce and outcomes 2021.

AIMS: To survey the national workforce that manages children and adolescents with type 1 diabetes (T1D) in Aotearoa New Zealand and compare with glycaemic outcomes for 2021. METHODS: A representative from each tertiary and regional diabetes service in Aotearoa New Zealand was asked to participate in an online survey assessing health-care professional (HCP) workforce numbers operating for the 2021 calendar year. Regional full-time-equivalent (FTE), glycaemic outcomes and population demographics were compared to a previously reported workforce surveys (2015 and 2019). RESULTS: Seventeen sites responded - including all four large tertiary centres - serving >99% of children and adolescents with T1D in Aotearoa New Zealand. HCP resourcing varied across sites, with median (range) HCP/100 patient ratios of: doctors: 0.40 (0.16-1.11), nurses: 1.19 (0.29-5.56), dietitians: 0.25 (0-1.11) and psychologist/social workers: 0 (0-0.26). No site met all of the International Society of Paediatric and Adolescent Diabetes (ISPAD) recommendations of HCP/100 patient ratios. Measures of socio-economic deprivation predicted HbA1c, rather than the diabetes clinic attended. Overall, only 15.1% (240/1585) of patients had an HbA1c less than the recommended 53 mmol/mol. CONCLUSIONS: The Aotearoa New Zealand workforce for children and adolescents with T1D is under-resourced and no site meets the ISPAD recommendations. There has been no significant increase in HCP/100 patient ratios compared to previous workforce surveys over the last decade. Few children and adolescents with T1D meet the recommended HbA1c. Resourcing according to recommended clinical need is required if equity in outcomes for young people with T1D is to be addressed.

Knowledge, safety, and impact of alcohol consumption in young adults with type 1 diabetes mellitus: a qualitative study.

PURPOSE: To explore the lived experiences of alcohol consumption among young adults with type 1 diabetes. METHODS: Fourteen semi-structured interviews were conducted amongst young adults aged between 18 and 25 years, inclusive, with type 1 diabetes and experience consuming alcohol. Interviews were transcribed verbatim and analysed to identify common themes regarding their experiences. RESULTS: The interviews confirmed that young adults with type 1 diabetes engage in social, and occasionally excessive, drinking behaviour. Furthermore, the interviews revealed four key themes: (i) Several sources contribute to a widely inconsistent understanding of the impact and management of alcohol consumption; (ii) Perceived inconvenience of maintaining healthy glycaemic control whilst drinking socially; (iii) Engagement in proactive strategies for harm reduction occurred when convenient; and (iv) Impact of modern diabetes technology in overcoming previous burdens and promoting glycaemic safety. CONCLUSION: Young adults with type 1 diabetes continue to need anticipatory education surrounding safe alcohol consumption and behaviours, as well as ongoing support and encouragement to ensure engagement with traditional self-management tasks. Significant alcohol-diabetes related safety issues, particularly hypoglycaemia do occur, and were captured within this small sample and study. Diabetes technology has an important complementary role along with education and tailored support strategies to support health and safe glucose control during alcohol consumption.

The role of dietary calcium in the etiology of childhood rickets in the past and the present.

For more than two centuries, lack of sunlight has been understood to cause vitamin D deficiency and documented as a primary cause of rickets. As such, evidence of rickets in the archeological record has been used as a proxy for vitamin D status in past individuals and populations. In the last decade, a clinical global consensus has emerged wherein it is recognized that dietary calcium deficiency also plays a role in the manifestation of rickets and classic skeletal deformities may not form if dietary calcium is normal even if vitamin D is deficient. This disease is now clinically called "nutritional rickets" to reflect the fact that rickets can take calcium deficiency-predominant or vitamin D deficiency-predominant forms. However, there are currently no paleopathological studies wherein dietary calcium deficiency is critically considered a primary etiology of the disease. We review here the interplay of calcium, vitamin D, and phosphorous in bone homeostasis, examine the role of dietary calcium in human health, and critically explore the clinical literature on calcium deficiency-predominant rickets. Finally, we report a case of rickets from the late Formative Period (~2500-1500 years ago) of the Atacama Desert and argue the disease in this infant is likely an example of calcium deficiency-predominant rickets. We conclude that most archeological cases of rickets are the result of multiple micronutrient deficiencies that compound to manifest in macroscopic skeletal lesions. For clinicians, these factors are important for implementing best treatment practice, and for paleopathologists they are necessary for appropriate interpretation of health in past communities.

Effect of divergent continuous glucose monitoring technologies on glycaemic control in type 1 diabetes mellitus: A systematic review and meta-analysis of randomised controlled trials.

AIMS: We aimed to conduct a systematic review and meta-analysis of randomised controlled clinical trials (RCTs) assessing separately and together the effect of the three distinct categories of continuous glucose monitoring (CGM) systems (adjunctive, non-adjunctive and intermittently-scanned CGM [isCGM]), compared with traditional capillary glucose monitoring, on HbA1c and CGM metrics. METHODS: PubMed, Web of Science, Scopus and Cochrane Central register of clinical trials were searched. Inclusion criteria were as follows: randomised controlled trials; participants with type 1 diabetes of any age and insulin regimen; investigating CGM and isCGM compared with traditional capillary glucose monitoring; and reporting glycaemic outcomes of HbA1c and/or time-in-range (TIR). Glycaemic outcomes were extracted post-intervention and expressed as mean differences and 95%CIs between treatment and comparator groups. Results were pooled using a random-effects meta-analysis. Risk of bias was assessed using the Cochrane Rob2 tool. RESULTS: This systematic review was conducted between January and April 2021; it included 22 RCTs (15 adjunctive, 5 non-adjunctive, and 2 isCGM)). The overall analysis of the pooled three categories showed a statistically significant absolute improvement in HbA1c percentage points (mean difference (95% CI): -0.22% [-0.31 to -0.14], I2  = 79%) for intervention compared with comparator and was strongest for adjunctive CGM (-0.26% [-0.36, -0.16]). Overall TIR (absolute change) increased by 5.4% (3.5 to 7.2), I2  = 71% for CGM intervention compared with comparator and was strongest with non-adjunctive CGM (6.0% [2.3, 9.7]). CONCLUSIONS: For individuals with T1D, use of CGM was beneficial for impacting glycaemic outcomes including HbA1c, TIR and time-below-range (TBR). Glycaemic improvement appeared greater for TIR for newer non-adjunctive CGM technology.

Use of intermittently scanned continuous glucose monitoring in young people with high-risk type 1 diabetes-Extension phase outcomes following a 6-month randomized control trial.

AIMS: To describe the impact of a 12-month intervention using intermittently scanned continuous glucose monitoring (isCGM) on glycaemic control and glucose test frequency in adolescents and young adults with type 1 diabetes (T1D) and high-risk glycaemic control (HbA1c ≥75 mmol/mol [≥9.0%]). METHODS: In total, 64 young people (aged 13-20 years, 16.6 ± 2.1 years; 48% female; 41% Maori or Pacific ethnicity; mean diabetes duration 7.5 ± 3.8 years) with T1D were enrolled in a 6-month, randomized, parallel-group study comparing glycaemic outcomes from the isCGM intervention (n = 33) to self monitoring blood glucose (SMBG) controls (n = 31). In this 6-month extension phase, both groups received isCGM; HbA1c , glucose time-in-range (TIR), and combined glucose test frequency were assessed at 9 and 12 months. RESULTS: At 12 months, the mean difference in HbA1c from baseline was -4 mmol/mol [-0.4%] (95% confidence interval, CI: -8, 1 mmol/mol [-0.8, 0.1%]; p = 0.14) in the isCGM intervention group, and -7 mmol/mol [-0.7%] (95% CI: -16, 1 mmol/mol [-1.5, 0.1%]; p = 0.08) in the SMBG control group. No participants achieved ≥70% glucose TIR (3.9-10.0 mmol/L). The isCGM intervention group mean rate of daily glucose testing was highest at 9 months, 2.4 times baseline rates (p < 0.001), then returned to baseline by 12 months (incidence rate ratio = 1.4; 95% CI: 0.9, 2.1; p = 0.091). CONCLUSIONS: The use of isCGM in young people with high-risk T1D resulted in transient improvements in HbA1c and glucose monitoring over a 9-month time frame; however, benefits were not sustained to 12 months.

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.

The effect of do-it-yourself real-time continuous glucose monitoring on psychological and glycemic variables in children with type 1 diabetes: A randomized crossover trial.

BACKGROUND: Continuous glucose monitoring (CGM) decreases fear of hypoglycemia (FOH) and improves glycemic control among those affected by type 1 diabetes (T1D). No studies to date have examined the impact of using do-it-yourself real-time continuous glucose monitoring (DIY RT-CGM) on psychological and glycemic outcomes. METHODS: Child-parent dyads were recruited for a multicentre randomized crossover trial. Children with T1D were current intermittently scanned CGM (isCGM) users and aged 2-13 years. Families received either 6 weeks of DIY RT-CGM with parental remote monitoring (intervention) or 6 weeks of isCGM plus usual diabetes care (control), followed by a 4-week washout period, then crossed over. The primary outcome was parental FOH. Secondary outcomes were glycemic control using traditional CGM metrics, as well as a range of other psychosocial measures. FINDINGS: Fifty five child-parent dyads were recruited. The child mean age was 9.1 ± 2.8 years. Although, there was no effect on parental FOH, -0.1 (95%CI: -0.3, 0.1, p = 0.4), time-in-range (TIR) (%3.9-10 mmol/L) was significantly higher with DIY RT-CGM over isCGM (54.3% ± 13.7 vs. 48.1% ± 13.6), mean difference, 5.7% (95%CI 1.8, 9.6, p <0.004). There was no difference for time spent in hypoglycemia. Parent diabetes treatment satisfaction was significantly higher following DIY RT-CGM compared to isCGM, mean difference 5.3 (95%CI: 2.3, 8.2, p <0.001). CONCLUSION: The use of DIY RT-CGM versus isCGM did not improve parental FOH; however, TIR and parental satisfaction with diabetes treatment were significantly improved. This suggests in the short term, DIY RT-CGM appears safe and may offer families some clinically important advantages over isCGM.

Decreased occurrence of ketoacidosis and preservation of beta cell function in relatives screened and monitored for type 1 diabetes in Australia and New Zealand.

AIMS: Islet autoantibody screening of infants and young children in the Northern Hemisphere, together with semi-annual metabolic monitoring, is associated with a lower risk of ketoacidosis (DKA) and improved glucose control after diagnosis of clinical (stage 3) type 1 diabetes (T1D). We aimed to determine if similar benefits applied to older Australians and New Zealanders monitored less rigorously. METHODS: DKA occurrence and metabolic control were compared between T1D relatives screened and monitored for T1D and unscreened individuals diagnosed in the general population, ascertained from the Australasian Diabetes Data Network. RESULTS: Between 2005 and 2019, 17,105 relatives (mean (SD) age 15.7 (10.8) years; 52% female) were screened for autoantibodies against insulin, glutamic acid decarboxylase, and insulinoma-associated protein 2. Of these, 652 screened positive to a single and 306 to multiple autoantibody specificities, of whom 201 and 215, respectively, underwent metabolic monitoring. Of 178 relatives diagnosed with stage 3 T1D, 9 (5%) had DKA, 7 of whom had not undertaken metabolic monitoring. The frequency of DKA in the general population was 31%. After correction for age, sex and T1D family history, the frequency of DKA in screened relatives was >80% lower than in the general population. HbA1c and insulin requirements following diagnosis were also lower in screened relatives, consistent with greater beta cell reserve. CONCLUSIONS: T1D autoantibody screening and metabolic monitoring of older children and young adults in Australia and New Zealand, by enabling pre-clinical diagnosis when beta cell reserve is greater, confers protection from DKA. These clinical benefits support ongoing efforts to increase screening activity in the region and should facilitate the application of emerging immunotherapies.

Youth and non-European ethnicity are associated with increased loss of publicly funded insulin pump access in New Zealand people with type 1 diabetes.

AIMS: Continuous subcutaneous insulin infusion (CSII) has been publicly funded in New Zealand for people living with type 1 diabetes since 2012. The aim of the current study was to investigate the loss of access, once obtained, to public-funded CSII. The frequency and socio-demographics of access, and loss, to CSII spanning the period 2012 to 2018 were examined. METHODS: Nationally held data collections including the New Zealand Virtual Diabetes Register were used to calculate the overall and subgroup proportions using and ceasing CSII. A logistic regression model was used to estimate odds ratios for pump use for the predictor variables (sex, age group, ethnicity and deprivation index) and to calculate odds ratios for pump cessation for the same demographic factors. RESULTS: Once CSII access is obtained, approximately 4% per year cease CSII in a subsequent year. This cessation of publicly funded CSII was not distributed equally among the population, showing over-representation in youth (aged 10-29 years) and non-Europeans, in particular Maori and Pasifika. Compounding this, it remains less likely for people with diabetes to initially access publicly funded CSII in New Zealand if they are non-European and more socio-economically deprived. CONCLUSIONS: In New Zealand, Maori and Pasifika, as well as youth, are over-represented in the cessation of CSII in comparison with Europeans and all other age groups. These groups are also less likely to gain initial access to public funding. Efforts to understand and reduce these disparities are needed, including review of current public funding access criteria.

Impact of high-risk glycemic control on habitual sleep patterns and sleep quality among youth (13-20 years) with type 1 diabetes mellitus compared to controls without diabetes.

BACKGROUND: In type 1 diabetes mellitus (T1D), glycemic control and sleep have a bidirectional relationship, with unhealthy glycemic control impacting sleep, and inadequate sleep impacting diabetes management. Youth are at risk for poor quality sleep; however, little is known about sleep among youth with high-risk glycemic control. OBJECTIVE: To assess differences in habitual sleep timing, duration, and quality among youth with T1D and controls. SUBJECTS: Two-hundred-thirty youth (13-20 years): 64 with T1D (mean age 16.6 ± 2.1 years, 48% female, diabetes duration 7.5 ± 3.8 years, HbA1c 96 ± 18.0 mmol/mol [10.9 ± 1.7%]), and 166 controls (mean age 15.3 ± 1.5, 58% female). METHODS: Comparison of data from two concurrent studies (from the same community) using subjective and objective methods to assess sleep in youth: Pittsburgh Sleep Quality Index evaluating sleep timing and quality; 7-day actigraphy measuring habitual sleep patterns. Regression analyses were used to compare groups. RESULTS: When adjusted for various confounding factors, youth with T1D reported later bedtimes (+36 min; p < 0.05) and shorter sleep duration (-53 min; p < 0.05) than controls, and were more likely to rate subjective sleep duration (OR 3.57; 95% CI 1.41-9.01), efficiency (OR 4.03; 95% CI 1.43-11.40), and quality (OR 2.59; 95% CI 1.16-5.76) as "poor" (p < 0.05). However, objectively measured sleep patterns were similar between the two groups. CONCLUSIONS: Youth with high-risk T1D experience sleep difficulties, with later bedtimes contributing to sleep deficit. Despite a lack of objective differences, they perceive their sleep quality to be worse than peers without diabetes.

Delayed access to care and late presentations in children during the COVID-19 pandemic New Zealand-wide lockdown: A New Zealand Paediatric Surveillance Unit study.

AIM: Describe paediatricians' experience of adverse health outcomes for children during the New Zealand-wide level 4 lockdown in response to the COVID-19 pandemic. METHODS: Weekly national survey of paediatricians with an open-ended questionnaire. RESULTS: During the 6-week study survey period, the New Zealand Paediatric Surveillance Unit received 33 reports about 55 instances where paediatricians believed care may have been compromised, about half (56%) relating to infants aged from birth to 6 weeks. Compromised care was for acute presentations in 75%, acute complications of a chronic illness in 14%, with 11% for chronic conditions. Paediatricians reported the outcome as moderately severe (short-term morbidity, increased length of stay, higher level of care) in 38 cases (69%) and in a further 4 (7%) as severe (potential to be life-threatening or result in permanent disability). CONCLUSION: Despite clear messaging, hospital avoidance and reduced access to primary and secondary care were associated with significant potential harm for children in New Zealand during a strict lockdown, with newborn infants disproportionately affected. During the implementation of interventions to eliminate community transmission of COVID-19, New Zealand paediatricians note the importance of face-to-face post-natal visits for newborns and primary care services for children with acute illness, to avoid preventable harm.

Cutaneous adverse events in a randomized controlled trial of flash glucose monitoring among youth with type 1 diabetes mellitus.

BACKGROUND: The literature regarding flash glucose monitoring (FGM)-associated cutaneous adverse events (AE) is limited. OBJECTIVES: This study among youth participating in a 6 month randomized controlled trial aimed to compare cutaneous AE between FGM and self-monitored blood glucose (SMBG) use and evaluate premature FGM sensor loss. METHODS: Patients aged 13 to 20 years with type 1 diabetes were randomized to intervention (FGM and usual care) or control (SMBG and usual care). Participants self-reported cutaneous AEs electronically every 14 days. Reports were analyzed to determine frequency, type, and severity of cutaneous AEs, and evaluate premature sensor loss. RESULTS: Sixty-four participants were recruited; 33 randomized to FGM and 31 to control. In total, 80 cutaneous AEs were reported (40 in each group); however, the proportion of participants experiencing cutaneous AEs was greater in the FGM group compared to control (58% and 23% respectively, P = .004). FGM participants most frequently reported erythema (50% of AEs), while controls most commonly reported skin hardening (60% of AEs). For FGM users, 80.0% of cutaneous AEs were mild, 17.5% moderate, and 2.5% severe. Among controls, 82.5% of cutaneous AEs were mild and 17.5% moderate. One participant ceased using FGM due to recurring cutaneous AEs. Additionally, over 6 months, 82% of FGM participants experienced at least one premature sensor loss, largely unrelated to a cutaneous AE. CONCLUSIONS: Cutaneous FGM-associated AEs are common, and mostly rated as mild. However, the majority of users continued FGM despite cutaneous AEs. Awareness of cutaneous complications and mitigation measures may reduce cutaneous AEs and improve the overall experience of FGM.

Sleep and Night-time Caregiving in Parents of Children and Adolescents with Type 1 Diabetes Mellitus - A Qualitative Study.

BACKGROUND: Type 1 diabetes mellitus (T1DM) is a common chronic illness of childhood, with parents assuming considerable responsibility for night-time diabetes caregiving. This qualitative study explored diabetes-related factors affecting, and solutions proposed to improve, parental sleep. PARTICIPANTS: 10 mothers and 10 fathers of children ≤18 years of age with T1DM in Otago, New Zealand. METHODS: Semi-structured individual interviews were audio-recorded, transcribed, and systematically coded for themes. Parents completed the Pittsburgh Sleep Quality Index (PSQI) and habitual sleep of parents and children were assessed via 7-day actigraphy. RESULTS: Parents (n = 20) and their children with T1DM (n = 16) were aged between 32 and 54 years, and 1 and 17 years, respectively. PSQI revealed poor quality sleep in 13/20 parents. A range of diabetes-related factors, including glucose monitoring and fear of hypoglycemia, contributed to parental sleep disturbance, including awakenings and the perception of "sleeping lightly". Two distinct time periods resulted in greater sleep disturbance, notably, following T1DM diagnosis and when transitioning to using a new diabetes technology. Factors influencing maternal and paternal sleep were similar, but, generally, mothers described greater night-time care burden and sleep disturbance. While the use of diabetes technologies was generally advocated to improve parental sleep and the provision of nocturnal T1DM care, they were also perceived to potentially contribute to parental sleep disturbance. CONCLUSIONS: Pediatric diabetes care teams should be aware of diabetes-related factors potentially affecting parental sleep, the mixed impacts of diabetes technologies, and consider tailored parental support and education to reduce the burden of nocturnal care.

Complications following frenotomy for ankyloglossia: A 24-month prospective New Zealand Paediatric Surveillance Unit study.

AIM: To investigate the incidence and characteristics of complications arising from frenotomy for ankyloglossia (tongue-tie) in New Zealand. METHODS: Prospective surveillance among hospital-based paediatricians of complications arising from frenotomy for ankyloglossia to children <1 year old was conducted by the New Zealand Paediatric Surveillance Unit for 24 months, from August 2016 to July 2018, inclusive. RESULTS: A total of 16 cases of complications arising from frenotomy were reported. The overall average annual incidence rate was 13.9/100 000. Geographic variation was noted with a peak of 85.6/100 000 in one region. Complications reported: poor feeding (44%), respiratory events (25%), pain (19%), bleeding (19%) and weight loss (19%). Three children (19%) also had delayed diagnosis of an underlying medical condition initially overlooked in favour of treating their ankyloglossia, this has not previously been reported. The majority (75%) of cases required admission to hospital. Treatments given included supplementary feeds (44%), surgical intervention (25%), breastfeeding support (19%), analgesia (13%) and blood products (13%). A total of 25% of children had one or more frenotomies; 50% were treated for two or more of: 'anterior' ankyloglossia, 'posterior' ankyloglossia or 'lip tie'; 50% had their frenotomies performed out of the hospital. Dentists were the most common performing practitioner (31%). CONCLUSIONS: Frenotomy rates in New Zealand are unknown. Poor feeding, pain, bleeding, weight loss and delayed diagnosis of an alternative underlying medical condition are important complications that require hospital assessment and admission. Practitioners and parents/families need to be aware of these possibilities. Centralised guidelines with access to specialist second opinions should be developed.

Global consensus on nutritional rickets: Implications for Australia.

In 2016, a global consensus on the prevention, diagnosis and management of nutritional rickets was published. The bone and mineral working group of the Australasian Paediatric Endocrine Group provides a summary and highlights differences to previous Australian and New Zealand (ANZ) guidelines on vitamin D deficiency and their implications for clinicians. Key points are: (i) The International Consensus document is focused on nutritional rickets, whereas the ANZ guidelines were focused on vitamin D deficiency. (ii) Definitions for the interpretation of 25-hydroxy vitamin D (25OHD) levels do not differ between statements. (iii) The global consensus recommends that routine 25OHD screening should not be performed in healthy children and recommendations for vitamin D supplementation are not based solely on 25OHD levels. The Australasian Paediatric Endocrine Group bone and mineral working group supports that screening for vitamin D deficiency should be restricted to populations at risk. (iv) Recommendations from the global consensus for vitamin D dosages for the therapy of nutritional rickets (diagnosed based on history, physical examination, biochemical testing and a confirmation by X-rays) are higher than in ANZ publications. (v) The global consensus recommends the implementation of public health strategies such as universal supplementation with vitamin D from birth to 1 year of age and food fortification. We conclude that updated global recommendations for therapy of nutritional rickets complement previously published position statements for Australia and New Zealand. Screening, management and the implementation of public health strategies need to be further explored for Australia.

Effect of 6 months' flash glucose monitoring in adolescents and young adults with type 1 diabetes and suboptimal glycaemic control: managing diabetes in a 'flash' randomised controlled trial protocol.

BACKGROUND: Teenagers and young adults with type 1 diabetes (T1D) experience significant burden managing this serious chronic condition and glycaemic control is at its unhealthiest during this life stage. Flash glucose monitoring (FGM) is a new technology that reduces the burden of glucose monitoring by easily and discreetly displaying glucose information when an interstitial glucose sensor worn on the upper arm is scanned with a handheld reader, as opposed to traditional capillary glucose sampling by finger prick (otherwise known as self-monitored blood glucose, SMBG). The effectiveness of this technology and impacts of its long-term use in youth with pre-existing suboptimal glycaemic control are unknown. This study therefore aims to investigate the effectiveness of FGM in addition to standard care in young people with T1D. METHODS: This is a two phase study programme including a multi-centre randomised, parallel-group study consisting of a 6-month comparison between SMBG and FGM, with an additional 6-month continuation phase. We will enrol adolescents with T1D aged 13-20 years (inclusive), with suboptimal glycaemic control (mean glycated haemoglobin (HbA1c) in past 6 months ≥75 mmol/mol [≥9%]). Participants will be randomly allocated (1:1) to FGM (FreeStyle Libre; intervention group) or to continue SMBG with capillary blood glucose testing (usual care group). All participants will continue other aspects of standard care with the study only providing the FreeStyle Libre. At 6 months, the control group will cross over to the intervention. The primary outcome is the between group difference in changes in HbA1c at 6 months. Additional outcomes include a range of psychosocial and health economic measures as well as FGM acceptability. DISCUSSION: >If improvements are found, this will further encourage steps towards integrating FGM into regular diabetes care for youth with unhealthy glycaemic control, with the expectation it will reduce daily diabetes management burden and improve short- and long-term health outcomes in this high-risk group. TRIAL REGISTRATION: This trial was registered with the Australian New Zealand Clinical Trials Registry on 5 March 2018 ( ACTRN12618000320257p ) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1205-5784).