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.

Experiences of adolescents and young adults with type 1 diabetes and chronically elevated glucose levels following the transition from multiple daily injections to advanced hybrid closed-loop: A qualitative study.

AIM: To understand experiences of using second-generation advanced hybrid closed-loop (AHCL) therapy in adolescents and young adults with chronically elevated glucose levels who were previously using multiple daily injections (MDI) therapy. METHOD: Semi-structured interviews with participants aged 13-25 years, on AHCL therapy for 3 months as part of a single-arm prospective study. Key inclusions: HbA1c ≥69 mmol/mol (8.5%); diabetes duration ≥1 year; and using MDI therapy prior to the study. Qualitative content analysis was used to identify themes and subthemes. RESULTS: Interviews were conducted among 14 participants with mean age 19.4 ± 4.3 years and mean baseline HbA1c 90 ± 25 mmol/mol (10.4 ± 4.5%). Three themes were identified: (1) substantially improved glucose levels improved perceptions of overall health; (2) features of AHCL aid in adoption and ongoing self-management; and (3) burden of care was reduced through automation of insulin delivery. Overall, there were positive impacts on physical, mental and social well-being. Participants were willing to overlook minor frustrations with AHCL because of the vast benefits that they had experienced. Four participants reported transient pseudo-hypoglycaemia: symptoms of hypoglycaemia when objectively measured glucose was in the clinically recommended range (3.9-10 mmol/L, 70-180 mg/dL). CONCLUSION: Transition to AHCL therapy positively impacted diabetes management in adolescents and youth with chronically elevated glucose levels. It appears to create a window of opportunity in which youth may re-engage with diabetes management. Pseudo-hypoglycaemia can occur during the transition to AHCL. This could be a barrier to AHCL uptake and is likely to require individualised support.

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.

Single-arm, first-in-human feasibility study results for an ultra-low-cost insulin pump.

BACKGROUND: Use of Continuous Subcutaneous Insulin Infusion (CSII) has been shown to improve glycemic outcomes in Type 1 Diabetes (T1D), but high costs limit accessibility. To address this issue, an inter-operable, open-source Ultra-Low-Cost Insulin Pump (ULCIP) was developed and previously shown to demonstrate comparable delivery accuracy to commercial models in standardised laboratory tests. This study aims to evaluate the updated ULCIP in-vivo, assessing its viability as an affordable alternative for those who cannot afford commercially available devices. METHODS: This first-in-human feasibility study recruited six participants with T1D. During a nine-hour inpatient stay, participants used the ULCIP under clinical supervision. Venous glucose, insulin, and ß-Hydroxybutyrate were monitored to assess device performance. RESULTS: Participants displayed expected blood glucose and blood insulin levels in response to programmed basal and bolus insulin dosing. One participant developed mild ketosis, which was treated and did not recur when a new pump reservoir was placed. All other participants maintained ß-Hydroxybutyrate < 0.6 mmol/L throughout. CONCLUSION: The ULCIP safely delivered insulin therapy to users in a supervised inpatient environment. Future work should focus on correcting a pump hardware issue identified in this trial and extending device capabilities for use in closed loop control. Longer-term outpatient studies are warranted. TRIAL REGISTRATION: The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623001288617) on the 11 December 2023.

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.

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.

Prevalence and incidence of type 1 diabetes in children aged 0-14 years old in New Zealand in 2021.

AIM: National prevalence and incidence data are important for understanding population trends and allocating health-care resources. We aimed to provide a current national snapshot of prevalence and annual incidence rates for children aged 0-14 with type 1 diabetes (T1D) in Aotearoa New Zealand and to identify differences associated with demographic variables. METHODS: Paediatric diabetes centres across Aotearoa were invited to record anonymised demographic and diabetes data on children under their services between 1 October 2020 and 30 September 2021. National prevalence and incidence were calculated using usually resident population counts from the 2018 census. The effect of ethnicity on prevalence and incidence was assessed using Poisson regression. RESULTS: There were 1209 children aged 0-14 with T1D in October 2021. The national prevalence was 131/100 000 (95% confidence interval (CI) 124-139). European children had twice the prevalence as those of Maori or Pacific ethnicity (P < 0.001). There was no effect by gender (P = 0.3) and prevalence predictably increased with age. The annualised incidence of T1D was 23/100 000 (95% CI 20-26). European children were 2.6 times as likely as Maori children to be diagnosed with T1D in that year (incidence rate ratio = 2.6, 95% CI 1.7-4.2). Regional differences in prevalence and incidence were noted, potentially due to the ethnicity differences across regions. Unadjusted prevalence and incidence decreased with lower socio-economic status, likely due to an over-representation of non-Europeans living in the most deprived areas. CONCLUSIONS: T1D affects an ethnically diverse population in Aotearoa and important regional differences exist that may impact workforce planning.

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.

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.

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.

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.

Hybrid closed-loop therapy with a first-generation system increases confidence and independence in diabetes management in youth with type 1 diabetes.

AIM: Hybrid closed-loop (HCL) therapy improves glycaemic control in adolescents with type 1 diabetes; however, little is known about their lived experience using these systems. The aim of this study was to explore the lived experiences of youth with type 1 diabetes using HCL therapy, and their parents, to provide insight into their lived experiences. METHODS: Adolescents and young adults aged 12-25 years, who used Medtronic MiniMed™ 670G HCL system during a 6-month randomised clinical trial, and their parents, were invited to participate in a semi-structured interview at the end of the study. Open-ended questions were used to explore the lived experiences of families using HCL. The interviews were audio-recorded, transcribed and analysed using thematic analysis to determine the main themes. RESULTS: In all, 17 young people with type 1 diabetes mean ± SD age: 17.5 ± 4.2 years, diabetes duration: 11.0 ± 4.9 years and HbA1c 64 ± 9 mmol/mol (8.0 ± 0.8%) and 10 parents were interviewed. Three themes were identified: (1) 'Developing confidence and trust in the system', (2) 'Reduction in anxiety' and (3) 'Issues with device'. They reported a positive experience using HCL, with improvements in glucose levels and increased independence with diabetes management. However, frustration around the number of alarms and notifications associated with the system were also identified as issues. CONCLUSION: Both youth and parents acknowledged the benefits of this first-generation HCL system in improving glycaemic outcomes and in providing flexibility and independence. These lived experiences provide valuable information in the introduction and provision of targeted education with HCL therapy.

Type 1 diabetes diagnosed before age 15 years in Canterbury, New Zealand: A 50 year record of increasing incidence.

OBJECTIVE: To describe the epidemiology of pediatric type 1 diabetes over 50 years in Canterbury, New Zealand. Further, to explore variation in case presentation according to age, gender, ethnicity, urban/rural character, socio-economic deprivation and immunogenetic features. RESEARCH DESIGN AND METHODS: Prospective ascertainment of cases commenced in 1982, and incident cases presenting 1970-1982 were ascertained retrospectively from clinical records. Eligibility criteria included diagnosis of type 1 diabetes by a physician and commencement of insulin therapy at diagnosis and age less than 15 years. Data collection included name, hospital number, date of birth, date of diagnosis, and date of initiation of insulin treatment. Full address at diagnosis was assigned an urban-rural classification, and a deprivation score. HLA-DQ susceptibility alleles and diabetes associated autoantibodies were determined. RESULTS: The incidence of type 1 diabetes increased more than 5-fold (3.9% per annum) over 50 years for the entire cohort. The mean for 5-year periods, starting from 1970, increased from 5.3 to 29.0 cases per 100,000 person years. Incidence was greatest in the 10-14 year age group. The cohort is predominantly European (89.4%), but there has been an increase in cases identifying as New Zealand Maori in the last three decades. Weak evidence was found for reduced incidence of type 1 diabetes in rural regions (adjusted IRR = 0.70, 95%CI 0.52 to 0.91, p = 0.011). CONCLUSIONS: The incidence of type 1 diabetes in children aged less than 15 years continues to increase with time. Incidence was significantly affected by age, ethnicity, and urban/rural characterization of address at diagnosis.

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.

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.

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.