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Aim. To assess children's subsequent device usage and caregiver attitudes to do-it-yourself real-time continuous glucose monitoring (DIY-rtCGM) at least 3 months after completing a randomized controlled trial (RCT). Methods. A brief online questionnaire or telephone call was used to collect the subsequent device usage and caregivers' attitudes from a total of 55 families at least 3 months after their completion of an RCT investigating DIY-rtCGM adapted from their preexisting intermittently scanned glucose sensors plus education on using DIY-rtCGM system. To be eligible for the RCT, children had to be aged 2–13 years, have type 1 diabetes ≥6 months, and be rtCGM naïve. Data collected investigated current CGM use post-RCT and attitudes/user experiences to DIY-rtCGM in the months since RCT study support ended. Results. Overall, responses from 81.8% (45/55) of caregivers were received. Mean age of children was 9.0 ± 2.7 years, and 31 (68.9%) children used insulin pumps. After 3 months, 44.4% (20/45) of responding caregivers reported ongoing DIY-rtCGM use, and of these, only 13 used DIY-rtCGM as the primary glucose monitoring method 100% of time. Of the 25 (55.6%) families who ceased DIY-rtCGM, 40% (10/25) had transitioned to commercial rtCGM. More than half of families (60%, 12/20) who continued DIY-rtCGM use had a very or extremely positive attitude toward the technology and 75% (15/20) of these families planned to continue DIY-rtCGM use. However, signal loss and sensor inaccuracy remained the major reasons among all responders both for decreased DIY-rtCGM wear time and eventual cessation. Burden of use primarily related to technical errors that could not be solved, and alarms, both of which were reported to contribute to discontinuation. Conclusions. This study highlights that, among families voluntarily using DIY-rtCGM at least 3 months following support from a trial, more than half have ceased using DIY-rtCGM, with 40% of those discontinuing switching to commercial rtCGM. While overall perceptions of DIY-rtCGM remain largely positive, burdens of use are high and contribute to discontinuation. [ABSTRACT FROM AUTHOR]

Background. The bidirectional relationship between sleep and blood glucose levels may particularly affect adolescents and young adults (AYA), who are more likely to experience less healthy glycemic outcomes and more disrupted sleep patterns. To date, few data exist describing the impact of intermittently scanned continuous glucose monitoring (isCGM) on habitual sleep patterns and sleep quality in AYA with type 1 diabetes (T1D). Objective. To evaluate the impact of 6-month use of isCGM on habitual sleep and wake timing, sleep duration, frequency, and duration of night-time awakenings, sleep efficiency, and perceived sleep quality in young people with T1D and HbA1c ≥ 75 mmol/mol. Participants. The study recruited 64 participants aged 13–20 years (mean 16.6 ± 2.1), 48% female, diabetes duration 7.5 ± 3.8 years, 41% Māori or Pasifika, and a mean HbA1c 96.0 ± 18.0 mmol/mol [10.9 ± 3.8%]; 33 were allocated to an isCGM plus self-monitoring blood glucose [SMBG] intervention, and 31 were allocated to the SMBG control group. Methods. Participants completed 7-day actigraphy measures and the Pittsburgh Sleep Quality Index questionnaire at the baseline and at 6 months. Regression analyses were used to model between-group comparisons, adjusted for baseline sleep measures. Results. At 6 months, subjective measures for overall sleep quality, latency, duration, efficiency, night-time disturbances, use of sleep medications, and daytime dysfunction were similar between the groups. Regression analyses of actigraphy found no significant differences in objectively measured sleep timing and duration across the week after adjusting for age, the period of the school year, and baseline sleep values. Conclusions. The use of first-generation isCGM in addition to finger-prick testing did not impact objective or subjective sleep measures in AYA with T1D, elevated HbA1c, and highly variable sleep patterns. Research using alternative interventions for improving glycemic outcomes and habitual sleep-wake timing, duration, and perceived sleep quality is warranted in this population group. [ABSTRACT FROM AUTHOR]

Background: Automated insulin delivery is the treatment of choice in adults with type 1 diabetes. Data are needed on the efficacy and safety of automated insulin delivery for children and youth with diabetes and elevated glycated hemoglobin levels. Methods: In this multicenter, open-label randomized controlled trial, we assigned patients with type 1 diabetes in a 1:1 ratio either to use an automated insulin delivery system (MiniMed 780G) or to receive usual diabetes care of multiple daily injections or non-automated pump therapy (control). The patients were children and youth (defined as 7 to 25 years of age) with elevated glycemia (glycated hemoglobin ≥8.5% with no upper limit). The primary outcome was the baseline-adjusted between-group difference in glycated hemoglobin at 13 weeks. Results: A total of 80 patients underwent randomization (37 to automated insulin delivery and 43 to control) and all patients completed the trial. At 13 weeks, the mean (±SD) glycated hemoglobin decreased from 10.5±1.9% to 8.1±1.8% in the automated insulin delivery group but remained relatively consistent in the control group, changing from 10.4±1.6% to 10.6±1.8% (baseline-adjusted between-group difference, -2.5 percentage points; 95% confidence interval [CI], -3.1 to -1.8; P<0.001). Patients in the automated insulin delivery group spent on average 8.4 hours more in the target glucose range of 70 to 180 mg/dl than those in the control group. One severe hypoglycemia event and two diabetic ketoacidosis events occurred in the control group, with no such events in the automated insulin delivery group. Conclusions: In this trial of 80 children and youth with elevated glycated hemoglobin, automated insulin delivery significantly reduced glycated hemoglobin compared with usual diabetes care, without resulting in severe hypoglycemia or diabetic ketoacidosis events. (Funded by Lions Clubs New Zealand District 202F and others; Australian New Zealand Clinical Trials Registry number, ACTRN12622001454763.) [ABSTRACT FROM AUTHOR]

BACKGROUND. Endothelial dysfunction, a precursor of vascular disease, begins early in type 1 diabetes mellitus and is associated with folate status. METHODS. A randomized, double-blind, placebo-controlled study of folate (5 mg daily) and vitamin [B.sub.6] (100 mg daily) in 124 children with type 1 diabetes determined the immediate and 8-week effects of these vitamins, alone and in combination, on endothelial function. Endothelial function, assessed as flow-mediated dilation and glyceryltrinitrate-induced dilation with high-resolution ultrasound of the brachial artery, was measured at baseline, at 2 and 4 hours after the first dose (n = 35), and at 4 and 8 weeks of treatment (n = 122). RESULTS. Flow-mediated dilation normalized in all treatment groups. From baseline to 8 weeks, flow-mediated dilation improved with folate from 2.6% [+ or -] 4.3% (mean [+ or -] SD) to 9.7% [+ or -] 6.0%, with vitamin [B.sub.6] from 3.5% [+ or -] 4.0% to 8.3% [+ or -] 4.2%, and with folate/vitamin [B.sub.6] from 2.8% [+ or -] 3.5% to 10.5% [+ or -] 4.4%. This improvement in flow-mediated dilation occurred within 2 hours and was maintained at 8 weeks for each treatment. Flow-mediated dilation in the placebo group, and glyceryltrinitrate-induced dilation in all groups, did not change. Increases in serum folate, red cell folate, and serum vitamin [B.sub.6] levels related to increases in flow-mediated dilation. Improvement in flow-mediated dilation was independent of changes in total plasma homocyst(e)ine, glucose, hemoglobin A1c, and high-sensitivity C-reactive protein levels. Baseline red cell folate levels and baseline diastolic blood pressure were related inversely to improvement in flow-mediated dilation. Serum triglyceride and low-density lipoprotein cholesterol inversely related to baseline flow-mediated dilation. CONCLUSIONS. High-dose folate and vitamin [B.sub.6] normalized endothelial dysfunction in children with type 1 diabetes. This effect was maintained over 8 weeks, with no additional benefit from combination treatment. www.pediatrics.org/cgi/doi/10.1542/peds.2005-2143 doi:10.1542/peds.2005-2143 Key Words type 1 diabetes, endothelial function, folate, pyridoxine, randomized, controlled trial Abbreviations FMD--flow-mediated dilation HbA1c--hemoglobin A1c Hs-CRP--high-sensitivity C-reactive protein LDL--low-density lipoprotein HDL--high-density lipoprotein RCF--red blood cell folate WCH--Women&apos;s and Children&apos;s Hospital, PREVENTION OF THE vascular complications of diabetes mellitus requires strategies that begin early in the course of the disease. Endothelial dysfunction, a fundamental event in the development of atherosclerosis, (1) [...]

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% Māori 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]