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Aims: To investigate the impact of real‐time continuous glucose monitoring (rtCGM) on glycaemia in a predominantly indigenous (Māori) 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% Māori, 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. [ABSTRACT FROM AUTHOR]

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]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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]

Objective: To investigate glycemic and psychosocial outcomes with hybrid closed-loop (HCL) versus user-determined insulin dosing with multiple daily injections (MDI) or insulin pump (i.e., standard therapy for most adults with type 1 diabetes).Research Design and Methods: Adults with type 1 diabetes using MDI or insulin pump without continuous glucose monitoring (CGM) were randomized to 26 weeks of HCL (Medtronic 670G) or continuation of current therapy. The primary outcome was masked CGM time in range (TIR; 70-180 mg/dL) during the final 3 weeks.Results: Participants were randomized to HCL (n = 61) or control (n = 59). Baseline mean (SD) age was 44.2 (11.7) years, HbA1c was 7.4% (0.9%) (57 [10] mmol/mol), 53% were women, and 51% used MDI. HCL TIR increased from (baseline) 55% (13%) to (26 weeks) 70% (10%) with the control group unchanged: (baseline) 55% (12%) and (26 weeks) 55% (13%) (difference 15% [95% CI 11, 19]; P < 0.0001). For HCL, HbA1c was lower (median [95% CI] difference -0.4% [-0.6, -0.2]; -4 mmol/mol [-7, -2]; P < 0.0001) and diabetes-specific positive well-being was higher (difference 1.2 [95% CI 0.4, 1.9]; P < 0.0048) without a deterioration in diabetes distress, perceived sleep quality, or cognition. Seventeen (9 device-related) versus 13 serious adverse events occurred in the HCL and control groups, respectively.Conclusions: In adults with type 1 diabetes, 26 weeks of HCL improved TIR, HbA1c, and their sense of satisfaction from managing their diabetes compared with those continuing with user-determined insulin dosing and self-monitoring of blood glucose. For most people living with type 1 diabetes globally, this trial demonstrates that HCL is feasible, acceptable, and advantageous. [ABSTRACT FROM AUTHOR]

The article presents research which focused on the outpatient closed-loop insulin delivery in patients with type 1 diabetes. Topics covered include the importance of sensor-augmented pump therapy with low-glucose suspend to patients in the trial. Also mentioned is the regular monitoring of the capillary blood glucose of participants in the study. [ABSTRACT FROM AUTHOR]

Background: This prerandomization analysis from the Australian HCL-Adult trial (registration number: ACTRN12617000520336) compared masked continuous glucose monitoring (CGM) metrics among adults using insulin pumps versus multiple daily injections (MDIs), who were all self-monitoring blood glucose (SMBG). Methods: Adults with type 1 diabetes, using an insulin pump or MDIs without real-time CGM (and entering a trial of closed-loop technology), were eligible. MDI users were given an insulin dosage calculator. All participants received diabetes and carbohydrate-counting education, then wore masked CGM sensors for 3 weeks. Ethics Approval: HREC-D 088/16 Results: Adults using MDIs (n = 61) versus pump (n = 59) did not differ by age, sex, diabetes duration, insulin total daily dose, or HbA1c at baseline. After education, median (interquartile range) CGM time in range (TIR) 70-180 mg/dL (3.9-10.0 mmol/L) was 54% (47, 62) for those using MDIs and 56% (48, 66) for those using pump (P = 0.40). All CGM metrics were equivalent for 24 h/day for MDI and pump users. Overnight, those using MDIs (vs. pump) spent more time with glucose <54 mg/dL (<3.0 mmol/L): 1.4% (0.1, 5.1) versus 0.5% (0.0, 2.0), respectively (P = 0.012). They also had more CGM hypoglycemia episodes (121 vs. 54, respectively; incidence rate ratio [95% confidence interval] 2.48 [1.51, 4.06]; P < 0.001). Conclusions: Adults with type 1 diabetes using pumps versus MDIs in conjunction with SMBG experienced less nocturnal hypoglycemia, measured by masked CGM, after equivalent diabetes and dietary education in conjunction with insulin dosage calculator provision to all. However, both groups had equivalent TIR. This observation may reflect advantages afforded by flexibility in basal insulin delivery provided by pumps. [ABSTRACT FROM AUTHOR]