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.

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.

Effect of 6 Months of Flash Glucose Monitoring in Youth With Type 1 Diabetes and High-Risk Glycemic Control: A Randomized Controlled Trial.

OBJECTIVE: To investigate whether intermittently scanned continuous glucose monitoring (isCGM) significantly improves glycemic control compared with capillary self-monitored blood glucose (SMBG) in youth with type 1 diabetes and high-risk glycemic control. RESEARCH DESIGN AND METHODS: This multicenter 6-month randomized, controlled, parallel-arm trial included 64 participants aged 13-20 years with established type 1 diabetes and glycated hemoglobin (HbA1c) ≥9% (≥75 mmol/mol). Participants were allocated to 6-month intervention (isCGM; FreeStyle Libre; Abbott Diabetes Care, Witney, U.K.) (n = 33) or control (SMBG; n = 31) using minimization. The primary outcome was the difference in change in HbA1c from baseline to 6 months. RESULTS: There was no evidence of a difference between groups for changes in HbA1c at 6 months (adjusted mean 0.2% greater improvement for isCGM [95% CI -0.9 to 0.5] [-2.1 mmol/mol (95% CI -9.6 to 5.4)]; P = 0.576). However, glucose-monitoring frequency was 2.83 (95% CI 1.72-4.65; P < 0.001) times higher in the isCGM group compared with that in the SMBG group at 6 months. The change in the Diabetes Treatment Satisfaction Questionnaire mean item score also favored isCGM at 6 months (P = 0.048), with no significant differences between groups for fear of hypoglycemia and quality of life (both general and diabetes specific) (all P > 0.1). CONCLUSIONS: For youth with high-risk glycemic control, isCGM led to improvements in glucose testing frequency and diabetes treatment satisfaction. However, these did not translate to greater improvement in glycemic control over usual care with SMBG at 6 months.

Initial experiences of adolescents and young adults with type 1 diabetes and high-risk glycemic control after starting flash glucose monitoring - a qualitative study.

PURPOSE: This study explored early experiences with a flash glucose monitoring system among adolescents and young adults with type 1 diabetes and high-risk glycemic control. METHODS: Adolescents and young adults with high-risk glycemic control (HbA1c ≥ 75 mmol/mol (9.0%) in the previous 6 months) who had recently commenced on flash glucose monitoring as part of a trial took part in a semi-structured interview exploring their experiences with the technology. All interviews were recorded, transcribed and analyzed using an inductive approach. RESULTS: Fifteen interviews were conducted. Overall, participants enjoyed flash glucose monitoring and planned to continue using their system. Key findings included flash glucose monitoring reduced diabetes management burden and increased glucose monitoring. Other impacts of flash glucose monitoring use included perceived improved mood and energy, increased capacity for physical activity and less parental conflict. While participants reported healthier glycemic control, participants' mean interstitial glucose level remained above the target range of 3.9-10.0 mmol/L (70-180 mg/dL) over the first month of flash glucose monitoring. Common challenges included premature sensor loss and decreased scanning over the first month of use. CONCLUSIONS: Flash glucose monitoring may be an acceptable self-management tool to increase monitoring frequency in adolescents and young adults with type 1 diabetes and high-risk glycemic control, with the potential to improve long-term glycemic control. Initial support efforts should focus on practical strategies to prolong sensor wear and motivate frequent scanning as well as education on interpreting glucose data and making informed treatment decisions to maximize the benefits of this technology.

The 'flash' adhesive study: a randomized crossover trial using an additional adhesive patch to prolong freestyle libre sensor life among youth with type 1 diabetes mellitus.

AIMS: Although strategies to prevent premature sensor loss for flash glucose monitoring (FGM) systems may have substantial benefit, limited data are available. This study among youth with high-risk type 1 diabetes evaluated whether an additional adhesive patch over FGM sensors would reduce premature sensor loss frequency and not cause additional cutaneous adverse events (AEs). METHODS: This is a six-month, open-label, randomized crossover trial. Participants were recruited at completion of prior 'Managing Diabetes in a Flash' randomized controlled trial and allocated to three months of Freestyle Libre FGM sensors with either standard adhesive (control) or additional adhesive patches (RockaDex, New Zealand) (intervention), before crossing over to the opposite study arm. Participants self-reported patch use or non-use, premature sensor loss and cutaneous AEs fortnightly via an electronic questionnaire. RESULTS: Thirty-four participants were enrolled: mean age (± SD) 17.0 (± 2.2) years; mean HbA1c (± SD) 89 (± 16) mmol/mol (10.3% ± 1.4%). The response rate of questionnaires was 77% (314/408). Premature sensor loss was reported in 18% (58/314) of questionnaires: 20% (32/162) from intervention and 17% (26/152) from control (p = 0.56). Thirty-eight percent (118/314) of questionnaires were non-compliant to protocol allocation. However, per-protocol analysis showed similar findings. No significant difference in AEs was reported between compliant adhesive patch use and non-use (6% [5/78] and 3% [3/118], respectively, p = 0.27). CONCLUSIONS: The adhesive patch investigated in this study does not appear to prevent premature FGM sensor loss. However, the low risk of AEs and low cost of an adhesive patch suggest an individualized approach to their use may still be warranted. Further research is needed to explore alternative strategies to prevent sensor loss.

Insulin pump initiation and education for children and adolescents - a qualitative study of current practice in New Zealand.

PURPOSE: Worldwide, the use of insulin pumps for the management of type 1 diabetes is increasing. There are no national or international published guidelines and few guidance recommendations detailing the education and training required to commence insulin pump therapy. The aim of this study is to describe current clinical practice regarding initiation of insulin pump therapy in children and adolescents with type 1 diabetes in New Zealand. METHODS: Pediatric diabetes nurse specialists from selected New Zealand hospitals (n = 16) were identified and invited to participate in this qualitative study. For those consenting, structured interviews were conducted. The questions covered basic hospital demographics and various aspects of insulin pump initiation including pump start planning, education, and aspects of follow-up and after-care. RESULTS: The response rate was 100% (16 out of 16 hospitals). Diabetes clinics interviewed varied in size from 50 to 450 pediatric patients and frequency of insulin pump use from 11% - 46%. Clinical practice differed between clinics. Important differences related to: use of continuous glucose monitoring (12/16); and differing views on immediate vs. delayed use of pump advanced features. Location of pump starts also varied, with both in-patient (2/16) and out-patient (14/16) approaches seen. The motivations and beliefs relating to these various pump start approaches also varied. CONCLUSIONS: Differences seen between hospitals reflected team preference, and possibly a lack of consensus/guidance from the medical literature. Lessons may be learnt and further rationalisation and improvement in education remains possible by combining and adopting strengths from different hospitals.

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).

Prior knowledge of blood glucose meter download improves the accuracy of verbal self-reported blood glucose in teenagers with type I diabetes at ski camp.

AIMS: Despite advances in diabetes management, self-monitoring of blood glucose (SMBG) remains fundamental. A number of studies, principally in adults, have confirmed that logbook entries and verbal SMBG reports are prone to common errors. In the context of an adolescent diabetes camp, the accuracy of verbally reported SMBG is crucial for guiding safe therapeutic management, and negating the risk of exercise-induced hypoglycemia. We aimed to assess whether awareness of a planned meter download at the completion of a diabetes camp would improve the overall accuracy of verbally reported SMBG. METHODS: Adolescents with type one diabetes (n = 26) attended a 3-day ski camp in 2014. Verbally reported SMBG values were recorded by camp supervisors at multiple time points throughout the camp. The intervention involved ensuring that all participants (at camp commencement) were aware of a planned meter download and SMBG review at camp conclusion. These data were then compared with historical camp data from 2012, collected using identical methodology, in which participants (n = 20) were unaware of the planned meter download. For analysis, blood glucose (BGL) data were classified as: matching, phantom (verbal SMBG value with no corresponding meter download value), and over- or underestimate (verbally reported value >/< meter downloaded value). RESULTS: Dual data regarding verbal SMBG and meter downloads were obtained on 550 instances of BGL testing during the 2014 camp (the intervention group). This was compared to dual data for 396 historical tests from the 2012 control group. For the intervention group, the overall error rate was 4.7 %, over 34 % of participants. There was a statistically significant improvement in accuracy compared to historical nonintervention data, in which there was an error rate of 14.1 % over 70 % of participants (p < 0.001). There was also a decrease in phantom readings to 2 %, from 8.6 % in 2012 (p < 0.001). CONCLUSIONS: This study demonstrates an improvement in accuracy and reliability of verbally reported SMBG, following a simple intervention of ensuring participants were aware of a meter download at the completion of camp. This intervention could be easily incorporated into adolescent diabetes camp safety protocols and may provide an easy, low-cost way of improving verbally reported SMBG accuracy and therefore safety on camp.

Exploring the motivations behind misreporting self-measured blood glucose in adolescents with type 1 diabetes - a qualitative study.

BACKGROUND: Despite advances in diabetes management, the reporting and self-monitoring of blood glucose (SMBG) remains fundamental. While previous work has established that the misreporting of SMBG to family and medical professionals is surprisingly common, the motivations behind this behaviour have never been examined. We aimed to investigate the motivations behind misreporting of SMBG in adolescents with type 1 diabetes (T1DM). METHODS: Fifteen semi-structured interviews were conducted with adolescents (aged 12-19 inclusive) with T1DM recruited through diabetes clinics across the Otago/Southland region of New Zealand from November 2015 to January 2016. These were transcribed and content analysis performed to identify themes and subthemes in misreporting behaviour. RESULTS: The mean age of participants was 15.7 years, 60 % were male, with 67 % using multiple daily insulin injections, and 33 % on insulin pumps. Their median HbA1c was 84 mmol/mol, range 52-130. Misreporting behaviour was described for both electronic pump records and written logbooks, as well as verbally. Multiple motivations for misreporting were given, spanning three major themes: Achieving potential benefits; the avoidance of negative consequences; and the avoidance of worry/concern (in self or in others). The main suggestion of participants to reduce misreporting behaviour was to reduce the negative reactions of others to suboptimal blood glucose readings. CONCLUSION: Electronic, written, and verbal SMBG misreporting remains common. This study provides deeper insight into the motivations leading to this behaviour in adolescents, suggesting that further understanding and attention to this aspect of adherence may lead to improvements not only in glycaemic control and safety, but also to the psychological wellbeing of those with T1DM.

Accuracy of verbal self-reported blood glucose in teenagers with type I diabetes at diabetes ski camp.

BACKGROUND: While there have been considerable advances in diabetes management, self-monitoring of blood glucose remains vital. A number of studies, predominantly in adults, have confirmed that logbook entries are prone to a number of common errors. To date, no studies in either adults or children have looked at the accuracy of verbally reported self-monitored blood glucose levels (SMBG). Our aim was to determine the accuracy of verbally reported SMBG levels in adolescents at a diabetes camp. METHODS: Dual Data (verbally reported and meter-downloaded values) were obtained as part of camp safety monitoring from 20 adolescents (aged 13-18 years) attending a 3 day diabetes winter camp. Blood glucose values were classified as: accurate, absent/phantom, or modified - verbally reported value > / < meter downloaded value. No participant had prior awareness of the planned meter data download at camp conclusion. RESULTS: Discrepancies between verbally reported and meter downloaded values were observed in 14/20 (70%) participants and in 53/394 (13.5%) instances of testing. Absent/Phantom readings were the most common error at 30/394 (7.6%). Errors relating to hypoglycaemia were seen in 8/47 (17%) hypoglycaemia-related incidents of testing. No relationship with HbA1c was found between those with reporting errors and those without (p > 0.05). CONCLUSION: While 70% of adolescents had errors, the overall error rate at 13.5% is lower than that previously reported for logbook studies. While this rate is lower than expected, misreporting remains a concern, particularly in the context of diabetes camp and exercise induced hypoglycaemia.