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Summary: Background: Closed-loop insulin delivery systems have the potential to address suboptimal glucose control in children and adolescents with type 1 diabetes. We compared safety and efficacy of the Cambridge hybrid closed-loop algorithm with usual care over 6 months in this population. Methods: In a multicentre, multinational, parallel randomised controlled trial, participants aged 6–18 years using insulin pump therapy were recruited at seven UK and five US paediatric diabetes centres. Key inclusion criteria were diagnosis of type 1 diabetes for at least 12 months, insulin pump therapy for at least 3 months, and screening HbA1c levels between 53 and 86 mmol/mol (7·0–10·0%). Using block randomisation and central randomisation software, we randomly assigned participants to either closed-loop insulin delivery (closed-loop group) or to usual care with insulin pump therapy (control group) for 6 months. Randomisation was stratified at each centre by local baseline HbA1c. The Cambridge closed-loop algorithm running on a smartphone was used with either (1) a modified Medtronic 640G pump, Medtronic Guardian 3 sensor, and Medtronic prototype phone enclosure (FlorenceM configuration), or (2) a Sooil Dana RS pump and Dexcom G6 sensor (CamAPS FX configuration). The primary endpoint was change in HbA1c at 6 months combining data from both configurations. The primary analysis was done in all randomised patients (intention to treat). Trial registration ClinicalTrials.gov, NCT02925299. Findings: Of 147 people initially screened, 133 participants (mean age 13·0 years [SD 2·8]; 57% female, 43% male) were randomly assigned to either the closed-loop group (n=65) or the control group (n=68). Mean baseline HbA1c was 8·2% (SD 0·7) in the closed-loop group and 8·3% (0·7) in the control group. At 6 months, HbA1c was lower in the closed-loop group than in the control group (between-group difference −3·5 mmol/mol (95% CI −6·5 to −0·5 [–0·32 percentage points, −0·59 to −0·04]; p=0·023). Closed-loop usage was low with FlorenceM due to failing phone enclosures (median 40% [IQR 26–53]), but consistently high with CamAPS FX (93% [88–96]), impacting efficacy. A total of 155 adverse events occurred after randomisation (67 in the closed-loop group, 88 in the control group), including seven severe hypoglycaemia events (four in the closed-loop group, three in the control group), two diabetic ketoacidosis events (both in the closed-loop group), and two non-treatment-related serious adverse events. There were 23 reportable hyperglycaemia events (11 in the closed-loop group, 12 in the control group), which did not meet criteria for diabetic ketoacidosis. Interpretation: The Cambridge hybrid closed-loop algorithm had an acceptable safety profile, and improved glycaemic control in children and adolescents with type 1 diabetes. To ensure optimal efficacy of the closed-loop system, usage needs to be consistently high, as demonstrated with CamAPS FX. Funding: National Institute of Diabetes and Digestive and Kidney Diseases.

Introduction Project ECHO (Extension for Community Healthcare Outcomes) is a tele-education outreach model that seeks to democratize specialty knowledge to reduce disparities and improve health outcomes. Limited utilization of endocrinologists forces many primary care providers (PCPs) to care for patients with type 1 diabetes (T1D) without specialty support. Accordingly, an ECHO T1D program was developed and piloted in Florida and California. Our goal was to demonstrate the feasibility of an ECHO program focused on T1D and improve PCPs’ abilities to manage patients with T1D.Research design and methods Health centers (ie, spokes) were recruited into the ECHO T1D pilot through an innovative approach, focusing on Federally Qualified Health Centers and through identification of high-need catchment areas using the Neighborhood Deprivation Index and provider geocoding. Participating spokes received weekly tele-education provided by the University of Florida and Stanford University hub specialty team through virtual ECHO clinics, real-time support with complex T1D medical decision-making, access to a diabetes support coach, and access to an online repository of diabetes care resources. Participating PCPs completed pre/post-tests assessing diabetes knowledge and confidence and an exit survey gleaning feedback about overall ECHO T1D program experiences.Results In Florida, 12 spoke sites enrolled with 67 clinics serving >1000 patients with T1D. In California, 11 spoke sites enrolled with 37 clinics serving >900 patients with T1D. During the 6-month intervention, 27 tele-education clinics were offered and n=70 PCPs (22 from Florida, 48 from California) from participating spoke sites completed pre/post-test surveys assessing diabetes care knowledge and confidence in diabetes care. There was statistically significant improvement in diabetes knowledge (p≤0.01) as well as in diabetes confidence (p≤0.01).Conclusions The ECHO T1D pilot demonstrated proof of concept for a T1D-specific ECHO program and represents a viable model to reach medically underserved communities which do not use specialists.

Introduction Diabetes management in very young children remains challenging. Glycaemic targets are achieved at the expense of high parental diabetes management burden and frequent hypoglycaemia, impacting quality of life for the whole family. Our objective is to assess whether automated insulin delivery can improve glycaemic control and alleviate the burden of diabetes management in this particular age group.Methods and analysis The study adopts an open-label, multinational, multicentre, randomised, crossover design and aims to randomise 72 children aged 1–7 years with type 1 diabetes on insulin pump therapy. Following screening, participants will receive training on study insulin pump and study continuous glucose monitoring devices. Participants will be randomised to 16-week use of the hybrid closed-loop system (intervention period) or to 16-week use of sensor-augmented pump therapy (control period) with 1–4 weeks washout period before crossing over to the other arm. The order of the two study periods will be random. The primary endpoint is the between-group difference in time spent in the target glucose range from 3.9 to 10.0 mmol/L based on sensor glucose readings during the 16-week study periods. Analyses will be conducted on an intention-to-treat basis. Key secondary endpoints are between group differences in time spent above and below target glucose range, glycated haemoglobin and average sensor glucose. Participants’ and caregivers’ experiences will be evaluated using questionnaires and qualitative interviews, and sleep quality will be assessed. A health economic analysis will be performed.Ethics and dissemination Ethics approval has been obtained from Cambridge East Research Ethics Committee (UK), Ethics Committees of the University of Innsbruck, the University of Vienna and the University of Graz (Austria), Ethics Committee of the Medical Faculty of the University of Leipzig (Germany) and Comité National d’Ethique de Recherche (Luxembourg). The results will be disseminated by peer-reviewed publications and conference presentations.Trial registration number NCT03784027.

Background: Older adults may be less comfortable with continuous glucose monitoring (CGM) technology or require additional education to support use. The Virtual Diabetes Specialty Clinic study provided the opportunity to understand glycemic outcomes and support needed for older versus younger adults living with diabetes and using CGM., Methods: Prospective, virtual study of adults with type 1 diabetes (T1D, N = 160) or type 2 diabetes (T2D, N = 74) using basal-bolus insulin injections or insulin pump therapy. Remote CGM diabetes education (3 scheduled visits over 1 month) was provided by Certified Diabetes Care and Education Specialists with additional visits as needed. CGM-measured glycemic metrics, HbA1c and visit duration were evaluated by age (<40, 40-64 and ≥65 years)., Results: Median CGM use was ≥95% in all age groups. From baseline to 6 months, time 70 to 180 mg/dL improved from 45% ± 22 to 57% ± 16%; 50 ± 25 to 65 ± 18%; and 60 ± 28 to 69% ± 18% in the <40, 40-64, and ≥65-year groups, respectively (<40 vs 40-64 years P = 0.006). Corresponding values for HbA1c were 8.0% ± 1.6 to 7.3% ± 1.0%; 7.9 ± 1.6 to 7.0 ± 1.0%; and 7.4 ± 1.4 to 7.1% ± 0.9% (all P > 0.05). Visit duration was 41 min longer for ages ≥65 versus <40 years ( P = 0.001)., Conclusions: Adults with diabetes experience glycemic benefit after remote CGM use training, but training time for those >65 years is longer compared with younger adults. Addressing individual training-related needs, including needs that may vary by age, should be considered., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: RSW reported personal fees from The Leona M. and Harry B. Helmsley Charitable Trust and Jaeb Center for Health Research during the conduct of the study; grants for participation in multicenter clinical trial through her institution from Eli Lilly, Novo Nordisk, Insulet, Tandem, Amgen, and MannKind outside the submitted work; and discounted devices for clinical research from Dexcom outside the submitted work. RLG reported grants from The Leona M. and Harry B. Helmsley Charitable Trust during the conduct of the study. RMB reported grants from Abbott Diabetes Care, Eli Lilly, Hygieia, Dexcom, Sanofi, Tandem Diabetes Care, Insulet, and Medtronic and consulting and/or advisory board fees paid to his institution from Abbott Diabetes Care, Dexcom, Onduo, Sanofi, Roche, Embecta, and Medtronic during the conduct of the study. CK reported grants from The Leona M. and Harry B. Helmsley Charitable Trust and nonfinancial support from Dexcom during the conduct of the study; grants from JDRF, Diasome, and MannKind outside the submitted work; and nonfinancial support from Tandem, Dexcom, and Insulet outside the submitted work. DK reported grants from Abbott and advisor and/or speaking fees from Abbott, Dexcom, and Jaeb Center for Health Research outside the submitted work. MLJ reported grants from Jaeb Center for Health Research paid to HealthPartners Institute during the conduct of the study and grants from Dexcom given directly to HealthPartners Institute outside the submitted work. BAO reported personal fees from Lagoon Health during the conduct of the study and stock ownership in Abbott Laboratories. SMO reported grants from The Leona M. and Harry B. Helmsley Charitable Trust during the conduct of the study and consulting fees from Cecelia Health and advisory board fees from Dexcom outside the submitted work. TKO reported grants from The Leona M. and Harry B. Helmsley Charitable Trust during the conduct of the study and consulting fees from Cecelia Health, advisory board fees from Dexcom, and an investigator-initiated grant from Abbott Diabetes Care outside the submitted work. RWB reported grants from The Leona M. and Harry B. Helmsley Charitable Trust during the conduct of the study and grants from Insulet, Tandem Diabetes Care, Beta Bionics, Dexcom, and Bigfoot Biomedical; nonfinancial support from Insulet, Tandem Diabetes Care, Beta Bionics, Dexcom, Medtronic, Ascenia, Roche, Eli Lilly, and Novo Nordisk; and consulting fees paid to his institution from Insulet, Tandem Diabetes Care, Beta Bionics, Eli Lilly, Novo Nordisk, Embecta, Hagar, and Ypsomed outside the submitted work. KH reported behavioral expertise consulting fees from Cecelia Health during the conduct of the study. GA reported grants from The Leona M. and Harry B. Helmsley Charitable Trust during the conduct of the study and personal fees from Bayer, Dexcom, and Insulet; nonfinancial support from Eli Lilly; and grants from Dexcom, Eli Lilly, Fractyl Health, Emmes, MannKind, Tandem Diabetes Care, and Welldoc outside the submitted work. No other disclosures were reported.

Background: The objective was to examine patient-reported outcomes (PROs) associated with access to a virtual clinic model for diabetes care. Methods: Adults with diabetes ( N = 234) received virtual care, including support for continuous glucose monitoring (CGM) over a 6-month study period. Care was led by a Certified Diabetes Care and Education Specialist and focused on optimizing self-management skills and response to glucose values observed on CGM. After 6 months of CGM use and access to diabetes education, participants could opt in to another 6 months of follow-up with access to the virtual care team. Participants completed PRO surveys and had health and glycemic measures collected at baseline, 3, 6, and 12 months. Results: Participants with type 1 diabetes ( N = 160) were 44 ± 14 years and had mean baseline HbA1c of 61 mmol/mol (7.7%). Participants with type 2 diabetes ( N = 74) were 52 ± 12 years and had mean baseline HbA1c of 66 mmol/mol (8.2%). Compared with baseline levels, at 6 months participants experienced less depression, diabetes distress, and hypoglycemic fears while also experiencing greater satisfaction with glucose monitoring, diabetes technology and specifically with CGM, and confidence for managing hypoglycemic ( p < 0.05). For participants with type 1 diabetes, more time in the target range for glucose levels (70-180 mg/dL) was associated with less depression, diabetes distress, and hypoglycemic fears. Conclusions: PROs improved for adults with diabetes utilizing virtual diabetes care, including support for CGM use. Paired with the glycemic improvements observed in this virtual clinic study, there were robust benefits on the quality of life of adults with diabetes. ClinicalTrials.gov Identifier: NCT04765358.

Continuous glucose monitors (CGMs) improve glycemic outcomes and quality of life for many people with diabetes. Research and clinical practice efforts have focused on CGM initiation and uptake. There is limited understanding of how to sustain CGM use to realize these benefits and limited consideration for different reasons/goals for CGM use. Therefore, we apply the Information-Motivation-Behavioral Skills (IMB) model as an organizing framework to advance understanding of CGM use as a complex, ongoing self-management behavior. We present a person-centered, dynamic perspective with the central thesis that IMB predictors of optimal CGM use vary based on the CGM use goal of the person with diabetes. This reframe emphasizes the importance of identifying and articulating each person's goal for CGM use to inform education and support., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: All authors’ contributions to this work were supported by the Leona M. and Harry B. Helmsley Charitable Trust (Author LSM is PI). Author NAA received consulting fees from Diathrive Health and has a grant from Dexcom for equipment being used in an NIH-funded research project. KH received consulting fees from Cecelia Health and Sanofi.

Few young people with type 1 diabetes (T1D) meet glucose targets. Continuous glucose monitoring improves glycemia, but access is not equitable. We prospectively assessed the impact of a systematic and equitable digital-health-team-based care program implementing tighter glucose targets (HbA1c < 7%), early technology use (continuous glucose monitoring starts <1 month after diagnosis) and remote patient monitoring on glycemia in young people with newly diagnosed T1D enrolled in the Teamwork, Targets, Technology, and Tight Control (4T Study 1). Primary outcome was HbA1c change from 4 to 12 months after diagnosis; the secondary outcome was achieving the HbA1c targets. The 4T Study 1 cohort (36.8% Hispanic and 35.3% publicly insured) had a mean HbA1c of 6.58%, 64% with HbA1c < 7% and mean time in the range (70-180 mg dl -1 ) of 68% at 1 year after diagnosis. Clinical implementation of the 4T Study 1 met the prespecified primary outcome and improved glycemia without unexpected serious adverse events. The strategies in the 4T Study 1 can be used to implement systematic and equitable care for individuals with T1D and translate to care for other chronic diseases. ClinicalTrials.gov registration: NCT04336969 ., (© 2024. The Author(s), under exclusive licence to Springer Nature America, Inc.)

Background: Fear of Hypoglycemia (FoH) in people with diabetes has a significant impact on their quality of life, psychological well-being, and self-management of disease. There are a few questionnaires assessing FoH in people living with diabetes, but they are more often used in research than clinical practice. This study aimed to develop and validate a short and actionable FoH screener for adults living with type 1 diabetes (T1D) for use in routine clinical practice., Methods: We developed an initial screener based on literature review and, interviews with healthcare providers (HCPs) and people with T1D. We developed a cross-sectional web-based survey, which was then conducted to examine the reliability and validity of the screener. Adults (aged ≥ 18 years) with diagnosis of T1D for ≥ 1 year were recruited from the T1D Exchange Registry (August-September 2020). The validation analyses were conducted using exploratory factor analyses, correlation, and multivariable regression models for predicting cut-off scores for the final screener., Results: The final FoH screener comprised nine items assessing two domains, "worry" (6-items) and "avoidance behavior" (three items), in 592 participants. The FoH screener showed good internal consistency (Cronbach's α = 0.88). The screener also demonstrated high correlations (r = 0.71-0.75) with the Hypoglycemia Fear Survey and moderate correlations with depression, anxiety, and diabetes distress scales (r = 0.44-0.66). Multivariable regression analysis showed that higher FoH screener scores were significantly associated with higher glycated hemoglobin (HbA1c) (b = 0.04) and number of comorbidities (b = 0.03)., Conclusions: This short FoH screener demonstrated good reliability and validity. Further research is planned to assess clinical usability to identify patients with FoH and assist effective HCP-patient conversations., (© 2023. The Author(s).)

Background: The use of continuous glucose monitors (CGMs) is recommended as the standard of care by the American Diabetes Association for individuals with type 1 diabetes (T1D). Few hardware-agnostic, open-source, whole-population tools are available to facilitate the use of CGM data by clinicians such as physicians and certified diabetes educators., Objective: This study aimed to develop a tool that identifies patients appropriate for contact using an asynchronous message through electronic medical records while minimizing the number of patients reviewed by a certified diabetes educator or physician using the tool., Methods: We used consensus guidelines to develop timely interventions for diabetes excellence (TIDE), an open-source hardware-agnostic tool to analyze CGM data to identify patients with deteriorating glucose control by generating generic flags (eg, mean glucose [MG] >170 mg/dL) and personalized flags (eg, MG increased by >10 mg/dL). In a prospective 7-week study in a pediatric T1D clinic, we measured the sensitivity of TIDE in identifying patients appropriate for contact and the number of patients reviewed. We simulated measures of the workload generated by TIDE, including the average number of time in range (TIR) flags per patient per review period, on a convenience sample of eight external data sets, 6 from clinical trials and 2 donated by research foundations., Results: Over the 7 weeks of evaluation, the clinical population increased from 56 to 64 patients. The mean sensitivity was 99% (242/245; SD 2.5%), and the mean reduction in the number of patients reviewed was 42.6% (182/427; SD 10.9%). The 8 external data sets contained 1365 patients with 30,017 weeks of data collected by 7 types of CGMs. The rates of generic and personalized TIR flags per patient per review period were, respectively, 0.15 and 0.12 in the data set with the lowest average MG (141 mg/dL) and 0.95 and 0.22 in the data set with the highest average MG (207 mg/dL)., Conclusions: TIDE is an open-source hardware-agnostic tool for personalized analysis of CGM data at the clinical population scale. In a pediatric T1D clinic, TIDE identified 99% of patients appropriate for contact using an asynchronous message through electronic medical records while reducing the number of patients reviewed by certified diabetes care and education specialists by 43%. For each of the 8 external data sets, simulation of the use of TIDE produced fewer than 0.25 personalized TIR flags per patient per review period. The use of TIDE to support telemedicine-based T1D care may facilitate sensitive and efficient guideline-based population health management., (©David Scheinker, Angela Gu, Joshua Grossman, Andrew Ward, Oseas Ayerdi, Daniel Miller, Jeannine Leverenz, Korey Hood, Ming Yeh Lee, David M Maahs, Priya Prahalad. Originally published in JMIR Diabetes (https://diabetes.jmir.org), 06.06.2022.)

Community health workers (CHWs) provide vital support to underserved communities in the promotion of health equity by addressing barriers related to the social determinants of health that often prevent people living with diabetes from achieving optimal health outcomes. Peer support programs in diabetes can also offer people living with diabetes invaluable support through a shared understanding of the disease and by offsetting diabetes-related stigma. As part of a Project Extension for Community Healthcare Outcomes (ECHO) Diabetes program, participating federally qualified healthcare centers were provided diabetes support coaches (DSCs) to facilitate patient engagement. DSCs hold invaluable expert knowledge, as they live with diabetes themselves and reside in areas they serve, thus combining the CHW role with peer support models. The use of DSCs and CHWs during the coronavirus disease 2019 pandemic and beyond is highly effective at reaching underserved communities with diabetes and promoting health equity., (© 2022 by the American Diabetes Association.)

Context: Youth with type 1 diabetes (T1D) do not meet glycated hemoglobin A1c (HbA1c) targets., Objective: This work aimed to assess HbA1c outcomes in children with new-onset T1D enrolled in the Teamwork, Targets, Technology and Tight Control (4T) Study., Methods: HbA1c levels were compared between the 4T and historical cohorts. HbA1c differences between cohorts were estimated using locally estimated scatter plot smoothing (LOESS). The change from nadir HbA1c (month 4) to 12 months post diagnosis was estimated by cohort using a piecewise mixed-effects regression model accounting for age at diagnosis, sex, ethnicity, and insurance type. We recruited 135 youth with newly diagnosed T1D at Stanford Children's Health. Starting July 2018, all youth within the first month of T1D diagnosis were offered continuous glucose monitoring (CGM) initiation and remote CGM data review was added in March 2019. The main outcomes measure was HbA1c., Results: HbA1c at 6, 9, and 12 months post diagnosis was lower in the 4T cohort than in the historic cohort (-0.54% to -0.52%, and -0.58%, respectively). Within the 4T cohort, HbA1c at 6, 9, and 12 months post diagnosis was lower in those patients with remote monitoring than those without (-0.14%, -0.18% to -0.14%, respectively). Multivariable regression analysis showed that the 4T cohort experienced a significantly lower increase in HbA1c between months 4 and 12 (P < .001)., Conclusion: A technology-enabled, team-based approach to intensified new-onset education involving target setting, CGM initiation, and remote data review statistically significantly decreased HbA1c in youth with T1D 12 months post diagnosis., (© The Author(s) 2021. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Hybrid Closed-Loop (HCL) systems aid individuals with type 1 diabetes in improving glycemic control; however, sustained use over time has not been consistent for all users. This study developed and validated prognostic models for successful 12-month use of the first commercial HCL system based on baseline and 1- or 3-month data. Methods and Materials: Data from participants at the Barbara Davis Center ( N  = 85) who began use of the MiniMed 670G HCL were used to develop prognostic models using logistic regression and Lasso model selection. Candidate factors included sex, age, duration of diabetes, baseline hemoglobin A1c (HbA1c), race, ethnicity, insurance status, history of insulin pump and continuous glucose monitor use, 1- or 3-month Auto Mode use, boluses per day, and time in range (TIR; 70-180 mg/dL), and scores on behavioral questionnaires. Successful use of HCL was predefined as Auto Mode use ≥60%. The 3-month model was then externally validated against a sample from Stanford University ( N  = 55). Results: Factors in the final model included baseline HbA1c, sex, ethnicity, 1- or 3-month Auto Mode use, Boluses per Day, and TIR. The 1- and 3-month prognostic models had very good predictive ability with area under the curve values of 0.894 and 0.900, respectively. External validity was acceptable with an area under the curve of 0.717. Conclusions: Our prognostic models use clinically accessible baseline and early device-use factors to identify risk for failure to succeed with 670G HCL technology. These models may be useful to develop targeted interventions to promote success with new technologies.

Introduction: Diabetes management in very young children remains challenging. Glycaemic targets are achieved at the expense of high parental diabetes management burden and frequent hypoglycaemia, impacting quality of life for the whole family. Our objective is to assess whether automated insulin delivery can improve glycaemic control and alleviate the burden of diabetes management in this particular age group., Methods and Analysis: The study adopts an open-label, multinational, multicentre, randomised, crossover design and aims to randomise 72 children aged 1-7 years with type 1 diabetes on insulin pump therapy. Following screening, participants will receive training on study insulin pump and study continuous glucose monitoring devices. Participants will be randomised to 16-week use of the hybrid closed-loop system (intervention period) or to 16-week use of sensor-augmented pump therapy (control period) with 1-4 weeks washout period before crossing over to the other arm. The order of the two study periods will be random. The primary endpoint is the between-group difference in time spent in the target glucose range from 3.9 to 10.0 mmol/L based on sensor glucose readings during the 16-week study periods. Analyses will be conducted on an intention-to-treat basis. Key secondary endpoints are between group differences in time spent above and below target glucose range, glycated haemoglobin and average sensor glucose. Participants' and caregivers' experiences will be evaluated using questionnaires and qualitative interviews, and sleep quality will be assessed. A health economic analysis will be performed., Ethics and Dissemination: Ethics approval has been obtained from Cambridge East Research Ethics Committee (UK), Ethics Committees of the University of Innsbruck, the University of Vienna and the University of Graz (Austria), Ethics Committee of the Medical Faculty of the University of Leipzig (Germany) and Comité National d'Ethique de Recherche (Luxembourg). The results will be disseminated by peer-reviewed publications and conference presentations., Trial Registration Number: NCT03784027., Competing Interests: Competing interests: SEH declares speaker honoraria from Eli Lilly, Pfizer and Sanofi. EF-R reports having received speaker honoraria from Minimed Medtronic and Eli Lilly, serving on advisory boards for Eli Lilly. TMK has received speaker honoraria from Minimed Medtronic, Roche and Eli Lilly and consulted Sanofi-Aventis. CdB has received speaker honoraria from Minimed Medtronic, and is member of their European Psychology Advisory Board. BR-M reports having received speaker honoraria from Abbott, Minimed Medtronic, Eli Lilly, Roche, Menarini and Novo Nordisk, serving on advisory boards for Eli Lilly. FC has received speaking fees from Abbott, Medtronic and Eli Lilly. RH reports having received speaker honoraria from Eli Lilly and Novo Nordisk, serving on advisory panel for Eli Lilly and Novo Nordisk; receiving license fees from BBraun and Medtronic; having served as a consultant to BBraun, patents and patent applications related to closed-loop insulin delivery, and director at CamDiab. JKM is shareholder of Decide Clinical Software, a member in the advisory board of Boehringer Ingelheim, Eli Lilly, Medtronic, Prediktor A/S, Roche Diabetes Care, Sanofi-Aventis and received speaker honoraria from Abbott Diabetes Care, Astra Zeneca, Dexcom, Eli Lilly, NovoNordisk A/S, Roche Diabetes Care, Servier and Takeda., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: Management of type 1 diabetes is challenging. We compared outcomes using a commercially available hybrid closed-loop system versus a new investigational system with features potentially useful for adolescents and young adults with type 1 diabetes., Methods: In this multinational, randomised, crossover trial (Fuzzy Logic Automated Insulin Regulation [FLAIR]), individuals aged 14-29 years old, with a clinical diagnosis of type 1 diabetes with a duration of at least 1 year, using either an insulin pump or multiple daily insulin injections, and glycated haemoglobin (HbA 1c ) levels of 7·0-11·0% (53-97 mmol/mol) were recruited from seven academic-based endocrinology practices, four in the USA, and one each in Germany, Israel, and Slovenia. After a run-in period to teach participants how to use the study pump and continuous glucose monitor, participants were randomly assigned (1:1) using a computer-generated sequence, with a permuted block design (block sizes of two and four), stratified by baseline HbA 1c and use of a personal MiniMed 670G system (Medtronic) at enrolment, to either use of a MiniMed 670G hybrid closed-loop system (670G) or the investigational advanced hybrid closed-loop system (Medtronic) for the first 12-week period, and then participants were crossed over with no washout period, to the other group for use for another 12 weeks. Masking was not possible due to the nature of the systems used. The coprimary outcomes, measured with continuous glucose monitoring, were proportion of time that glucose levels were above 180 mg/dL (>10·0 mmol/L) during 0600 h to 2359 h (ie, daytime), tested for superiority, and proportion of time that glucose levels were below 54 mg/dL (<3·0 mmol/L) calculated over a full 24-h period, tested for non-inferiority (non-inferiority margin 2%). Analysis was by intention to treat. Safety was assessed in all participants randomly assigned to treatment. This trial is registered with ClinicalTrials.gov, NCT03040414, and is now complete., Findings: Between June 3 and Aug 22, 2019, 113 individuals were enrolled into the trial. Mean age was 19 years (SD 4) and 70 (62%) of 113 participants were female. Mean proportion of time with daytime glucose levels above 180 mg/dL (>10·0 mmol/L) was 42% (SD 13) at baseline, 37% (9) during use of the 670G system, and 34% (9) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] -3·00% [95% CI -3·97 to -2·04]; p<0·0001). Mean 24-h proportion of time with glucose levels below 54 mg/dL (<3·0 mmol/L) was 0·46% (SD 0·42) at baseline, 0·50% (0·35) during use of the 670G system, and 0·46% (0·33) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] -0·06% [95% CI -0·11 to -0·02]; p<0·0001 for non-inferiority). One severe hypoglycaemic event occurred in the advanced hybrid closed-loop system group, determined to be unrelated to study treatment, and none occurred in the 670G group., Interpretation: Hyperglycaemia was reduced without increasing hypoglycaemia in adolescents and young adults with type 1 diabetes using the investigational advanced hybrid closed-loop system compared with the commercially available MiniMed 670G system. Testing an advanced hybrid closed-loop system in populations that are underserved due to socioeconomic factors and testing during pregnancy and in individuals with impaired awareness of hypoglycaemia would advance the effective use of this technology FUNDING: National Institute of Diabetes and Digestive and Kidney Diseases., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Introduction: Chronic pain conditions are common among children and engender cascading effects across social, emotional, and behavioral domains for the child and family. Mobile health (mHealth) describes the practice of delivering healthcare via mobile devices and may be an ideal solution to increase access and reach of evidence-based behavioral health interventions., Areas Covered: The aim of this narrative review is to present a state-of-the-art overview of evidence-based mHealth efforts within the field of pediatric chronic pain and consider new and promising directions for study. Given the nascent nature of the field, published mHealth interventions in all stages of development are discussed. Literature was identified through a non-systematic search in PubMed and Google Scholar, and a review of reference lists of papers that were identified as particularly relevant or foundational (within and outside of the chronic pain literature)., Expert Opinion: mHealth is a promising interventional modality with early evidence suggesting it is primed to enhance behavioral health delivery and patient outcomes. There are many exciting future directions to be explored including drawing inspiration from digital health technology to generate new ways of thinking about the optimal treatment of pediatric chronic pain.

Background: Closed loop (CL) automated insulin delivery systems are demonstrated to be safe and effective in regulating glucose levels and reducing cognitive burden in people with type 1 diabetes (T1D). However, given the limited market options and the do-it-yourself nature of most systems, it can be difficult for potential users to shape their expectations fitting them into daily lives and management routines. As such, we examined the potential feasibility of a virtual reality (VR) intervention., Methods: A four-part VR intervention was created to expose adults with T1D to expected CL system barriers: body image, perceived hassles of using CL, deskilling fears, and unwanted social attention. Goals of the pilot were to assess feasibility and expose patients to CL. Surveys were conducted pre- and postparticipating in the VR experience., Results: A total of 20 adults with T1D completed the pilot. Average time to complete the experience was 14.1 minutes (8.8-39.9). Reported VR sickness was low. Willingness to use VR was maintained in 90% ( n  = 18) and did not change expectations of CL in 95% ( n  = 19). Virtual reality changed perceived hassles of CL in 25% ( n  = 5) with four concerned over alarms and one connectivity issues: positive diabetes technology attitudes, confidence in managing hypoglycemia, overall perceptions of appearance, and positive affect maintained after the VR intervention. Negative affect significantly decreased after exposure and perceptions of being overweight trended toward significance., Conclusion: This pilot VR intervention demonstrated high potential in addressing expected barriers to uptake and usage of CL systems without decreasing enthusiasm or changing expectations of CL.

The purpose of this study was to evaluate feasibility of initiating continuous glucose monitoring (CGM) through telehealth as a means of expanding access. Adults with type 1 diabetes (N = 27) or type 2 diabetes using insulin (N = 7) and interest in starting CGM selected a CGM system (Dexcom G6 or Abbott FreeStyle Libre), which they received by mail. CGM was initiated with a certified diabetes care and education specialist providing instruction via videoconference or phone. The primary outcome was days per week of CGM use during the last 4 weeks. Hemoglobin A 1c (HbA 1c ) was measured at baseline and 12 weeks. Participant self-reported outcome measures were also evaluated. All 34 participants (mean age, 46 ± 18 years; 53% female, 85% white) were using CGM at 12 weeks, with 94% using CGM at least 6 days per week during weeks 9 to 12. Mean HbA 1c decreased from 8.3 ± 1.6 at baseline to 7.2 ± 1.3 at 12 weeks ( P  < .001) and mean time in range (70-180 mg/dL, 3.9-10.0 mmol/L) increased from an estimated 48% ± 18% to 59% ± 20% ( P  < .001), an increase of approximately 2.7 hours/day. Substantial benefits of CGM to quality of life were observed, with reduced diabetes distress, increased satisfaction with glucose monitoring, and fewer perceived technology barriers to management. Remote CGM initiation was successful in achieving sustained use and improving glycemic control after 12 weeks as well as improving quality-of-life indicators. If widely implemented, this telehealth approach could substantially increase the adoption of CGM and potentially improve glycemic control for people with diabetes using insulin., (© Endocrine Society 2020.)

Importance: Adolescents and young adults with type 1 diabetes exhibit the worst glycemic control among individuals with type 1 diabetes across the lifespan. Although continuous glucose monitoring (CGM) has been shown to improve glycemic control in adults, its benefit in adolescents and young adults has not been demonstrated., Objective: To determine the effect of CGM on glycemic control in adolescents and young adults with type 1 diabetes., Design, Setting, and Participants: Randomized clinical trial conducted between January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9%., Interventions: Participants were randomized 1:1 to undergo CGM (CGM group; n = 74) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n = 79)., Main Outcomes and Measures: The primary outcome was change in HbA1c from baseline to 26 weeks. There were 20 secondary outcomes, including additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate., Results: Among the 153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study. In the CGM group, 68% of participants used CGM at least 5 days per week in month 6. Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01). Of 20 prespecified secondary outcomes, there were statistically significant differences in 3 of 7 binary HbA1c outcomes, 8 of 9 CGM metrics, and 1 of 4 patient-reported outcomes. The most commonly reported adverse events in the CGM and BGM groups were severe hypoglycemia (3 participants with an event in the CGM group and 2 in the BGM group), hyperglycemia/ketosis (1 participant with an event in CGM group and 4 in the BGM group), and diabetic ketoacidosis (3 participants with an event in the CGM group and 1 in the BGM group)., Conclusions and Relevance: Among adolescents and young adults with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in glycemic control over 26 weeks. Further research is needed to understand the clinical importance of the findings., Trial Registration: ClinicalTrials.gov Identifier: NCT03263494.

Introduction: Management of newly diagnosed type 1 diabetes (T1D) in children and adolescents is challenging for patients, families and healthcare professionals. The objective of this study is to determine whether continued intensive metabolic control using hybrid closed-loop (CL) insulin delivery following diagnosis of T1D can preserve C-peptide secretion, a marker of residual beta-cell function, compared with standard multiple daily injections (MDI) therapy., Methods and Analysis: The study adopts an open-label, multicentre, randomised, parallel design, and aims to randomise 96 participants aged 10-16.9 years, recruited within 21 days of diagnosis with T1D. Following a baseline mixed meal tolerance test (MMTT), participants will be randomised to receive 24 months treatment with conventional MDI therapy or with CL insulin delivery. A further 24-month optional extension phase will be offered to all participants to continue with the allocated treatment. The primary outcome is the between group difference in area under the stimulated C-peptide curve (AUC) of the MMTT at 12 months post diagnosis. Analyses will be conducted on an intention-to-treat basis. Key secondary outcomes are between group differences in time spent in target glucose range (3.9-10 mmol/L), glycated haemoglobin (HbA1c) and time spent in hypoglycaemia (<3.9 mmol/L) at 12 months. Secondary efficacy outcomes include between group differences in stimulated C-peptide AUC at 24 months, time spent in target glucose range, glucose variability, hypoglycaemia and hyperglycaemia as recorded by periodically applied masked continuous glucose monitoring devices, total, basal and bolus insulin dose, and change in body weight. Cognitive, emotional and behavioural characteristics of participants and parents will be evaluated, and a cost-utility analysis performed to support adoption of CL as a standard treatment modality following diagnosis of T1D., Ethics and Dissemination: Ethics approval has been obtained from Cambridge East Research Ethics Committee. The results will be disseminated by peer-reviewed publications and conference presentations., Trial Registration Number: NCT02871089; Pre-results., Competing Interests: Competing interests: RH reports having received speaker honoraria from Eli Lilly and Novo Nordisk, serving on advisory panel for Eli Lilly and Novo Nordisk, receiving licence fees from BBraun and Medtronic. RH and MEW report patient patents and patent applications. MT has received speaker honoraria from Medtronic and Novo Nordisk. SH is a member of Sigma (Dexcom) advisory board and reports having received training honoraria from Medtronic and Sanofi. TLR has received speaker honoraria from Novo Nordisk and serves as a consultant for Abbott Diabetes Care. KH has received research support from Dexcom, Inc for an investigator-initiated project; he has received consultant fees from Lilly Innovation Center, Bigfoot Biomedical, and Insulet, Inc., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Recent, rapid changes in the treatment of type 1 diabetes have allowed for commercialization of an "artificial pancreas" that is better described as a closed-loop controller of insulin delivery. This review presents the current state of closed-loop control systems and expected future developments with a discussion of the human factor issues in allowing automation of glucose control. The goal of these systems is to minimize or prevent both short-term and long-term complications from diabetes and to decrease the daily burden of managing diabetes. The closed-loop systems are generally very effective and safe at night, have allowed for improved sleep, and have decreased the burden of diabetes management overnight. However, there are still significant barriers to achieving excellent daytime glucose control while simultaneously decreasing the burden of daytime diabetes management. These systems use a subcutaneous continuous glucose sensor, an algorithm that accounts for the current glucose and rate of change of the glucose, and the amount of insulin that has already been delivered to safely deliver insulin to control hyperglycemia, while minimizing the risk of hypoglycemia. The future challenge will be to allow for full closed-loop control with minimal burden on the patient during the day, alleviating meal announcements, carbohydrate counting, alerts, and maintenance. The human factors involved with interfacing with a closed-loop system and allowing the system to take control of diabetes management are significant. It is important to find a balance between enthusiasm and realistic expectations and experiences with the closed-loop system., (Copyright © 2019 Endocrine Society.)

Objective: In September 2016, the U.S. Food and Drug Administration approved the Medtronic 670G "hybrid" closed-loop system. In Auto Mode, this system automatically controls basal insulin delivery based on continuous glucose monitoring data but requires users to enter carbohydrates and blood glucose for boluses. To track real-world experience with this first commercial closed-loop device, we prospectively followed pediatric and adult patients starting the 670G system., Research Design and Methods: This was a 1-year prospective observational study of patients with type 1 diabetes starting the 670G system between May 2017 and May 2018 in clinic., Results: Of the total of 84 patients who received 670G and consented, 5 never returned for follow-up, with 79 (aged 9-61 years) providing data at 1 week and 3, 6, 9, and/or 12 months after Auto Mode initiation. For the 86% (68 out of 79) with 1-week data, 99% (67 out of 68) successfully started. By 3 months, at least 28% (22 out of 79) had stopped using Auto Mode; at 6 months, 34% (27 out of 79); at 9 months, 35% (28 out of 79); and by 12 months, 33% (26 out of 79). The primary reason for continuing Auto Mode was desire for increased time in range. Reasons for discontinuation included sensor issues in 62% (16 out of 26), problems obtaining supplies in 12% (3 out of 26), hypoglycemia fear in 12% (3 out of 26), multiple daily injection preference in 8% (2 out of 26), and sports in 8% (2 out of 26). At all visits, there was a significant correlation between hemoglobin A 1c (HbA 1c ) and Auto Mode utilization., Conclusions: While Auto Mode utilization correlates with improved glycemic control, a focus on usability and human factors is necessary to ensure use of Auto Mode. Alarms and sensor calibration are a major patient concern, which future technology should alleviate., (© 2019 by the American Diabetes Association.)

Background: We tested the safety and performance of the "insulin-only" configuration of the bionic pancreas (BP) closed-loop blood-glucose control system in a home-use setting to assess glycemic outcomes using different static and dynamic glucose set-points., Method: This is an open-label non-randomized study with three consecutive intervention periods. Participants had consecutive weeks of usual care followed by the insulin-only BP with (1) an individualized static set-point of 115 or 130 mg/dL and (2) a dynamic set-point that automatically varied within 110 to 130 mg/dL, depending on hypoglycemic risk. Human factors (HF) testing was conducted using validated surveys. The last five days of each study arm were used for data analysis., Results: Thirteen participants were enrolled with a mean age of 28 years, mean A1c of 7.2%, and mean daily insulin dose of 0.6 U/kg (0.4-1.0 U/kg). The usual care arm had an average glucose of 145 ± 20 mg/dL, which increased in the static set-point arm (159 ± 8 mg/dL, P = .004) but not in the dynamic set-point arm (154 ± 10 mg/dL, P = ns). There was no significant difference in time spent in range (70-180 mg/dL) among the three study arms. There was less time <70 mg/dL with both the static (1.8% ± 1.4%, P = .009) and dynamic set-point (2.7±1.5, P = .051) arms compared to the usual-care arm (5.5% ± 4.2%). HF testing demonstrated preliminary user satisfaction and no increased risk of diabetes burden or distress., Conclusions: The insulin-only configuration of the BP using either static or dynamic set-points and initialized only with body weight performed similarly to other published insulin-only systems.

Despite advances in diabetes technology and treatment, a majority of children and adolescents with type 1 diabetes (T1D) fail to meet hemoglobin A1c (HbA1c) targets. Among high-income nations, the United States has one of the highest mean HbA1c values. We tracked the HbA1c values of 261 patients diagnosed with T1D in our practice over a 2.5-year period to identify inflection points in the HbA1c trajectory. The HbA1c declined until 5 months postdiagnosis. There was a rise in the HbA1c between the fifth and sixth month postdiagnosis. The HbA1c continued to steadily rise and by 18 months postdiagnosis, the mean HbA1c was 8.2%, which is also our clinic mean. Understanding the HbA1c trajectory early in the course of diabetes has helped to identify opportunities for intensification of diabetes management to flatten the trajectory of HbA1c and improve clinical outcomes.

Introduction: Closed-loop systems titrate insulin based on sensor glucose levels, providing novel means to reduce the risk of hypoglycaemia while improving glycaemic control. We will assess effectiveness of 6-month day-and-night closed-loop insulin delivery compared with usual care (conventional or sensor-augmented pump therapy) in children and adolescents with type 1 diabetes., Methods and Analysis: The trial adopts an open-label, multicentre, multinational (UK and USA), randomised, single-period, parallel design. Participants (n=130) are children and adolescents (aged ≥6 and <19 years) with type 1 diabetes for at least 1 year, and insulin pump use for at least 3 months with suboptimal glycaemic control (glycated haemoglobin ≥58 mmol/mol (7.5%) and ≤86 mmol/mol (10%)). After a 2-3 week run-in period, participants will be randomised to 6-month use of hybrid closed-loop insulin delivery, or to usual care. Analyses will be conducted on an intention-to-treat basis. The primary outcome is glycated haemoglobin at 6 months. Other key endpoints include time in the target glucose range (3.9-10 mmol/L, 70-180 mg/dL), mean sensor glucose and time spent above and below target. Secondary outcomes include SD and coefficient of variation of sensor glucose levels, time with sensor glucose levels <3.5 mmol/L (63 mg/dL) and <3.0 mmol/L (54 mg/dL), area under the curve of glucose <3.5 mmol/L (63 mg/dL), time with glucose levels >16.7 mmol/L (300 mg/dL), area under the curve of glucose >10.0 mmol/L (180 mg/dL), total, basal and bolus insulin dose, body mass index z-score and blood pressure. Cognitive, emotional and behavioural characteristics of participants and caregivers and their responses to the closed-loop and clinical trial will be assessed. An incremental cost-effectiveness ratio for closed-loop will be estimated., Ethics and Dissemination: Cambridge South Research Ethics Committee and Jaeb Center for Health Research Institutional Review Office approved the study. The findings will be disseminated by peer-review publications and conference presentations., Trial Registration Number: NCT02925299; Pre-results., Competing Interests: Competing interests: RH reports having received speaker honoraria from Eli Lilly and Novo Nordisk, serving on advisory panel for Eli Lilly and Novo Nordisk, receiving licence fees from BBraun and Medtronic. RH and MEW report patent patents and patent applications. MT has received speaker honoraria from Medtronic and NovoNordisk. PW reports receiving speaker honoraria from Dexcom and serving on advisory panels for Eli Lilly and Novo Nordisk and research support from Bigfoot Biomedical, Dexcom, Lexicon, Mannkind and Novo Nordisk. BAB is on Advisory Boards for Novo Nordisk and Convatec, has received research support from Medtronic Diabetes, Tandem Diabetes, Insulet, Convatec and Dexcom. SW has received speaker honoraria from Medtronic, Insulet and Tandem, and has received consultant honoraria from Sanofi and Zealand Pharmaceuticals. KH has received research support from Dexcom for an investigator-initiated project; he has received consultant fees from Lilly Innovation Center, Bigfoot Biomedical and Insulet. LDM reports grants from Medtronic., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

The purpose of this phenomenological qualitative study was to examine the quality of life among college students living with Type 1 diabetes (T1D). Inclusion criteria included age 18 to 24, current college student, and a diagnosis of T1D for at least 1 year. Semi-structured interviews were conducted, in-person and by phone. During these interviews, college students shared stories of living with T1D and its impact on their quality of life. Three major themes emerged, which included "planning ahead," "thinking positive," and "seeking support." These findings provide a better understanding of the transitional experience of living with T1D and the impact on perceived quality of life while attending college. Techniques and strategies aimed at the enhancement of perceived quality of life for college students living with T1D were identified. These findings will provide valuable insight for professionals working with this population., (© The Author(s) 2016.)

Adolescents with type 1 diabetes have an increased risk for a variety of emotional and behavioral challenges as well as negative diabetes outcomes. This study was designed to compare the effectiveness of a depression-prevention, resilience promotion program with an advanced diabetes education program. Each program consisted of 9 group-based sessions. There were 264 adolescents enrolled in this multi-site randomized clinical trial. The primary outcomes were depressive symptoms and glycemic control; secondary outcomes included resilience skills, diabetes management and adherence, and diabetes-specific distress. The goal of the present paper is to describe the study design, the intervention, and the baseline characteristics of the sample. Preliminary data suggests that enrollment, randomization and retention were successful. Longitudinal follow-up and examination of mechanisms of action as they relate to psychosocial and glycemic outcomes will be explored in the future., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Type 1 diabetes (T1D) is a complex chronic disease that has many facets for successful management. The burden of this management falls largely on the individual and their family members. Self-management has a major influence on T1D health outcomes, and with successful management, children and adolescents with T1D can lead long and healthy lives. We discuss how various individual, family, and systemic/technologic factors influence T1D self-management, providing research that supports interventions targeting each of these factors. With this information, health care practitioners and researchers can better understand the role of T1D self-management and bolster this important aspect of T1D care.

Objective: Although substantial literature has reported regional cerebral blood flow (rCBF) abnormalities in adults with depression, these studies commonly necessitated the injection of radioisotopes into subjects. The recent development of arterial spin labeling (ASL), however, allows noninvasive measurements of rCBF. Currently, no published ASL studies have examined cerebral perfusion in adolescents with depression. Thus, the aim of the present study was to examine baseline cerebral perfusion in adolescent depression using a newly developed ASL technique: pseudocontinuous arterial spin labeling (PCASL)., Method: A total of 25 medication-naive adolescents (13-17 years of age) diagnosed with major depressive disorder (MDD) and 26 well-matched control subjects underwent functional magnetic resonance imaging. Baseline rCBF was measured via a novel PCASL method that optimizes tagging efficiency., Results: Voxel-based whole brain analyses revealed significant frontal, limbic, paralimbic, and cingulate hypoperfusion in the group with depression (p < .05, corrected). Hyperperfusion was also observed within the subcallosal cingulate, putamen, and fusiform gyrus (p < .05, corrected). Similarly, region-of-interest analyses revealed amygdalar and insular hypoperfusion in the group with depression, as well as hyperperfusion in the putamen and superior insula (p < .05, corrected)., Conclusions: Adolescents with depression and healthy adolescents appear to differ on rCBF in executive, affective, and motor networks. Dysfunction in these regions may contribute to the cognitive, emotional, and psychomotor symptoms commonly present in adolescent depression. These findings point to possible biomarkers for adolescent depression that could inform early interventions and treatments, and establishes a methodology for using PCASL to noninvasively measure rCBF in clinical and healthy adolescent populations., (Copyright © 2013 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.)

Objectives: To evaluate the reliability and cluster structure of the Pediatric Quality of Life Inventory Type 1 Diabetes Module 3.0 (PedsQL-T1DM) and associated subscales and to explore the associations between PedsQL-T1DM total score and demographic and clinical characteristics and clinical indicators among a large racially/ethnically diverse cohort of youth with type 1 diabetes., Study Design: Principal components analysis was conducted on responses from the PedsQL-T1DM child self-report forms completed by SEARCH for Diabetes in Youth study participants aged ≥ 5 years. Multivariate linear regression models were fit to examine the associations among PedsQL-T1DM total score, demographic and clinical characteristics, and clinical indicators., Results: The sample comprised 2602 youth with a mean age of 13.6 ± 4.1 years and a mean T1DM duration of 62.1 ± 47.0 months. Principal components analysis did not support the 5 existing PedsQL-T1DM subscales. In multivariate analyses, the PedsQL-T1DM total score was negatively and significantly associated with younger age (5-7 years), female sex, receiving insulin by injection (vs pump), having parents without a college degree, Medicaid/Medicare insurance, and having a comorbid medical condition. Youth with poor glycemic control based on their age-specific hemoglobin A1c target values and those with depressive symptoms had significantly lower PedsQL-T1DM scores than their counterparts with good control and no or limited depressive symptoms., Conclusion: This study has identified sociodemographic and clinical characteristics of youth with T1DM more likely to experience poor diabetes-specific quality of life. The association of lower PedsQL-T1DM scores with depressive symptoms and poor glycemic control is especially concerning and may be the focus of future interventions and studies., (Copyright © 2012 Mosby, Inc. All rights reserved.)

Aims: To identify demographic, family and clinical characteristics associated with provider recommended frequency of blood glucose monitoring (BGM), actual frequency of BGM, and concordance between these categories in youth with type 1 diabetes (T1D) as reported by child's caregiver., Methods: Caregivers of 390 children 10-17 years were interviewed about their children's providers' recommendations for frequency of BGM and their child's frequency of performance of BGM., Results: The majority (92%) of caregivers reported being told that their child should BGM ≥4 times per day and 78% reported their child checked that frequently. Caregivers of children who were younger, non-Hispanic White, from two-parent households, higher income households, and on insulin pumps were more likely to report being told by their provider to perform BGM ≥6 times per day and more likely to report that their child performed BGM ≥6 times per day. Younger children and those with private health insurance were more likely to adhere to reported recommendations. Children whose caregivers reported that their child met/exceeded their provider recommendations had lower A1c values than those who did not., Conclusions: These findings may help clinicians identify subgroups of youth at-risk for poor diabetes management and provide further education in order to improve outcomes., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Improving outcomes for children and adolescents with mental health needs demands a broad meta-systemic orientation to overcome persistent problems in current service systems. Improving outcomes necessitates inclusion of current and emerging evidence about effective practices for the diverse population of youth and their families. Key components of the meta-system for children with emotional or behavioral needs include families, cultural norms and values, and service sectors such as schools, pediatric health centers, specialty mental health systems, juvenile justice systems, child protection services, and substance use treatment systems. We describe each component of the meta-system, noting challenges to the provision of evidence-based practice (EBP) and highlighting ways to optimize outcomes. Our focus is on the inclusion of evidence-based assessment and interventions, including prevention, within a developmentally driven and culturally responsive contextual model. Recommendations for addressing disparities in research funding and essential steps to foster communication and coordination of EBP across settings are provided., (2009 APA, all rights reserved.)