Towards the standardisation of adult person-reported outcome domains in diabetes research: A Consensus Statement development panel.

Diabetes is unique among chronic diseases because clinical outcomes are intimately tied to how the person living with diabetes reacts to and implements treatment recommendations. It is further characterised by widespread social stigma, judgement and paternalism. This physical, social and psychological burden collectively influences self-management behaviours. It is widely recognised that the individual's perspective about the impact of trying to manage the disease and the burden that self-management confers must be addressed to achieve optimal health outcomes. Standardised, rigorous assessment of mental and behavioural health status, in interaction with physical health outcomes is crucial to aid understanding of person-reported outcomes (PROs). Whilst tempting to conceptualise PROs as an issue of perceived quality of life (QoL), in fact health-related QoL is multi-dimensional and covers indicators of physical or functional health status, psychological and social well-being. This complexity is illuminated by the large number of person reported outcome measures (PROMs) that have been developed across multiple psychosocial domains. Often measures are used inappropriately or because they have been used in the scientific literature rather than based on methodological or outcome assessment rigour. Given the broad nature of psychosocial functioning/mental health, it is important to broadly define PROs that are evaluated in the context of therapeutic interventions, real-life and observational studies. This report summarises the central themes and lessons derived in the assessment and use of PROMs amongst adults with diabetes. Effective assessment of PROMs routinely in clinical research is crucial to understanding the true impact of any intervention. Selecting appropriate measures, relevant to the specific factors of PROs important in the research study will provide valuable data alongside physical health data.

Psychosocial outcomes with the Omnipod® 5 Automated Insulin Delivery System in caregivers of very young children with type 1 diabetes.

AIM: Automated insulin delivery (AID) systems have demonstrated improved glycaemic outcomes in people with type 1 diabetes (T1D), yet limited data exist on these systems in very young children and their impact on caregivers. We evaluated psychosocial outcomes following use of the tubeless Omnipod® 5 AID System in caregivers of very young children. MATERIALS AND METHODS: This 3-month single-arm, multicentre, pivotal clinical trial enrolled 80 children aged 2.0-5.9 years with T1D to use the Omnipod 5 AID System. Caregivers completed questionnaires assessing psychosocial outcomes-diabetes distress (Problem Areas in Diabetes), hypoglycaemia confidence (Hypoglycemia Confidence Scale), well-being (World Health Organization 5 Well-Being Index), sleep quality (Pittsburgh Sleep Quality Index), insulin delivery satisfaction (Insulin Delivery Satisfaction Survey) and system usability (System Usability Scale) at baseline with standard therapy and after 3 months of AID use. RESULTS: Following 3 months of Omnipod 5 use, caregivers experienced significant improvements across all measures, including diabetes-related psychosocial outcomes (Problem Areas in Diabetes; p < 0.0001, Hypoglycemia Confidence Scale; p < 0.01), well-being (World Health Organization 5 Well-Being Index; p < 0.0001) and perceived system usability (System Usability Scale; p < 0.0001). Significant improvements were seen in the Pittsburgh Sleep Quality Index total score and the overall sleep quality, sleep duration and efficiency subscales (all p < 0.05). Insulin Delivery Satisfaction Survey scores improved on all subscales (greater satisfaction, reduced burden and reduced inconvenience; all p < 0.0001). CONCLUSIONS: Caregivers face unique challenges when managing T1D in very young children. While glycaemic metrics have unquestioned importance, these results evaluating psychosocial outcomes reveal additional meaningful benefits and suggest that the Omnipod 5 AID System alleviates some of the burdens caregivers face with diabetes management.

Twelve-month psychosocial outcomes of continuous glucose monitoring with behavioural support in parents of young children with type 1 diabetes.

AIM: Managing type 1 diabetes in young children can cause significant stress for parents. Continuous glucose monitoring (CGM) may reduce parental burden. The Strategies to Enhance CGM Use in Early Childhood (SENCE) trial randomized parents of children (ages 2 to <8 years) with type 1 diabetes to CGM with family behavioural intervention (CGM + FBI), CGM alone (Standard-CGM) or blood glucose monitoring for 26 weeks before receiving CGM + FBI (BGM-Crossover). This report assesses changes in psychosocial outcomes for all groups over 52 weeks. METHODS: CGM + FBI (n = 45), Standard-CGM (n = 42) and BGM-Crossover (n = 44) participants completed psychosocial assessments at baseline, 26 weeks and 52 weeks. Repeated measures linear regression models evaluated change within and between treatment groups. RESULTS: The BGM-Crossover group reported improved diabetes burden (Δ -6.9, 95% CI [-11.3, -2.6], p = 0.003), fear of hypoglycaemia (Δ -6.4, CI [-10.1, -2.6], p = 0.002) and technology satisfaction (Δ 7.3, CI [2.4, 12.2], p = 0.005) from 26 to 52 weeks, similar to published findings in the CGM + FBI group over the first 26 weeks. The Standard-CGM group reported increased technology satisfaction (Δ 7.3, CI [0.6, 14.0], p = 0.027) from baseline to 52 weeks. The CGM + FBI group reported less diabetes burden and fear of hypoglycaemia from baseline to 52 weeks, but changes were not statistically significant. Scores from 26 to 52 weeks did not deteriorate. CONCLUSIONS: Parents demonstrated psychosocial benefits following FBI that appeared to maintain without additional intervention. CGM-focused education with behavioural support likely helps parents of young children with type 1 diabetes reduce burden and worry in the short- and long-term.

Efficacy and safety of ultra-rapid lispro versus lispro in children and adolescents with type 1 diabetes: The PRONTO-Peds trial.

AIMS: To evaluate the efficacy and safety of ultra-rapid lispro (URLi) versus lispro in a paediatric population with type 1 diabetes (T1D) in a Phase 3, treat-to-target study. MATERIALS AND METHODS: After a 4-week lead-in to optimize basal insulin, participants were randomized to double-blind URLi (n = 280) or lispro (n = 298) injected 0 to 2 minutes prior to meals (mealtime), or open-label URLi (n = 138) injected up to 20 minutes after start of meals (postmeal). Participants remained on pre-study basal insulin (degludec, detemir or glargine). The primary endpoint was glycated haemoglobin (HbA1c) change from baseline after 26 weeks (noninferiority margin 4.4 mmol/mol [0.4%]). RESULTS: Both mealtime and postmeal URLi demonstrated noninferiority to lispro for HbA1c: estimated treatment difference (ETD) for mealtime URLi -0.23 mmol/mol (95% confidence interval [CI] -1.84, 1.39) and postmeal URLi -0.17 mmol/mol (95% CI -2.15, 1.81). Mealtime URLi reduced 1-hour postprandial glucose (PPG) daily mean (P = 0.001) and premeal to 1 hour postmeal PPG excursion daily mean (P < 0.001) versus lispro. The rate and incidence of severe, nocturnal or documented hypoglycaemia (<3.0 mmol/L [54 mg/dL]) were similar for all treatments. With mealtime URLi versus lispro, the rate of postdose hypoglycaemia (<3.0 mmol/L) was higher at ≤2 hours (P = 0.034). The incidence of treatment-emergent adverse events was similar for all treatments. More participants reported an injection site reaction with mealtime URLi (7.9%) versus postmeal URLi (2.9%) and lispro (2.7%). CONCLUSIONS: In children and adolescents with T1D, URLi demonstrated good glycaemic control, and noninferiority to lispro in HbA1c change for mealtime and postmeal URLi. When dosed at the beginning of meals, URLi reduced 1-hour PPG and PPG excursions versus lispro.

Trajectories of eGFR and risk of albuminuria in youth with type 2 diabetes: results from the TODAY cohort study.

BACKGROUND: We conducted exploratory analyses to identify distinct trajectories of estimated glomerular filtration rate (eGFR) and their relationship with hyperfiltration, subsequent rapid eGFR decline, and albuminuria in participants with youth-onset type 2 diabetes enrolled in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study. METHODS: Annual serum creatinine, cystatin C, urine albumin, and creatinine measurements were obtained from 377 participants followed for ≥ 10 years. Albuminuria and eGFR were calculated. Hyperfiltration peak is the greatest eGFR inflection point during follow-up. Latent class modeling was applied to identify distinct eGFR trajectories. RESULTS: At baseline, participants' mean age was 14 years, type 2 diabetes duration was 6 months, mean HbA1c was 6%, and mean eGFR was 120 ml/min/1.73 m2. Five eGFR trajectories associated with different rates of albuminuria were identified, including a "progressive increasing eGFR" group (10%), three "stable eGFR" groups with varying starting mean eGFR, and an "eGFR steady decline" group (1%). Participants who exhibited the greatest peak eGFR also had the highest levels of elevated albuminuria at year 10. This group membership was characterized by a greater proportion of female and Hispanic participants. CONCLUSIONS: Distinct eGFR trajectories that associate with albuminuria risk were identified, with the eGFR trajectory characterized by increasing eGFR over time associating with the highest level of albuminuria. These descriptive data support the current recommendations to estimate GFR annually in young persons with type 2 diabetes and provide insight into eGFR-related factors which may contribute to predictive risk strategies for kidney disease therapies in youth with type 2 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00081328, date registered 2002. A higher resolution version of the Graphical abstract is available as Supplementary information.

School Nurses' Comfort With Diabetes Management and Technology From 2012 to 2019.

Objective: School nurses are integral to optimizing diabetes management for students with type 1 diabetes. The aim of this study was to describe the use of diabetes technology in schools over time and assess school nurses' comfort level performing diabetes management tasks. Study design: From 2012 to 2019, school nurses who attended a diabetes education program completed a survey about their experience and comfort level with diabetes management. Results: A total of 1,796 school nurses completed the survey; 56% had at least 5 years of school nursing experience. Most (86%) had at least one student with type 1 diabetes. Among school nurses with at least one student with type 1 diabetes, 73% had at least one student using insulin pump therapy, and 48% had at least one student using continuous glucose monitoring (CGM). There was no change in pump use over time, but the percentage of nurses who had a student using CGM increased significantly from 24% in 2012 to 86% in 2019 (P <0.001). School nurses' comfort level using pumps remained stable over time. Overall, 47% reported being mostly/very comfortable giving boluses using a pump, and 17% reported being mostly/very comfortable troubleshooting problems with a pump. However, there was a significant increase in school nurses reporting feeling mostly/very comfortable working with CGM devices, increasing from 9% in 2012 to 44% in 2019 (P <0.001). Conclusion: School nurses are an important part of diabetes management for school-aged youth with type 1 diabetes. There is a need for additional diabetes education and support to build their confidence with diabetes management and technology, especially with further technological advancements in management.

Associations of Executive Function With Diabetes Management and Glycemic Control in Adolescents With Type 1 Diabetes.

Aims: The aims of this study were to assess domains of executive function in relation to diabetes management and glycemic control in adolescents with type 1 diabetes and to compare adolescent self-report and parent proxy-report of adolescent executive function. Methods: Adolescents with type 1 diabetes (N = 169, 46% female, age 15.9 ± 1.3 years) and their parents completed self-report and parent proxy-report versions of the Behavior Rating Inventory of Executive Function (BRIEF). Results: Self-report and parent proxy-report BRIEF T scores were moderately to strongly correlated; parent proxy scores were significantly higher than self-report scores. Executive function problems (Global Executive Composite T score ≥60) occurred in 9% of adolescents by self-report and 26% by parent proxy-report. For almost all Metacognition Index scales, elevated (T score ≥60) parent proxy scores were associated with lower adherence, lower adolescent diabetes self-efficacy, and more parent involvement in diabetes management. Elevated scores on several Metacognition Index scales were associated with less pump use (Plan/Organize by self-report, Initiate by parent proxy-report, and Monitor by parent proxy-report) and higher A1C (Plan/Organize by self-report and parent proxy-report and Organization of Materials by parent proxy-report). The only significant associations for the Behavioral Regulation Index scales occurred for adherence (by parent proxy-report) and diabetes self-efficacy (by self-report and parent-report). Conclusion: Adolescents with type 1 diabetes who have problems with metacognition may need additional support for diabetes self-management.

Use of Telemedicine in Adults with Type 1 Diabetes: Do Age and Use of Diabetes-Related Technology Matter?

Objective: Older adults are generally less proficient in technology use compared with younger adults. Data on telemedicine use during the COVID-19 pandemic in older persons with type 1 diabetes (T1D) and the association of telemedicine with the use of diabetes-related technology are limited. We evaluated care delivery to older adults compared with younger adults with T1D in a prepandemic and pandemic period. Methods: Data from electronic health records were evaluated for visit types (in-person, phone, and video) from two sequential 12-month intervals: prepandemic (April 2019-March 2020) and pandemic (April 2020-March 2021). Results: Data from 2,832 unique adults with T1D were evaluated in two age cohorts: younger (40-64 years) and older (≥65 years). Half of each group used continuous glucose monitoring (CGM), whereas 54% of the younger and 37% of the older cohort used pump therapy (p < 0.001). During the pandemic compared with the prepandemic period, visit frequency increased in both the younger (0.65 vs. 0.76 visits/patient/quarter; p < 0.01) and older (0.72 vs. 0.80 visits/patient/quarter; p < 0.01) cohorts. During the pandemic, older adults used more phone visits compared with younger adults (48% vs. 32%; p = 0.001). Patients using either pump therapy or CGM were more likely to use video visits compared with phone visits in both younger (41% vs. 24%; p < 0.001) and older cohorts (53% vs. 42%; p < 0.001). Conclusions: Adults using diabetes-related technologies, independent of age, accessed more video visits than those not using devices. Telemedicine visits appeared to maintain continuity of care for younger and older adults with T1D, supporting the future of a hybrid-care model.

Coordination of glucose monitoring, self-care behaviour and mental health: achieving precision monitoring in diabetes.

Monitoring of glucose plays an essential role in the management of diabetes. However, to fully understand and meaningfully interpret glucose levels, additional information on context is necessary. Important contextual factors include data on behaviours such as eating, exercise, medication-taking and sleep, as well as data on mental health aspects such as stress, affect, diabetes distress and depressive symptoms. This narrative review provides an overview of the current state and future directions of precision monitoring in diabetes. Precision monitoring of glucose has made great progress over the last 5 years with the emergence of continuous glucose monitoring (CGM), automated analysis of new glucose variables and visualisation of CGM data via the ambulatory glucose profile. Interestingly, there has been little progress in the identification of subgroups of people with diabetes based on their glycaemic profile. The integration of behavioural and mental health data could enrich such identification of subgroups to stimulate precision medicine. There are a handful of studies that have used innovative methodology such as ecological momentary assessment to monitor behaviour and mental health in people's everyday life. These studies indicate the importance of the interplay between behaviour, mental health and glucose. However, automated integration and intelligent interpretation of these data sources are currently not available. Automated integration of behaviour, mental health and glucose could lead to the identification of certain subgroups that, for example, show a strong association between mental health and glucose in contrast to subgroups that show independence of mental health and glucose. This could inform precision diagnostics and precision therapeutics. We identified just-in-time adaptive interventions as a potential means by which precision monitoring could lead to precision therapeutics. Just-in-time adaptive interventions consist of micro-interventions that are triggered in people's everyday lives when a certain problem is identified using monitored behaviour, mental health and glucose variables. Thus, these micro-interventions are responsive to real-life circumstances and are adaptive to the specific needs of an individual with diabetes. We conclude that, with current developments in big data analysis, there is a huge potential for precision monitoring in diabetes.

A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial.

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 (HbA1c) 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 HbA1c 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.

Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes.

BACKGROUND: Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes. METHODS: In this 6-month randomized, multicenter trial, patients with type 1 diabetes were assigned in a 2:1 ratio to receive treatment with a closed-loop system (closed-loop group) or a sensor-augmented pump (control group). The primary outcome was the percentage of time that the blood glucose level was within the target range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter), as measured by continuous glucose monitoring. RESULTS: A total of 168 patients underwent randomization; 112 were assigned to the closed-loop group, and 56 were assigned to the control group. The age range of the patients was 14 to 71 years, and the glycated hemoglobin level ranged from 5.4 to 10.6%. All 168 patients completed the trial. The mean (±SD) percentage of time that the glucose level was within the target range increased in the closed-loop group from 61±17% at baseline to 71±12% during the 6 months and remained unchanged at 59±14% in the control group (mean adjusted difference, 11 percentage points; 95% confidence interval [CI], 9 to 14; P<0.001). The results with regard to the main secondary outcomes (percentage of time that the glucose level was >180 mg per deciliter, mean glucose level, glycated hemoglobin level, and percentage of time that the glucose level was <70 mg per deciliter or <54 mg per deciliter [3.0 mmol per liter]) all met the prespecified hierarchical criterion for significance, favoring the closed-loop system. The mean difference (closed loop minus control) in the percentage of time that the blood glucose level was lower than 70 mg per deciliter was -0.88 percentage points (95% CI, -1.19 to -0.57; P<0.001). The mean adjusted difference in glycated hemoglobin level after 6 months was -0.33 percentage points (95% CI, -0.53 to -0.13; P = 0.001). In the closed-loop group, the median percentage of time that the system was in closed-loop mode was 90% over 6 months. No serious hypoglycemic events occurred in either group; one episode of diabetic ketoacidosis occurred in the closed-loop group. CONCLUSIONS: In this 6-month trial involving patients with type 1 diabetes, the use of a closed-loop system was associated with a greater percentage of time spent in a target glycemic range than the use of a sensor-augmented insulin pump. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; iDCL ClinicalTrials.gov number, NCT03563313.).

Concept of the "Universal Slope": Toward Substantially Shorter Decentralized Insulin Immunoassays.

Decentralized sensing of analytes in remote locations is today a reality. However, the number of measurable analytes remains limited, mainly due to the requirement for time-consuming successive standard additions calibration used to address matrix effects and resulting in greatly delayed results, along with more complex and costly operation. This is particularly challenging in commonly used immunoassays of key biomarkers that typically require from 60 to 90 min for quantitation based on two standard additions, hence hindering their implementation for rapid and routine diagnostic applications, such as decentralized point-of-care (POC) insulin testing. In this work we have developed and demonstrated the theoretical framework for establishing a universal slope for direct calibration-free POC insulin immunoassays in serum samples using an electrochemical biosensor (developed originally for extended calibration by standard additions). The universal slope is presented as an averaged slope constant, relying on 68 standard additions-based insulin determinations in human sera. This new quantitative analysis approach offers reliable sample measurement without successive standard additions, leading to a dramatically simplified and faster assay (30 min vs 90 min when using 2 standard additions) and greatly reduced costs, without compromising the analytical performance while significantly reducing the analyses costs. The substantial improvements associated with the new universal slope concept have been demonstrated successfully for calibration-free measurements of serum insulin in 30 samples from individuals with type 1 diabetes using meticulous statistical analysis, supporting the prospects of applying this immunoassay protocol to routine decentralized POC insulin testing.

Microneedle Aptamer-Based Sensors for Continuous, Real-Time Therapeutic Drug Monitoring.

The ability to continuously monitor the concentration of specific molecules in the body is a long-sought goal of biomedical research. For this purpose, interstitial fluid (ISF) was proposed as the ideal target biofluid because its composition can rapidly equilibrate with that of systemic blood, allowing the assessment of molecular concentrations that reflect full-body physiology. In the past, continuous monitoring in ISF was enabled by microneedle sensor arrays. Yet, benchmark microneedle sensors can only detect molecules that undergo redox reactions, which limits the ability to sense metabolites, biomarkers, and therapeutics that are not redox-active. To overcome this barrier, here, we expand the scope of these devices by demonstrating the first use of microneedle-supported electrochemical, aptamer-based (E-AB) sensors. This platform achieves molecular recognition based on affinity interactions, vastly expanding the scope of molecules that can be sensed. We report the fabrication of microneedle E-AB sensor arrays and a method to regenerate them for multiple uses. In addition, we demonstrate continuous molecular measurements using these sensors in flow systems in vitro using single and multiplexed microneedle array configurations. Translation of the platform to in vivo measurements is possible as we demonstrate with a first E-AB measurement in the ISF of a rodent. The encouraging results reported in this work should serve as the basis for future translation of microneedle E-AB sensor arrays to biomedical research in preclinical animal models.

Development and delivery of a brief family behavioral intervention to support continuous glucose monitor use in young children with type 1 diabetes.

BACKGROUND: Despite potential glycemic benefits of continuous glucose monitor (CGM) use in young children with type 1 diabetes, psychosocial and behavioral challenges may interfere with sustained use. We developed a 5-session family behavioral intervention (FBI) to support CGM use. OBJECTIVE: We report on the multi-step development of the FBI, training interventionists, implementation in a 14-site clinical trial, and participant satisfaction. METHODS: A multidisciplinary team created the FBI based on mixed-methods (i.e., survey data, qualitative research) preliminary work with parents of young children. Investigators trained non-physician staff to deliver the 5 sessions per an intervention manual. Trial participants received the FBI either during the first (FBI group, n = 50) or second 6-months (Crossover group, n = 44) of the 1-year trial. Investigators listened to session recordings to rate intervention fidelity, and participants rated satisfaction with the FBI. RESULTS: The complete 5-session FBI was delivered to 89% of participants, in-person (73%) or by telephone (23%). Sessions lasted 23 min on average, and fidelity was high across sessions. Over 80% of participants rated very high satisfaction with all aspects of the FBI and offered few recommendations for improvement. CONCLUSIONS: Having been developed based on experiences and input of families of young children with type 1 diabetes, the FBI represented a novel behavioral approach to enhance sustained CGM use during a challenging developmental period. Evidence of strong feasibility and acceptability supports its potential for implementation in research and clinical care. As diabetes technologies evolve, the FBI may continue to be refined to address parents' most relevant concerns.

Acquisition of Self-Care Responsibility in Youth With Type 1 Diabetes: Opportunities for Improving Tailored Diabetes Education and Support Programs.

Background: There is gradual acquisition of type 1 diabetes self-care responsibility across childhood as youth mature and gain more independence from their family. Understanding the timing of diabetes self-care by youth can guide the tailoring of diabetes education and support programs. Objective: To investigate parent-perceived responsibility for diabetes self-care tasks across childhood. Methods: Parents/guardians of youth (ages 5-18 years) with type 1 diabetes reported parent involvement in diabetes management using the Diabetes Family Responsibility Questionnaire. Survey items were divided items into five domains: nutrition, monitoring, insulin dosing, communication, and health surveillance. Age-groups for analyses were 5-10 years (elementary school), 11-14 years (early adolescence), and 15-18 years (late adolescence). Demographic, diabetes management, and A1C data were collected at the time of survey completion. Results: Youth (n = 148, 50% male) were a mean age of 12.9 ± 3.3 years, with a mean type 1 diabetes duration of 6.2 ± 3.6 years; 66% used insulin pump therapy, and the mean A1C was 8.4 ± 1.3%. Of the parents (84% mothers, 91% White), 83% were married, and 52% were college educated. Per parent report, less parental involvement was associated with older youth age (P <0.001). Across all age-groups, more overall parental involvement was related to lower A1C (P = 0.02). Youth self-care in the nutrition domain began in elementary school, whereas self-care in monitoring and insulin dosing began in early adolescence, and self-care with regard to communication started in late adolescence. Responsibility for health surveillance remained mainly under parent care throughout childhood and adolescence. Conclusion: Providing education and support for youth during their acquisition of self-care tasks, especially those relating to nutrition, monitoring, and insulin dosing, may help to prevent glycemic deterioration later in childhood and adolescence.

Rapid Adoption of Telemedicine Along with Emergent Use of Continuous Glucose Monitors in the Ambulatory Care of Young Persons with New-Onset Type 1 Diabetes in the Time of COVID-19: A Case Series.

Aims: The COVID-19 pandemic has caused strain on hospital systems and potential delay in diagnosis of type 1 diabetes (T1D). Outpatient diagnosis and treatment of metabolically stable young persons with new-onset T1D have been shown to be equivalent to inpatient. We describe an approach to outpatient management of newly diagnosed T1D during the COVID-19 pandemic using an interdisciplinary team, telemedicine, and diabetes technologies including rapid implementation of continuous glucose monitoring (CGM). Methods: Following the onset of the COVID-19 pandemic, new-onset cases of T1D were tracked. After laboratory confirmation of diagnosis and metabolic stability, patients and families were referred for ambulatory initiation of insulin therapy and diabetes education. These cases were reviewed using data extracted from the electronic health record, comments from multidisciplinary team members, and cloud-based glucose data. Results: We report on seven young people with new-onset T1D without diabetic ketoacidosis from April to June 2020, during the COVID-19 pandemic. Ages ranged 9-23 years with presenting hemoglobin A1c (HbA1c) values 10-14.5%. Initial evaluation was generally face-to-face, followed by frequent telemedicine visits. Five patients had a family history of T1D. Two patients had access to at-home HbA1c kits prompting evaluation in the absence of symptoms. Four patients required emergency department evaluation. Five patients presented with ketosis. All patients were prescribed CGM at the first visit, most starting within 1 month. Conclusions: Technology is extraordinarily useful for the care of young persons with new-onset T1D in the ambulatory setting during the COVID-19 pandemic. Large observational studies are needed to better understand outcomes of an outpatient, technology-focused approach.

Ready or not? Greater readiness for independent self-care predicts better self-management but not HbA1c in teens with type 1 diabetes.

OBJECTIVE: Prior to the transfer from paediatric to adult health care transition, teens with type 1 diabetes seek increasing independence in diabetes self-care while parent involvement in care decreases. Yet, few teens attain glycaemic targets. This study aimed to assess changes in perceived readiness for independent self-care in teens with type 1 diabetes over 18 months, from both teens' and parents' perspectives, and to evaluate its predictive value for diabetes self-management and haemoglobin A1c (HbA1c ). RESEARCH DESIGN AND METHODS: At baseline, 6, 12 and 18 months, 178 teens with type 1 diabetes (mean ± SD age 14.9±1.3 years; HbA1c 8.5 ± 1.0% (69 ± 11 mmol/mol); 48% female) and their parents completed the Readiness for Independent Self-Care Questionnaire (RISQ-T and RISQ-P, respectively) and a measure of self-management. Chart review provided HbA1c values. Statistical analyses encompassed bivariate correlations, paired t-tests and multivariable longitudinal mixed models. RESULTS: Teens perceived greater self-care readiness than their parents at baseline and over 18 months of follow-up. Both teen and parent perceptions of teen readiness for independent self-care increased over time, and significantly predicted higher teen self- and parent proxy-reported teen diabetes self-management, respectively, but not improved HbA1c . CONCLUSIONS: The current findings may point to a disconnect between how increased readiness for independent self-care may translate into better perceived diabetes self-management, but not into better HbA1c . In an effort to optimize HbA1c in teens with type 1 diabetes, future research is needed to design interventions that align perceived readiness for independent self-care with self-care behaviours that improve HbA1c .

Association of executive function problems and disordered eating behaviours in teens with type 1 diabetes.

AIM: To explore cross-sectional associations between executive function problems and disordered eating behaviours in teens with type 1 diabetes. METHODS: Executive function was assessed by the Behavior Rating Inventory of Executive Function (BRIEF), self-report and parent proxy-report versions. Scores ≥60 (on Global Executive Composite, Behavioral Regulation Index, Metacognition Index or clinical scales) indicated problems with executive function. Disordered eating behaviour was assessed by the Diabetes Eating Problem Survey Revised (DEPS-R) and categorized as follows: <10 low, 10-19 moderate and ≥20 high. RESULTS: In the 169 teens (46% girls, median age 16.0 years [range 13.7-18.7], median diabetes duration 8.9 years [range 1.4-16.6]), 29% had moderate and 12% had high level of disordered eating behaviours. Executive function problems were present in 9% by self report and 26% by parent proxy-report. Among teens with moderate/high level of disordered eating behaviours, 19% had executive function problems by self report (vs. 2% of teens with low level of disordered eating behaviours, p < 0.001) and 33% had executive function problems by parent proxy-report (vs. 20% of teens with low level of disordered eating behaviours, p = 0.056). A greater level of disordered eating behaviours was associated with executive function problems by teen self report on the General Executive Composite (p < 0.001), Behavioral Regulation Index (p < 0.001), emotional control clinical scale (p < 0.001), shift clinical scale (p < 0.001) and by parent proxy-report on the task initiation clinical scale (p = 0.008). CONCLUSIONS: Assessing executive function and screening for disordered eating behaviours in teens with type 1 diabetes could help identify a subset of teens at high risk for adverse outcomes and need for intervention.

Health-related quality of life in youth with type 1 diabetes: Associations with multiple comorbidities and mental health conditions.

AIM: This cross-sectional study examined the associations of comorbid conditions on health-related quality of life (HRQOL) in 601 youth with type 1 diabetes. We evaluated associations between number of comorbid conditions (0, 1, ≥2) and particular comorbid conditions and youth HRQOL by self-report and parent proxy-report. RESEARCH DESIGN AND METHODS: Youth with type 1 diabetes, aged 5-18 years, and their parents completed the PedsQL 4.0 Generic Core Scales self-report and parent proxy-report, respectively; they also reported youths' comorbid medical and mental health conditions. Separate linear regression models tested the relationship between number of comorbid conditions and specific comorbid conditions with youth-reported and parent proxy-reported HRQOL. RESULTS: Youth with ≥2 comorbid conditions had significantly lower HRQOL by both self- and parent proxy-reports compared with youth with 0 or 1 comorbid condition (youth self-report: 0: 85 ± 12, 1: 85 ± 13, 2+: 78 ± 16, p = <0.0001; parent proxy-report: 0: 83 ± 12, 1: 81 ± 13, 2+: 74 ± 15, p = <0.0001). Amongst the comorbid conditions, only a mental health comorbidity was associated with lower HRQOL. For youth and parent proxy-reports, both the number of comorbidities (≥2) and the presence of a mental health comorbidity were significantly associated with lower HRQOL. CONCLUSIONS: Health-related quality of life seems to be preserved in youth with type 1 diabetes unless confronted by multiple comorbidities as reported by youth and their parents. Our findings highlight the importance of tracking the presence of multiple comorbid conditions, possibly by reviewing problem and medication lists in the medical record, as well as screening for and addressing mental health conditions in routine diabetes care.