Consensus guidance for monitoring individuals with islet autoantibody-positive pre-stage 3 type 1 diabetes.

Given the proven benefits of screening to reduce diabetic ketoacidosis (DKA) likelihood at the time of stage 3 type 1 diabetes diagnosis, and emerging availability of therapy to delay disease progression, type 1 diabetes screening programmes are being increasingly emphasised. Once broadly implemented, screening initiatives will identify significant numbers of islet autoantibody-positive (IAb+) children and adults who are at risk of (confirmed single IAb+) or living with (multiple IAb+) early-stage (stage 1 and stage 2) type 1 diabetes. These individuals will need monitoring for disease progression; much of this care will happen in non-specialised settings. To inform this monitoring, JDRF in conjunction with international experts and societies developed consensus guidance. Broad advice from this guidance includes the following: (1) partnerships should be fostered between endocrinologists and primary-care providers to care for people who are IAb+; (2) when people who are IAb+ are initially identified there is a need for confirmation using a second sample; (3) single IAb+ individuals are at lower risk of progression than multiple IAb+ individuals; (4) individuals with early-stage type 1 diabetes should have periodic medical monitoring, including regular assessments of glucose levels, regular education about symptoms of diabetes and DKA, and psychosocial support; (5) interested people with stage 2 type 1 diabetes should be offered trial participation or approved therapies; and (6) all health professionals involved in monitoring and care of individuals with type 1 diabetes have a responsibility to provide education. The guidance also emphasises significant unmet needs for further research on early-stage type 1 diabetes to increase the rigour of future recommendations and inform clinical care.

Consensus Guidance for Monitoring Individuals With Islet Autoantibody-Positive Pre-Stage 3 Type 1 Diabetes.

Given the proven benefits of screening to reduce diabetic ketoacidosis (DKA) likelihood at the time of stage 3 type 1 diabetes diagnosis, and emerging availability of therapy to delay disease progression, type 1 diabetes screening programs are being increasingly emphasized. Once broadly implemented, screening initiatives will identify significant numbers of islet autoantibody-positive (IAb+) children and adults who are at risk for (confirmed single IAb+) or living with (multiple IAb+) early-stage (stage 1 and stage 2) type 1 diabetes. These individuals will need monitoring for disease progression; much of this care will happen in nonspecialized settings. To inform this monitoring, JDRF, in conjunction with international experts and societies, developed consensus guidance. Broad advice from this guidance includes the following: 1) partnerships should be fostered between endocrinologists and primary care providers to care for people who are IAb+; 2) when people who are IAb+ are initially identified, there is a need for confirmation using a second sample; 3) single IAb+ individuals are at lower risk of progression than multiple IAb+ individuals; 4) individuals with early-stage type 1 diabetes should have periodic medical monitoring, including regular assessments of glucose levels, regular education about symptoms of diabetes and DKA, and psychosocial support; 5) interested people with stage 2 type 1 diabetes should be offered trial participation or approved therapies; and 6) all health professionals involved in monitoring and care of individuals with type 1 diabetes have a responsibility to provide education. The guidance also emphasizes significant unmet needs for further research on early-stage type 1 diabetes to increase the rigor of future recommendations and inform clinical care.

School-based diabetes care: A national survey of U.S. pediatric diabetes providers.

Objectives: To understand the practices, attitudes, and beliefs of type 1 diabetes (T1D) providers towards school-based diabetes care (SBDC), including counseling families and communicating with schools, and explore the barriers and facilitators which affect their support of SBDC. Research Design and Methods: We conducted a national survey of pediatric T1D providers about their perceived support of SBDC, including family counseling and school communication. We used descriptive statistics to analyze results and explored differences by practice size (<500, 500-999, and ≥1000 patients) and environment (academic vs non-academic). Results: A total of 149 providers completed the survey. Nearly all (95%) indicated SBDC was very important. Though most (63%) reported counseling families about SBDC multiple times per year, few (19%) spoke with school staff routinely, reporting that was a shared responsibility among different providers. Close to 90% agreed school feedback on T1D management plans would be helpful, yet only 31% routinely requested this input. Moderate to extremely significant barriers to SBDC communication included internal factors, such as staff resources (67%) and time (82%), and external factors, such as school nurse education needs (62%) and differing school district policies (70%). Individuals from large or academic practices reported more barriers in their knowledge of SBDC, including federal/state laws. Desired facilitators for SBDC included a designated school liaison (84%), electronic transmission for school forms (90%), and accessible school staff education (95%). Conclusions: Though providers universally agree that SBDC is important, there are multilevel internal (practice) and external (policy) barriers to facilitating a bidirectional relationship between schools and health teams.

Roadmap to the Effective Use of Continuous Glucose Monitoring by Diabetes Care and Education Specialists as Technology Champions.

This article describes the implementation of a diabetes technology educational program targeting continuous glucose monitoring (CGM) adoption that significantly increased utilization of CGM in the Division of Pediatric Endocrinology at the University of Florida. The author proposes that diabetes care and education specialists (DCESs) are uniquely positioned in the health care ecosystem to serve as diabetes technology champions. The article provides a step-by-step roadmap that DCESs and clinicians can use as they lead efforts to expand CGM adoption and durable use.

Long-term Continuous Glucose Monitor Use in Very Young Children With Type 1 Diabetes: One-Year Results From the SENCE Study.

OBJECTIVES: Achieving optimal glycemic outcomes in young children with type 1 diabetes (T1D) is challenging. This study examined the durability of continuous glucose monitoring (CGM) coupled with a family behavioral intervention (FBI) to improve glycemia. STUDY DESIGN: This one-year study included an initial 26-week randomized controlled trial of CGM with FBI (CGM+FBI) and CGM alone (Standard-CGM) compared with blood glucose monitoring (BGM), followed by a 26-week extension phase wherein the BGM Group received the CGM+FBI (BGM-Crossover) and both original CGM groups continued this technology. RESULTS: Time in range (70-180 mg/dL) did not improve with CGM use (CGM+FBI: baseline 37%, 52 weeks 41%; Standard-CGM: baseline 41%, 52 weeks 44%; BGM-Crossover: 26 weeks 38%, 52 weeks 40%). All three groups sustained decreases in hypoglycemia (<70 mg/dL) with CGM use (CGM+FBI: baseline 3.4%, 52 weeks 2.0%; Standard-CGM: baseline 4.1%, 52 weeks 2.1%; BGM-Crossover: 26 weeks 4.5%, 52 weeks 1.7%, P-values <.001). Hemoglobin A1c was unchanged with CGM use (CGM+FBI: baseline 8.3%, 52 weeks 8.2%; Standard-CGM: baseline 8.2%, 52 weeks 8.0%; BGM-Crossover: 26 weeks 8.1%, 52 weeks 8.3%). Sensor use remained high (52-week study visit: CGM+FBI 91%, Standard-CGM 92%, BGM-Crossover 88%). CONCLUSION: Over 12 months young children with T1D using newer CGM technology sustained reductions in hypoglycemia and, in contrast to prior studies, persistently wore CGM. However, pervasive hyperglycemia remained unmitigated. This indicates an urgent need for further advances in diabetes technology, behavioral support, and diabetes management educational approaches to optimize glycemia in young children.

COVID-19 Pandemic Effects on Caregivers of Youth With Type 1 Diabetes: Stress and Self-Efficacy.

Background: Little is known about the coronavirus disease 2019 (COVID-19) pandemic's psychological effects on caregivers of children with type 1 diabetes. Objective: This study aimed to investigate the experience of caregivers of youth with type 1 diabetes during the COVID-19 pandemic. Methods: A 49-item questionnaire using a 5-point Likert scale and open-response questions was distributed via e-mail and type 1 diabetes-related social media platforms from 4 May to 22 June 2020. Quantitative data were analyzed using SPSS v.25 statistical software. Descriptive statistics were used. Relationships were compared using Pearson correlation. Qualitative data were coded and categorized. Results: A total of 272 caregivers participated (mean ± SD respondent age 42.1 ± 7.8 years; 94.5% females; 81.3% with college degree or higher; 52.6% with annual income >$99,000; 80.1% with private insurance). The mean ± SD age of caregivers' children with type 1 diabetes was 11.0 ± 4.1 years, and their mean ± SD diabetes duration was 4.2 ± 3.5 years. Participants reported being diagnosed with or knowing someone with COVID-19 (24.6%), increased stress (71.9%), job loss (10.3%), and financial difficulty (26.8%) as a result of the pandemic. General self-efficacy scores were high (mean ± SD 16.2 ± 2.6, range 8-20) and significantly correlated with COVID-19-related self-efficacy (mean ± SD 12.6 ± 2.1; R = 0.394, P <0.001) and type 1 diabetes self-efficacy during COVID-19 (mean ± SD 17.1 ± 2.5; R = 0.421, P <0.001). Conclusion: Despite reporting high overall self-efficacy, caregivers of children with type 1 diabetes reported greater overall stress and challenges during the pandemic. Health care providers should be prepared to provide families with specific social and mental health support.

Learning experience design of an mHealth self-management intervention for adolescents with type 1 diabetes.

Type 1 diabetes (T1D) is a lifelong and chronic condition that can cause severely compromised health. The T1D treatment regimen is complex, and is a particular challenge for adolescents, who frequently experience a number of treatment adherence barriers (e.g., forgetfulness, planning and organizational challenges, stress). Diabetes Journey is a gamified mHealth program designed to improve T1D self-management through a specific focus on decreasing adherence barriers and improving executive functioning skills for adolescents. Grounded in situativity theory and guided by a sociotechnical-pedagogical usability framework, Diabetes Journey was designed, developed, and evaluated using a learning experience design approach. This approach applied design thinking methods within a Successive Approximation Model design process. Iterative design and formative evaluation were conducted across three design phases, and improvements were implemented following each phase. Findings from the user testing phase indicate Diabetes Journey is a user-friendly mHealth program with high usability that holds promise for enhancing adolescents' T1D self-management. Implications for future designers and researchers are discussed regarding the social dimension of the sociotechnical-pedagogical usability framework. An extension to the framework is proposed to extend the social dimension to include socio-cultural and contextual considerations when designing mHealth applications. Consideration of the pedagogical and sociocultural dimensions of learning is imperative when developing psychoeducational interventions.

Professional Competencies for Diabetes Technology Use in the Care Setting.

PURPOSE: The integration of diabetes technology into diabetes care and self-management is evolving so rapidly that providing sufficient support has become an obstacle for many health care professionals (HCPs) in practice. Diabetes technology requires HCPs to stay current with treatment goals and practice guidelines. Diabetes care and education specialists (DCESs) are well positioned to take on this challenge by seizing opportunities to apply their skills, knowledge, and experience to contribute to a technology-enabled practice environment. Diabetes technology includes devices, hardware, and software utilized to manage all aspects of diabetes care, including lifestyle management, glucose monitoring, and insulin delivery. The complexities of caring for persons with diabetes (PWD) who utilize diabetes technology is best accomplished in partnership with other members of the care team and support staff to cover all aspects of technology including prior authorizations, onboarding PWD, downloading and interpreting data, and supporting ongoing utilization. The purpose of this article is to introduce a comprehensive set of role-based competencies for HCPs, DCESs, and staff for the selection, implementation, and sustainability of diabetes technology when providing diabetes care, education, and support. The role-based competencies described in this article are intended to support the initiation, continuation, and optimal use of diabetes technology in practice through ongoing education and guidance of care team members. CONCLUSION: This article describes the diabetes technology competencies essential for all levels of the care team and support staff in various care settings to deliver comprehensive diabetes management and support to PWD utilizing diabetes technology in their self-care regimen.

Building the 2022 Diabetes Technology Practice Competencies Using Modified Delphi Methodology.

PURPOSE: The purpose of this study was to construct professional competencies for diabetes technology use in various care settings reflecting the mission of the Association of Diabetes Care & Education Specialists (ADCES). METHOD: ADCES convened a core team of nationally representative diabetes technology experts to develop professional competencies specifically related to diabetes technology use. A modified Delphi methodology, which comprised 4 rounds, was used for consensus development among these experts. First, experts developed and arrived at a consensus on the initial draft of competencies. They also identified health care professionals and staff essential for effective technology integration in various diabetes care settings. A survey was completed by diabetes technology experts that are members of ADCES. Next, a multidisciplinary focus group was conducted to gain feedback. Finally, the edited competencies were distributed via survey for feedback by diabetes technology experts from various disciplines. RESULTS: One hundred four diabetes technology experts in the United States participated in the final survey, representing various health care professions and clinical settings. A final set of 94 competencies across 7 domains was determined. CONCLUSION: Modified Delphi methodology is an effective way to utilize multidisciplinary expertise to develop diabetes technology-related competencies for diabetes care professionals and staff in a variety of settings. These competencies align with the mission of ADCES to empower diabetes care and education specialists to expand the horizons of innovative education, management, and support.

Type 1 diabetes knowledge assessment: The KAT-1 validation study.

OBJECTIVE: This study sought to examine the reliability and validity of a novel pediatric type 1 diabetes knowledge assessment (KAT-1) designed for children, adolescents, young adults and their parents/guardians. The instrument was designed to be integrated into the clinic workflow to obtain objective data electronically. RESEARCH DESIGN AND METHODS: KAT-1 was developed by a multidisciplinary team and includes 11 independent topical subscales. Forty children/caregivers participated in a pilot study; their feedback was used to improve item clarity and readability. Subsequently, a validation study was performed in 200 participants (100 children/adolescents/young adults with type 1 diabetes ages 11-21 years and 100 parents/guardians of children with type 1 diabetes ages 1-15 years) to examine correlations between the KAT-1 scores and Revised Diabetes Knowledge Test (DKT2) scores and HbA1c. An item analysis was conducted to determine internal consistency and reliability; topical subscales were evaluated using Cronbach's alpha. RESULTS: Total KAT-1 scores were positively correlated with DKT2 scores r = 0.674, p < 0.001, and negatively correlated with HbA1c, r = -0.3, p < 0.001. All KAT-1 subscales were positively and significantly correlated with one another and with total KAT-1 score. Internal consistency of total KAT-1 score was strong (Cronbach's α = 0.938, mean score 84.6, SD = 16.1) and 9 of 11 independent topical subscales demonstrated strong internal consistency. Completion time for subscales was <5 min. CONCLUSIONS: KAT-1 is a valid instrument to assess type 1 diabetes knowledge. The instrument's short topical subscales can be used to objectively assess specific knowledge and individualize diabetes education. KAT-1 has been integrated into our electronic health record (EPIC) and is available online at no cost.

Videoconference based training on diabetes technology for school nurses and staff: Pilot study.

PURPOSE: Children with diabetes spend a significant portion of time at school and in school-related activities and rely on school nurses for diabetes management support. Diabetes technologies are rapidly evolving, and there are no standardized competencies or training programs for school personnel providing diabetes care. DESIGN AND METHODS: A virtual diabetes education program was provided to school nurses and staff in 3 Florida school districts. Program feasibility was measured by attendance; acceptability was measured with a usability survey; and efficacy was measured by participants' improvements in scores on pre- and post-training knowledge assessments. Descriptive statistics were generated and improvements in knowledge were evaluated via t-test. P-values <0.05 were considered significant. RESULTS: Pilot survey data (n = 91) revealed high demand for diabetes technology and basic management education among school nurses and staff. Eighty-eight school personnel from 64 schools attended the training, with 67 participants completing the demographic survey and at least one of the pre- and post-training assessments. Post-test scores demonstrated mean + 10.6% absolute improvement on the diabetes technology subscale, +11.5% on the basic management subscale, and + 10.9% on the ketone management subscale, all p < 0.001. Fifty-three participants completed the usability survey with 92% reporting they benefitted from training. CONCLUSIONS: Virtual training is feasible and acceptable for delivering diabetes technology education to large numbers of school personnel. Study results demonstrate improved diabetes knowledge. PRACTICE IMPLICATIONS: Establishing a standardized training program on diabetes technology for school personnel can optimize diabetes care in the school setting.

Changes in HbA1c Between 2011 and 2017 in Germany/Austria, Sweden, and the United States: A Lifespan Perspective.

Aims: This study assessed hemoglobin A1c (HbA1c) across the lifespan in people with type 1 diabetes (T1D) in Germany/Austria, Sweden, and the United States between 2011 and 2017 to ascertain temporal and age-related trends. Methods: Data from the Diabetes-Patienten-Verlaufsdokumentation (DPV) (n = 25,651 in 2011, n = 29,442 in 2017); Swedish Pediatric Diabetes Quality Registry (SWEDIABKIDS)/National Diabetes Register (NDR), (n = 44,474 in 2011, n = 53,690 in 2017); and T1D Exchange (n = 16,198 in 2011, n = 17,087 in 2017) registries were analyzed by linear regression to compare mean HbA1c overall and by age group. Results: Controlling for age, sex, and T1D duration, HbA1c increased in the United States between 2011 and 2017, decreased in Sweden, and did not change in Germany/Austria. Controlling for sex and T1D duration, mean HbA1c decreased between 2011 and 2017 in all age cohorts in Sweden (P < 0.001). In the United States, HbA1c stayed the same for participants <6 years and 45 to <65 years and increased in all other age groups (P < 0.05). In Germany/Austria, HbA1c stayed the same for participants <6 to <13 years and 18 to <25 years; decreased for participants ages 13 to <18 years (P < 0.01); and increased for participants ≥25 years (P < 0.05). Conclusions: The comparison of international trends in HbA1c makes it possible to identify differences, explore underlying causes, and share quality improvement processes. National quality improvement initiatives are well accepted in Europe but have yet to be implemented systematically in the United States. However, disparities created by the lack of universal access to health care coverage, unequal access to diabetes technologies (e.g., continuous glucose monitoring) regardless of insurance status, and high out-of-pocket cost for the underinsured ultimately limit the potential of quality improvement initiatives.

Inequities in Health Outcomes in Children and Adults With Type 1 Diabetes: Data From the T1D Exchange Quality Improvement Collaborative.

Health care inequities among racial and ethnic groups remain prevalent. For people with type 1 diabetes who require increased medical access and care, disparities are seen in access to care and health outcomes. This article reports on a study by the T1D Exchange Quality Improvement Collaborative evaluating differences in A1C, diabetic ketoacidosis (DKA), severe hypoglycemia, and technology use among racial and ethnic groups. In a diverse cohort of nearly 20,000 children and adults with type 1 diabetes, A1C was found to differ significantly among racial and ethnic groups. Non-Hispanic Blacks had higher rates of DKA and severe hypoglycemia and the lowest rate of technology use. These results underscore the crucial need to study and overcome the barriers that lead to inequities in the care and outcomes of people with type 1 diabetes.

Adoption of Telemedicine for Type 1 Diabetes Care During the COVID-19 Pandemic.

Background: We describe the utilization of telemedicine visits (video or telephone) across the type 1 diabetes (T1D) Exchange Quality Improvement Collaborative (T1DX-QI) during the COVID-19 pandemic. Metrics, site-level survey results, and examples of interventions conducted to support telemedicine in T1D are shown. Materials and Methods: Thirteen clinics (11 pediatric, 2 adult) provided monthly telemedicine metrics between December 2019 and August 2020 and 21 clinics completed a survey about their telemedicine practices. Results: The proportion of telemedicine visits in T1DX-QI before the pandemic was <1%, rising to an average of 95.2% in April 2020 (range 52.3%-99.5%). Three sites initially used mostly telephone visits before converting to video visits. By August 2020, the proportion of telemedicine visits decreased to an average of 45% across T1DX-QI (range 10%-86.6%). The majority of clinics (62%) performed both video and telephone visits; Zoom was the most popular video platform used. Over 95% of clinics reported using CareLink™, Clarity®, Glooko™, and/or t:connect® to view device data, with only one center reporting automated data upload into the electronic medical record. The majority of centers had multidisciplinary teams participating in the video visits. All sites reported reimbursement for video visits, and 95% of sites reported coverage for telephone visits early on in the pandemic. Conclusions: There was rapid adoption of telemedicine in T1DX-QI during the COVID-19 pandemic. Future insurance reimbursement for telemedicine visits and the ideal ratio of telemedicine to in-person visits in T1D care remain to be determined.

School Nurse Perspectives on Do-It-Yourself Automated Pancreas Systems in the School Setting.

Do-it-yourself (DIY) artificial pancreas systems (APSs) are gaining popularity among children with type 1 diabetes. Little is known about how school systems provide care for children who use DIY APSs, and available guidance for schools is limited. This study explored school staff perspectives on DIY APSs through a national survey of school nurses about their current practices, beliefs, and attitudes toward DIY APSs. Although one-quarter (23%) of school nurses reported experience with DIY APSs in school, nearly half (46%) had no prior knowledge of this new technology. The majority (82%) reported that children should be allowed to use DIY APSs in school, although there was less consensus about school nurse responsibilities with these devices. Qualitative responses added context regarding potential barriers, including the need for more informed guidelines and training and fears of liability. Future development of school guidelines for DIY APSs is necessary and should incorporate stakeholder perspectives.

Diabetic ketoacidosis drives COVID-19 related hospitalizations in children with type 1 diabetes.

BACKGROUND: Diabetes is a risk factor for poor COVID-19 outcomes, but pediatric patients with type 1 diabetes are poorly represented in current studies. METHODS: T1D Exchange coordinated a US type 1 diabetes COVID-19 registry. Forty-six diabetes centers submitted pediatric cases for patients with laboratory confirmed COVID-19. Associations between clinical factors and hospitalization were tested with Fisher's Exact Test. Logistic regression was used to calculate odds ratios for hospitalization. RESULTS: Data from 266 patients with previously established type 1 diabetes aged <19 years with COVID-19 were reported. Diabetic ketoacidosis (DKA) was the most common adverse outcome (n = 44, 72% of hospitalized patients). There were four hospitalizations for severe hypoglycemia, three hospitalizations requiring respiratory support (one of whom was intubated and mechanically ventilated), one case of multisystem inflammatory syndrome in children, and 10 patients who were hospitalized for reasons unrelated to COVID-19 or diabetes. Hospitalized patients (n = 61) were more likely than nonhospitalized patients (n = 205) to have minority race/ethnicity (67% vs 39%, P < 0.001), public insurance (64% vs 41%, P < 0.001), higher A1c (11% [97 mmol/mol] vs 8.2% [66 mmol/mol], P < 0.001), and lower insulin pump and lower continuous glucose monitoring use (26% vs 54%, P < 0.001; 39% vs 75%, P < 0.001). Age and gender were not associated with risk of hospitalization. Higher A1c was significantly associated with hospitalization, with an odds ratio of 1.56 (1.34-1.84) after adjusting for age, gender, insurance, and race/ethnicity. CONCLUSIONS: Higher A1c remained the only predictor for hospitalization with COVID-19. Diabetic ketoacidosis is the primary concern among this group.

Feasibility of the Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitor (IDEAL CGM) Training and Follow-Up Support Intervention: Randomized Controlled Pilot Study.

BACKGROUND: Proper training and follow-up for patients new to continuous glucose monitor (CGM) use are required to maintain adherence and achieve diabetes-related outcomes. However, CGM training is hampered by the lack of evidence-based standards and poor reimbursement. We hypothesized that web-based CGM training and education would be effective and could be provided with minimal burden to the health care team. OBJECTIVE: The aim of this study was to perform a pilot feasibility study testing a theory-driven, web-based intervention designed to provide extended training and follow-up support to adolescents and young adults newly implementing CGM and to describe CGM adherence, glycemic control, and CGM-specific psychosocial measures before and after the intervention. METHODS: The "Intervention Designed to Educate and improve Adherence through Learning to use CGM (IDEAL CGM)" web-based training intervention was based on supporting literature and theoretical concepts adapted from the health belief model and social cognitive theory. Patients new to CGM, who were aged 15-24 years with type 1 diabetes for more than 6 months were recruited from within a public university's endocrinology clinic. Participants were randomized to enhanced standard care or enhanced standard care plus the IDEAL CGM intervention using a 1:3 randomization scheme. Hemoglobin A1c levels and psychosocial measures were assessed at baseline and 3 months after start of the intervention. RESULTS: Ten eligible subjects were approached for recruitment and 8 were randomized. Within the IDEAL CGM group, 4 of the 6 participants received exposure to the web-based training. Half of the participants completed at least 5 of the 7 modules; however, dosage of the intervention and level of engagement varied widely among the participants. This study provided proof of concept for use of a web-based intervention to deliver follow-up CGM training and support. However, revisions to the intervention are needed in order to improve engagement and determine feasibility. CONCLUSIONS: This pilot study underscores the importance of continued research efforts to optimize the use of web-based intervention tools for their potential to improve adherence and glycemic control and the psychosocial impact of the use of diabetes technologies without adding significant burden to the health care team. Enhancements should be made to the intervention to increase engagement, maximize responsiveness, and ensure attainment of the skills necessary to achieve consistent use and improvements in glycemic control prior to the design of a larger well-powered clinical trial to establish feasibility. TRIAL REGISTRATION: ClinicalTrials.gov NCT03367351, https://clinicaltrials.gov/ct2/show/NCT03367351.

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.

Inequities in Diabetic Ketoacidosis Among Patients With Type 1 Diabetes and COVID-19: Data From 52 US Clinical Centers.

OBJECTIVE: We examined whether diabetic ketoacidosis (DKA), a serious complication of type 1 diabetes (T1D) was more prevalent among Non-Hispanic (NH) Black and Hispanic patients with T1D and laboratory-confirmed coronavirus disease 2019 (COVID-19) compared with NH Whites. METHOD: This is a cross-sectional study of patients with T1D and laboratory-confirmed COVID-19 from 52 clinical sites in the United States, data were collected from April to August 2020. We examined the distribution of patient factors and DKA events across NH White, NH Black, and Hispanic race/ethnicity groups. Multivariable logistic regression analysis was performed to examine the odds of DKA among NH Black and Hispanic patients with T1D as compared with NH White patients, adjusting for potential confounders, such as age, sex, insurance, and last glycated hemoglobin A1c (HbA1c) level. RESULTS: We included 180 patients with T1D and laboratory-confirmed COVID-19 in the analysis. Forty-four percent (n = 79) were NH White, 31% (n = 55) NH Black, 26% (n = 46) Hispanic. NH Blacks and Hispanics had higher median HbA1c than Whites (%-points [IQR]: 11.7 [4.7], P < 0.001, and 9.7 [3.1] vs 8.3 [2.4], P = 0.01, respectively). We found that more NH Black and Hispanic presented with DKA compared to Whites (55% and 33% vs 13%, P < 0.001 and P = 0.008, respectively). After adjusting for potential confounders, NH Black patients continued to have greater odds of presenting with DKA compared with NH Whites (OR [95% CI]: 3.7 [1.4, 10.6]). CONCLUSION: We found that among T1D patients with COVID-19 infection, NH Black patients were more likely to present in DKA compared with NH White patients. Our findings demonstrate additional risk among NH Black patients with T1D and COVID-19.