Search

To examine changes in the lived experience of type 1 diabetes after use of hybrid closed loop (CL), including the CamAPS FX CL system.The primary study was conducted as an open-label, single-period, randomized, parallel design contrasting CL versus insulin pump (with or without continuous glucose monitoring). Participants were asked to complete patient-reported outcomes before starting CL and 3 and 6 months later. Surveys assessed diabetes distress, hypoglycaemia concerns and quality of life. Qualitative focus group data were collected at the completion of the study.In this sample of 98 youth (age range 6-18, mean age 12.7 ± 2.8 years) and their parents, CL use was not associated with psychosocial benefits overall. However, the subgroup (n = 12) using the CamAPS FX system showed modest improvements in quality of life and parent distress, reinforced by both survey (p .05) and focus group responses. There were no negative effects of CL use reported by study participants.Closed loop use via the CamAPS FX system was associated with modest improvements in aspects of the lived experience of managing type 1 diabetes in youth and their families. Further refinements of the system may optimize the user experience.

The greatest change in the treatment of people living with type 1 diabetes in the last decade has been the explosion of technology assisting in all aspects of diabetes therapy, from glucose monitoring to insulin delivery and decision making. Through screening of 835 peer-reviewed articles followed by systematic review of 70 of them (focusing on randomized trials and extension studies with ≥50 participants from the past 10 years), we conclude that novel technologies, ranging from continuous glucose monitoring systems, insulin pumps and decision support tools to the most advanced hybrid closed loop systems, improve important measures like HbA1c, time in range, and glycemic variability, while reducing hypoglycemia risk. Several studies included person-reported outcomes, allowing assessment of the burden or benefit of the technology in the lives of those with type 1 diabetes, demonstrating positive results or, at a minimum, no increase in self-care burden compared with standard care. Important limitations of the trials to date are their small size, the scarcity of pre-planned or powered analyses in sub-populations such as children, racial/ethnic minorities, people with advanced complications, and variations in baseline glycemic levels. In addition, confounders including education with device initiation, concomitant behavioral modifications, and frequent contact with the healthcare team are rarely described in enough detail to assess their impact. Our review highlights the potential of technology in the treatment of people living with type 1 diabetes and provides suggestions for optimization of outcomes and areas of further study for precision medicine-directed technology use in type 1 diabetes.Preface (Lay Abstract)We reviewed literature of the last decade to evaluate the impact of technology on the treatment of people living with type 1 diabetes. Screening of 835 articles and in-depth review of 70 showed that novel technologies, ranging from continuous glucose monitoring systems, insulin pumps and decision support tools to the most advanced hybrid closed loop systems, improve important measures like HbA1c and time in range, while reducing hypoglycemia risk. Of importance, several studies showed a positive impact on person-reported outcomes, like quality of life or, at a minimum, no increase in self-care burden compared with standard care.

BACKGROUND: Loop is an open-source automated insulin dosing system that allows users unrivaled control over system settings that affect future glucose prediction. Thousands use Loop, but little is known about those who discontinue. METHODS: In a large observational study, 874 Loop participants completed surveys and provided glycemic data, 46 (5.3%) of those self-identified as discontinuing Loop use during the observation window, 45 completed a discontinued use survey, 22 provided system settings data, and 19 participated in semistructured interviews about their discontinuation. Qualitative data were transcribed, coded, and analyzed. RESULTS: Older age and not trusting Loop were associated with discontinued use, although no other demographic or clinical characteristics were significant correlates. The most endorsed reasons were “I decided to try something else” (27.8%) followed by “It just didn't help as much as I thought it would” (22.2%). Qualitative analyses revealed prominent themes centered upon mental and emotional burden and adjusting settings. Other reasons for discontinued use included fear of disapproval of Loop use from diabetes provider, barriers to acquiring component devices, a desire to try new/different technologies, concerns that Loop could not accommodate specific exercise or low insulin dose regimens, and worry about Loop use during pregnancy. It was noted that burdens might be alleviated by enhanced technical assistance and expert guidance. CONCLUSIONS: Although the majority of individuals in the Loop observational study continued use, those who discontinued reported similar challenges. Technical support and education specific to setting calculations could expand Loop benefits, alleviate burden, and support sustained use among new Loop users. Clinical Trial Registration: clinicaltrials.gov (NCT03838900).

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-month 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 HbA1c, race, ethnicity, insurance status, history of insulin pump and continuous glucose monitor use, 1-month or 3-month Auto Mode use, boluses per day, and time in range (70-180 mg/dL; TIR), 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-month or 3-month Auto Mode use, Boluses per Day, and TIR. The 1-month 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.

BACKGROUND: The possible advantage of hybrid closed-loop therapy (i.e., artificial pancreas) over sensor-augmented pump therapy in very young children with type 1 diabetes is unclear. METHODS: In this multicenter, randomized, crossover trial, we recruited children 1 to 7 years of age with type 1 diabetes who were receiving insulin-pump therapy at seven centers across Austria, Germany, Luxembourg, and the United Kingdom. Participants received treatment in two 16-week periods, in random order, in which the closed-loop system was compared with sensor-augmented pump therapy (control). The primary end point was the between-treatment difference in the percentage of time that the sensor glucose measurement was in the target range (70 to 180 mg per deciliter) during each 16-week period. The analysis was conducted according to the intention-to-treat principle. Key secondary end points included the percentage of time spent in a hyperglycemic state (glucose level, >180 mg per deciliter), the glycated hemoglobin level, the mean sensor glucose level, and the percentage of time spent in a hypoglycemic state (glucose level

BACKGROUND In the U.S., there are over 37 million people with diabetes (PwD), but only 8,000 endocrinologists. Therefore, many PwD receive care exclusively from primary care providers (PCPs). To democratize knowledge regarding insulin-requiring diabetes through tele-education, Stanford University and the University of Florida developed Project Extension for Community Healthcare Outcomes (ECHO) Diabetes. OBJECTIVE ECHO Diabetes uses a Hub and Spoke model connecting specialists (the “Hub”) with PCPs (the “Spokes”). One-hour, weekly sessions include Hub diabetes didactic presentations and Spoke de-identified case presentations. Lessons learned during these sessions target provider knowledge and confidence surrounding diabetes management and patient care. METHODS Spokes were asked to provide short descriptions of PwD whose diabetes management improved directly or indirectly from their providers’ participation and/or their involvement with a Diabetes Support Coach (DSC). We provide a case series to describe individuals and outcomes. Because this study was not a randomized controlled trial and was a prospective observation of patients with the intervention delivered to providers, the trial is not registered in a public trials registry. RESULTS A case series of 11 PwD was compiled from 10 PCPs and one DSC from California and Florida between 2021 and 2022. The principal impact of ECHO Diabetes is the education amplified from PCPs and DSCs to PwD. In all cases, PwD reported increased engagement and improved diabetes management. Several cases reflected increased access to diabetes technology, improvement in glycemic outcomes, and positive trends in mental health measures. CONCLUSIONS This case series elucidates the potential value of the ECHO Diabetes program to PwD who receive their diabetes care from PCPs. Those matched with a DSC saw clinically significant improvements in HbA1c and mental health outcomes. CLINICALTRIAL Not applicable - Because this study was not a randomized controlled trial and was a prospective observation of patients with the intervention delivered to providers, the trial is not registered in a public trials registry.

ContextEarly initiation of continuous glucose monitoring (CGM) is advocated for youth with type 1 diabetes (T1D). Data to guide CGM use on time-in-range (TIR), hypoglycemia, and the role of partial clinical remission (PCR) are limited.ObjectiveOur aims were to assess whether 1) an association between increased TIR and hypoglycemia exists, and 2) how time in hypoglycemia varies by PCR status.MethodsWe analyzed 80 youth who were started on CGM shortly after T1D diagnosis and were followed for up to 1-year post diagnosis. TIR and hypoglycemia rates were determined by CGM data and retrospectively analyzed. PCR was defined as (visit glycated hemoglobin A1c) + (4*units/kg/day) less than 9.ResultsYouth were started on CGM 8.0 (interquartile range, 6.0-13.0) days post diagnosis. Time spent at less than 70 mg/dL remained low despite changes in TIR (highest TIR 74.6 ± 16.7%, 2.4 ± 2.4% hypoglycemia at 1 month post diagnosis; lowest TIR 61.3 ± 20.3%, 2.1 ± 2.7% hypoglycemia at 12 months post diagnosis). No events of severe hypoglycemia occurred. Hypoglycemia was rare and there was minimal difference for PCR vs non-PCR youth (54-70 mg/dL: 1.8% vs 1.2%, P = .04; ConclusionAs TIR gradually decreased over 12 months post diagnosis, hypoglycemia was limited with no episodes of severe hypoglycemia. Hypoglycemia rates did not vary in a clinically meaningful manner by PCR status. With CGM being started earlier, consideration needs to be given to modifying CGM hypoglycemia education, including alarm settings. These data support a trial in the year post diagnosis to determine alarm thresholds for youth who wear CGM.

Introduction: Hybrid closed-loop systems increase time-in-range (TIR) and reduce glycemic variability. Person-reported outcomes (PROs) are essential to assess the utility of new devices and their impact on quality of life. This article focuses on the PROs for pediatric participants (ages 6-13 years) with type 1 diabetes (T1D) and their parents during a trial using the Tandem Control-IQ system, which was shown to increase TIR and improve other glycemic metrics. Research Design and Methods: One hundred and one children 6 to 13 years old with T1D were randomly assigned to closed-loop control (CLC) or sensor-augmented pump (SAP) in a 16-week randomized clinical trial with extension to 28 weeks during which the SAP group crossed over to CLC. Health-related quality of life and treatment satisfaction measures were obtained from children and their parents at baseline, 16 weeks, and 28 weeks. Results: Neither the children in the CLC group nor their parents had statistically significant changes in PRO outcomes compared with the SAP group at the end of the 16-week randomized controlled trial and the 28-week extension. Parents in the CLC group reported nonsignificant improvements in some PRO scores when compared with the SAP group at 16 weeks, which were sustained at 28 weeks. Sleep scores for parents improved from "poor sleep quality" to "adequate sleep quality" between baseline and 16 weeks, however, the change in scores was not statistically different between groups. Conclusions: Children with T1D who used the Control-IQ system did not experience increased burden compared with those using SAP based on person-reported outcomes from the children and their parents. Clinical Trials Registration: NCT03844789.

Aim: To identify correlates of device uptake in people with insulin-requiring diabetes before and after interacting with DiabetesWise.org, a free, unbranded online resource. Methods: The sample included 458 participants (Mage=37.1, SD=9.73; 66% female; 81% type 1) with minimal diabetes device use at enrollment. Participants used DiabetesWise.org, had their activity tracked, and completed online surveys. Chi-square and t-tests evaluated factors associated with past device use and new device (CGM/pump) uptake and prescriptions at 1- and 3-months post-use. Results: Less than half (41%) the sample reported past CGM use. Past CGM use was associated with being female, younger age, type 1 (vs. type 2) diabetes, and receiving care in a large/academic medical center. By 1 month, 11% reported new prescriptions and 5% of participants reported new device uptake (all CGM starts) , which was associated with younger age. By 3 months, 16% reported new uptake and 20% reported new prescriptions (93% for CGM) , which were more common among those with type 1 diabetes. Conclusions: DiabetesWise.org promotes diabetes device uptake and starts are unhindered by the personal, medical, or system-level barriers to prior device use. One in five users reported new prescriptions/uptake of diabetes devices. These findings support DiabetesWise.org as an effective avenue to promote device access and equity. Disclosure J.J.Wong: None. S.Hanes: None. S.Nelmes: None. K.K.Hood: Consultant; Cecelia Health, Havas Health, Insulet Corporation, LifeScan Diabetes Institute. Funding The Leona M. and Harry B. Helmsley Charitable Trust; NIH K23-DK121771

Objective: To evaluate the safety and effectiveness of the Loop Do-It-Yourself automated insulin delivery system. Research Design and Methods: A prospective real-world observational study was conducted, which included 558 adults and children (age range 1–71 years, mean HbA1c 6.8% ± 1.0%) who initiated Loop either on their own or with community-developed resources and provided data for 6 months. Results: Mean time-in-range 70–180 mg/dL (TIR) increased from 67% ± 16% at baseline (before starting Loop) to 73% ± 13% during the 6 months (mean change from baseline 6.6%, 95% confidence interval [CI] 5.9%–7.4%; P

OBJECTIVE Disparities in type 1 diabetes related to use of technologies like continuous glucose monitors (CGMs) and utilization of diabetes care are pronounced based on socioeconomic status (SES), race, and ethnicity. However, systematic reports of perspectives from patients in vulnerable communities regarding barriers are limited. RESEARCH DESIGN AND METHODS To better understand barriers, focus groups were conducted in Florida and California with adults ≥18 years old with type 1 diabetes with selection criteria including hospitalization for diabetic ketoacidosis, HbA1c >9%, and/or receiving care at a Federally Qualified Health Center. Sixteen focus groups were conducted in English or Spanish with 86 adults (mean age 42 ± 16.2 years). Transcript themes and pre–focus group demographic survey data were analyzed. In order of frequency, barriers to diabetes technology and endocrinology care included 1) provider level (negative provider encounters), 2) system level (financial coverage), and 3) individual level (preferences). RESULTS Over 50% of participants had not seen an endocrinologist in the past year or were only seen once including during hospital visits. In Florida, there was less technology use overall (38% used CGMs in FL and 63% in CA; 43% used pumps in FL and 69% in CA) and significant differences in pump use by SES (P = 0.02 in FL; P = 0.08 in CA) and race/ethnicity (P = 0.01 in FL; P = 0.80 in CA). In California, there were significant differences in CGM use by race/ethnicity (P = 0.05 in CA; P = 0.56 in FL) and education level (P = 0.02 in CA; P = 0.90 in FL). CONCLUSIONS These findings provide novel insights into the experiences of vulnerable communities and demonstrate the need for multilevel interventions aimed at offsetting disparities in diabetes.

Background: Diabetes technology use is associated with favorable type 1 diabetes (T1D) outcomes. American youth with public insurance, a proxy for low socioeconomic status, use less diabetes technology than those with private insurance. We aimed to evaluate the role of insurance-mediated provider implicit bias, defined as the systematic discrimination of youth with public insurance, on diabetes technology recommendations for youth with T1D in the United States. Methods: Multi-disciplinary pediatric diabetes providers completed a bias assessment comprised of a clinical vignette and ranking exercises ( n = 39). Provider bias was defined as providers: (1) recommending more technology for those on private insurance versus public insurance or (2) ranking insurance in the top 2 of 7 reasons to offer technology. Bias and provider characteristics were analyzed with descriptive statistics, group comparisons, and multivariate logistic regression. Results: The majority of providers [44.1 ± 10.0 years old, 83% female, 79% non-Hispanic white, 49% physician, 12.2 ± 10.0 practice-years] demonstrated bias ( n = 33/39, 84.6%). Compared to the group without bias, the group with bias had practiced longer (13.4±10.4 years vs 5.7 ± 3.6 years, P = .003) but otherwise had similar characteristics including age (44.4 ± 10.2 vs 42.6 ± 10.1, p = 0.701). In the logistic regression, practice-years remained significant (OR = 1.47, 95% CI [1.02,2.13]; P = .007) when age, sex, race/ethnicity, provider role, percent public insurance served, and workplace location were included. Conclusions: Provider bias to recommend technology based on insurance was common in our cohort and increased with years in practice. There are likely many reasons for this finding, including healthcare system drivers, yet as gatekeepers to diabetes technology, providers may be contributing to inequities in pediatric T1D in the United States.

Summary 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 ( 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 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.

Underrepresented youth have less access to diabetes technology research and usage. The BEAD-T1D study aims to build an evidence-based intervention to reduce disparities in diabetes technology uptake in youth with public insurance and type 1 diabetes (T1D). Here, we present our strategies to optimize recruitment of underrepresented groups. | Our recruitment strategy started with hiring a bilingual and bicultural Latino research assistant (RA) to facilitate culturally competent recruitment. Youth with public insurance aged Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.

BACKGROUND: Loop is an open-source automated insulin delivery (AID) system, used by more than 9,000 people with type 1 diabetes. Understanding the pros and cons of Loop use may help improve disease management and support population level innovation. METHODS: Focus groups revealed 72 new and existing users' perspectives on Loop uptake, use, and persistence. A subsample of participants from a mixed-methods, observational cohort study shared first-hand accounts of their experiences using Loop. Participants were predominately white (95%), male (50%), privately insured (94%), and reported annual household income ≥$100K (73%) and education exceeding a bachelor's degree (87%) with a mean HbA1c of 6.6% ± 0.8%. Data were analyzed and synthesized by a multidisciplinary team. RESULTS: Participants detailed their experiences with (1) Loop technical support and troubleshooting, (2) decreased mental/behavioral burden, (3) technical issues with parts of the system, (4) glycemic control, (5) personalizing settings, and (6) providers while using Loop. Decreased burden was the most endorsed benefit defined by less worry, stress, and cognitive effort and less time spent on diabetes management tasks. Participants highlighted the benefits of Loop overnight and their introduction to “Loop communities” during use. The most discussed challenges involved technical issues. A range of provider attitudes and knowledge about Loop complicated users' clinical experiences and disclosure. CONCLUSIONS: This sample of new and experienced Loop users reported benefits to quality of life and glycemic control that outweighed challenges of setting up system components, customizing the system to suit one's lifestyle and habits, and adjusting system settings. Challenges related to system setup and calibrating settings are remediable and, if addressed, may better serve Loop users. Users reported feeling empowered by the customizability of and the educational effects facilitated by the open-source AID system. Loop helped users learn more about their chronic illness and physiology in an acceptable format. Clinical Trial Registration number: NCT03838900.

OBJECTIVE This article reports the 3-year outcomes for the Supporting Teen Problem-Solving (STePS) multisite Randomized Control Trial (RCT); reporting the overall impact of the STePS trial, and the differential impact of each arm of the trial (a resilience promoting intervention [PRP T1D] vs. a diabetes education intervention [EI]) on diabetes-specific emotional distress and depressive symptoms. METHOD Participants included 264 adolescents with Type 1 diabetes (T1D), ages 14-18, in Chicago and San Francisco. Both intervention arms lasted 4.5 months and assessments were conducted at baseline, postintervention (4.5 months), and 5 follow-up visits (8, 12, 16, 28, and 40 months from baseline). Intervention efficacy was investigated using latent growth curve modeling (LGCM) to analyze the rate and shape of change of outcomes from preintervention across postintervention and follow-up time points. RESULTS Mean age of participants was 15.7 years, mean T1D duration was 6.9 years, mean HbA1c at baseline was 9.1%. The sample was diverse with nearly 35% identifying as racial or ethnic minorities, and 60% were female. PRP T1D participants reported significantly lower diabetes distress compared with EI participants, and the effect size increased over time. For the pooled sample, while 40% of youth reported elevated distress at baseline, only 23% reported elevated distress 3 years postintervention. Moreover, PRP T1D participants experienced a significant decline in depressive symptoms from 16 to 40 months postbaseline, while participants in the education arm did not. CONCLUSIONS Results from the 3-year outcomes assessment demonstrate the robust effects of PRP T1D in adolescents with declines in distress and depressive symptoms. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Background: Despite the demonstrated benefits of diabetes device use, uptake of insulin pumps and continuous glucose monitors (CGMs) remains quite low. The current study aimed to identify profiles ...

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.

To evaluate psychosocial outcomes for adults with type 1 diabetes (T1D) using the tubeless Omnipod® 5 Automated Insulin Delivery (AID) System.A single-arm, multicenter (across the United States), prospective safety and efficacy study of the tubeless AID system included 115 adults with T1D. Participants aged 18-70 years completed questionnaires assessing psychosocial outcomes - diabetes distress (T1-DDS), hypoglycemic confidence (HCS), well-being (WHO-5), sleep quality (PSQI), insulin delivery satisfaction (IDSS), diabetes treatment satisfaction (DTSQ), and system usability (SUS) - before and after 3 months of AID use. Associations among participant characteristics, psychosocial measures and glycemic outcomes were evaluated using linear regression analyses.Adults using the tubeless AID system demonstrated improvements in diabetes-specific psychosocial measures, including diabetes distress, hypoglycemic confidence, insulin delivery satisfaction, diabetes treatment satisfaction, and system usability after 3 months (all P 0.001). No changes in general well-being or sleep quality were observed. The psychosocial outcomes assessed were not consistently associated with baseline participant characteristics (i.e., age, sex, diabetes duration, glycemic outcomes including percent time in range 70-180 mg/dL, percent time below range 70 mg/dL, hemoglobin A1c, or insulin regimen).Use of the Omnipod 5 AID system was associated with significant improvements in diabetes-related psychosocial outcomes for adults with T1D.NCT04196140.

Open-source automated insulin delivery systems, commonly referred to as do-it-yourself automated insulin delivery systems, are examples of user-driven innovations that were co-created and supported by an online community who were directly affected by diabetes. Their uptake continues to increase globally, with current estimates suggesting several thousand active users worldwide. Real-world user-driven evidence is growing and provides insights into safety and effectiveness of these systems. The aim of this consensus statement is two-fold. Firstly, it provides a review of the current evidence, description of the technologies, and discusses the ethics and legal considerations for these systems from an international perspective. Secondly, it provides a much-needed international health-care consensus supporting the implementation of open-source systems in clinical settings, with detailed clinical guidance. This consensus also provides important recommendations for key stakeholders that are involved in diabetes technologies, including developers, regulators, and industry, and provides medico-legal and ethical support for patient-driven, open-source innovations.

An implantable cardioverter-defibrillator (ICD) in the pediatric patient (and the precipitating events that led to ICD placement) can be traumatic for patients and their families and may lead to posttraumatic stress disorder (PTSD).This study aimed to estimate the prevalence of PTSD in pediatric patients with an ICD and their parents and identify the factors associated with PTSD incidence.Pediatric participants with an ICD aged 8-21 years and parents of children aged 0-21 years completed surveys that included demographic characteristics and PTSD measures. Pediatric participants completed additional psychosocial measures, such as anxiety and depression self-report questionnaires.Fifty youth (30% female) and 43 parents (70% female) completed the measures. Six of 50 youth (12%) met the screening criteria for a likely PTSD diagnosis, while 20 of 43 parents (47%) met the cutoff for PTSD on the screening measure. Children with PTSD were more likely to have had a secondary prevention ICD (83% vs 17%; P = .021), meet the clinical cutoff for depression (67% vs 16%; P = .005), and had higher shock anxiety scores (31.7 vs 17.9; P = .003) than children without PTSD. Female gender (57% vs 23%; P = .043) and patient depression (31% vs 5%; P = .042) were associated with PTSD in parents.Parents were found to be more likely to meet the criteria for PTSD than youth. In youth, PTSD was associated with medical and psychosocial factors, whereas PTSD in parents was associated with being female and child depression. Clinic-based screenings and management planning of emotional functioning are warranted to address psychological distress in patients and parents.

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 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.

Objectives Our aim was to evaluate self-reported depressive symptoms and clinical outcomes during routine screening for adolescents and young adults with type 2 diabetes (T2D), and examine associations among depressive symptoms and demographic and clinical characteristics. Methods The Patient Health Questionnaire (PHQ) was administered to 197 adolescents and young adults with T2D using the PHQ-2 or PHQ-9 in routine pediatric diabetes care at 4 academic medical centres. Data from electronic health records were extracted from the screening date and 12 months earlier. Results Adolescents and young adults with T2D (mean age, 16.85 years; 57% male; 77.2% non-Caucasian) completed the PHQ as part of routine diabetes care. On the PHQ, 19.3% of adolescents and young adults endorsed elevated depressive symptoms (PHQ score ≥10) and, among a subsample with item-level data (n=53), 18.9% endorsed thoughts of self-harm. Subsequently, 50.0% of those with depressive symptoms had a documented referral for mental health treatment in the electronic health record after the positive screening outcome. Older age, shorter diabetes duration, higher glycated hemoglobin level, being non-Hispanic white, more blood glucose checks per day and being prescribed oral medications were significantly associated with more depressive symptoms. Conclusions Screening for depressive symptoms identifies individuals in need of referral for mental health treatment. A focus on self-harm assessment, standardized methods for documentation of symptoms and mental health referrals and increased referral resources are needed.

Purpose Youth with type 1 diabetes (T1D) often use Continuous Glucose Monitoring (CGM) devices; however, many do not wear them consistently enough to obtain optimal glycemic benefit. This study aimed to identify demographic and psychosocial predictors of optimal CGM use in adolescents with T1D to inform nurse-led interventions to improve adherence. Design and methods Cross-sectional survey data from youth (12–19 years) using CGM were analyzed to determine whether perceived benefits/burdens of CGM, self-efficacy, and coping predicted being a “CGM Optimizer” (wearing CGM 6–7 days/week) or “CGM Sub-user.” Results Of 282 adolescents (54% female), 161 were CGM Optimizers and 121 were CGM Sub-Users. Optimizers were younger (15.91 ± 2.17 years vs. 16.79 ± 2.17, p = 0.001), more likely non-Hispanic White (91.9% vs 83.5%, p = 0.029), and more likely to have private insurance (82.0% vs. 69.4%, p = 0.009). Every 1-point increase on Benefits of CGM scale was associated with 2.8 times greater odds of being an Optimizer (OR = 2.82, 95% CI 1.548–5.132, p = 0.001), and every 1-point increase on the Burdens of CGM scale was associated with a 52% decrease in odds (OR = 0.48, 95% CI = 0.283–0.800, p = 0.005), with final logistic regression model (including only these two predictors) explaining 22.3% of variance. Conclusion CGM Optimizing adolescents were more likely to perceive higher benefit and lower burden of CGM. Practical implications Nurse-led interventions to promote benefits of CGM and mitigate burden may help youth increase adherence with CGM to achieve glycemic benefit.

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.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 HbAOf 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 HbAThe 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.National Institute of Diabetes and Digestive and Kidney Diseases.

This article reports on the lived experience of Medtronic advanced hybrid closed-loop (AHCL) in comparison to first generation hybrid closed-loop (HCL) in a randomized, open-label, two-period crossover trial. Patient-reported outcome (PROs) measures were administered before randomization and at the end of each study period in 113 adolescents and young adults with type 1 diabetes. Glucose monitoring satisfaction subscales for emotional burden and behavioral burden improved significantly (P

Background: Continuous glucose monitoring (CGM) can improve glycemic control for adults with type 1 diabetes (T1D) but certain barriers interfere with consistent use including cost, data overload, alarm fatigue, physical discomfort, and unwanted social attention. This pilot study aimed to examine feasibility and acceptability of a behavioral intervention, ONBOARD (Overcoming Barriers and Obstacles to Adopting Diabetes Devices) to support adults with T1D in optimizing CGM use. Methods: Adults (18–50 years) with T1D in their first year of CGM use were invited to participate in a tailored, multicomponent telehealth-based intervention delivered over four 60-min sessions every 2–3 weeks. Participants completed surveys (demographics; diabetes distress, Diabetes Distress Scale for adults with type 1 diabetes; satisfaction with program) and provided CGM data at baseline and postintervention (3 months). Data were analyzed using paired t-tests and Wilcoxon signed-rank tests. Results: Twenty-two participants (age = 30.95 ± 8.32 years; 59% women; 91% non-Hispanic; 86% White, 5% Black, 9% other; 73% pump users) completed the study. ONBOARD demonstrated acceptability and a high rate of retention. Moderate effect sizes were found for reductions in diabetes distress (P = 0.01, r = −0.37) and increases in daytime spent in target range (70–180 mg/dL: P = 0.03, r = −0.35). There were no significant increases in hypoglycemia. Conclusions: Findings show preliminary evidence of feasibility, acceptability, and efficacy of ONBOARD for supporting adults with T1D in optimizing CGM use while alleviating diabetes distress. Further research is needed to examine ONBOARD in a larger sample over a longer period.

Objective Resilience processes include modifiable individual and family-based skills and behaviors and are associated with better health and emotional outcomes for youth with Type I diabetes (T1D). There is likely heterogeneity among adolescents with T1D based on differing profiles of resilience processes. At-risk adolescents with lower levels of modifiable skills and assets may benefit more from psychosocial skill-building interventions, compared to adolescents who already have strong resilience processes. This article identified whether there are subgroups of adolescents with T1D based on resilience process profiles and assessed differences in glycemic control, diabetes management behaviors, and distress at baseline. It also evaluated subgroups as moderators of the efficacy of a psychosocial skill-building program. Method Two hundred sixty-four adolescents with T1D (14 to 18 years) were randomly assigned to a resilience-promoting program (N = 133) or diabetes education control (N = 131). Data were collected at seven time points over 3 years and analyzed with latent profile analysis and latent growth curve modeling. Results There were two subgroups with high- versus low-resilience processes. The low-resilience subgroup exhibited more distress, higher HbA1c, less glucose monitoring, and fewer diabetes management behaviors at baseline. Differences persisted over 3 years. Subgroup membership did not moderate the efficacy of a resilience-promoting program compared to control. The resilience program resulted in lower distress regardless of subgroup. Conclusions There is heterogeneity in resilience process profiles, which are associated with clinically meaningful differences in distress, diabetes management, and glycemic control. Findings can be used to identify at-risk teenagers and inform a targeted approach to care. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Background: Loop is an open-source do-it-yourself (DIY) automated insulin delivery system that allows users unrivaled control over physiologic settings that effect future glucose prediction. Over 9,000 individuals have adopted Loop, but little is known about those who discontinue. Methods: Twenty Loop users (14 adults and 6 caregivers; 60% female, 85% white, 75% household income >$100k/year, and HbA1c 6.7±1.0%) participated in semi-structured interviews about their experiences with Loop following discontinuation. Qualitative data were transcribed, coded, and analyzed. Results: Prominent themes reflected the perception that the stress, effort and/or time required to set up Loop and achieve management goals exceeded potential benefits. Two quotes: “I couldn’t spend any more time trying to work on my settings and trying to make it better,” and “I know I could get an improvement with it, but the problem was the cost of it⋯I couldn’t concentrate anymore at work⋯it felt like fog in my brain.” Technical issues with component devices, connectivity issues, lack of technical support, cost (time, energy, supplies), fear of provider disapproval, concerns related to pregnancy, exercise, hypoglycemia and managing low insulin doses, and desire to try other new technologies were among other reasons for ending use. Participants indicated that improved technical assistance and expert guidance might lead to them to use Loop again in the future. Conclusions: For those who manage to set up Loop there are additional challenges, even among individuals with adequate glycemic control and access to various financial, social, and personal resources. Technical support and education specific to setting calculations could expand Loop benefits, alleviate burden, and support sustained use among new Loop users. Disclosure J. J. Wong: None. S. Suttiratana: Employee; Spouse/Partner; CVS Health. M. S. Lanning: None. A. Dunlap: None. S. Hanes: None. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. R. Lal: Consultant; Self; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Morgan Stanley, Tidepool. D. Naranjo: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust

Aims: We assessed safety and efficacy of Cambridge hybrid closed-loop (HCL) compared with usual care over 6 months in children and young people with T1D. Methods: In an open-label multicentre multinational parallel randomised controlled trial, we randomly assigned participants on insulin pump therapy aged 6 to 18 years to receive either HCL therapy (CL) or continue usual care (control) for 6 months. We used the same Cambridge model predictive control algorithm in two consecutive hardware iterations, FlorenceM then CamAPS FX. Primary endpoint was central laboratory HbA1c at 6 months. Results: We randomised 133 participants: 65 to CL and 68 to control (baseline HbA1c 8.2±0.7% vs. 8.3±0.8%). At 6 months mean HbA1c was 0.32% lower in CL compared to control (95% CI -0.59 to -0.04; p=0.02). Closed-loop usage was low (40% [26, 53]; median [IQR]) with FlorenceM due to hardware issues, and high (93% [88, 96]) with CamAPS FX. In the CamAPS FX CL group (n=21) HbA1c was 1.05% lower (95% CI -1.43 to -0.67; p Conclusion: Cambridge HCL is safe and significantly improves glycaemic control in children and young people with T1D. Efficacy relies on consistent usage of closed-loop, as demonstrated by CamAPS FX. Disclosure J. Fuchs: None. B. A. Buckingham: Advisory Panel; Self; Medtronic, Tolerion, Inc., Research Support; Self; Beta Bionics, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. N. Davis: None. L. Dimeglio: Advisory Panel; Self; MannKind Corporation. N. Mauras: Advisory Panel; Self; Novo Nordisk, Research Support; Self; LifeScan, Medtronic, Novo Nordisk. R. Besser: None. A. Ghatak: None. S. A. Weinzimer: Advisory Panel; Self; Dompe, Zealand Pharma A/S, Speaker’s Bureau; Self; Medtronic. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. D. Fox: None. L. Kanapka: None. C. K. Boughton: None. C. Kollman: Consultant; Self; Diasome Pharmaceuticals, Inc., Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. J. Sibayan: None. R. Beck: Consultant; Self; Bigfoot Biomedical, Inc., Diasome Pharmaceuticals, Inc., Insulet Corporation, Lilly Diabetes, vTv Therapeutics, Research Support; Self; Beta Bionics, Inc., Dexcom, Inc., Medtronic, Novo Nordisk, Tandem Diabetes Care. R. Hovorka: Research Support; Self; Abbott Laboratories, Dexcom, Inc., Medtronic, Speaker’s Bureau; Self; Dexcom, Inc., Eli Lilly and Company, Stock/Shareholder; Self; CamDiab Ltd. Dan05 consortium: n/a. J. M. Allen: None. M. E. Wilinska: Consultant; Self; CamDiab Ltd. M. Tauschmann: None. L. Denvir: None. A. Thankamony: None. F. Campbell: n/a. R. Wadwa: Consultant; Self; Tandem Diabetes Care, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Tandem Diabetes Care. Funding National Institute of Diabetes and Digestive and Kidney Diseases (UC4DK108520)

CGM use is associated with improvements in A1c. We hypothesized that initiation of CGM in the 1st month after T1D diagnosis would improve A1c. Youth with newly diagnosed T1D from July 2018 to May 2020 (pilot cohort, n=122) were offered CGM initiation in the 1st month after T1D diagnosis (119 started CGM). We compared A1c outcomes in the pilot cohort with those diagnosed from 2014-2016 (controls, n=272) who were not offered early CGM. We visualized A1c trajectories using locally estimated scatter plot smoothing (Fig). We and assessed for differences in A1c trajectory by cohort via interaction terms in a linear mixed model adjusted for baseline characteristics (age, sex, race and insurance type). The mean A1c at diagnosis was higher in the pilot cohort (12.2 vs. 10.7%). The median age of diagnosis was 9.5 years [6.8, 13.3], 64% male, 38% non-Hispanic White, and 76% with private insurance in the pilot cohort. In this pilot, 89% initiated CGM in the first 30 days after diagnosis compared to 2% in the control cohort. After adjusting for baseline characteristics, the mean A1c of the pilot cohort was lower at 6 months (-0.81, p = 0.019), 9 months (-1.43, p = 0.013), and 12 months (-2.05, p = 0.012) post-diagnosis compared to the historic cohort. Early initiation of CGM was associated with a lower A1c compared to those in a historic cohort. These data support early initiation of CGM as standard of care in youth with T1D. Disclosure P. Prahalad: None. J. Senaldi: None. A. Freeman: None. A. Addala: None. D. P. Zaharieva: None. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. D. Scheinker: Advisory Panel; Self; Carta Healthcare. M. Desai: None. D. M. Maahs: Advisory Panel; Self; Abbott Diabetes, Dompe, Eli Lilly and Company, Medtronic, Novo Nordisk, Consultant; Self; aditxt. V. Ding: None. B. Leverenz: None. J. Hooper: None. A. Chmielewski: None. B. P. Conrad: Advisory Panel; Self; Abbott Diabetes. J. Leverenz: None. A. Martinez-singh: None. P. Sagan: None. Funding National Institutes of Health (R18DK122422, P30DK116074)

Previous studies have shown that CGM use and frequent contact with the care team is associated with improved A1c. We hypothesized that youth with new onset T1D started on CGM with weekly CGM data review by a CDE would have improved outcomes compared to those on CGM alone. Youth with newly diagnosed T1D from 7/2018 to 3/2019 were started on CGM alone (control, n=46) while those from 3/2019 to 5/2020 were started on CGM with weekly data review by a CDE (GluVue, n=76). Dose adjustments were made via secure messaging. We visualized A1c trajectories using locally estimated scatter plot smoothing (Fig) and assessed for differences in A1c trajectory by GluVue status via cohort*time and cohort*time2 interaction terms in a linear mixed model regression adjusted for baseline characteristics (age, sex, race and insurance type). The mean (SD) A1c at diagnosis was 12.0% (1.8) in the control group and 12.3% (2.3) in the GluVue group. Baseline characteristics of control vs. GluVue: male 25% vs. 39%, Non-Hispanic White 41.3% vs. 35.5%, private insurance 80.4% vs. 73.7%. Mean A1c of the GluVue cohort was lower at 6 months (-0.45%), 9 months (-0.07%), and 12 months (-0.52%) post-diagnosis. A1c trajectories were significantly different between groups via regression analysis (p=0.004). Early initiation of CGM with remote monitoring was associated with lower A1c compared to CGM alone. These data support early CGM initiation plus care team contact in youth with T1D. Disclosure P. Prahalad: None. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. D. Scheinker: Advisory Panel; Self; Carta Healthcare. M. Desai: None. D. M. Maahs: Advisory Panel; Self; Abbott Diabetes, Dompe, Eli Lilly and Company, Medtronic, Novo Nordisk, Consultant; Self; aditxt. V. Ding: None. B. Leverenz: None. J. Hooper: None. J. Leverenz: None. P. Sagan: None. A. Martinez-singh: None. A. Freeman: None. D. P. Zaharieva: None. Funding National Institutes of Health (P30DK116074, R18DK122422)

Type 1 diabetes (T1D) is a lifelong disease that requires constant monitoring. New technologies seeking to relieve this burden must be user-friendly and provide treatment satisfaction to enable widespread adoption, glycemic benefit, and long-term success. We assessed these parameters for the Omnipod 5 Automated Insulin Delivery System during a 3-month outpatient study of the system. Participants (N=240) with T1D aged 6-70y completed validated assessment tools at study start and end, including the Insulin Device Satisfaction Survey (IDSS), Diabetes Treatment Satisfaction Questionnaire (DTSQ), and System Usability Scale (SUS). Parents/guardians of participants aged 6-11.9y (children, N=83) and 12-17.9y (teens, N=42) were assessed as appropriate. Participants were aged (mean±SD) 25±17y, with T1D duration 12±11y and baseline A1C 7.4±0.9%. Perceived usability and satisfaction with the treatment regimen and device were significantly improved with the study system compared to prior therapy (Table). Improvements were also seen in the IDSS subscales for burden and inconvenience (both p Disclosure S. A. Macleish: Advisory Panel; Self; Insulet Corporation. W. H. Polonsky: Advisory Panel; Self; Intarcia Therapeutics, Inc., Consultant; Self; Abbott Diabetes, ADOCIA, Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Insulet Corporation, Lilly Diabetes, Novo Nordisk, Onduo LLC., Sanofi US. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. C. J. Levy: Advisory Panel; Self; Dexcom, Inc., Eli Lilly and Company, Employee; Spouse/Partner; AbbVie Inc., Other Relationship; Self; Dexcom, Inc., Research Support; Self; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care. L. M. Huyett: Employee; Self; Insulet Corporation, Stock/Shareholder; Self; Insulet Corporation. T. Vienneau: Employee; Self; Insulet Corporation, Stock/Shareholder; Self; Insulet Corporation. T. T. Ly: Employee; Self; Insulet Corporation. Funding Insulet Corporation

Background: Loop is an open-source AID system used by more than 9,000 people with type 1 diabetes. Understanding the pros and cons of Loop use may help improve disease management and support population level innovation. Methods: Focus groups illuminated 72 new and experienced users’ perspectives on Loop uptake, use and persistence. Participants were predominately white (95%), male (50%), privately insured (94%), reported annual household income ≥ $100K (73%) and education exceeding a bachelor’s degree (87%) with a mean HbA1c of 6.6±0.8%. Twenty discontinuers who stopped using Loop during the study (60% female, 85% white, 85% privately insured) completed interviews. Qualitative data, collected as part of the larger observational study, were analyzed and synthesized by a multidisciplinary team. Results: High frequency thematic content described experiences with: a) technical support and troubleshooting, b) decreased mental/behavioral burden, c) technical issues with parts of the system, d) glycemic control, e) personalizing settings, and f) providers while using Loop. Users also emphatically highlighted the effects of Loop on overnight experiences and the role that “Loop communities” played during use. Decreased burden was the most endorsed benefit characterized by less worry, stress, and cognitive effort; less time spent on diabetes management tasks, and more space to think about nondiabetes aspects of life. The most discussed drawback was having technical issues with any part of the system including challenges with insulin pumps, CGMs, infusion sites, signal loss, the app, and/or the algorithm. A range of provider attitudes and knowledge about Loop complicated users’ disclosure and experiences. Conclusions: This sample of Loop users reported benefits to quality of life and glycemic control that outweighed challenges of setting up system components and adjusting settings. Users reported being empowered by the customizability and educational effects of the open-source AID system. Disclosure S. Suttiratana: Employee; Spouse/Partner; CVS Health. J. J. Wong: None. M. S. Lanning: None. A. Dunlap: None. S. Hanes: None. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. R. Lal: Consultant; Self; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Morgan Stanley, Tidepool. D. Naranjo: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust

There are pervasive disparities in health outcomes for people living with diabetes based on socioeconomic status, race, and ethnicity. These longstanding disparities are magnified by the devastating impact of COVID-19 for underserved communities with diabetes. As part of a Project Extension for Community Healthcare Outcomes (ECHO™) Diabetes outreach program in Florida and California, over 15 participating Federally Qualified Health Centers (FQHC) were provided Diabetes Support Coaches (DSC) to facilitate patient engagement. DSCs hold invaluable expert knowledge as they live with diabetes, themselves, and reside in the geographic catchment areas they serve - combining a traditional Community Health Worker (CHW) role with peer support models. DSCs complete standardized training in health coaching and receive Diabetes Paraprofessional Level 1 certification through the American Association of Diabetes Care and Education Specialists (ADCES). DSCs offer one-on-one peer support for interested patients, create local resource guides for diabetes management, host community events, disseminate information about technologies like continuous glucose monitors (CGM), and assist with appointment reminders and other engagement activities. Patient encounters with DSCs are documented in REDCap® and pre/post-test evaluation for patients includes HbA1c, the Diabetes Distress Scale, use of diabetes technology, and social support density. Preliminary data from n=19 adults with T1D and T2D (9 Hispanic, 10 Non-Hispanic Black) participating with DSCs at two FQHCs in Miami show statistically significant improvement in HbA1c mean ± SD: -1.21 ± 1.49, 95% CI (-1.93, -0.49) p Disclosure A. F. Walker: None. S. L. Filipp: None. N. Cuttriss: Consultant; Self; Cecelia Health. L. G. Baer: None. L. Figg: None. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. R. Lal: Consultant; Self; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Morgan Stanley, Tidepool. M. Basina: None. J. J. Wong: None. K. Yabut: None. D. M. Maahs: Advisory Panel; Self; Abbott Diabetes, Dompe, Eli Lilly and Company, Medtronic, Novo Nordisk, Consultant; Self; aditxt. M. J. Haller: Board Member; Self; SAB Biotherapeutics, Inc., Consultant; Self; MannKind Corporation, Other Relationship; Self; Janssen Pharmaceuticals, Inc., Sanofi. E. Sheehan: None. S. C. Westen: None. C. Anez-zabala: None. X. Roque: None. A. Bernier: None. L. Bain: None. M. J. Gurka: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust

Background: Access to psychosocial services is limited, especially during a pandemic. A Zoom-delivered family-based intervention for adolescents with type 1 diabetes has the potential to enhance access to psychosocial services. Methods: Nine families enrolled in a pilot of a 6-session online (Zoom) intervention for adolescents with type 1 diabetes and their parents during the COVID-19 pandemic. Qualitative and quantitative data were collected via online focus groups and surveys. Results: Teens’ ages ranged from 12-17 years (M=14.9, SD=1.76) and most self-identified as male (78%). All parents self-identified as female and most families self-identified as non-Hispanic white (78%). Qualitative results revealed that participants found the program to be generally helpful and would recommend the program to others. Perceived benefits included increased parental empathy toward teens, enhanced parental involvement in teens’ diabetes management, and decreased parent-teen conflict. Participants conveyed that these benefits were particularly impactful given increased family contact and tensions related to the COVID-19 pandemic. Identified areas for improvement included adding follow-up group sessions with parents to maintain program impact on parenting over time and to target teens in early adolescence, when family dynamics are more malleable. Quantitative results from paired t-tests of pre-post comparisons revealed no significant differences in teen or parental diabetes distress or depression (all p>0.05), but should be interpreted with caution due to small sample size. Conclusions: Adolescents with type 1 diabetes and their parents responded positively to this program and found it particularly relevant during the current pandemic. Zoom delivery of these programs may be instrumental in their feasibility, acceptability, and ultimately dissemination in the future. Disclosure J. J. Wong: None. M. S. Lanning: None. J. Ngo: None. C. A. Wu: None. S. Hanes: None. H. M. Linzmeyer: None. D. Naranjo: None. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. Funding National Institute of Diabetes and Digestive and Kidney Diseases (1K23DK121771-01A1)

The Project Extension for Community Healthcare Outcomes (ECHO™) model addresses disparities by empowering primary care provider (PCPs), through tele-education, to meet the needs of underserved communities lacking access to subspecialty care. Given the rapid replication of this model, it is vital to understand the perspectives of participating PCPs to refine program implementation. Project ECHO™ Type 1 Diabetes (T1D) program was piloted in Florida and California with >15 Federally Qualified Health Centers (FQHC). PCPs completed pre/post-test surveys assessing knowledge and confidence in T1D care. Exit surveys and focus groups were conducted to understand their experiences (N=92 providers, 41 from FL and 51 from CA were queried). Qualitative analysis of open-ended survey feedback and thematic analysis of focus group data used the Consolidated Framework for Implementation Research (CFIR). The CFIR identifies five domains that affect intervention implementation - including internal and external factors to the healthcare organization. Pre/post surveys demonstrated significant improvements in providers’ diabetes knowledge; mean ± SD change in score for an 11-item knowledge evaluation from pre/post: (1.0 ± 1.8, [Min: -2, Max: +5], p-value: 0.0003) and increase in overall confidence evaluated on a 4-point likert scale (0.6 ± 0.4 [Min: -0.1, Max: 1.6] p-value Disclosure A. F. Walker: None. S. L. Filipp: None. K. Turner: None. G. L. Zori: None. J. Maizel: None. N. Cuttriss: Consultant; Self; Cecelia Health. L. G. Baer: None. L. Figg: None. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. R. Lal: Consultant; Self; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Morgan Stanley, Tidepool. M. Basina: None. M. J. Haller: Board Member; Self; SAB Biotherapeutics, Inc., Consultant; Self; MannKind Corporation, Other Relationship; Self; Janssen Pharmaceuticals, Inc., Sanofi. J. J. Wong: None. K. Yabut: None. D. Naranjo: None. E. Lewit: None. D. M. Maahs: Advisory Panel; Self; Abbott Diabetes, Dompe, Eli Lilly and Company, Medtronic, Novo Nordisk, Consultant; Self; aditxt. E. Sheehan: None. S. C. Westen: None. C. Anez-zabala: None. X. Roque: None. B. C. Fitzgerald: None. A. Bernier: None. M. J. Gurka: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust

Background: Despite observational evidence for the efficacy and safety of open-source automated insulin delivery (OS-AID) there is a lack of guidance for healthcare providers. The ethics of providing care for those using unregulated technology is a concern. Methods: Consensus guidelines are in development, through the OPEN project, by an experienced multi-disciplinary group of endocrinologists, diabetes care and education specialists, exercise physiologists and psychologists. Results: The principles of biomedical ethics - autonomy, justice, beneficence and non-maleficence - provide a framework for analysis. Autonomy requires that the user understands system risks and benefits. OS-AID provides complete transparency and customization, facilitating understanding and control. Algorithms used in commercial systems are proprietary, impeding the ability to discuss and personalize operation. Justice requires burdens and benefits be distributed fairly. Commercial systems are not uniformly accessible. OS-AID provides freely available software and allows the mixing and matching of compatible CGMs and pumps, supporting equity. Beneficence means doing good for the individual. In real-world observational trials both open-source (OpenAPS: n=34, mean TIR 71->80% at max 2.5 years; Loop: n=558, mean TIR 67->73% at 6 months) and commercial AID systems (670G: n=3141, mean TIR 66->73% at 3 months; Control-IQ: n=1659, median TIR: 68->78% at 1 month) provide a statistically significant and clinically meaningful increase in TIR at the population level. Non-maleficence requires treatment does not harm the individual. AID systems can reduce burden, hypoglycemia and hyperglycemia. Conclusions: The international consensus group concludes OS-AID is ethical, but unregulated. We recommend legal interpretations and frameworks be clarified and updated so that individuals are not deprived of beneficial therapy. Commercial AID systems may benefit from transparency and equity offered by OS-AID systems. Disclosure K. Braune: None. M. Riddell: Advisory Panel; Self; Zealand Pharma A/S, Consultant; Self; Lilly Diabetes, Research Support; Self; Dexcom, Inc., Insulet Corporation, Speaker’s Bureau; Self; Novo Nordisk Inc., Sanofi, Stock/Shareholder; Self; Zucara Therapeutics Inc. T. C. Skinner: Advisory Panel; Self; Liva Health Care, Novo Nordisk. K. Raile: Advisory Panel; Self; Abbott Diabetes, Lilly Diabetes, Research Support; Self; Dexcom, Inc. C. Johnston: None. R. Lal: Consultant; Self; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Morgan Stanley, Tidepool. S. Hussain: Speaker’s Bureau; Self; Novo Nordisk. M. Quigley: None. L. Petruzelkova: None. G. Scheiner: Advisory Panel; Self; Capillary Biomedical, Inc., Companion Medical, Eli Lilly and Company, Consultant; Self; ADOCIA, Ascensia Diabetes Care, mySugr, Triple Jump, Ypsomed, Speaker’s Bureau; Self; Dexcom, Inc., Xeris Pharmaceuticals, Inc. P. Winterdijk: None. S. Schmidt: None. L. H. Raimond: None. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. Funding National Institute of Diabetes and Digestive and Kidney Diseases (T32DK007217, 1K12DK122550, 1K23DK122017, P30DK116074); European Commission’s Horizon 2020 Research and Innovation Programme/Marie Sklodowska-Curie Action Research and Innovation Staff Exchange (RISE) grant agreement number 823902

AIMS To explore the auxiliary psychosocial effects of a monetary reinforcement intervention targeting self-monitoring of blood glucose among young people with Type 1 diabetes. METHODS Sixty young people with Type 1 diabetes, HbA1c concentrations between 58 and 119 mmol/mol (7.5-13.0%), and average self-monitoring of blood glucose

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 A1c (HbA1c) 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.