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.

Roadmap to Continuous Glucose Monitoring Adoption and Improved Outcomes in Endocrinology: The 4T (Teamwork, Targets, Technology, and Tight Control) Program.

Glucose monitoring is essential for the management of type 1 diabetes and has evolved from urine glucose monitoring in the early 1900s to home blood glucose monitoring in the 1980s to continuous glucose monitoring (CGM) today. Youth with type 1 diabetes struggle to meet A1C goals; however, CGM is associated with improved A1C in these youth and is recommended as a standard of care by diabetes professional organizations. Despite their utility, expanding uptake of CGM systems has been challenging, especially in minoritized communities. The 4T (Teamwork, Targets, Technology, and Tight Control) program was developed using a team-based approach to set consistent glycemic targets and equitably initiate CGM and remote patient monitoring in all youth with new-onset type 1 diabetes. In the pilot 4T study, youth in the 4T cohort had a 0.5% improvement in A1C 12 months after diabetes diagnosis compared with those in the historical cohort. The 4T program can serve as a roadmap for other multidisciplinary pediatric type 1 diabetes clinics to increase CGM adoption and improve glycemic outcomes.

Primary Care Providers in California and Florida Report Low Confidence in Providing Type 1 Diabetes Care.

People with type 1 diabetes may receive a significant portion of their care from primary care providers (PCPs). To understand the involvement of PCPs in delivering type 1 diabetes care, we performed surveys in California and Florida, two of the most populous and diverse states in the United States. PCPs fill insulin prescriptions but report low confidence in providing type 1 diabetes care and difficulty accessing specialty referrals to endocrinologists.

Equitable implementation of a precision digital health program for glucose management in individuals with newly diagnosed type 1 diabetes.

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

Multisite Quality Improvement Program Within the Project ECHO Diabetes Remote Network.

BACKGROUND: The telementoring Project ECHO (Extension for Community Healthcare Outcomes) model has been shown to improve disease management in diabetes in many underserved communities. The authors aim to evaluate if ECHO could also be an effective tool for quality improvement (QI) of diabetes care in these communities. METHODS: Thirteen clinics in underserved communities in California and Florida participating in Project ECHO Diabetes were recruited for a 12-month QI program. The program provided weekly tele-education sessions, including a didactic presentation and case-based discussion. In addition, clinics chose their own set of quality measures to improve and met remotely to discuss their efforts, successes, and setbacks every quarter with mentorship from QI experts. RESULTS: Of the 31 QI initiatives attempted by different clinics, all had either made improvements (25 initiatives, 80.6%) or were in the process of making improvements (6 initiatives, 19.4%) in structural, process, and outcome measures. Examples of these measures include whether clinics have protocols to identify high-risk patients (structure), numbers of continuous glucose monitor prescriptions submitted by the clinics (process), and percentage of patients with diabetes whose most recent HbA1c are > 9% (outcome). For one measure, 40.0% of the clinics had achieved a higher percentage of cumulative HbA1c measurement in the third quarter of the year, compared to the fourth quarter in the previous year. The cost of QI implementation varied widely due to different number of personnel involved across sites. CONCLUSION: A QI program delivered via Project ECHO Diabetes can facilitate quality improvements in underserved communities.

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.

A quantitative model to ensure capacity sufficient for timely access to care in a remote patient monitoring program.

INTRODUCTION: Algorithm-enabled remote patient monitoring (RPM) programs pose novel operational challenges. For clinics developing and deploying such programs, no standardized model is available to ensure capacity sufficient for timely access to care. We developed a flexible model and interactive dashboard of capacity planning for whole-population RPM-based care for T1D. METHODS: Data were gathered from a weekly RPM program for 277 paediatric patients with T1D at a paediatric academic medical centre. Through the analysis of 2 years of observational operational data and iterative interviews with the care team, we identified the primary operational, population, and workforce metrics that drive demand for care providers. Based on these metrics, an interactive model was designed to facilitate capacity planning and deployed as a dashboard. RESULTS: The primary population-level drivers of demand are the number of patients in the program, the rate at which patients enrol and graduate from the program, and the average frequency at which patients require a review of their data. The primary modifiable clinic-level drivers of capacity are the number of care providers, the time required to review patient data and contact a patient, and the number of hours each provider allocates to the program each week. At the institution studied, the model identified a variety of practical operational approaches to better match the demand for patient care. CONCLUSION: We designed a generalizable, systematic model for capacity planning for a paediatric endocrinology clinic providing RPM for T1D. We deployed this model as an interactive dashboard and used it to facilitate expansion of a novel care program (4 T Study) for newly diagnosed patients with T1D. This model may facilitate the systematic design of RPM-based care programs.

Project ECHO Diabetes Cost Modeling to Support the Replication and Expansion of Tele-mentoring Programs in Non-research Settings.

INTRODUCTION: Project ECHO Diabetes is a tele-education learning model for primary care providers (PCPs) seeking to improve care for patients with diabetes from marginalized communities. Project ECHO Diabetes utilized expert "hub" teams comprising endocrinologists, dieticians, nurses, psychologists, and social workers and "spokes" consisting of PCPs and their patients with diabetes. This Project ECHO Diabetes model provided diabetes support coaches to provide additional support to patients. We sought to estimate the costs of operating a Project ECHO Diabetes hub, inclusive of diabetes support coach costs. METHODS: Data from Project ECHO Diabetes from June 2021 to June 2022 and wages from national databases were used to estimate hub and diabetes support coach costs to operate a 6-month, 24-session Project ECHO Diabetes program at hubs (University of Florida and Stanford University) and spokes (PCP clinic sites in Florida and California). RESULTS: Hub costs for delivering a 6-month Project ECHO Diabetes program to five spoke clinics were $96,873. Personnel costs were the principal driver. Mean cost was $19,673 per spoke clinic and $11.37 per spoke clinic patient. Diabetes support coach costs were estimated per spoke clinic and considered scalable in that they would increase proportionately with the number of spoke clinics in a Project ECHO Diabetes cohort. Mean diabetes support coach costs were $6,506 per spoke clinic and $3.72 per patient. Total program costs per hub were $129,404. Mean cost per clinic was $25,881. Mean cost per patient was $15.03. CONCLUSION: Herein, we document real-world costs to operate a Project ECHO Diabetes hub and diabetes support coaches. Future analysis of Project ECHO Diabetes will include estimates of spoke participation costs and changes in health care costs and savings. As state agencies, insurers, and philanthropies consider the replication of Project ECHO Diabetes, this analysis provides important initial information regarding primary operating costs.

The Promising Success of Project Extension for Community Healthcare Outcomes (ECHO) Diabetes: Case Series.

BACKGROUND: In the United States, there are over 37 million people with diabetes but only 8000 endocrinologists. Therefore, many people with diabetes 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 deidentified 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 people with diabetes whose diabetes management improved directly or indirectly from their providers' participation 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 people with diabetes was compiled from 10 PCPs and 1 DSC from California and Florida between 2021 and 2022. The principal impact of ECHO Diabetes is the education amplified from PCPs and DSCs to people with diabetes. In all cases, people with diabetes 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 people with diabetes who receive their diabetes care from PCPs. Those matched with a DSC saw clinically significant improvements in hemoglobin A1c and mental health outcomes.

Weight Management in Youth with Type 1 Diabetes and Obesity: Challenges and Possible Solutions.

PURPOSE OF REVIEW: This review highlights challenges associated with weight management in children and adolescents with type 1 diabetes (T1D). Our purpose is to propose potential solutions to improve weight outcomes in youth with T1D. RECENT FINDINGS: A common barrier to weight management in T1D is reluctance to engage in exercise for fear of hypoglycemia. Healthcare practitioners generally provide limited guidance for insulin dosing and carbohydrate modifications to maintain stable glycemia during exercise. Adherence to dietary guidelines is associated with improved glycemia; however, youth struggle to meet recommendations. When psychosocial factors are addressed in combination with glucose trends, this often leads to successful T1D management. Newer medications also hold promise to potentially aid in glycemia and weight management, but further research is necessary. Properly addressing physical activity, nutrition, pharmacotherapy, and psychosocial factors while emphasizing weight management may reduce the likelihood of obesity development and its perpetuation in this population.

Efficacy of the Flexible Lifestyles Empowering Change intervention on metabolic and psychosocial outcomes in adolescents with type 1 diabetes (FLEX): a randomised controlled trial.

BACKGROUND: Adolescents with type 1 diabetes commonly have poor glycaemic control. We aimed to test the efficacy of a newly developed adaptive behavioral intervention (Flexible Lifestyles Empowering Change; FLEX) on metabolic and psychosocial outcomes in adolescents with type 1 diabetes. METHODS: Young people (13-16 years, type 1 diabetes duration >1 year, HbA1c of 64-119 mmol/mol [8·0-13·0%], and without other serious medical conditions or pregnancy) from two clinical sites (Colorado and Ohio, USA) were eligible for enrolment. One caregiver was required to participate actively in the study. Adolescent participants were randomly assigned to the FLEX intervention, which used motivational interviewing and problem-solving skills training to enhance patients' self-management, or usual care control. Intervention fidelity was assessed by a behavioral psychologist with specific expertise in motivational interviewing and who was not otherwise involved in the study via audiotaped sessions. The primary outcome was measurement of glycated haemoglobin A1c (HbA1c) at 18 months. Secondary outcomes included motivation and intention, problem solving skills, self-management behaviors, symptoms of depression, health related quality of life, fear of hypoglycemia, diabetes family conflict, risk factors for T1D complications (BMI, blood pressure, and plasma lipids), and hypoglycemia derived from continuous glucose monitoring (percent time below 3·0 and 3·9 mmol/l [54 and 70 mg/dl]). Intention-to-treat analyses used mixed effects models, with fixed effects including site, timepoint, intervention group, intervention by timepoint, and baseline level of primary (HbA1c) or secondary outcomes (α=0·05). FLEX is registered on clinicaltrials.gov, number NCT01286350. FINDINGS: Young people recruited from May 1, 2014 to April 4, 2016 were randomly assigned to FLEX (n=130) or usual care control (n=128). Mean diabetes duration was 6·4 (SD 3·8) years, and 71% (181 out of 256) of patients used insulin pump therapy. Retention was 93%, with 241 out of 258 completing the 18-month assessment. The intervention fidelity score was 4·40 of 5·00 for motivational interviewing and 97% for session content. At 18 months, HbA1c was not significantly different between intervention (83 [13] mmol/mol at baseline; 84 [19] mmol/mol at follow-up); and control (80 [14] mmol/mol at baseline; 82 [17] mmol/mol at follow-up); change in intervention versus control was -0·7 mmol/mol (95% CI -4·7 to 3·4, p=0·75). The intervention was associated with improved scores for motivation (p=0·011), problem solving (p=0·024), diabetes self-management profile (p=0·013), youth report of overall quality of life (p=0·0089), selected domains related to fear of hypoglycaemia (p=0·036 for youth's helplessness or worry; p=0·0051 for parent's efforts to maintain high blood glucose), parent report of diabetes family conflict (p=0·0001), total cholesterol (p=0·038), and diastolic blood pressure (p=0·015). A total of 54 serious adverse events were identified; 34 of these were diabetes-related, including low blood glucose requiring assistance (n=3) and high blood glucose with diabetic ketoacidosis and emergency response (n=25). INTERPRETATION: The FLEX intervention did not significantly change HbA1c among these adolescents with elevated HbA1c, but did positively affect several psychosocial outcomes over 18 months. Further analyses will provide information regarding drivers of positive response to the intervention and will point to future directions for improvement in the approach. FUNDING: National Institutes of Health and National Institute of Diabetes Digestive Diseases and Kidney and the Helmsley Charitable Trust.