Frequency and Causes of Nocturnal Alarms in Youth and Young Adults With Type 1 Diabetes Using a First-Generation Hybrid Closed-Loop System.

Background: Meeting glycemic recommendations is challenging for youth with type 1 diabetes. Diabetes technology, including continuous glucose monitoring (CGM) and hybrid closed-loop (HCL) automated insulin delivery systems, significantly increase achievement of glycemic targets; however, many youth struggle to sustain use of early HCL systems. Nocturnal alarm fatigue contributes to disrupted sleep and device discontinuation. Methods: We examined the frequency and causes of nocturnal (10:00 p.m. to 6:00 a.m.) alarms in pediatric patients (N = 76, median age 14.5 years [interquartile range 11.8-17.0 years, range 7-24 years]) starting on a first-generation HCL system in a prospective observational study. Device data were analyzed with linear mixed-effects models to examine change across time at 3-month intervals for 12 months. Results: At baseline (HCL system in nonautomated mode), participants averaged 3.3 ± 0.6 alarms per night. In the 2 weeks after starting HCL (automated) mode, alarm frequency significantly increased to 5.4 ± 0.5 times per night (P <0.001). Alarm frequency decreased through the remainder of the observational period; however, CGM sensor and HCL system use also declined. The types of alarms were evenly distributed among sensor maintenance, sensor threshold, pump, and HCL-specific alarms. Conclusion: These data show that HCL system nocturnal alarms are frequent and may be barriers to sleep quality and device use. Further research is needed to assess the impact of diabetes technology on sleep and to determine method to improve sleep quality with technology use.

Clinical Implementation of the Omnipod 5 Automated Insulin Delivery System: Key Considerations for Training and Onboarding People With Diabetes.

Automated insulin delivery (AID) systems, which connect an insulin pump, continuous glucose monitoring system, and software algorithm to automate insulin delivery based on real-time glycemic data, hold promise for improving outcomes and reducing therapeutic burden for people with diabetes. This article reviews the features of the Omnipod 5 Automated Insulin Delivery System and how it compares to other AID systems available on or currently under review for the U.S. market. It also provides practical guidance for clinicians on how to effectively train and onboard people with diabetes on the Omnipod 5 System, including how to personalize therapy and optimize glycemia. Many people with diabetes receive their diabetes care in primary care settings rather than in a diabetes specialty clinic. Therefore, it is important that primary care providers have access to resources to support the adoption of AID technologies such as the Omnipod 5 System.

Real-world performance of hybrid closed loop in youth, young adults, adults and older adults with type 1 diabetes: Identifying a clinical target for hybrid closed-loop use.

AIM: To describe real-world hybrid closed loop (HCL) use and glycaemic outcomes across the lifespan and identify a clinical threshold for HCL use associated with meeting the internationally recommended target of 70% sensor glucose time in range (TIR; 70-180 mg/dL). MATERIALS AND METHODS: Mixed models examined MiniMed 670G HCL use and glycaemic outcomes in 276 people with type 1 diabetes from four age groups: youth (aged <18 years), young adults (18-25 years), adults (26-49 years) and older adults (≥50 years) for 1 year. ROC analysis identified the minimum percentage HCL use associated with meeting the TIR goal of 70%. RESULTS: HCL use at month 1 was 70.7% ± 2.9% for youth, 71.0% ± 3.8% for young adults, 78.9% ± 2.1% for adults and 84.7% ± 3.8% in older adults. HCL use declined significantly at 12 months to 49.3% ± 3.2% in youth (P < .001) and 55.7% ± 4.3% in young adults (P = .002). HCL use was sustained at 12 months in adults (76.4% ± 2.2%, P = .36) and older adults (80.4% ± 3.9%, P = .36). HCL use of 70.6% was associated with 70% TIR (sensitivity 58.3%, specificity 85%, AUC 0.77). Older age, 80% or higher continuous glucose monitor use and four or more blood glucose checks per day were associated with attaining the HCL-use threshold. CONCLUSIONS: HCL use of 70% or higher may be a useful target for clinicians to use to assist people with diabetes in attaining glycaemic goals. Youth may struggle with HCL use more than adults and require clinical intervention to help sustain HCL use across time.

Initiating hybrid closed loop: A program evaluation of an educator-led Control-IQ follow-up at a large pediatric clinic.

BACKGROUND: Control-IQ (Tandem Diabetes) is a hybrid closed-loop (HCL) system that users self-initiate after completing online training. Best practices for clinical follow-up are not known. Our quality improvement objective was to evaluate the usefulness of an educator-led follow-up program for new HCL users in a type 1 diabetes pediatric clinic. METHODS: We implemented an ''HCLCheck-in'' program, first determining when users started HCL, then having diabetes educators contact them for a follow-up call 2-weeks after start. Educators used a Clinical Tool to inform insulin dose and behavior recommendations, and used four benchmarks to determine need for further follow-up: ≥71% HCL use, ≥71% CGM use, ≥60% Time-in-Range (TIR, 70-180 mg/dL), <5% below 70 mg/dL. Family and educator satisfaction were surveyed. RESULTS: One-hundred-twenty-three youth [mean age 13.6 ± 3.7 y, 53.7% female, mean HbA1c 7.6 ± 1.4% (60 mmol/mol)] completed an HCLCheck-in call a median (IQR) of 18(15, 21) days post-HCL start. 74 users (60%) surpassed benchmarks with 94% HCL use and 71% TIR. Of the 49 who did not, 16 completed a second call, and improved median TIR 12.5% (p = 0.03). HCL users reported high satisfaction with the program overall [median 10 (9, 10) out of 10]. Educators spent a median of 45 (32,70) minutes per user and rated satisfaction with the program as 8 (7,9.5) and the Tool as 9 (9, 10). CONCLUSION: Our HCLCheck-in program received high satisfaction ratings and resulted in improved TIR for those initially not meeting benchmarks, suggesting users may benefit from early follow-up. Similar programs may be beneficial for other new technologies.

Psychosocial outcomes in young adolescents with type 1 diabetes participating in shared medical appointments.

For youth with type 1 diabetes (T1D), the early adolescent period is associated with worsening diabetes management and high rates of negative psychosocial issues, including depressive symptoms and family conflict. Alternative clinical models may help improve both diabetes and psychosocial outcomes. Our study aims to investigate whether Team Clinic, a shared medical appointment model developed specifically for adolescents with T1D, will improve psychosocial outcomes for middle school-aged youth. Youth with T1D, 11-13 years of age, and their caregivers, participated in a randomized controlled trial comparing Team Clinic to traditional clinic visits (control group). Diabetes characteristics were obtained at every visit. Participants and caregivers completed depression screening and family conflict questionnaires at baseline and end of study. Changes in mean scores on clinical and psychosocial outcomes from baseline to end of study were compared between groups using linear mixed-effects models. Eighty-six youth (51% female; 74% White; 10% Hispanic) completed at least one visit during the 12-month study period. At the end of the study, control group participants reported increases in Emotional Problems compared to Team Clinic participants, including higher levels of Negative Mood/Physical Symptoms (p = 0.02). Team Clinic participants reported reduced family conflict surrounding diabetes at study end, compared to control group participants (p = 0.03). Caregivers did not report change in depressive symptoms or family conflict during the study. Hemoglobin A1C levels did not change over time in either group. Participation in Team Clinic was associated with improved psychosocial outcomes in middle school-aged participants with T1D.

A School Nurse Application of the ECHO Model.

Type I diabetes (T1D) is one of the most common childhood diseases and Type 2 diabetes (T2D) is increasing at alarming rates. Given that children spend a great percentage of their time in school, this setting is a critical environment for models of care that lead to better management of this and other health conditions. The School Nurses Managing Diabetes Care ECHO was offered to Colorado school nurses to build their capacity in providing evidence-based management of T1D. The purpose of this effort was to (1) determine whether or not the model could be used as a tool of collaboration and dissemination for school nurses across Colorado and (2) assess the effectiveness of the "School Nurses Managing Diabetes Care" ECHO learning series. Post-series survey results demonstrated a 25% increase in self-efficacy ratings, moving learners from "average among my peers" toward "competent." Additionally, all respondents planned to make one or more practice changes to improve care for students with T1D. Expanding the use of the ECHO model to implement intensive management of children and youth with T1D is critically important as rates of this and other chronic conditions continue to increase.

Real world hybrid closed-loop discontinuation: Predictors and perceptions of youth discontinuing the 670G system in the first 6 months.

OBJECTIVE: To describe predictors of hybrid closed loop (HCL) discontinuation and perceived barriers to use in youth with type 1 diabetes. SUBJECTS: Youth with type 1 diabetes (eligible age 2-25 y; recruited age 8-25 y) who initiated the Minimed 670G HCL system were followed prospectively for 6 mo in an observational study. RESEARCH DESIGN AND METHODS: Demographic, glycemic (time-in-range, HbA1c), and psychosocial variables [Hypoglycemia Fear Survey (HFS); Problem Areas in Diabetes (PAID)] were collected for all participants. Participants who discontinued HCL (<10% HCL use at clinical visit) completed a questionnaire on perceived barriers to HCL use. RESULTS: Ninety-two youth (15.7 ± 3.6 y, HbA1c 8.8 ± 1.3%, 50% female) initiated HCL, and 28 (30%) discontinued HCL, with the majority (64%) discontinuing between 3 and 6 mo after HCL start. Baseline HbA1c predicted discontinuation (P = .026) with the odds of discontinuing 2.7 times higher (95% CI: 1.123, 6.283) for each 1% increase in baseline HbA1c. Youth who discontinued HCL rated difficulty with calibrations, number of alarms, and too much time needed to make the system work as the most problematic aspects of HCL. Qualitatively derived themes included technological difficulties (error alerts, not working correctly), too much work (calibrations, fingersticks), alarms, disappointment in glycemic control, and expense (cited by parents). CONCLUSIONS: Youth with higher HbA1c are at greater risk for discontinuing HCL than youth with lower HbA1c, and should be the target of new interventions to support device use. The primary reasons for discontinuing HCL relate to the workload required to use HCL.

Six months of hybrid closed loop in the real-world: An evaluation of children and young adults using the 670G system.

OBJECTIVE: To describe glycemic and psychosocial outcomes in youth with type 1 diabetes using a hybrid closed loop (HCL) system. SUBJECTS: Youth with type 1 diabetes (2-25 years) starting the 670G HCL system for their diabetes care were enrolled in an observational study. METHODS: Prospective data collection occurred during routine clinical care and included glycemic variables (sensor time in range [70-180 mg/dL], HbA1c), and psychosocial variables (Hypoglycemia Fear Survey [HFS]; Problem Areas in Diabetes [PAID]). Mixed models were used to analyze change across time. RESULTS: Ninety-two youth (mean age 15.7 ± 3.6 years, 50% female, HbA1c 8.8% ± 1.8%) started HCL for their diabetes care. Youth used Auto Mode 65.5% ± 3.0% of the time at month 1, which decreased to 51.2% ± 3.4% at month 6 (P = .001). Sensor time in range increased from 50.7% ± 1.8% at baseline to 56.9% ± 2.1% at 6 months (P = .007). HbA1c decreased from 8.7% ± 0.2% at baseline to 8.4% ± 0.2% after 6 months of use (P ≤ .0001), with the greatest HbA1c decline in participants with high baseline HbA1c. Increased percent time in auto mode was associated with lower HbA1c (P = .02). Thirty percent of youth discontinued HCL in the first 6 months of use. There were no changes in the HFS or PAID scores across time. CONCLUSIONS: HCL use is associated with improved glycemic control and no change in psychosocial outcomes in this clinical sample. The decline in HCL use across time suggests that youth experience barriers in sustaining use of HCL. Further research is needed to understand reasons for HCL discontinuation and determine intervention strategies.

Graduated exposure to treat fear of hypoglycemia in a young adult with type 1 diabetes: A case study.

Hypoglycemia is a common and dangerous complication of type 1 diabetes (T1D). Although some worry about hypoglycemia is adaptive, some individuals develop severe and impairing anxiety symptoms about hypoglycemic episodes. This presentation, known as severe fear of hypoglycemia (FOH), is similar to a specific phobia, and becomes problematic when it interferes with one's quality of life or T1D management. Although FOH is common, there have not yet been any treatment studies to address severe and impairing levels of FOH in the T1D population. The purpose of the following case report is to: (a) describe the presentation of a severe case of FOH in a young adult with T1D; (b) demonstrate the effectiveness of graduated exposure therapy for treatment of severe FOH; and (c) provide implications for clinical practice. A previously developed conceptual model for FOH management guided treatment. Treatment using graduated exposure therapy for FOH resulted in reduced worry about low blood glucose (BG) and significant reduction in behaviors to maintain high BG levels. Assessment of FOH and the risk and benefits of using a continuous glucose monitor among individuals with T1D and their families are discussed.

A Clinical Overview of Insulin Pump Therapy for the Management of Diabetes: Past, Present, and Future of Intensive Therapy.

IN BRIEF Insulin pump therapy is advancing rapidly. This article summarizes the variety of insulin pump technologies available to date and discusses important clinical considerations for each type of technology.

Biopsychosocial Factors Associated With Satisfaction and Sustained Use of Artificial Pancreas Technology and Its Components: a Call to the Technology Field.

PURPOSE OF REVIEW: Summarize biopsychosocial factors associated with using continuous glucose monitors (CGMs), insulin pumps, and artificial pancreas (AP) systems and provide a "call to the field" about their importance to technology uptake and maintained use. RECENT FINDINGS: Insulin pumps and CGMs are becoming standard of care for individuals with type 1 diabetes (T1D). AP systems combining a CGM, insulin pump, and automated dosing algorithm are available for commercial use. Despite improved glycemic control with AP system use, numerous barriers exist which may limit their benefit. Studies on components of AP systems (pumps, CGMs) are limited and demonstrate mixed results of their impact on fear of hypoglycemia, adherence, quality of life, depression and anxiety, and diabetes distress. Studies examining biopsychological factors associated specifically with sustained use of AP systems are also sparse. Biological, psychological and social impacts of AP systems have been understudied and the information they provide has not been capitalized upon.

Team Clinic: An Innovative Group Care Model for Youth with Type 1 Diabetes-Engaging Patients and Meeting Educational Needs.

The purpose of this pilot was to implement an innovative group care model, "Team Clinic", for adolescents with type 1 diabetes and assess patient and provider perspectives. Ninety-one intervention patients and 87 controls were enrolled. Ninety-six percent of intervention adolescents endorsed increased support and perceived connecting with peers as important. The medical providers and staff also provided positive feedback stating Team Clinic allowed more creativity in education and higher quality of care. Team Clinic may be a promising model to engage adolescents and incorporate education and support into clinic visits in a format valued by patients and providers.

Accuracy of a Continuous Glucose Monitor During Pediatric Type 1 Diabetes Inpatient Admissions.

Objective: Continuous glucose monitors (CGMs) used for type 1 diabetes management are associated with lower hemoglobin A1c. CGMs are not approved for inpatient use, when close glucose monitoring and intensive insulin management are essential for optimal health. Accuracy data from adult hospitalizations have been published, but pediatric data are limited. Design and Methods: This retrospective review of Dexcom G6 data from youth with type 1 diabetes during hospitalization assessed CGMs and matched (within 5 min) point-of-care (POC) and laboratory glucose values. Glucose values >400 and <40 mg/dL were excluded due to sensor reporting capabilities. Standard methods for CGM accuracy were used including mean absolute relative difference (MARD), Clarke Error Grids, and percentage of CGM values within 15%/20%/30% if glucose value is >100 mg/dL and 15/20/30 mg/dL if value is ≤100 mg/dL. Results: A total of 1120 POC and 288 laboratory-matched pairs were collected from 83 unique patients (median age 12.0 years, 68.7% non-Hispanic white, 54.2% male) during 100 admissions. For POC values, overall, MARD was 11.8%, that on the medical floor was 13.5%, and that in the intensive care unit was 7.9%. The MARD for all laboratory values was 6.5%. In total, 98% of matched pairs were within Clarke Error Grid A and B zones. Conclusions: Findings from our pediatric population were similar to accuracy reported in hospitalized adults, indicating the potential role for CGM use during pediatric hospitalizations. Additional research is needed to assess accuracy under various conditions, including medication use, as well as development of safe hospital protocols for successful CGM implementation for routine inpatient care.

Accuracy of a Real-Time Continuous Glucose Monitor in Pediatric Diabetic Ketoacidosis Admissions.

Objective: Continuous glucose monitoring (CGM) devices are integral in the outpatient care of people with type 1 diabetes, although they lack inpatient labeling. Food and Drug Administration began allowing inpatient use during the coronavirus disease 2019 (COVID-19) pandemic, with some accuracy data now available, primarily from adult hospitals. Pediatric inpatient data remain limited, particularly during diabetic ketoacidosis (DKA) admissions and for patients receiving intravenous (IV) insulin. Design and Methods: This retrospective chart review compared point-of-care glucose values to personal Dexcom G6 sensor data during pediatric hospitalizations. Accuracy was assessed using mean absolute relative difference (MARD), Clarke Error Grids, and the percentage of values within 15/20/30% if glucose value >100 mg/dL and 15/20/30 mg/dL if glucose value ≤100 mg/dL. Results: Matched paired glucose values (N = 612) from 36 patients (median age 14 years, 58.3% non-Hispanic White, 47.2% male) and 42 inpatient encounters were included in this subanalysis of DKA admissions. The MARDs for DKA and non-DKA admissions (N = 503) were 11.8% and 11.7%, with 97.6% and 98.6% of pairs falling within A and B zones of the Clarke Error Grid, respectively. Severe DKA admissions (pH <7.15 and/or bicarbonate <5 mmol/L) had a MARD of 8.9% compared to 14.3% for nonsevere DKA admissions. The MARD during administration of IV insulin (N = 266) was 13.4%. Conclusions: CGM accuracy is similar between DKA and non-DKA admissions and is maintained in severe DKA and during IV insulin administration, suggesting potential usability in pediatric hospitalizations. Further study on the feasibility of implementation of CGM in the hospital is needed.

Real-World Evidence of Omnipod® 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes.

Background: The Omnipod® 5 Automated Insulin Delivery System was associated with favorable glycemic outcomes for people with type 1 diabetes (T1D) in two pivotal clinical trials. Real-world evidence is needed to explore effectiveness in nonstudy conditions. Methods: A retrospective analysis of the United States Omnipod 5 System users (aged ≥2 years) with T1D and sufficient data (≥90 days of data; ≥75% of days with ≥220 continuous glucose monitor readings/day) available in Insulet Corporation's device and person-reported datasets as of July 2023 was performed. Target glucose setting usage (i.e., 110-150 mg/dL in 10 mg/dL increments) was summarized and glycemic outcomes were examined. Subgroup analyses of those using the lowest average glucose target (110 mg/dL) and stratification by baseline characteristics (e.g., age, prior therapy, health insurance coverage) were conducted. Results: In total, 69,902 users were included. Multiple and higher glucose targets were more commonly used in younger age groups. Median percentage of time in range (TIR; 70-180 mg/dL) was 68.8%, 61.3%, and 53.6% for users with average glucose targets of 110, 120, and 130-150 mg/dL, respectively, with minimal time <70 mg/dL (all median <1.13%). Among those with an average glucose target of 110 mg/dL (n = 37,640), median TIR was 65.0% in children and adolescents (2-17 years) and 69.9% in adults (≥18 years). Subgroup analyses of users transitioning from Omnipod DASH or multiple daily injections and of Medicaid/Medicare users demonstrated favorable glycemic outcomes among these groups. Conclusion: These glycemic outcomes from a large and diverse sample of nearly 70,000 children and adults demonstrate effective use of the Omnipod 5 System under real-world conditions.

Evaluation of a New Clinical Tool to Enhance Clinical Care of Control-IQ Users.

BACKGROUND: The purpose of this study was to develop and test a new Clinic Tool to assist health care professionals with clinical care of persons with diabetes using the Control-IQ system. METHODS: A Clinic Tool was iteratively developed with input from diabetes clinicians, which outlined a systematic process for assessing data, reviewing insulin settings, providing education, and documenting the encounter. Diabetes clinicians were recruited to trial the Clinical Tool in up to five clinical encounters (in-person, telehealth, or telephone). Quantitative surveys and free-text responses, including a knowledge quiz and the System Usability Scale (SUS), were administered to determine clinician satisfaction, confidence, knowledge, and implications for practice. RESULTS: Twenty-nine clinicians (43% endocrinologists, mean 10.7 years in practice) enrolled in the study and completed 89 encounters using the Control-IQ Clinic Tool. Participants spent an average of 10 minutes using the Tool and reported excellent SUS scores within the 90%-95% percentile for usability. Knowledge quiz scores increased in 42% of participants. Both familiarity with Control-IQ and confidence providing clinical care to Control-IQ users significantly improved (P = .009 and P < .001 respectively). Ninety percent of participants agreed that the Tool will change their clinical care going forward. CONCLUSION: The Control-IQ Clinical Tool is highly usable and impacted clinical care delivery to Control-IQ users. Tools that serve to improve clinician confidence in delivery of care to diabetes device users should be expanded, leveraged, and studied to assess the impact on adherence and glycemic control for persons with diabetes.

Predicting Success with a First-Generation Hybrid Closed-Loop Artificial Pancreas System Among Children, Adolescents, and Young Adults with Type 1 Diabetes: A Model Development and Validation Study.

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

Barriers to Uptake of Insulin Technologies and Novel Solutions.

Diabetes-related technology has undergone great advancement in recent years. These technological devices are more commonly utilized in the type 1 diabetes population, which requires insulin as the primary treatment modality. Available devices include insulin pumps, continuous glucose monitors, and hybrid systems referred to as automated insulin delivery systems or hybrid closed-loop systems, which combine those two devices along with software algorithms to achieve advanced therapeutic capabilities, including automatic modulation of insulin delivery based on sensor-derived glucose levels to minimize abnormal glucose trends. Use of diabetes technology is associated with significant positive health and psychosocial outcomes, yet utilization rates are generally lacking across both adult and pediatric type 1 diabetes populations in the United States and other countries. There are consistent themes in existing barriers to technology uptake reported by individuals with type 1 diabetes or parents of children with type 1 diabetes, including physical burdens associated with wearing the devices, concerns in navigating the technology and the devices' abilities to meet user expectations, high cost, inadequate resources within the healthcare team to support device use, disparities in technology access, and psychosocial barriers. It is important to understand the common barriers to uptake of not only the automated insulin delivery systems but also their component devices (insulin pumps and continuous glucose monitors) to fully support individuals in utilizing these devices and optimizing health benefits. The purpose of this article is to summarize the current automated insulin delivery devices that are available for use in management of type 1 diabetes, review common barriers to uptake of those systems and their component devices, and provide expert opinion on existing and future solutions to identified barriers.