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.

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.

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.

Impact of 6-months of an advanced hybrid closed-loop system on sleep and psychosocial outcomes in youth with type 1 diabetes and their parents.

INTRODUCTION: Youth with type 1 diabetes (T1D) and parents experience reduced quality of life and sleep quality due to nocturnal monitoring, hypoglycemia fear, and diabetes-related disruptions. This study examined the sleep and quality of life impact of advanced technology. METHODS: Thirty-nine youth with T1D, aged 2-17 years, starting an advanced hybrid closed-loop (HCL) system and a parent participated in an observational study. Surveys, actigraphy, sleep diaries, and glycemic data (youth) were captured prior to HCL, at one week, 3 months, and 6 months. Outcomes were modeled using linear mixed effects models with random intercepts to account for within-subject correlation, with least-squares means at each timepoint compared to baseline. RESULTS: Parents and youth reported improvements in health-related quality of life and fear of hypoglycemia after HCL initiation. Concurrently, nocturnal glycemia improved. Actigraphy-derived sleep outcomes showed improved 6 month adolescent efficiency and 3 and 6 month parent wake after sleep onset. Additionally, parents reported improved subjective sleep quality and child sleep-related impairment at 3 months. CONCLUSIONS: With nocturnal glycemic improvements in youth using HCL technology, some aspects of parent and youth sleep and quality of life improved. This may reflect decreased parental monitoring and worry and highlights benefits for youth beyond glycemia.

The future of telehealth in type 1 diabetes.

PURPOSE OF REVIEW: Although telemedicine and telehealth services have been a part of type 1 diabetes (T1D) clinical care for several decades, the expansion of in-home telemedicine during the COVID-19 pandemic significantly increased interest in long-term use as part of routine care. This review highlights the current literature regarding telemedicine in T1D care as well as the benefits and barriers to use in a postpandemic world. RECENT FINDINGS: Telemedicine has increased patient contact with healthcare providers, allowing for more frequent insulin dose adjustments and improvements in glycemic outcomes. In addition to routine clinical care, T1D device training and mental healthcare have been successful through telemedicine. Significant barriers to continued telemedicine care exist, including patient access and technology knowledge, language, and loss of face-to-face interaction. Healthcare providers additionally face unpredictable reimbursement and loss of continuity across state lines, and lack of resources and training for device downloads and telemedicine software. SUMMARY: Telemedicine can be successfully used in T1D care and has the potential to significantly impact glycemic and long-term outcomes. Due to continued interest for in-person visits by people with T1D and providers, it is likely that long-term telemedicine use will include a hybrid format.

Friend or Foe: a Narrative Review of the Impact of Diabetes Technology on Sleep.

PURPOSE OF REVIEW: The purpose of this review is to present a review of sleep science, the relationship between sleep and type 1 diabetes, and highlight the current literature on sleep outcomes in adult and pediatric diabetes technology research. RECENT FINDINGS: Sleep quality is associated with glycemic outcomes, diabetes self-management, and mental health in people with type 1 diabetes. Diabetes technologies, including insulin pumps, continuous glucose monitors, and hybrid closed-loop systems improve glycemic outcomes. However, many people find this technology challenging for a variety of reasons, including increased burden and frequent alarms, especially during the night. The impact of different devices on sleep quality and quantity has been mixed. The newest technology, the hybrid closed-loop systems, offers the best opportunity for nocturnal glycemic regulation and has improved patient and family perspectives on sleep quality. However, objective sleep assessment has not shown significant improvement on sleep duration. Sleep quality and quantity in people with type 1 diabetes are widely recognized as an important component of health care, and the literature regarding the impact of diabetes devices on sleep is increasing. However, sleep disruptions are common and a barrier to device use. Despite finding minimal changes to sleep duration with device use, subjective accounts of sleep quality are overall positive, especially in those using hybrid closed-loop systems. Sleep quantity and quality are important outcomes to consider as diabetes technology continues to evolve.

Improvements in Parental Sleep, Fear of Hypoglycemia, and Diabetes Distress With Use of an Advanced Hybrid Closed-Loop System.

OBJECTIVE: Parental sleep quality may contribute to glycemic control in youth with type 1 diabetes. In this article we present sleep analysis from a multicenter, randomized trial of children ages 6-13 years with type 1 diabetes evaluating the Tandem Control-IQ (CIQ) hybrid closed-loop (HCL) system. RESEARCH DESIGN AND METHODS: Pittsburgh Sleep Quality Index (PSQI) scores were assessed at baseline to identify parents as "poor" sleepers (PSQI >5). Glycemic and psycho-behavioral outcomes before and after CIQ use were analyzed in poor sleepers (n = 49) and their children. RESULTS: Nocturnal time in range (P < 0.001) and time hyperglycemic (P < 0.001), Hypoglycemia Fear Survey for Parents score (P < 0.001), Problem Areas in Diabetes scale score (P < 0.001), PSQI score (P < 0.001), and Hypoglycemia Fear Survey for Children score (P = 0.025) significantly improved. Of poor sleepers, 27 became good sleepers (PSQI score <5). CONCLUSIONS: Use of CIQ in youth with type 1 diabetes ages 6-13 years significantly improved sleep and psychosocial measures in parent poor sleepers, coinciding with improvements in child nocturnal glycemia, highlighting the relationship between HCL systems and parent sleep quality.

Diabetes Technology Use in Remote Pediatric Patients with Type 1 Diabetes Using Clinic-to-Clinic Telemedicine.

Background: Clinic-to-clinic telemedicine can increase visit frequency in pediatric patients with type 1 diabetes (T1D) living far from a diabetes specialty clinic, but the impact on adoption of diabetes technology is unclear. Materials and Methods: Pediatric patients with T1D in Colorado and surrounding states who received diabetes care using clinic-to-clinic telemedicine were enrolled. Medical records and surveys were reviewed to ascertain technology use, and data were compared to patients from the main clinic population. Results: Patients (N = 128, baseline mean age 12.4 ± 4.2 years, median T1D duration 3.3 years [IQR 1.4-7.7], mean A1c 8.9% ± 1.8%, 60% male, 75% non-Hispanic white, 77% private insurance) who utilized telemedicine were included. Technology use among telemedicine patients was not associated with gender, T1D duration, insurance, distance from the main clinic or rural designation but was associated with ethnicity and A1c. Compared to the main clinic cohort (N = 3636), continuous glucose monitor (CGM) use and pump/CGM combination use was lower among patients participating in clinic-to-clinic telemedicine (CGM: 29.7% vs. 56.0%, P < 0.001; CGM/pump combination: 27.3% vs. 40.3%, P = 0.004). Technology use was associated with lower A1c regardless of cohort. Conclusions: Compared to patients attending in-person clinic, pediatric T1D patients who use clinic-to-clinic telemedicine due to their distance from the main clinic, have lower CGM and combination CGM/pump use. For both telemedicine and main clinic patients, CGM and CGM/pump combination was associated with lower A1c. Additional research is needed to explore reasons for this discrepancy and find methods to improve CGM use in this population.

Predictors of Time-in-Range (70-180 mg/dL) Achieved Using a Closed-Loop Control System.

Background: Studies of closed-loop control (CLC) in patients with type 1 diabetes (T1D) consistently demonstrate improvements in glycemic control as measured by increased time-in-range (TIR) 70-180 mg/dL. However, clinical predictors of TIR in users of CLC systems are needed. Materials and Methods: We analyzed data from 100 children aged 6-13 years with T1D using the Tandem Control-IQ CLC system during a randomized trial or subsequent extension phase. Continuous glucose monitor data were collected at baseline and during 12-16 weeks of CLC use. Participants were stratified into quartiles of TIR on CLC to compare clinical characteristics. Results: TIR for those in the first, second, third, and fourth quartiles was 54%, 65%, 71%, and 78%, respectively. Lower baseline TIR was associated with lower TIR on CLC (r = 0.69, P < 0.001). However, lower baseline TIR was also associated with greater improvement in TIR on CLC (r = -0.81, P < 0.001). During CLC, participants in the highest versus lowest TIR-quartile administered more user-initiated boluses daily (8.5 ± 2.8 vs. 5.8 ± 2.6, P < 0.001) and received fewer automated boluses (3.5 ± 1.0 vs. 6.0 ± 1.6, P < 0.001). Participants in the lowest (vs. the highest) TIR-quartile received more insulin per body weight (1.13 ± 0.27 vs. 0.87 ± 0.20 U/kg/d, P = 0.008). However, in a multivariate model adjusting for baseline TIR, user-initiated boluses and insulin-per-body-weight were no longer significant. Conclusions: Higher baseline TIR is the strongest predictor of TIR on CLC in children with T1D. However, lower baseline TIR is associated with the greatest improvement in TIR. As with open-loop systems, user engagement is important for optimal glycemic control.

Health-Related Quality of Life and Treatment Satisfaction in Parents and Children with Type 1 Diabetes Using Closed-Loop Control.

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.

First Outpatient Evaluation of a Tubeless Automated Insulin Delivery System with Customizable Glucose Targets in Children and Adults with Type 1 Diabetes.

Background: The objective of this study was to assess the safety and effectiveness of the first commercial configuration of a tubeless automated insulin delivery system, Omnipod® 5, in children (6-13.9 years) and adults (14-70 years) with type 1 diabetes (T1D) in an outpatient setting. Materials and Methods: This was a single-arm, multicenter, prospective clinical study. Data were collected over a 14-day standard therapy (ST) phase followed by a 14-day hybrid closed-loop (HCL) phase, where participants (n = 36) spent 72 h at each of three prespecified glucose targets (130, 140, and 150 mg/dL, 9 days total) then 5 days with free choice of glucose targets (110-150 mg/dL) using the Omnipod 5. Remote safety monitoring alerts were enabled during the HCL phase. Primary endpoints were difference in time in range (TIR) (70-180 mg/dL) between ST and HCL phases and proportion of participants reporting serious device-related adverse events. Results: Mean TIR was significantly higher among children in the free-choice period overall (64.9% ± 12.2%, P < 0.01) and when using a 110 mg/dL target (71.2% ± 10.2%, P < 0.01), a 130 mg/dL target (61.5% ± 7.7%, P < 0.01), and a 140 mg/dL target (64.8% ± 11.6%, P < 0.01), and among adults using a 130 mg/dL target (75.1% ± 11.6%, P < 0.05), compared to the ST phase (children: 51.0% ± 13.3% and adults: 65.6% ± 15.7%). There were no serious device-related adverse events reported during the HCL phase, nor were there episodes of severe hypoglycemia or diabetic ketoacidosis. Conclusion: The Omnipod 5 System was safe and effective when used at glucose targets from 110 to 150 mg/dL for 14 days at home in children and adults with T1D.

Review of the Omnipod® 5 Automated Glucose Control System Powered by Horizon™ for the treatment of Type 1 diabetes.

Type 1 diabetes (T1D) is a medical condition that requires constant management, including monitoring of blood glucose levels and administration of insulin. Advancements in diabetes technology have offered methods to reduce the burden on people with T1D. Several hybrid closed-loop systems are commercially available or in clinical trials, each with unique features to improve care for patients with T1D. This article reviews the Omnipod® 5 Automated Glucose Control System Powered by Horizon™ and the safety and efficacy data to support its use in the management of T1D.

Impact of the Hybrid Closed-Loop System on Sleep and Quality of Life in Youth with Type 1 Diabetes and Their Parents.

Background: Insufficient sleep is common in youth with type 1 diabetes (T1D) and parents, likely secondary to diabetes-related disturbances, including fear of hypoglycemia, nocturnal glucose monitoring, hypoglycemia, and device alarms. Hybrid closed-loop (HCL) systems improve glycemic variability and potentially reduce nocturnal awakenings. Methods: Adolescents with T1D (N = 37, mean age 13.9 years, 62% female, mean HbA1c 8.3%) and their parents were enrolled in this observational study when starting the Medtronic 670G HCL system. Participants completed study measures (sleep and psychosocial surveys and actigraphy with sleep diaries) before starting auto mode and ∼3 months later. Results: Based on actigraphy data, neither adolescents' nor parents' sleep characteristics changed significantly pre-post device initiation. Adolescents' mean total sleep time decreased from 7 h 16 min (IQR: [6:43-7:47]) to 7 h 9 min (IQR: [6:44-7:52]), while parents' total sleep time decreased from 6 h 47 min (IQR: [6:16-7:10]) to 6 h 38 min (IQR: [5:57-6:57]). Although there were no significant differences in most of the survey measures, there was a moderate effect for improved sleep quality in parents and fear of hypoglycemia in adolescents. In addition, adolescents reported a significant increase in self-reported glucose monitoring satisfaction. Adolescents averaged 44.7% use of auto mode at 3 months. Conclusions: Our data support previous research showing youth with T1D and their parents are not achieving the recommended duration of sleep. Lack of improvement in sleep may be due to steep learning curves involved with new technology. We observed moderate improvements in parental subjective report of sleep quality despite no change in objective measures of sleep duration. Further evaluation of sleep with long-term HCL use and larger sample size is needed.

Stress, Depression, and Quality of Life Among Caregivers of Children With Osteogenesis Imperfecta.

INTRODUCTION: The purpose of this study was to evaluate stress, depressive symptoms, and quality of life (QOL) among caregivers of children with osteogenesis imperfecta (OI) and to determine if associations exist with patient disease-related characteristics. METHODS: Psychosocial outcomes were evaluated in 33 caregivers of 31 patients with OI using the Pediatric Inventory for Parents (assessing stress), PedsQL Family Impact Module (assessing QOL), and Center for Epidemiologic Studies Depression Scale (assessing depressive symptoms). RESULTS: Higher levels of patient pain and lower patient physical functioning were significantly associated with both higher caregiver stress and poorer QOL (p < .05). Center for Epidemiologic Studies Depression Scale scores were not associated with patient pain or physical functioning. DISCUSSION: Parents caring for children with OI with higher levels of pain and/or lower physical functioning are at higher risk of suffering from increased stress and poorer QOL. Interventions should be developed to screen for and target these at-risk caregiver groups with resources and support.

Missed insulin boluses for snacks in youth with type 1 diabetes.

OBJECTIVE To evaluate the effects of missed insulin boluses for snacks in youth with type 1 diabetes. RESEARCH DESIGN AND METHODS Three months of simultaneous continuous subcutaneous insulin infusion and continuous glucose monitoring data from nine subjects were retrospectively evaluated. Glucose excursions between 1330 and 1700 h were defined as relating to snacks with insulin or snacks with no insulin administered. Area under the curve >180 mg/dl (AUC >180), average Delta glucose, and rate of change were analyzed and compared within and between groups. RESULTS A total of 94 snacks without insulin and 101 snacks with insulin were analyzed. Snacks without insulin had significantly higher log (AUC >180 + 1) (1.26 vs. 0.44 mg/dl per event; P < 0.001), Delta glucose (114 vs. 52 mg/dl; P < 0.001), and average rate of change (1.3 vs. 1.1 mg/dl per minute; P < 0.001). CONCLUSIONS This study shows that afternoon snacks without insulin boluses are common and result in significantly higher glucose excursions than snacks with insulin administration.

A pilot trial of pramlintide home usage in adolescents with type 1 diabetes.

OBJECTIVE: The objective of this study was to evaluate the safety and efficacy of home pramlintide use in adolescents with type 1 diabetes. PATIENTS AND METHODS: This was a randomized, 28-day pilot trial of pramlintide (maximum dose: 30 microg per meal) in 10 adolescents aged 13 to 17 years. End points included changes in hemoglobin A1c (HbA1c) values, body weight, and postprandial peak blood glucose levels and area under the curve on continuous glucose monitoring. RESULTS: Changes in HbA1c values, body weight, and total insulin dose declined in the treatment group compared with the control group (bootstrapped, P