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.pediatrics, artificial pancreas, automated insulin delivery, continuous glucose monitor The use of diabetes technology is a promising treatment strategy to improve diabetes outcomes in youth. Use of insulin pumps and continuous glucose monitors (CGM) are associated with reduction in HbA1c, both when used separately and together. 7 The most advanced technology currently available for diabetes care is a hybrid closed loop (HCL) insulin delivery system. HCL technology automates basal insulin delivery in response to CGM glucose trends while users deliver bolus doses for carbohydrate consumption. The MiniMed 670G is the first HCL device to be commercially available, which consists of the 670G insulin pump and the Guardian 3 CGM.The 670G operates in two modes, both as a standard insulin pump ("Manual Mode"), and as HCL ("Auto Mode"). 8 When using the 670G system in Auto Mode, the basal insulin delivery is calculated every 5 min by the pump's HCL algorithm, based on sensor glucose data. 9 To maintain Auto Mode use, the user must wear the CGM consistently, calibrate the CGM sensor at least twice per day, and respond to alerts in a timely manner. The system exits users from Auto Mode to Manual Mode if: (a) there is prolonged hyperglycemia (ie, sensor glucose >250 mg/dL for 3 h or >300 mg/dL for 1 h); (b) the pump has delivered a minimum or maximum insulin rate for 1-3 h; or (c) sensor glucose data are missing or inaccurate...
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. K E Y W O R D Sartificial pancreas, continuous glucose monitor, insulin pump, hybrid closed loop, pediatrics, type 1 diabetes Type 1 diabetes (T1D), typically diagnosed in childhood 1,2 requires lifelong replacement of exogenous insulin, and monitoring of glucose levels to minimize hypoglycemia and hyperglycemia. 3 Long-term consequences of suboptimal glycemic control include both microvascular and macrovascular complications that increase morbidity and mortality for individuals with T1D. 3 Sub-optimal glycemic control also increases risk of emergent complications such as hypoglycemic seizures and loss of consciousness, and diabetic ketoacidosis or diabetic coma. 4,5 The T1D Exchange Registry recently showed that in the United States only 21% of adults and 17% of youth with T1D meet hemoglobin A1c (HbA1c) goals set forth by the American Diabetes Association, signifying the need for improvements in treatment and care of T1D. 6
Continuous glucose monitoring (CGM) is an essential part of diabetes care. Real-time CGM data are beneficial to patients for daily glucose management, and aggregate summary statistics of CGM measures are valuable to direct insulin dosing and as a tool for researchers in clinical trials. Yet, the various commercial systems still report CGM data in disparate, non-standard ways. Accordingly, there is a need for a standardized, free, open-source approach to CGM data management and analysis. A package titled cgmanalysis was developed in the free programming language R to provide a rapid, easy, and consistent methodology for CGM data management, summary measure calculation, and descriptive analysis. Variables calculated by our package compare well to those generated by various CGM software, and our functions provide a more comprehensive list of summary measures available to clinicians and researchers. Consistent handling of CGM data using our R package may facilitate collaboration between research groups and contribute to a better understanding of free-living glucose patterns.
CFNG youth have higher glucoses and glucose variability than HC on CGM. Higher and more variable glucoses correlate with lung function decline. Whether earlier treatment of CGM abnormalities improves lung function in CF requires further study.
HbA does not underestimate ASG in CF as previously assumed. No alternate glycemic marker correlated more strongly with ASG than HbA. %GA shows strong correlation with ASG and added to the prediction of ASG beyond HbA. However, we are not advocating use of HbA for diabetes screening in CF based on these results. Further study will determine whether glycemic measures other than ASG differ among different types of diabetes for a given HbA.
Glycemic abnormalities persisted in CF patients treated with lumacaftor-ivacaftor, although sex-dependent differences in glycemic response to treatment may exist.
Objective: To describe real-world outcomes for youth using the Tandem t:slim X2 insulin pump with Control-IQ technology (''Control-IQ'') for 6 months at a large pediatric clinic. Methods: Youth with type 1 diabetes, who started Control-IQ for routine care, were prospectively followed. Data on system use and glycemic control were collected before Control-IQ start, and at 1, 3, and 6 months after start. Mixed models assessed change across time; interactions with baseline hemoglobin A1c (HbA1c) and age were tested. Results: In 191 youth (median age 14, 47% female, and median HbA1c 7.6%), percent time with glucose levels 70-180 mg/dL (time-in-range [TIR]) improved from 57% at baseline to 66% at 6 months (P < 0.001). The proportion of participants reaching TIR target (>70%) doubled from 23.5% at baseline to 47.8% at 3 months, sustaining at 46.7% at 6 months (P < 0.001). Glucose management indicator (approximation of HbA1c) improved from 7.5% at baseline to 7.1% at 3 months and 7.2% at 6 months (P < 0.001). Those with higher baseline HbA1c experienced the most substantial improvements in glycemic control. Percent time using the Control-IQ feature was 86.4% at 6 months, and <4% of cohort discontinued use. Conclusion:The Control-IQ system clinically and significantly improved glycemic control in a large sample of youth. System use was high at 6 months, with only a small proportion discontinuing use, indicating potential for sustaining results long term.
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.
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