يعرض 1 - 10 نتائج من 14 نتيجة بحث عن '"(1"', وقت الاستعلام: 1.09s تنقيح النتائج
  1. 1
    دورية أكاديمية

    الوصف: Objective: We aimed to assess whether percentage of time spent in hypoglycemia during closed-loop insulin delivery differs by age group and time of day. Methods: We retrospectively analyzed data from hybrid closed-loop studies involving young children (2-7 years), children and adolescents (8-18 years), adults (19-59 years), and older adults (≥60 years) with type 1 diabetes. Main outcome was time spent in hypoglycemia <3.9 mmol/L (<70 mg/dL). Eight weeks of data for 88 participants were analyzed. Results: Median time spent in hypoglycemia over the 24-h period was highest in children and adolescents (4.4% [interquartile range 2.4-5.0]) and very young children (4.0% [3.4-5.2]), followed by adults (2.7% [1.7-4.0]), and older adults (1.8% [1.2-2.2]); P < 0.001 for difference between age groups. Time spent in hypoglycemia during nighttime (midnight-05:59) was lower than during daytime (06:00-23:59) across all age groups. Conclusion: Time in hypoglycemia was highest in the pediatric age group during closed-loop insulin delivery. Hypoglycemia burden was lowest overnight across all age groups.

    وصف الملف: application/msword

  2. 2

    المصدر: Diabetes Technology & Therapeutics

    الوصف: Background: The objective of this study was to assess the safety and performance of the Omnipod® personalized model predictive control (MPC) algorithm in adults, adolescents, and children aged ≥6 years with type 1 diabetes (T1D) under free-living conditions using an investigational device. Materials and Methods: A 96-h hybrid closed-loop (HCL) study was conducted in a supervised hotel/rental home setting following a 7-day outpatient standard therapy (ST) phase. Eligible participants were aged 6–65 years with A1C

  3. 3

    المصدر: Diabetes Technology & Therapeutics

    الوصف: Background: The safety and feasibility of the OmniPod personalized model predictive control (MPC) algorithm in adult, adolescent, and pediatric patients with type 1 diabetes were investigated. Methods: This multicenter, observational trial included a 1-week outpatient sensor-augmented pump open-loop phase and a 36-h inpatient hybrid closed-loop (HCL) phase with announced meals ranging from 30 to 90 g of carbohydrates and limited physical activity. Patients aged 6–65 years with HbA1c between 6.0% and 10.0% were eligible. The investigational system included a modified version of OmniPod, the Dexcom G4 505 Share® AP System, and the personalized MPC algorithm running on a tablet computer. Primary endpoints included sensor glucose percentage of time in hypoglycemia 250 mg/dL. Additional glycemic targets were assessed. Results: The percentage of time 250 mg/dL was 8.0 (7.5), 3.6 (3.7), 4.9 (6.3), and 6.7 (5.6) in the study groups, respectively. Percentage of time in the target range of 70–180 mg/dL was 69.5 (14.4), 73.0 (15.0), 72.6 (15.5), and 70.1 (12.3), respectively. Conclusions: The OmniPod personalized MPC algorithm performed well and was safe during day and night use in adult, adolescent, and pediatric patients with type 1 diabetes. Longer term studies will assess the safety and performance of the algorithm under free living conditions with extended use.

  4. 4

    المصدر: Diabetes Technology & Therapeutics. 20:235-246

    الوصف: Background: Automatically attenuating the postprandial rise in the blood glucose concentration without manual meal announcement is a significant challenge for artificial pancreas (AP) systems. In this study, a meal module is proposed to detect the consumption of a meal and to estimate the amount of carbohydrate (CHO) intake. Methods: The meals are detected based on qualitative variables describing variation of continuous glucose monitoring (CGM) readings. The CHO content of the meals/snacks is estimated by a fuzzy system using CGM and subcutaneous insulin delivery data. The meal bolus amount is computed according to the patient's insulin to CHO ratio. Integration of the meal module into a multivariable AP system allows revision of estimated CHO based on knowledge about physical activity, sleep, and the risk of hypoglycemia before the final decision for a meal bolus is made. Results: The algorithm is evaluated by using 117 meals/snacks in retrospective data from 11 subjects with type 1 diabetes. Sensitivity, defined as the percentage of correctly detected meals and snacks, is 93.5% for meals and 68.0% for snacks. The percentage of false positives, defined as the proportion of false detections relative to the total number of detected meals and snacks, is 20.8%. Conclusions: Integration of a meal detection module in an AP system is a further step toward an automated AP without manual entries. Detection of a consumed meal/snack and infusion of insulin boluses using an estimate of CHO enables the AP system to automatically prevent postprandial hyperglycemia.

  5. 5
    دورية أكاديمية

    الوصف: OBJECTIVE: To explore individuals' experiences of daytime use of a day-and-night hybrid closed-loop system, their information and support needs, and their views about how future systems could be improved. RESEARCH DESIGN AND METHODS: Twenty-four adults, adolescents, and parents were interviewed before using a hybrid day-and-night closed-loop system and 3 months later, data were analyzed thematically. RESULTS: Participants praised the closed loop's ability to respond to high and low blood glucose in ways which extended beyond their own capabilities and to act as a safety net and mop up errors, such as when a mealtime bolus was forgotten or unplanned activity was undertaken. Participants also described feeling less burdened by diabetes as a consequence and more able to lead flexible, spontaneous lives. Contrary to their initial expectations, and after trust in the system had been established, most individuals wanted opportunities to collaborate with the closed loop to optimize its effectiveness. Such individuals expressed a need to communicate information, such as when routines changed or to indicate different intensities of physical activity. While individuals valued frequent contact with staff in the initial month of use, most felt that their long-term support needs would be no greater than when using an insulin pump. CONCLUSIONS: While participants reported substantial benefits to using the closed loop during the day, they also identified ways in which the technology could be refined and education and training tailored to optimize effective use. Our findings suggest that mainstreaming this technology will not necessarily lead to increased demands on clinical staff.

    وصف الملف: Print-Electronic; application/vnd.openxmlformats-officedocument.wordprocessingml.document

  6. 6

    المصدر: Diabetes Technology & Therapeutics. 19:288-292

    الوصف: Predictions based on continuous glucose monitoring (CGM) data are the basis for automatic suspension and resumption of insulin delivery by a predictive low-glucose management feature termed "suspend before low," which is part of the Medtronic MiniMedIn-clinic standardized increases in basal insulin delivery rates were used to induce nocturnal hypoglycemia in subjects (14-75 years) with type 1 diabetes wearing the MiniMed 640G system. The "suspend before low" feature was set at 65 mg/dL, and as a result, the predictive algorithm suspended insulin delivery when the forecasted glucose was predicted to be ≤85 mg/dL in 30 min (a 20 mg/dL safety buffer). Reference plasma glucose values (Yellow Springs Instruments [YSI], Yellow Springs, OH) were used to establish hypoglycemia and were defined as ≥2 consecutive values ≤65 mg/dL.Eighty subjects were screened. Among the 69 successful completers, 27 experienced a hypoglycemic event and 42 did not, a prevention rate of 60%. The mean (±standard deviation) YSI value at the time of pump suspension was 101 ± 18.5 mg/dL, and the mean duration of the 68 "suspend before low" events was 105 ± 27 min. At 120 min after the start of the pump suspension events, the mean YSI value was 102 ± 34.6 mg/dL.The MiniMed 640G "suspend before low" feature prevented 60% of induced predicted hypoglycemic events without significant rebound hyperglycemia.

  7. 7

    المصدر: Diabetes Technology & Therapeutics. 19:41-48

    الوصف: A learning-type artificial pancreas has been proposed to exploit the repetitive nature in the blood glucose dynamics. We clinically evaluated the efficacy of the learning-type artificial pancreas.We conducted a pilot clinical study in 10 participants of mean age 36.1 years (standard deviation [SD] 12.7; range 16-58) with type 1 diabetes. Each trial was conducted for eight consecutive mornings. The first two mornings were open-loop to obtain the individualized parameters. Then, the following six mornings were closed-loop, during which a learning-type model predictive control algorithm was employed to calculate the insulin infusion rate. To evaluate the algorithm's robustness, each participant took exercise or consumed alcohol on the fourth or sixth closed-loop day and the order was determined randomly. The primary outcome was the percentage of time spent in the target glucose range of 3.9-8.0 mmol/L between 0900 and 1200 h.The percentage of time with glucose spent in target range was significantly improved from 51.6% on day 1 to 71.6% on day 3 (mean difference between groups 17.9%, confidence interval [95% CI] 3.6-32.1; P = 0.020). There were no hypoglycemic episodes developed on day 3 compared with two episodes on day 1. There was no difference in the percentage of time with glucose spent in target range between exercise day versus day 5 and alcohol day versus day 5.The learning-type artificial pancreas system achieved good glycemic regulation and provided increased effectiveness over time. It showed a satisfactory performance even when the blood glucose was challenged by exercise or alcohol.

  8. 8

    المصدر: Diabetes Technology & Therapeutics. 18:772-783

    الوصف: We compared glycemia, treatment satisfaction, sleep quality, and cognition using a nighttime Android-based hybrid closed-loop system (Android-HCLS) with sensor-augmented pump with low-glucose suspend function (SAP-LGS) in people with type 1 diabetes.An open-label, prospective, randomized crossover study of 16 adults (mean [SD] age 42.1 [9.6] years) and 12 adolescents (15.2 [1.6] years) was conducted. All participants completed four consecutive nights at home with Android-HCLS (proportional integral derivative with insulin feedback algorithm; Medtronic) and SAP-LGS.percent continuous glucose monitoring (CGM) time (00:00-08:00 h) within target range (72-144 mg/dL). Secondary endpoints: percent CGM time above target (144 mg/dL); below target (72 mg/dL); glycemic variability (SD); symptomatic hypoglycemia; adult treatment satisfaction; sleep quality; and cognitive function.The primary outcome for all participants was not statistically different between Android-HCLS and SAP-LGS (mean [SD] 59.4 [17.9]% vs. 53.1 [18]%; p = 0.14). Adults had greater percent time within target range (57.7 [18.6]% vs. 44.5 [14.5]%; p 0.006); less time above target (42.0 [18.7]% vs. 52.6 [16.5]%; p = 0.034); lower glycemic variability (35 [10.7] mg/dL vs. 46 [10.7] mg/dL; p = 0.003); and less (median [IQR]) time below target (0.0 [0.0-0.4]% vs. 0.80 [0.0-3.9]%; p = 0.025). In adolescents, time below target was lower with Android-HCLS vs. SAP-LGS (0.0 [0.0-0.0]% vs. 1.8 [0.1-7.9]%; p = 0.011). Nocturnal symptomatic hypoglycemia was less (1 vs. 10; p = 0.007) in adolescents, but not adults (5 vs. 13; p = 0.059). In adults, treatment satisfaction increased by 10 points (p 0.02). Sleep quality and cognition did not differ.Android-HCLS in both adults and adolescents reduced nocturnal hypoglycemia and, in adults, improved overnight time in target range and treatment satisfaction compared with SAP-LGS.

  9. 9

    المصدر: Diabetes Technology & Therapeutics. 17:311-315

    الوصف: The primary focus of artificial pancreas (AP) research has been on technical achievements, such as time in range for glucose levels or prevention of hypoglycemia. Few studies have attempted to ascertain the expectations of users of AP technology.Persons with type 1 diabetes and parents of children with type 1 diabetes were invited to take part in an online survey concerning future use and expectations of AP technology. The survey was advertised via Twitter, Facebook, and DiabetesMine, plus advocacy groups and charities including INPUT, Diabetes UK, and the Diabetes Research and Wellness Foundation. Quantitative responses were categorized on a 5-point Likert scale. Free text responses were analyzed using content analysis.Two hundred sixty-six surveys were completed over a 1-month period. Two hundred forty participants indicated they were highly likely to use a fully automated 24-h AP. Approximately half of the respondents indicated they would be likely to use a device that only functioned overnight. Size, visibility, and lack of effectiveness were the top reasons for not wanting an AP. Despite perceived potential downsides, participants expressed a strong need for a device that will help minimize the burden of disease, help facilitate improved psychosocial functioning, and improve quality of life.The views of people who would use an AP are crucial in the development of such devices to ensure they are fit for use alongside biomedical and engineering excellence. Without this, it is unlikely that an AP will be sufficiently successful to meet the needs of users and to achieve their ultimate goals.

  10. 10

    المصدر: Diabetes Technology & Therapeutics. 17:1-7

    الوصف: Closed-loop control clinical research trials have been considerably accelerated by in silico trials using the Food and Drug Administration-accepted type 1 diabetes mellitus (T1DM) simulator. We have recently demonstrated that postprandial insulin sensitivity (SI) in T1DM subjects was lower at breakfast (B) than lunch (L) and dinner (D), but not significantly, because of the small population size. The goal of this study was therefore to incorporate this novel information into the University of Virginia/Padova T1DM simulator and to reproduce in silico the observed circadian variability.Twenty T1DM subjects received an identical mixed meal at B, L, and D. SI was calculated for each meal using the oral glucose minimal model. Seven SI daily patterns were identified, and their probabilities were estimated. Each in silico subject was linked to a time-varying SI profile, while random deviations of up to 40% were allowed.Simulations were compared with experimental data. The integrated area above the basal glucose curve values were 2.60 ± 0.91 (B), 1.38 ± 0.91 (L), and 1.44 ± 1.07 (D) 10(4) min · mg/dL in silico versus 2.87 ± 1.65 (B), 1.98 ± 1.56 (L), and 2.16 ± 2.00 (D) 10(4) min · mg/dL in vivo. Incremental peak glucose values were 109 ± 33 (B), 80 ± 29 (L), and 81 ± 30 (D) mg/dL in silico versus 136 ± 39 (B), 126 ± 37 (L), and 125 ± 48 (D) mg/dL in vivo.The incorporation of a time-varying SI into the simulator makes this technology suitable for running multiple-meal scenarios, thus enabling a more robust design of artificial pancreas algorithms.