المؤلفون: Ekhlaspour, Laya, Nally, Laura M., El-Khatib, Firas H., Ly, Trang T., Clinton, Paula, Frank, Eliana, Tanenbaum, Molly L., Hanes, Sarah J., Selagamsetty, Rajendranath R., Hood, Korey, Damiano, Edward R., Buckingham, Bruce A.

المساهمون: leona m. and harry b. helmsley charitable trust

المصدر: Journal of Diabetes Science and Technology ; volume 13, issue 6, page 1001-1007 ; ISSN 1932-2968 1932-2968

مصطلحات موضوعية: Biomedical Engineering, Bioengineering, Endocrinology, Diabetes and Metabolism, Internal Medicine

الوصف: Background: We tested the safety and performance of the “insulin-only” configuration of the bionic pancreas (BP) closed-loop blood-glucose control system in a home-use setting to assess glycemic outcomes using different static and dynamic glucose set-points. Method: This is an open-label non-randomized study with three consecutive intervention periods. Participants had consecutive weeks of usual care followed by the insulin-only BP with (1) an individualized static set-point of 115 or 130 mg/dL and (2) a dynamic set-point that automatically varied within 110 to 130 mg/dL, depending on hypoglycemic risk. Human factors (HF) testing was conducted using validated surveys. The last five days of each study arm were used for data analysis. Results: Thirteen participants were enrolled with a mean age of 28 years, mean A1c of 7.2%, and mean daily insulin dose of 0.6 U/kg (0.4-1.0 U/kg). The usual care arm had an average glucose of 145 ± 20 mg/dL, which increased in the static set-point arm (159 ± 8 mg/dL, P = .004) but not in the dynamic set-point arm (154 ± 10 mg/dL, P = ns). There was no significant difference in time spent in range (70-180 mg/dL) among the three study arms. There was less time <70 mg/dL with both the static (1.8% ± 1.4%, P = .009) and dynamic set-point (2.7±1.5, P = .051) arms compared to the usual-care arm (5.5% ± 4.2%). HF testing demonstrated preliminary user satisfaction and no increased risk of diabetes burden or distress. Conclusions: The insulin-only configuration of the BP using either static or dynamic set-points and initialized only with body weight performed similarly to other published insulin-only systems.

الإتاحة: https://doi.org/10.1177/1932296819872225Test

المؤلفون: Layne, Jennifer E., Huyett, Lauren M., Ly, Trang T.

المساهمون: insulet corporation

المصدر: Journal of Diabetes Science and Technology ; volume 13, issue 6, page 1180-1181 ; ISSN 1932-2968 1932-2968

مصطلحات موضوعية: Biomedical Engineering, Bioengineering, Endocrinology, Diabetes and Metabolism, Internal Medicine

الإتاحة: https://doi.org/10.1177/1932296819868698Test

المؤلفون: de Bock, Martin, Cooper, Matthew, Retterath, Adam, Nicholas, Jennifer, Ly, Trang, Jones, Timothy, Davis, Elizabeth

المصدر: Journal of Diabetes Science and Technology ; volume 10, issue 3, page 627-632 ; ISSN 1932-2968 1932-2968

مصطلحات موضوعية: Biomedical Engineering, Bioengineering, Endocrinology, Diabetes and Metabolism, Internal Medicine

الوصف: Aims: This study reports continuous glucose monitoring (CGM) adherence patterns and contributing factors in patients who were part of a 6-month clinical trial using sensor augmented pump therapy with low glucose insulin suspension. Methods: CGM data from 38 patients using sensor augmented pump therapy for 6 months were analyzed. CGM adherence was defined by having a working sensor available and determined by the time it was switched on as a proportion of available time for the 6 month study period with allowance for practical CGM use. Age, gender, HbA1c, duration of diagnosis, capillary blood glucose testing frequency, sensor accuracy, and insulin pump alarm frequency were characterized and examined for an association with CGM adherence. Results: Overall CGM adherence was 75% (range: 35% to 96%), CGM adherence was demonstrated to fall after 9 to 11 weeks before reaching a steady rate. CGM adherence patterns showed substantial variation. Mean adherence differed ( P < .01) between age groups 72% (<12 years), 69% (12-18 years), and 88% (≥18 years). Sensor accuracy predicted adherence, where every 1% decline in mean absolute difference in a given week was associated with a 0.5% decline in sensor adherence ( P < .01). Gender, HbA1c, duration of diagnosis, capillary blood glucose testing frequency, and insulin pump alarm frequency were not associated with CGM adherence. Conclusions: CGM adherence and patterns of use are individualized. However, a predictable fall in adherence at 9 to 11 weeks may present an opportunity for timed interventions to increase CGM use. Adolescent age and sensor accuracy predict CGM adherence.

الإتاحة: https://doi.org/10.1177/1932296816633484Test

المؤلفون: Ma, Xiaosu, Waterhouse, Timothy, Ilag, Liza L., Ly, Trang, Juneja, Rattan, Garhyan, Parag, Hardy, Thomas, Hood, Robert C.

المساهمون: eli lilly and company

المصدر: Journal of Diabetes Science and Technology ; volume 15, issue 5, page 1195-1197 ; ISSN 1932-2968 1932-2968

مصطلحات موضوعية: Biomedical Engineering, Bioengineering, Endocrinology, Diabetes and Metabolism, Internal Medicine

الإتاحة: https://doi.org/10.1177/19322968211026626Test

المؤلفون: Stenerson, Matthew, Cameron, Fraser, Payne, Shelby R., Payne, Sydney L., Ly, Trang T., Wilson, Darrell M., Buckingham, Bruce A.

المصدر: Journal of Diabetes Science and Technology ; volume 9, issue 1, page 80-85 ; ISSN 1932-2968 1932-2968

مصطلحات موضوعية: Biomedical Engineering, Bioengineering, Endocrinology, Diabetes and Metabolism, Internal Medicine

الوصف: Background: Exercise-associated hypoglycemia is a common adverse event in people with type 1 diabetes. Previous in silico testing by our group demonstrated superior exercise-associated hypoglycemia mitigation when a predictive low glucose suspend (PLGS) algorithm was augmented to incorporate activity data. The current study investigates the effectiveness of an accelerometer-augmented PLGS algorithm in an outpatient exercise protocol. Methods: Subjects with type 1 diabetes on insulin pump therapy participated in two structured soccer sessions, one utilizing the algorithm and the other using the subject’s regular basal insulin rate. Each subject wore their own insulin pump and a Dexcom G4™ Platinum continuous glucose monitor (CGM); subjects on-algorithm also wore a Zephyr BioHarness™ 3 accelerometer. The algorithm utilized a Kalman filter with a 30-minute prediction horizon. Activity and CGM readings were manually entered into a spreadsheet and at five-minute intervals, the algorithm indicated whether the basal insulin infusion should be on or suspended; any changes were then implemented by study staff. The rate of hypoglycemia during and after exercise (until the following morning) was compared between groups. Results: Eighteen subjects (mean age 13.4 ± 3.7 years) participated in two separate sessions 7-22 days apart. The difference in meter blood glucose levels between groups at each rest period did not achieve statistical significance at any time point. Hypoglycemia during the session was recorded in three on-algorithm subjects, compared to six off-algorithm subjects. In the postexercise monitoring period, hypoglycemia occurred in two subjects who were on-algorithm during the session and four subjects who were off-algorithm. Conclusions: The accelerometer-augmented algorithm failed to prevent exercise-associated hypoglycemia compared to subjects on their usual basal rates. A larger sample size may have achieved statistical significance. Further research involving an automated system, a larger sample size, and ...

الإتاحة: https://doi.org/10.1177/1932296814551045Test

المؤلفون: DeSalvo, Daniel J., Shanmugham, Satya, Ly, Trang T., Wilson, Darrell M., Buckingham, Bruce A.

المصدر: Journal of Diabetes Science and Technology ; volume 8, issue 5, page 969-973 ; ISSN 1932-2968 1932-2968

مصطلحات موضوعية: Biomedical Engineering, Bioengineering, Endocrinology, Diabetes and Metabolism, Internal Medicine

الوصف: Objective: This pilot study evaluated the difference in accuracy between the Bayer Contour® Next (CN) and HemoCue® (HC) glucose monitoring systems in children with type 1 diabetes participating in overnight closed-loop studies. Research Design and Methods: Subjects aged 10-18 years old were admitted to a clinical research center and glucose values were obtained every 30 minutes overnight. Glucose values were measured using whole blood samples for CN and HC readings and results were compared to Yellow Springs Instrument (YSI) reference values obtained with plasma from the same sample. System accuracy was compared using mean absolute relative difference (MARD) and International Organization for Standardization (ISO) accuracy standards. Results: A total of 28 subjects were enrolled in the study. Glucose measurements were evaluated at 457 time points. CN performed better than HC with an average MARD of 3.13% compared to 10.73% for HC ( P < .001). With a limited sample size, CN met ISO criteria (2003 and 2013) at all glucose ranges while HC did not. Conclusions: CN performed very well, and would make an excellent meter for future closed-loop studies outside of a research center.

الإتاحة: https://doi.org/10.1177/1932296814532238Test