المؤلفون: Kanapka, Lauren G., Wadwa, R. Paul, Breton, Marc D., Ruedy, Katrina J., Ekhlaspour, Laya, Forlenza, Gregory P., Cengiz, Eda, Schoelwer, Melissa J., Jost, Emily, Carria, Lori, Emory, Emma, Hsu, Liana J., Weinzimer, Stuart A., DeBoer, Mark D., Buckingham, Bruce A., Oliveri, Mary, Kollman, Craig, Dokken, Betsy B., Cherñavvsky, Daniel, Beck, Roy W.

المصدر: Diabetes Care; Feb2021, Vol. 44 Issue 2, p473-478, 6p

مصطلحات موضوعية: TYPE 1 diabetes, CLOSED loop systems, GLYCEMIC control, DIABETIC acidosis, CLINICAL trials, INSULIN therapy, RESEARCH, RESEARCH methodology, HYPOGLYCEMIC agents, BLOOD sugar, MEDICAL cooperation, EVALUATION research, COMPARATIVE studies, RANDOMIZED controlled trials, HYPOGLYCEMIA, INSULIN pumps, RESEARCH funding

مستخلص: Objective: To further evaluate the safety and efficacy of the Control-IQ closed-loop control (CLC) system in children with type 1 diabetes.Research Design and Methods: After a 16-week randomized clinical trial (RCT) comparing CLC with sensor-augmented pump (SAP) therapy in 101 children 6-13 years old with type 1 diabetes, 22 participants in the SAP group initiated use of the CLC system (referred to as SAP-CLC cohort), and 78 participants in the CLC group continued use of CLC (CLC-CLC cohort) for 12 weeks.Results: In the SAP-CLC cohort, mean percentage of time in range 70-180 mg/dL (TIR) increased from 55 ± 13% using SAP during the RCT to 65 ± 10% using CLC (P < 0.001), with 36% of the cohort achieving TIR >70% plus time <54 mg/dL <1% compared with 14% when using SAP (P = 0.03). Substantial improvement in TIR was seen after the 1st day of CLC. Time <70 mg/dL decreased from 1.80% to 1.34% (P < 0.001). In the CLC-CLC cohort, mean TIR increased from 53 ± 17% prerandomization to 67 ± 10% during the RCT and remained reasonably stable at 66 ± 10% through the 12 weeks post-RCT. No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either cohort.Conclusions: This further evaluation of the Control-IQ CLC system supports the findings of the preceding RCT that use of a closed-loop system can safely improve glycemic control in children 6-13 years old with type 1 diabetes from the 1st day of use and demonstrates that these improvements can be sustained through 28 weeks of use. [ABSTRACT FROM AUTHOR]

: Copyright of Diabetes Care is the property of American Diabetes Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

المؤلفون: Brown, Sue, Raghinaru, Dan, Emory, Emma, Kovatchev, Boris

المصدر: Diabetes Care; 2018, Vol. 41 Issue 12, p2634-2636, 3p

مصطلحات موضوعية: TYPE 1 diabetes, HYPOGLYCEMIA, INSULIN therapy, GLYCEMIC control, CLOSED loop systems, BLOOD sugar analysis, BLOOD sugar, BLOOD sugar monitoring, CLINICAL trials, COMPARATIVE studies, HYPOGLYCEMIC agents, INSULIN, INSULIN pumps, RESEARCH methodology, MEDICAL cooperation, PATENTS, RESEARCH, RESEARCH funding, PILOT projects, EVALUATION research

مستخلص: Objective: To pilot test a new closed-loop control technology to validate it for a further large clinical trial.Research Design and Methods: The t:slim X2 insulin pump with Control-IQ Technology (Tandem Diabetes Care) includes a Dexcom G6 sensor and a closed-loop algorithm implemented in the pump that 1) automates insulin correction boluses, 2) has a dedicated hypoglycemia safety system, and 3) gradually intensifies control overnight, aiming for blood glucose levels of approximately 100-120 mg/dL every morning.Results: Five patients with type 1 diabetes (mean age 52.8 years, 2/3 male/female, mean A1C 6.5%) used Control-IQ in an outpatient setting (hotel) for approximately 37 h. During the closed loop, mean glucose was 129 mg/dL (135/121 mg/dL during the day/night), time within target range 70-180 mg/dL was 87% (82%/94% during the day/night), and time <60 mg/dL was 1.1% (2.0%/0.0% during the day/night).Conclusions: Following this pilot trial, Control-IQ was deployed in several studies, including the large-scale National Institutes of Health International Diabetes Closed-Loop (iDCL) Trial. [ABSTRACT FROM AUTHOR]

: Copyright of Diabetes Care is the property of American Diabetes Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

المؤلفون: Schoelwer, Melissa J¹ (AUTHOR), Kanapka, Lauren G² (AUTHOR), Wadwa, R Paul³ (AUTHOR), Breton, Marc D¹ (AUTHOR), Ruedy, Katrina J² (AUTHOR), Ekhlaspour, Laya⁴ (AUTHOR), Forlenza, Gregory P³ (AUTHOR), Cobry, Erin C³ (AUTHOR), Messer, Laurel H³ (AUTHOR), Cengiz, Eda⁵ (AUTHOR), Jost, Emily³ (AUTHOR), Carria, Lori⁵ (AUTHOR), Emory, Emma¹ (AUTHOR), Hsu, Liana J⁴ (AUTHOR), Weinzimer, Stuart A⁵ (AUTHOR), Buckingham, Bruce A⁴ (AUTHOR), Lal, Rayhan A⁴ (AUTHOR), Oliveri, Mary Clancy¹ (AUTHOR), Kollman, Craig C¹ (AUTHOR), Dokken, Betsy B⁶ (AUTHOR)

المصدر: Diabetes Technology & Therapeutics. Jul2021, Vol. 23 Issue 7, p475-481. 7p.

مصطلحات موضوعية: *CLOSED loop systems, *FORECASTING, *TYPE 1 diabetes, *GLYCEMIC control, *BODY weight, *INSULIN therapy, *RESEARCH, *BLOOD sugar monitoring, *RESEARCH methodology, *HYPOGLYCEMIC agents, *BLOOD sugar, *EVALUATION research, *COMPARATIVE studies, *INSULIN pumps, *RESEARCH funding

مستخلص: 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. [ABSTRACT FROM AUTHOR]

المؤلفون: Breton, Marc D.¹, Kanapka, Lauren G.², Beck, Roy W.², Ekhlaspour, Laya³, Forlenza, Gregory P.⁴, Cengiz, Eda⁵, Schoelwer, Melissa¹, Ruedy, Katrina J.², Jost, Emily⁴, Carria, Lori⁵, Emory, Emma¹, Hsu, Liana J.³, Oliveri, Mary¹, Kollman, Craig C.², Dokken, Betsy B.⁶, Weinzimer, Stuart A.⁵, Deboer, Mark D.¹, Buckingham, Bruce A.³, Cherňavvsky, Daniel¹, Wadwa, R. Paul⁴ paul.wadwa@cuanschutz.edu

المصدر: New England Journal of Medicine. 8/27/2020, Vol. 383 Issue 9, p836-845. 10p.

مصطلحات موضوعية: *TYPE 1 diabetes, *GLYCOSYLATED hemoglobin, *CLOSED loop systems, *ARTIFICIAL pancreases, *INSULIN pumps, *BLOOD sugar analysis, *RESEARCH, *RESEARCH methodology, *HYPOGLYCEMIC agents, *ARTIFICIAL organs, *EVALUATION research, *MEDICAL cooperation, *DRUG infusion pumps, *INSULIN, *COMPARATIVE studies, *RANDOMIZED controlled trials, *HYPOGLYCEMIA, *RESEARCH funding, *DIABETIC acidosis, *SUBCUTANEOUS injections

مستخلص: Background: A closed-loop system of insulin delivery (also called an artificial pancreas) may improve glycemic outcomes in children with type 1 diabetes.Methods: In a 16-week, multicenter, randomized, open-label, parallel-group trial, we assigned, in a 3:1 ratio, children 6 to 13 years of age who had type 1 diabetes to receive treatment with the use of either a closed-loop system of insulin delivery (closed-loop group) or a sensor-augmented insulin pump (control group). The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring.Results: A total of 101 children underwent randomization (78 to the closed-loop group and 23 to the control group); the glycated hemoglobin levels at baseline ranged from 5.7 to 10.1%. The mean (±SD) percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter increased from 53±17% at baseline to 67±10% (the mean over 16 weeks of treatment) in the closed-loop group and from 51±16% to 55±13% in the control group (mean adjusted difference, 11 percentage points [equivalent to 2.6 hours per day]; 95% confidence interval, 7 to 14; P<0.001). In both groups, the median percentage of time that the glucose level was below 70 mg per deciliter was low (1.6% in the closed-loop group and 1.8% in the control group). In the closed-loop group, the median percentage of time that the system was in the closed-loop mode was 93% (interquartile range, 91 to 95). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group.Conclusions: In this 16-week trial involving children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with the use of a closed-loop system than with the use of a sensor-augmented insulin pump. (Funded by Tandem Diabetes Care and the National Institute of Diabetes and Digestive and Kidney Diseases; ClinicalTrials.gov number, NCT03844789.). [ABSTRACT FROM AUTHOR]