المؤلفون: Faggionato, Edoardo, Schiavon, Michele, Ekhlaspour, Laya, Buckingham, Bruce, Dalla Man, Chiara

المصدر: IEEE Transactions on Biomedical Engineering. 71(3)

مصطلحات موضوعية: Humans, Adult, Middle Aged, Glucose, Diabetes Mellitus, Type 1, Insulin Resistance, Blood Glucose, Blood Glucose Self-Monitoring, Bayes Theorem, Insulin, Hypoglycemic Agents

الوصف: OBJECTIVE: Modeling the effect of meal composition on glucose excursion would help in designing decision support systems (DSS) for type 1 diabetes (T1D) management. In fact, macronutrients differently affect post-prandial gastric retention (GR), rate of appearance (R[Formula: see text]), and insulin sensitivity (S[Formula: see text]). Such variables can be estimated, in inpatient settings, from plasma glucose (G) and insulin (I) data using the Oral glucose Minimal Model (OMM) coupled with a physiological model of glucose transit through the gastrointestinal tract (reference OMM, R-OMM). Here, we present a model able to estimate those quantities in daily-life conditions, using minimally-invasive (MI) technologies, and validate it against the R-OMM. METHODS: Forty-seven individuals with T1D (weight =78±13 kg, age =42±10 yr) underwent three 23-hour visits, during which G and I were frequently sampled while wearing continuous glucose monitoring (CGM) and insulin pump (IP). Using a Bayesian Maximum A Posteriori estimator, R-OMM was identified from plasma G and I measurements, and MI-OMM was identified from CGM and IP data. RESULTS: The MI-OMM fitted the CGM data well and provided precise parameter estimates. GR and R[Formula: see text] model parameters were not significantly different using the MI-OMM and R-OMM (p 0.05) and the correlation between the two S[Formula: see text] was satisfactory ( ρ =0.77). CONCLUSION: The MI-OMM is usable to estimate GR, R[Formula: see text], and S[Formula: see text] from data collected in real-life conditions with minimally-invasive technologies. SIGNIFICANCE: Applying MI-OMM to datasets where meal compositions are available will allow modeling the effect of each macronutrient on GR, R[Formula: see text], and S[Formula: see text]. DSS could finally exploit this information to improve diabetes management.

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/4zm3c05sTest

المؤلفون: Cardona-Hernandez, Roque, Dôvc, Klemen, Biester, Torben, Macedoni, Maddalena, Tauschmann, Martin, Mameli, Chiara, Ekhlaspour, Laya

مصطلحات موضوعية: Automated insulin delivery, Children, Technology, Time in range, Type 1 diabetes, Youths, Young Adult, Humans, Adolescent, Child, Adult, Diabetes Mellitus, Type 1, Hypoglycemic Agents, Glycemic Control, Blood Glucose Self-Monitoring, Blood Glucose, Insulin, Insulin Infusion Systems

الوصف: Type 1 diabetes (T1D) is the most frequent form of diabetes in pediatric age, affecting more than 1.5 million people younger than age 20 years worldwide. Early and intensive control of diabetes provides continued protection against both microvascular and macrovascular complications, enhances growth, and ensures normal pubertal development. In the absence of definitive reversal therapy for this disease, achieving and maintaining the recommended glycemic targets is crucial. In the last 30 years, enormous progress has been made using technology to better treat T1D. In spite of this progress, the majority of children, adolescents and young adults do not reach the recommended targets for glycemic control and assume a considerable burden each day. The development of promising new therapeutic advances, such as more physiologic insulin analogues, pioneering diabetes technology including continuous glucose monitoring and closed loop systems as well as new adjuvant drugs, anticipate a new paradigm in T1D management over the next few years. This review presents insights into current management of T1D in youths.

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/7s31w37tTest

المؤلفون: Ekhlaspour, Laya, Raghinaru, Dan, Forlenza, Gregory, Isganaitis, Elvira, Kudva, Yogish, Lam, David, Levister, Camilla, OMalley, Grenye, Church, Mei, Lum, John, Buckingham, Bruce, Brown, Sue

المصدر: DST. 17(4)

مصطلحات موضوعية: closed-loop control, continuous glucose monitoring, efficacy, insulin pump, multiple daily injection, Humans, Diabetes Mellitus, Type 1, Hypoglycemic Agents, Blood Glucose Self-Monitoring, Blood Glucose, Insulin, Insulin, Regular, Human, Insulin Infusion Systems

الوصف: BACKGROUND: We investigated the potential benefits of automated insulin delivery (AID) among individuals with type 1 diabetes (T1D) in sub-populations of baseline device use determined by continuous glucose monitor (CGM) use status and insulin delivery via multiple daily injections (MDI) or insulin pump. MATERIALS AND METHODS: In a six-month randomized, multicenter trial, 168 individuals were assigned to closed-loop control (CLC, Control-IQ, Tandem Diabetes Care), or sensor-augmented pump (SAP) therapy. The trial included a two- to eight-week run-in phase to train participants on study devices. The participants were stratified into four subgroups: insulin pump and CGM (pump+CGM), pump-only, MDI and CGM (MDI+CGM), and MDI users without CGM (MDI-only) users. We compared glycemic outcomes among four subgroups. RESULTS: At baseline, 61% were pump+CGM users, 18% pump-only users, 10% MDI+CGM users, and 11% MDI-only users. Mean time in range 70-180 mg/dL (TIR) improved from baseline in the four subgroups using CLC: pump+CGM, 62% to 73%; pump-only, 61% to 70%; MDI+CGM, 54% to 68%; and MDI-only, 61% to 69%. The reduction in time below 70 mg/dL from baseline was comparable among the four subgroups. No interaction effect was detected with baseline device use for TIR (P = .67) or time below (P = .77). On the System Usability Questionnaire, scores were high at 26 weeks for all subgroups: pump+CGM: 87.2 ± 12.1, pump-only: 89.4 ± 8.2, MDI+CGM 87.2 ± 9.3, MDI: 78.1 ± 15. CONCLUSIONS: There was a consistent benefit in patients with T1D when using CLC, regardless of baseline insulin delivery modality or CGM use. These data suggest that this CLC system can be considered across a wide range of patients.

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/3cf3h4vgTest

المؤلفون: Wadwa, R, Reed, Zachariah, Buckingham, Bruce, DeBoer, Mark, Ekhlaspour, Laya, Forlenza, Gregory, Schoelwer, Melissa, Lum, John, Kollman, Craig, Beck, Roy, Breton, Marc

المصدر: New England Journal of Medicine. 388(11)

مصطلحات موضوعية: Child, Child, Preschool, Humans, Blood Glucose, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Hypoglycemic Agents, Insulin, Insulin Infusion Systems

الوصف: BACKGROUND: Closed-loop control systems of insulin delivery may improve glycemic outcomes in young children with type 1 diabetes. The efficacy and safety of initiating a closed-loop system virtually are unclear. METHODS: In this 13-week, multicenter trial, we randomly assigned, in a 2:1 ratio, children who were at least 2 years of age but younger than 6 years of age who had type 1 diabetes to receive treatment with a closed-loop system of insulin delivery or standard care that included either an insulin pump or multiple daily injections of insulin plus a continuous glucose monitor. 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. Secondary outcomes included the percentage of time that the glucose level was above 250 mg per deciliter or below 70 mg per deciliter, the mean glucose level, the glycated hemoglobin level, and safety outcomes. RESULTS: A total of 102 children underwent randomization (68 to the closed-loop group and 34 to the standard-care group); the glycated hemoglobin levels at baseline ranged from 5.2 to 11.5%. Initiation of the closed-loop system was virtual in 55 patients (81%). The mean (±SD) percentage of time that the glucose level was within the target range increased from 56.7±18.0% at baseline to 69.3±11.1% during the 13-week follow-up period in the closed-loop group and from 54.9±14.7% to 55.9±12.6% in the standard-care group (mean adjusted difference, 12.4 percentage points [equivalent to approximately 3 hours per day]; 95% confidence interval, 9.5 to 15.3; P

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/53h9d0w8Test

المؤلفون: Russell, Steven, Beck, Roy, Damiano, Edward, El-Khatib, Firas, Ruedy, Katrina, Balliro, Courtney, Li, Zoey, Calhoun, Peter, Wadwa, R, Buckingham, Bruce, Zhou, Keren, Daniels, Mark, Raskin, Philip, White, Perrin, Lynch, Jane, Pettus, Jeremy, Hirsch, Irl, Goland, Robin, Buse, John, Kruger, Davida, Mauras, Nelly, Muir, Andrew, McGill, Janet, Cogen, Fran, Weissberg-Benchell, Jill, Sherwood, Jordan, Castellanos, Luz, Hillard, Mallory, Tuffaha, Marwa, Putman, Melissa, Sands, Mollie, Forlenza, Gregory, Slover, Robert, Messer, Laurel, Cobry, Erin, Shah, Viral, Polsky, Sarit, Lal, Rayhan, Ekhlaspour, Laya, Hughes, Michael, Basina, Marina, Hatipoglu, Betul, Olansky, Leann, Bhangoo, Amrit, Forghani, Nikta, Kashmiri, Himala, Sutton, Francoise, Choudhary, Abha, Penn, Jimmy, Jafri, Rabab, Rayas, Maria, Escaname, Elia, Kerr, Catherine, Favela-Prezas, Ruby, Trikudanathan, Subbulaxmi, Williams, Kristen, Leibel, Natasha, Kirkman, M, Bergamo, Kate, Klein, Klara, Dostou, Jean, Machineni, Sriram, Young, Laura, Diner, Jamie, Bhan, Arti, Jones, J, Benson, Matthew, Bird, Keisha, Englert, Kimberly, Permuy, Joe, Cossen, Kristina, Felner, Eric, Salam, Maamoun, Silverstein, Julie, Adamson, Samantha, Cedeno, Andrea, Meighan, Seema, Dauber, Andrew, Boeder, Schafer

المصدر: The New England Journal of Medicine. 387(13)

مصطلحات موضوعية: Adolescent, Adult, Aged, Bionics, Blood Glucose, Blood Glucose Self-Monitoring, Child, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Insulin Aspart, Insulin Infusion Systems, Insulin Lispro, Middle Aged, Young Adult

الوصف: BACKGROUND: Currently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine operation. In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting. METHODS: In this 13-week, multicenter, randomized trial, we randomly assigned in a 2:1 ratio persons at least 6 years of age with type 1 diabetes either to receive bionic pancreas treatment with insulin aspart or insulin lispro or to receive standard care (defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring). The primary outcome was the glycated hemoglobin level at 13 weeks. The key secondary outcome was the percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter; the prespecified noninferiority limit for this outcome was 1 percentage point. Safety was also assessed. RESULTS: A total of 219 participants 6 to 79 years of age were assigned to the bionic-pancreas group, and 107 to the standard-care group. The glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic-pancreas group and did not change (was at 7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, -0.5 percentage points; 95% confidence interval [CI], -0.6 to -0.3; P

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/1m5021wbTest

المؤلفون: Pinsker, Jordan, Dassau, Eyal, Deshpande, Sunil, Raghinaru, Dan, Buckingham, Bruce, Kudva, Yogish, Laffel, Lori, Levy, Carol, Church, Mei, Desrochers, Hannah, Ekhlaspour, Laya, Kaur, Ravinder, Levister, Camilla, Shi, Dawei, Lum, John, Kollman, Craig, Doyle, Francis

المصدر: Diabetes Technology and Therapeutics. 24(9)

مصطلحات موضوعية: Adaptation, Artificial pancreas, Automated insulin delivery, Glycemic control, Type 1 diabetes, Adult, Blood Glucose, Cross-Over Studies, Diabetes Mellitus, Type 1, Humans, Hypoglycemic Agents, Infant, Newborn, Insulin, Insulin Infusion Systems, Insulin, Regular, Human, Middle Aged, Outpatients, Young Adult

الوصف: Background: Automated insulin delivery (AID) systems have proven effective in increasing time-in-range during both clinical trials and real-world use. Further improvements in outcomes for single-hormone (insulin only) AID may be limited by suboptimal insulin delivery settings. Methods: Adults (≥18 years of age) with type 1 diabetes were randomized to either sensor-augmented pump (SAP) (inclusive of predictive low-glucose suspend) or adaptive zone model predictive control AID for 13 weeks, then crossed over to the other arm. Each week, the AID insulin delivery settings were sequentially and automatically updated by an adaptation system running on the study phone. Primary outcome was sensor glucose time-in-range 70-180 mg/dL, with noninferiority in percent time below 54 mg/dL as a hierarchical outcome. Results: Thirty-five participants completed the trial (mean age 39 ± 16 years, HbA1c at enrollment 6.9% ± 1.0%). Mean time-in-range 70-180 mg/dL was 66% with SAP versus 69% with AID (mean adjusted difference +2% [95% confidence interval: -1% to +6%], P = 0.22). Median time

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/76x9t6n0Test

المؤلفون: Ekhlaspour, Laya, Town, Marissa, Raghinaru, Dan, Lum, John, Brown, Sue, Buckingham, Bruce

المصدر: Diabetes Technology and Therapeutics. 24(8)

مصطلحات موضوعية: Closed-loop system, Continuous glucose monitoring, Glycemic management, International Diabetes Closed-Loop Trial, Time in range, Type 1 diabetes, Blood Glucose, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Humans, Hyperglycemia, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems

الوصف: Using a closed-loop system significantly improves time in range (TIR) 70-180 mg/dL in patients with type 1 diabetes (T1D). In a 6-month RCT, 112 subjects were randomly assigned to closed-loop control (Tandem Control-IQ) after obtaining 2 weeks of baseline Continuous glucose monitoring (CGM) data from sensor-augmented pump therapy. We compared glycemic outcomes from baseline to end of study among subgroups classified by baseline HbA1c levels. All HbA1c subgroups showed an improvement in TIR due to reduction of both hyperglycemia and hypoglycemia. Those with HbA1c

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/2zk1901gTest

المؤلفون: Forlenza, Gregory, Ekhlaspour, Laya, DiMeglio, Linda, Fox, Larry, Rodriguez, Henry, Shulman, Dorothy, Kaiserman, Kevin, Liljenquist, David, Shin, John, Lee, Scott, Buckingham, Bruce

المصدر: Pediatric Diabetes. 23(3)

مصطلحات موضوعية: A1C, automated insulin delivery, hybrid closed loop, pediatric, time-in-range, type 1 diabetes, Blood Glucose, Blood Glucose Self-Monitoring, Child, Child, Preschool, Diabetes Mellitus, Type 1, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems

الوصف: BACKGROUND: Highly variable insulin sensitivity, susceptibility to hypoglycemia and inability to effectively communicate hypoglycemic symptoms pose significant challenges for young children with type 1 diabetes (T1D). Herein, outcomes during clinical MiniMed™ 670G system use were evaluated in children aged 2-6 years with T1D. METHODS: Participants (N = 46, aged 4.6 ± 1.4 years) at seven investigational centers used the MiniMed™ 670G system in Manual Mode during a two-week run-in period followed by Auto Mode during a three-month study phase. Safety events, mean A1C, sensor glucose (SG), and percentage of time spent in (TIR, 70-180 mg/dl), below (TBR, 180 mg/dl) range were assessed for the run-in and study phase and compared using a paired t-test or Wilcoxon signed-rank test. RESULTS: From run-in to end of study (median 87.1% time in auto mode), mean A1C and SG changed from 8.0 ± 0.9% to 7.5 ± 0.6% (p

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/9df278vwTest

المؤلفون: Hood, Korey K., Schneider-Utaka, Aika K., Reed, Zachariah W., Buckingham, Bruce A., Cobry, Erin, DeBoer, Mark D., Ekhlaspour, Laya, Schoelwer, Melissa, Paul Wadwa, R., Lum, John, Kollman, Craig, Beck, Roy W., Breton, Marc D.

المساهمون: Juvenile Diabetes Research Foundation United States of America, National Institutes of Health, Novo Nordisk, National Institute of Diabetes and Digestive and Kidney Diseases, Medtronic

المصدر: Diabetes Research and Clinical Practice ; volume 208, page 111114 ; ISSN 0168-8227

مصطلحات موضوعية: Endocrinology, General Medicine, Endocrinology, Diabetes and Metabolism, Internal Medicine

الإتاحة: https://doi.org/10.1016/j.diabres.2024.111114Test
https://api.elsevier.com/content/article/PII:S0168822724000275?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S0168822724000275?httpAccept=text/plainTest

المؤلفون: Bisio, Alessandro, Anderson, Stacey, Norlander, Lisa, OMalley, Grenye, Robic, Jessica, Ogyaadu, Selassie, Hsu, Liana, Levister, Camilla, Ekhlaspour, Laya, Lam, David, Levy, Carol, Buckingham, Bruce, Breton, Marc

المصدر: Diabetes reviews (Alexandria, Va.). 45(1)

مصطلحات موضوعية: Adolescent, Adult, Blood Glucose, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Retrospective Studies

الوصف: OBJECTIVE: Achieving optimal glycemic control for many individuals with type 1 diabetes (T1D) remains challenging, even with the advent of newer management tools, including continuous glucose monitoring (CGM). Modern management of T1D generates a wealth of data; however, use of these data to optimize glycemic control remains limited. We evaluated the impact of a CGM-based decision support system (DSS) in patients with T1D using multiple daily injections (MDI). RESEARCH DESIGN AND METHODS: The studied DSS included real-time dosing advice and retrospective therapy optimization. Adults and adolescents (age >15 years) with T1D using MDI were enrolled at three sites in a 14-week randomized controlled trial of MDI + CGM + DSS versus MDI + CGM. All participants (N = 80) used degludec basal insulin and Dexcom G5 CGM. CGM-based and patient-reported outcomes were analyzed. Within the DSS group, ad hoc analysis further contrasted active versus nonactive DSS users. RESULTS: No significant differences were detected between experimental and control groups (e.g., time in range [TIR] +3.3% with CGM vs. +4.4% with DSS). Participants in both groups reported lower HbA1c (-0.3%; P = 0.001) with respect to baseline. While TIR may have improved in both groups, it was statistically significant only for DSS; the same was apparent for time spent

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/715955w1Test