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1دورية أكاديمية
المؤلفون: Kanapka, Lauren, Wadwa, R, Breton, Marc, Ruedy, Katrina, Ekhlaspour, Laya, Forlenza, Gregory, Cengiz, Eda, Schoelwer, Melissa, Jost, Emily, Carria, Lori, Emory, Emma, Hsu, Liana, Weinzimer, Stuart, DeBoer, Mark, Buckingham, Bruce, Oliveri, Mary, Kollman, Craig, Dokken, Betsy, Cherñavvsky, Daniel, Beck, Roy
المصدر: Diabetes reviews (Alexandria, Va.). 44(2)
مصطلحات موضوعية: Adolescent, Blood Glucose, Child, Diabetes Mellitus, Type 1, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems
الوصف: 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
وصف الملف: application/pdf
الوصول الحر: https://escholarship.org/uc/item/5jj8v889Test
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2دورية أكاديمية
المؤلفون: Kudva, Yogish, Laffel, Lori, Brown, Sue, Raghinaru, Dan, Pinsker, Jordan, Ekhlaspour, Laya, Levy, Carol, Messer, Laurel, Kovatchev, Boris, Lum, John, Beck, Roy, Gonder-Frederick, Linda, Anderson, Stacey, Emory, Emma, Voelmle, Mary, Conshafter, Katie, Morris, Kim, Oliveri, Mary, Mitchell, Harry, Calvo, Kayla, Wakeman, Christian, Breton, Marc, Isganaitis, Elvira, Ambler-Osborn, Louise, Flint, Emily, Kim, Kenny, Roethke, Lindsay, Church, Mei, Andre, Camille, Piper, Molly, Lam, David, O'Malley, Grenye, Levister, Camilla, Ogyaadu, Selassie, Lovett, Jessica, Simha, Vinaya, Dadlani, Vikash, Mccrady-Spitzer, Shelly, Reid, Corey, Kumari, Kanchan, Wadwa, R. Paul, Forlenza, Greg, Alonso, G. Todd, Slover, Robert, Jost, Emily, Berget, Cari, Towers, Lindsey, Rossick-Solis, Alex, Buckingham, Bruce, Jacobson, Tali, Town, Marissa, Tabatabai, Ideen, Keller, Jordan, Salas, Evalina, Doyle, Francis, Dassau, Eyal, Passman, Samantha, Campos, Tiffany, Kollman, Craig, Murphy, Carlos, Patibandla, Nandan, Borgman, Sarah, Arreaza-Rubín, Guillermo, Green, Neal, Renard, Eric, Cobelli, Claudio, Reznik, Yves, Janicek, Robert, Gabrielson, Deanna, Belle, Steven, Castle, Jessica, Green, Jennifer, Legault, Laurent, Willi, Steven, Wysham, Carol, Eggerman, Thomas
المساهمون: Mayo Clinic Rochester, Joslin Diabetes Center, Harvard Medical School Boston (HMS), University of Virginia, Jaeb Center for Health Research, William Sansum Diabetes Center (SDRI), Stanford University, Icahn School of Medicine at Mount Sinai New York (MSSM), Barbara Davis Center for Childhood Diabetes (BDC), University of Colorado Anschutz Aurora, Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier), Institut de Génomique Fonctionnelle (IGF), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)
المصدر: ISSN: 1520-9156.
مصطلحات موضوعية: Adolescents, Adults, Diabetes distress, Hypoglycemia awareness, Hypoglycemia fear, Patient-reported outcomes, Usability, MESH: Adolescent, MESH: Adult, MESH: Blood Glucose, MESH: Blood Glucose Self-Monitoring, MESH: Diabetes Mellitus, Type 1, MESH: Humans, MESH: Hypoglycemic Agents, MESH: Insulin, MESH: Insulin Infusion Systems, MESH: Patient Reported Outcome Measures, [SDV.MHEP.EM]Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism
الوصف: International audience ; Background: Closed-loop control (CLC) has been shown to improve glucose time in range and other glucose metrics; however, randomized trials >3 months comparing CLC with sensor-augmented pump (SAP) therapy are limited. We recently reported glucose control outcomes from the 6-month international Diabetes Closed-Loop (iDCL) trial; we now report patient-reported outcomes (PROs) in this iDCL trial. Methods: Participants were randomized 2:1 to CLC (N = 112) versus SAP (N = 56) and completed questionnaires, including Hypoglycemia Fear Survey, Diabetes Distress Scale (DDS), Hypoglycemia Awareness, Hypoglycemia Confidence, Hyperglycemia Avoidance, and Positive Expectancies of CLC (INSPIRE) at baseline, 3, and 6 months. CLC participants also completed Diabetes Technology Expectations and Acceptance and System Usability Scale (SUS). Results: The Hypoglycemia Fear Survey Behavior subscale improved significantly after 6 months of CLC compared with SAP. DDS did not differ except for powerless subscale scores, which worsened at 3 months in SAP. Whereas Hypoglycemia Awareness and Hyperglycemia Avoidance did not differ between groups, CLC participants showed a tendency toward improved confidence in managing hypoglycemia. The INSPIRE questionnaire showed favorable scores in the CLC group for teens and parents, with a similar trend for adults. At baseline and 6 months, CLC participants had high positive expectations for the device with Diabetes Technology Acceptance and SUS showing high benefit and low burden scores. Conclusion: CLC improved some PROs compared with SAP. Participants reported high benefit and low burden with CLC. Clinical Trial Identifier: NCT03563313.
العلاقة: info:eu-repo/semantics/altIdentifier/pmid/34115959; hal-03652114; https://hal.umontpellier.fr/hal-03652114Test; PUBMED: 34115959; PUBMEDCENTRAL: PMC8573794
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3دورية أكاديمية
المؤلفون: Schoelwer, Melissa, Kanapka, Lauren, Wadwa, R Paul, Breton, Marc, Ruedy, Katrina, Ekhlaspour, Laya, Forlenza, Gregory, Cobry, Erin, Messer, Laurel, Cengiz, Eda, Jost, Emily, Carria, Lori, Emory, Emma, Hsu, Liana, Weinzimer, Stuart, Buckingham, Bruce, Lal, Rayhan, Oliveri, Mary Clancy, Kollman, Craig, Dokken, Betsy, Cherñavvsky, Daniel, Beck, Roy, Deboer, Mark, Wadwa, R. Paul, Gonder-Frederick, Linda, Robic, Jessica, Voelmle, Mary, Conschafter, Katie, Morris, Kimberly, Barnett, Charlotte, Carr, Kelly, Hellmann, Jacob, Kime, Matthew, Todd Alonso, G., Slover, Robert, Berget, Cari, Towers, Lindsey, Lange, Samantha, Maahs, David, Norlander, Lisa, Hood, Korey, Town, Marissa, Weir, Christine, Smith, Kerren, Shinksy, Deanna, Viana, Julia, Weyman, Kate, Zgorski, Melinda, Borgman, Sarah, Rusnak, Jessica, Murphy, Carlos, Arreza-Rubin, Guillermo, Green, Neal, Kovatchev, Boris, Brown, Sue, Anderson, Stacey, Laffel, Lori, Pinsker, Jordan, Levy, Carol, Kudva, Yogish, Doyle Iii, Francis, Renard, Eric, Cobelli, Claudio, Reznik, Yves, Lum, John, Janicek, Robert, Gabrielson, Deanna
المساهمون: University of Virginia, University of South Florida Tampa (USF), Barbara Davis Center for Childhood Diabetes (BDC), University of Colorado Anschutz Aurora, Stanford University, Yale School of Medicine New Haven, Connecticut (YSM), Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier), Institut de Génomique Fonctionnelle (IGF), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)
المصدر: ISSN: 1520-9156.
مصطلحات موضوعية: Closed-loop systems, Insulin pump, Time-in-range, Type 1 diabetes, MESH: Adolescent, MESH: Blood Glucose, MESH: Blood Glucose Self-Monitoring, MESH: Child, MESH: Diabetes Mellitus, Type 1, MESH: Humans, MESH: Hypoglycemic Agents, MESH: Insulin, MESH: Insulin Infusion Systems, [SDV.MHEP.EM]Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism
الوصف: International audience ; 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.
العلاقة: info:eu-repo/semantics/altIdentifier/pmid/33689454; hal-03672247; https://hal.science/hal-03672247Test; PUBMED: 33689454; PUBMEDCENTRAL: PMC8252894; WOS: 000627903500001
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4دورية أكاديمية
المؤلفون: Cobry, Erin, Kanapka, Lauren, Cengiz, Eda, Carria, Lori, Ekhlaspour, Laya, Buckingham, Bruce, Hood, Korey, Hsu, Liana, Messer, Laurel, Schoelwer, Melissa, Emory, Emma, Ruedy, Katrina, Beck, Roy, Wadwa, Raj Paul, Gonder-Frederick, Linda, Breton, Marc, DeBoer, Mark, Cherñavvsky, Daniel, Robic, Jessica, Voelmle, Mary, Conschafter, Katie, Morris, Kimberly, Barnett, Charlotte, Carr, Kelly, Hellmann, Jacob, Kime, Matthew, Oliveri, Mary, Forlenza, Greg, Alonso, G. Todd, Slover, Robert, Jost, Emily, Berget, Cari, Towers, Lindsey, Lange, Samantha, Maahs, David, Lal, Rayhan, Norlander, Lisa, Town, Marissa, Weir, Christine, Smith, Kerren, Shinksy, Deanna, Viana, Julia, Weinzimer, Stuart, Weyman, Kate, Zgorski, Melinda, Borgman, Sarah, Rusnak, Jessica, Kollman, Craig, Murphy, Carlos, Arreza-Rubin, Guillermo
المساهمون: University of Colorado Colorado Springs (UCCS), Yale University New Haven, Stanford University, University of Virginia Charlottesville
المصدر: ISSN: 1520-9156.
مصطلحات موضوعية: Closed-loop systems, Continuous glucose monitoring, Hypoglycemic fear, Person-reported outcomes, Quality of life, Sensor augmented insulin pump, Time in range, Type 1 diabetes, MESH: Adolescent, MESH: Blood Glucose, MESH: Personal Satisfaction, MESH: Quality of Life, MESH: Blood Glucose Self-Monitoring, MESH: Child, MESH: Diabetes Mellitus, Type 1, MESH: Humans, MESH: Hypoglycemic Agents, MESH: Insulin, MESH: Insulin Infusion Systems, MESH: Parents, [SDV]Life Sciences [q-bio], psy, socio
الوصف: International audience ; Introduction: Hybrid closed-loop systems increase time-in-range (TIR) and reduce glycemic variability. Person-reported outcomes (PROs) are essential to assess the utility of new devices and their impact on quality of life. This article focuses on the PROs for pediatric participants (ages 6-13 years) with type 1 diabetes (T1D) and their parents during a trial using the Tandem Control-IQ system, which was shown to increase TIR and improve other glycemic metrics. Research Design and Methods: One hundred and one children 6 to 13 years old with T1D were randomly assigned to closed-loop control (CLC) or sensor-augmented pump (SAP) in a 16-week randomized clinical trial with extension to 28 weeks during which the SAP group crossed over to CLC. Health-related quality of life and treatment satisfaction measures were obtained from children and their parents at baseline, 16 weeks, and 28 weeks. Results: Neither the children in the CLC group nor their parents had statistically significant changes in PRO outcomes compared with the SAP group at the end of the 16-week randomized controlled trial and the 28-week extension. Parents in the CLC group reported nonsignificant improvements in some PRO scores when compared with the SAP group at 16 weeks, which were sustained at 28 weeks. Sleep scores for parents improved from "poor sleep quality" to "adequate sleep quality" between baseline and 16 weeks, however, the change in scores was not statistically different between groups. Conclusions: Children with T1D who used the Control-IQ system did not experience increased burden compared with those using SAP based on person-reported outcomes from the children and their parents. Clinical Trials Registration: NCT03844789.
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5دورية أكاديمية
المؤلفون: O'Malley, Grenye, Messer, Laurel, Levy, Carol, Pinsker, Jordan, Forlenza, Gregory, Isganaitis, Elvira, Kudva, Yogish, Ekhlaspour, Laya, Raghinaru, Dan, Lum, John, Brown, Sue, Kovatchev, Boris, Anderson, Stacey, Emory, Emma, Voelmle, Mary, Conshafter, Katie, Morris, Kim, Oliveri, Mary, Gondor-Fredrick, Linda, Mitchell, Harry, Calvo, Kayla, Wakeman, Christian, Breton, Marc, Laffel, Lori, Ambler-Osborn, Louise, Flint, Emily, Kim, Kenny, Roethke, Lindsay, Church, Mei Mei, Andre, Camille, Piper, Molly, Lam, David, Levister, Camilla, Ogyaadu, Selassie, Lovett, Jessica, Simha, Vinaya, Dadlani, Vikash, McCrady-Spitzer, Shelly, Reid, Corey, Kumari, Kanchan, Wadwa, R. Paul, Alonso, G. Todd, Slover, Robert, Jost, Emily, Berget, Cari, Towers, Lindsey, Rossick-Solis, Alex, Buckingham, Bruce, Jacobson, Tali, Town, Marissa, Tabatabai, Ideen, Keller, Jordan, Salas, Evalina, Paulson, John, Beck, J.L. Roy, Passman, Samantha, Campos, Tiffany, Kollman, D.R. Craig, Murphy, Carlos, Patibandla, Nandan, Borgman, Sarah, Arreza-Rubin, Guillermo, Eggerman, Thomas, Green, Neal, Renard, Eric, Cobelli, Claudio, Reznik, Yves, Beck., J.L. Roy
المساهمون: Icahn School of Medicine at Mount Sinai New York (MSSM), University of Colorado Colorado Springs (UCCS), Harvard Medical School Boston (HMS), Mayo Clinic Rochester, University of Virginia Charlottesville
المصدر: ISSN: 1520-9156.
مصطلحات موضوعية: Automated insulin delivery, Closed-loop control, Continuous glucose monitor, Pump parameters, Type 1 diabetes, MESH: Blood Glucose Self-Monitoring, MESH: Diabetes Mellitus, Type 1, MESH: Humans, MESH: Hypoglycemic Agents, MESH: Insulin, MESH: Insulin Infusion Systems, [SDV]Life Sciences [q-bio]
الوصف: International audience ; Background: Data are limited on the need for and benefits of pump setting optimization with automated insulin delivery. We examined clinical management of a closed-loop control (CLC) system and its relationship to glycemic outcomes. Materials and Methods: We analyzed personal parameter adjustments in 168 participants in a 6-month multicenter trial of CLC with Control-IQ versus sensor-augmented pump (SAP) therapy. Preset parameters (BR = basal rates, CF = correction factors, CR = carbohydrate ratios) were optimized at randomization, 2 and 13 weeks, for safety issues, participant concerns, or initiation by participants' usual diabetes care team. Time in range (TIR 70-180 mg/dL) was compared in the week before and after parameter changes. Results: In 607 encounters for parameter changes, there were fewer adjustments for CLC than SAP (3.4 vs. 4.1/participant). Adjustments involved BR (CLC 69%, SAP 80%), CR (CLC 68%, SAP 50%), CF (CLC 44%, SAP 41%), and overnight parameters (CLC 62%, SAP 75%). TIR before and after adjustments was 71.2% and 71.3% for CLC and 61.0% and 62.9% for SAP. The highest baseline HbA1c CLC subgroup had the largest TIR improvement (51.2% vs. 57.7%). When a CR was made more aggressive in the CLC group, postprandial time >180 mg/dL was 43.1% before the change and 36.0% after the change. The median postprandial time <70 mg/dL before making CR less aggressive was 1.8%, and after the change was 0.7%. Conclusions: No difference in TIR was detected with parameter changes overall, but they may have an effect in higher HbA1c subgroups or following user-directed boluses, suggesting that changes may matter more in suboptimal control or during discrete periods of the day. Clinical Trials Registration number: NCT03563313.
العلاقة: info:eu-repo/semantics/altIdentifier/pmid/33155824; hal-03654244; https://hal.archives-ouvertes.fr/hal-03654244Test; PUBMED: 33155824; PUBMEDCENTRAL: PMC8114941
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6دورية أكاديمية
المؤلفون: Breton, Marc, Kanapka, Lauren, Beck, Roy, Ekhlaspour, Laya, Forlenza, Gregory, Cengiz, Eda, Schoelwer, Melissa, Ruedy, Katrina, Jost, Emily, Carria, Lori, Emory, Emma, Hsu, Liana, Oliveri, Mary, Kollman, Craig, Dokken, Betsy, Weinzimer, Stuart, Deboer, Mark, Buckingham, Bruce, Cherñavvsky, Daniel, Wadwa, R. Paul, Research Group, Idcl Trial, Renard, Eric
المساهمون: University of Virginia, Jaeb Center for Health Research, Stanford University, Barbara Davis Center for Childhood Diabetes (BDC), University of Colorado Anschutz Aurora, Yale School of Medicine New Haven, Connecticut (YSM), Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier), Université de Montpellier (UM)
المصدر: ISSN: 0028-4793.
مصطلحات موضوعية: MESH: Adolescent, MESH: Blood Glucose, MESH: Infusion Pumps, Implantable, MESH: Injections, Subcutaneous, MESH: Insulin, MESH: Insulin Infusion Systems, MESH: Male, MESH: Pancreas, Artificial, MESH: Child, MESH: Diabetes Mellitus, Type 1, MESH: Diabetic Ketoacidosis, MESH: Female, MESH: Glycated Hemoglobin A, MESH: Humans, MESH: Hypoglycemia, MESH: Hypoglycemic Agents, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
الوصف: International audience ; 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.).
العلاقة: info:eu-repo/semantics/altIdentifier/pmid/32846062; hal-03342494; https://hal.umontpellier.fr/hal-03342494Test; PUBMED: 32846062; PUBMEDCENTRAL: PMC7920146
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7دورية أكاديمية
المؤلفون: Brown, Sue, Beck, Roy, Raghinaru, Dan, Buckingham, Bruce, Laffel, Lori, Wadwa, R Paul, Kudva, Yogish, Levy, Carol, Pinsker, Jordan, Dassau, Eyal, Doyle, Francis, Ambler-Osborn, Louise, Anderson, Stacey, Church, Mei Mei, Ekhlaspour, Laya, Forlenza, Gregory, Levister, Camilla, Simha, Vinaya, Breton, Marc, Kollman, Craig, Lum, John, Kovatchev, Boris, Wadwa, R. Paul, Emory, Emma, Voelmle, Mary, Conshafter, Katie, Morris, Kim, Oliveri, Mary, Gondor-Fredrick, Linda, Mitchell, Harry, Calvo, Kayla, Wakeman, Christian, Isganaitis, Elvira, Flint, Emily, Kim, Kenny, Roethke, Lindsay, Andre, Camille, Piper, Molly, Lam, David, O’malley, Grenye, Ogyaadu, Selassie, Lovett, Jessica, Dadlani, Vikash, Mccrady-Spitzer, Shelly, Reid, Corey, Kumari, Kanchan, Forlenza, Greg, Alonso, G. Todd, Slover, Robert, Jost, Emily, Messer, Laurel, Berget, Cari, Towers, Lindsey, Rossick-Solis, Alex, Jacobson, Tali, Town, Marissa, Tabatabai, Ideen, Keller, Jordan, Salas, Evalina, Passman, Samantha, Campos, Tiffany, Murphy, Carlos, Patibandla, Nandan, Borgman, Sarah, Arreza-Rubin, Guillermo, Eggerman, Thomas, Green, Neal, Doyle Iii, Francis, Renard, Eric, Cobelli, Claudio, Reznik, Yves, Janicek, Robert, Gabrielson, Deanna, Belle, Steven, Castle, Jessica, Green, Jennifer, Legault, Laurent, Willi, Steven, Wysham, Carol
المساهمون: University of Virginia, Jaeb Center for Health Research, Stanford University School of Medicine CA, USA, Joslin Diabetes Center, Barbara Davis Center for Childhood Diabetes (BDC), University of Colorado Anschutz Aurora, Department of Health Sciences Research Mayo Clinic (HSR), Mayo Clinic, Icahn School of Medicine at Mount Sinai New York (MSSM), William Sansum Diabetes Center (SDRI), Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS), Harvard University, William Sansum Diabetes Research Institute (SDRI), Stanford University, The International Diabetes Closed Loop (iDCL), Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier)
المصدر: ISSN: 0149-5992.
مصطلحات موضوعية: MESH: Adolescent, MESH: Adult, MESH: Insulin, MESH: Insulin Infusion Systems, MESH: Intention to Treat Analysis, MESH: Male, MESH: Middle Aged, MESH: Prognosis, MESH: Treatment Outcome, MESH: United States, MESH: Young Adult, MESH: Aged, MESH: Blood Glucose, MESH: Blood Glucose Self-Monitoring, MESH: Diabetes Mellitus, Type 1, MESH: Female, MESH: Humans, MESH: Hypoglycemia, MESH: Injections, Subcutaneous, [SDV.MHEP.EM]Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism
الوصف: International audience ; OBJECTIVE Limited information is available about glycemic outcomes with a closed-loop control (CLC) system compared with a predictive low-glucose suspend (PLGS) system. RESEARCH DESIGN AND METHODS After 6 months of use of a CLC system in a randomized trial, 109 participants with type 1 diabetes (age range, 14–72 years; mean HbA1c, 7.1% [54 mmol/mol]) were randomly assigned to CLC (N = 54, Control-IQ) or PLGS (N = 55, Basal-IQ) groups for 3 months. The primary outcome was continuous glucose monitor (CGM)-measured time in range (TIR) for 70–180 mg/dL. Baseline CGM metrics were computed from the last 3 months of the preceding study. RESULTS All 109 participants completed the study. Mean ± SD TIR was 71.1 ± 11.2% at baseline and 67.6 ± 12.6% using intention-to-treat analysis (69.1 ± 12.2% using per-protocol analysis excluding periods of study-wide suspension of device use) over 13 weeks on CLC vs. 70.0 ± 13.6% and 60.4 ± 17.1% on PLGS (difference = 5.9%; 95% CI 3.6%, 8.3%; P < 0.001). Time >180 mg/dL was lower in the CLC group than PLGS group (difference = −6.0%; 95% CI −8.4%, −3.7%; P < 0.001) while time <54 mg/dL was similar (0.04%; 95% CI −0.05%, 0.13%; P = 0.41). HbA1c after 13 weeks was lower on CLC than PLGS (7.2% [55 mmol/mol] vs. 7.5% [56 mmol/mol], difference −0.34% [−3.7 mmol/mol]; 95% CI −0.57% [−6.2 mmol/mol], −0.11% [1.2 mmol/mol]; P = 0.0035). CONCLUSIONS Following 6 months of CLC, switching to PLGS reduced TIR and increased HbA1c toward their pre-CLC values, while hypoglycemia remained similarly reduced with both CLC and PLGS.
العلاقة: info:eu-repo/semantics/altIdentifier/pmid/32471910; hal-03595199; https://hal.umontpellier.fr/hal-03595199Test; PUBMED: 32471910; PUBMEDCENTRAL: PMC7372060
