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2. How introduction of automated insulin delivery systems may influence psychosocial outcomes in adults with type 1 diabetes: Findings from the first investigation with the Omnipod® 5 System

Author

Polonsky, William H., Hood, Korey K., Levy, Carol J., MacLeish, Sarah A., Hirsch, Irl B., Brown, Sue A., Bode, Bruce W., Carlson, Anders L., Shah, Viral N., Weinstock, Ruth S., Bhargava, Anuj, Jones, Thomas C., Aleppo, Grazia, Mehta, Sanjeev N., Laffel, Lori M., Forlenza, Gregory P., Sherr, Jennifer L., Huyett, Lauren M., Vienneau, Todd E., and Ly, Trang T.

Published
2022
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4. Continuous Glucose Monitoring Profiles in Pregnancies With and Without Gestational Diabetes Mellitus.

Author

Durnwald, Celeste, Beck, Roy W., Li, Zoey, Norton, Elizabeth, Bergenstal, Richard M., Johnson, Mary, Dunnigan, Sean, Banfield, Matthew, Krumwiede, Katie, Sibayan, Judy, Calhoun, Peter, and Carlson, Anders L.

Subjects
CONTINUOUS glucose monitoring, GESTATIONAL diabetes, PREGNANT women, HYPERGLYCEMIA, GLUCOSE tolerance tests
Abstract

OBJECTIVE: To determine whether continuous glucose monitoring (CGM)-derived glycemic patterns can characterize pregnancies with gestational diabetes mellitus (GDM) as diagnosed by standard oral glucose tolerance test at 24–28 weeks' gestation compared with those without GDM. RESEARCH DESIGN AND METHODS: The analysis includes 768 individuals enrolled from two sites prior to 17 weeks' gestation between June 2020 and December 2021 in a prospective observational study. Participants wore blinded Dexcom G6 CGMs throughout gestation. Main outcome of interest was a diagnosis of GDM by oral glucose tolerance test (OGTT). Glycemic levels in participants with GDM versus without GDM were characterized using CGM-measured glycemic metrics. RESULTS: Participants with GDM (n = 58 [8%]) had higher mean glucose (109 ± 13 vs. 100 ± 8 mg/dL [6.0 ± 0.7 vs. 5.6 ± 0.4 mmol/L], P < 0.001), greater glucose SD (23 ± 4 vs. 19 ± 3 mg/dL [1.3 ± 0.2 vs. 1.1 ± 0.2 mmol/L], P < 0.001), less time in range 63–120 mg/dL (3.5–6.7 mmol/L) (70% ± 17% vs. 84% ± 8%, P < 0.001), greater percent time >120 mg/dL (>6.7 mmol/L) (median 23% vs. 12%, P < 0.001), and greater percent time >140 mg/dL (>7.8 mmol/L) (median 7.4% vs. 2.7%, P < 0.001) than those without GDM throughout gestation prior to OGTT. Median percent time >120 mg/dL (>6.7 mmol/L) and time >140 mg/dL (>7.8 mmol/L) were higher as early as 13–14 weeks of gestation (32% vs. 14%, P < 0.001, and 5.2% vs. 2.0%, P < 0.001, respectively) and persisted during the entire study period prior to OGTT. CONCLUSIONS: Prior to OGTT at 24–34 weeks' gestation, pregnant individuals who develop GDM have higher CGM-measured glucose levels and more hyperglycemia compared with those who do not develop GDM. [ABSTRACT FROM AUTHOR]

Published
2024
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5. Control-IQ Technology Use in Individuals With High Insulin Requirements: Results From the Multicenter Higher-IQ Trial

Author

Carlson, Anders L., primary, Graham, Timothy E., additional, Akturk, Halis K., additional, Liljenquist, David R., additional, Bergenstal, Richard M., additional, Sulik, Becky, additional, Shah, Viral N., additional, Sulik, Mark, additional, Zhao, Peter, additional, Briggs, Peter, additional, Sassan-Katchalski, Ravid, additional, and Pinsker, Jordan E., additional

Published
2024
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9. Two Years with a Tubeless AID System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes

Author

Criego, Amy, primary, Carlson, Anders L, additional, Brown, Sue, additional, Forlenza, Gregory P., additional, Bode, Bruce, additional, Levy, Carol, additional, Hansen, David, additional, Hirsch, Irl B, additional, Bergenstal, Richard M, additional, Sherr, Jennifer L, additional, Mehta, Sanjeev, additional, Laffel, Lori MB, additional, Shah, Viral N, additional, Bhargava, Anuj, additional, Weinstock, Ruth S., additional, MacLeish, Sarah A, additional, DeSalvo, Daniel J, additional, Jones, Thomas C., additional, Aleppo, Grazia, additional, Buckingham, Bruce A, additional, and Ly, Trang T, additional

Published
2023
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10. Safety and glycemic outcomes during the MiniMed™ advanced hybrid closed-loop (AHCL) system pivotal trial in children and adolescents with type 1 diabetes

Author

Pihoker, Catherine, primary, Shulman, Dorothy I, additional, Forlenza, Gregory P., additional, Kaiserman, Kevin B, additional, Sherr, Jennifer L, additional, Thasher, James R, additional, Buckingham, Bruce A, additional, Kipnes, Mark S., additional, Bode, Bruce W, additional, Carlson, Anders L, additional, Lee, Scott, additional, Latif, Kashif, additional, Lilenquist, David R, additional, Slover, Robert H, additional, Dai, Zheng, additional, Niu, Fang, additional, Shin, John, additional, Jonkers, Richard A. M., additional, Roy, Anirban, additional, Grosman, Benyamin, additional, Vella, Melissa, additional, Cordero, Toni L, additional, McVean, Jennifer, additional, Rhinehart, Andrew S, additional, and Vigersky, Robert A, additional

Published
2023
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11. Consensus Recommendations for the Use of Automated Insulin Delivery Technologies in Clinical Practice

Author

Phillip, Moshe, Nimri, Revital, Bergenstal, Richard M, Barnard-Kelly, Katharine, Danne, Thomas, Hovorka, Roman, Kovatchev, Boris P, Messer, Laurel H, Parkin, Christopher G, Ambler-Osborn, Louise, Amiel, Stephanie A, Bally, Lia, Beck, Roy W, Biester, Sarah, Biester, Torben, Blanchette, Julia E, Bosi, Emanuele, Boughton, Charlotte K, Breton, Marc D, Brown, Sue A, Buckingham, Bruce A, Cai, Albert, Carlson, Anders L, Castle, Jessica R, Choudhary, Pratik, Close, Kelly L, Cobelli, Claudio, Criego, Amy B, Davis, Elizabeth, de Beaufort, Carine, de Bock, Martin I, DeSalvo, Daniel J, DeVries, J Hans, Dovc, Klemen, Doyle, Francis J, Ekhlaspour, Laya, Shvalb, Naama Fisch, Forlenza, Gregory P, Gallen, Geraldine, Garg, Satish K, Gershenoff, Dana C, Gonder-Frederick, Linda A, Haidar, Ahmad, Hartnell, Sara, Heinemann, Lutz, Heller, Simon, Hirsch, Irl B, Hood, Korey K, Isaacs, Diana, Klonoff, David C, Kordonouri, Olga, Kowalski, Aaron, Laffel, Lori, Lawton, Julia, Lal, Rayhan A, Leelarathna, Lalantha, Maahs, David M, Murphy, Helen R, Nørgaard, Kirsten, O'Neal, David, Oser, Sean, Oser, Tamara, Renard, Eric, Riddell, Michael C, Rodbard, David, Russell, Steven J, Schatz, Desmond A, Shah, Viral N, Sherr, Jennifer L, Simonson, Gregg D, Wadwa, R Paul, Ward, Candice, Weinzimer, Stuart A, Wilmot, Emma G, Battelino, Tadej, General Internal Medicine, APH - Health Behaviors & Chronic Diseases, and AGEM - Amsterdam Gastroenterology Endocrinology Metabolism

Subjects
closed-loop, Endocrinology, consensus recommendations, automated insulin delivery, type 1 diabetes, Endocrinology, Diabetes and Metabolism, 610 Medicine & health, 610 Medizin und Gesundheit
Abstract

The significant and growing global prevalence of diabetes continues to challenge people with diabetes (PwD), healthcare providers, and payers. While maintaining near-normal glucose levels has been shown to prevent or delay the progression of the long-term complications of diabetes, a significant proportion of PwD are not attaining their glycemic goals. During the past 6 years, we have seen tremendous advances in automated insulin delivery (AID) technologies. Numerous randomized controlled trials and real-world studies have shown that the use of AID systems is safe and effective in helping PwD achieve their long-term glycemic goals while reducing hypoglycemia risk. Thus, AID systems have recently become an integral part of diabetes management. However, recommendations for using AID systems in clinical settings have been lacking. Such guided recommendations are critical for AID success and acceptance. All clinicians working with PwD need to become familiar with the available systems in order to eliminate disparities in diabetes quality of care. This report provides much-needed guidance for clinicians who are interested in utilizing AIDs and presents a comprehensive listing of the evidence payers should consider when determining eligibility criteria for AID insurance coverage.

Published
2023

13. Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes.

Author

Criego, Amy B., Carlson, Anders L., Brown, Sue A., Forlenza, Gregory P., Bode, Bruce W., Levy, Carol J., Hansen, David W., Hirsch, Irl B., Bergenstal, Richard M., Sherr, Jennifer L., Mehta, Sanjeev N., Laffel, Lori M., Shah, Viral N., Bhargava, Anuj, Weinstock, Ruth S., MacLeish, Sarah A., DeSalvo, Daniel J., Jones, Thomas C., Aleppo, Grazia, and Buckingham, Bruce A.

Subjects
*TYPE 1 diabetes, *CLINICAL trial registries, *ADULTS, *INSULIN, *DIABETIC acidosis
Abstract

Background: The Omnipod® 5 Automated Insulin Delivery (AID) System was shown to be safe and effective following 3 months of use in people with type 1 diabetes (T1D); however, data on the durability of these results are limited. This study evaluated the long-term safety and effectiveness of Omnipod 5 use in people with T1D during up to 2 years of use. Materials and Methods: After a 3-month single-arm, multicenter, pivotal trial in children (6–13.9 years) and adolescents/adults (14–70 years), participants could continue system use in an extension phase. HbA1c was measured every 3 months for up to 15 months; continuous glucose monitor metrics were collected for up to 2 years. Results: Participants (N = 224) completed median (interquartile range) 22.3 (21.7, 22.7) months of AID. HbA1c was reduced in the pivotal trial from 7.7% ± 0.9% in children and 7.2% ± 0.9% in adolescents/adults to 7.0% ± 0.6% and 6.8% ± 0.7%, respectively, (P < 0.0001), and was maintained at 7.2% ± 0.7% and 6.9% ± 0.6% after 15 months (P < 0.0001 from baseline). Time in target range (70–180 mg/dL) increased from 52.4% ± 15.6% in children and 63.6% ± 16.5% in adolescents/adults at baseline to 67.9% ± 8.0% and 73.8% ± 10.8%, respectively, during the pivotal trial (P < 0.0001) and was maintained at 65.9% ± 8.9% and 72.9% ± 11.3% during the extension (P < 0.0001 from baseline). One episode of diabetic ketoacidosis and seven episodes of severe hypoglycemia occurred during the extension. Children and adolescents/adults spent median 96.1% and 96.3% of time in Automated Mode, respectively. Conclusion: Our study supports that long-term use of the Omnipod 5 AID System can safely maintain improvements in glycemic outcomes for up to 2 years of use in people with T1D. Clinical Trials Registration Number: NCT04196140 [ABSTRACT FROM AUTHOR]

Published
2024
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14. Safety and Glycemic Outcomes During the MiniMedTM Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes.

Author

Pihoker, Catherine, Shulman, Dorothy I., Forlenza, Gregory P., Kaiserman, Kevin B., Sherr, Jennifer L., Thrasher, James R., Buckingham, Bruce A., Kipnes, Mark S., Bode, Bruce W., Carlson, Anders L., Lee, Scott W., Latif, Kashif, Liljenquist, David R., Slover, Robert H., Dai, Zheng, Niu, Fang, Shin, John, Jonkers, Richard A.M., Roy, Anirban, and Grosman, Benyamin

Published
2023
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19. Increase Access, Reduce Disparities: Recommendations for Modifying Medicaid CGM Coverage Eligibility Criteria

Author

Galindo, Rodolfo J., primary, Aleppo, Grazia, additional, Parkin, Christopher G., additional, Baidal, David A., additional, Carlson, Anders L., additional, Cengiz, Eda, additional, Forlenza, Gregory P., additional, Kruger, Davida F., additional, Levy, Carol, additional, McGill, Janet B., additional, and Umpierrez, Guillermo E., additional

Published
2022
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22. Consensus Recommendations for the Use of Automated Insulin Delivery Technologies in Clinical Practice

Author

Phillip, Moshe, primary, Nimri, Revital, additional, Bergenstal, Richard M, additional, Barnard-Kelly, Katharine, additional, Danne, Thomas, additional, Hovorka, Roman, additional, Kovatchev, Boris P, additional, Messer, Laurel H, additional, Parkin, Christopher G, additional, Ambler-Osborn, Louise, additional, Amiel, Stephanie A, additional, Bally, Lia, additional, Beck, Roy W, additional, Biester, Sarah, additional, Biester, Torben, additional, Blanchette, Julia E, additional, Bosi, Emanuele, additional, Boughton, Charlotte K, additional, Breton, Marc D, additional, Brown, Sue A, additional, Buckingham, Bruce A, additional, Cai, Albert, additional, Carlson, Anders L, additional, Castle, Jessica R, additional, Choudhary, Pratik, additional, Close, Kelly L, additional, Cobelli, Claudio, additional, Criego, Amy B, additional, Davis, Elizabeth, additional, de Beaufort, Carine, additional, de Bock, Martin I, additional, DeSalvo, Daniel J, additional, DeVries, J Hans, additional, Dovc, Klemen, additional, Doyle, Francis J, additional, Ekhlaspour, Laya, additional, Shvalb, Naama Fisch, additional, Forlenza, Gregory P, additional, Gallen, Geraldine, additional, Garg, Satish K, additional, Gershenoff, Dana C, additional, Gonder-Frederick, Linda A, additional, Haidar, Ahmad, additional, Hartnell, Sara, additional, Heinemann, Lutz, additional, Heller, Simon, additional, Hirsch, Irl B, additional, Hood, Korey K, additional, Isaacs, Diana, additional, Klonoff, David C, additional, Kordonouri, Olga, additional, Kowalski, Aaron, additional, Laffel, Lori, additional, Lawton, Julia, additional, Lal, Rayhan A, additional, Leelarathna, Lalantha, additional, Maahs, David M, additional, Murphy, Helen R, additional, Nørgaard, Kirsten, additional, O’Neal, David, additional, Oser, Sean, additional, Oser, Tamara, additional, Renard, Eric, additional, Riddell, Michael C, additional, Rodbard, David, additional, Russell, Steven J, additional, Schatz, Desmond A, additional, Shah, Viral N, additional, Sherr, Jennifer L, additional, Simonson, Gregg D, additional, Wadwa, R Paul, additional, Ward, Candice, additional, Weinzimer, Stuart A, additional, Wilmot, Emma G, additional, and Battelino, Tadej, additional

Published
2022
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23. BMI, insulin sensitivity, and cognition in early type 2 diabetes: The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study.

Author

Luchsinger, José A., Kazemi, Erin J., Sanchez, Danurys L., Larkin, Mary E., Valencia, Willy Marcos, Desouza, Cyrus, Carlson, Anders L., Pop‐Busui, Rodica, Seaquist, Elizabeth R., Florez, Hermes J., and Barzilay, Joshua

Subjects
INSULIN sensitivity, TYPE 2 diabetes, COMPARATIVE method, VERBAL behavior testing, COGNITIVE testing, VERBAL memory
Abstract

Objective: This study explored the association of BMI and insulin sensitivity with cognitive performance in type 2 diabetes. Methods: A cross‐sectional analysis of data from the baseline assessment of the Glycemia Reduction Approaches in Diabetes: a Comparative Effectiveness Study (GRADE) was conducted. BMI was used as a surrogate of adiposity and the Matsuda index as the measure of insulin sensitivity. Cognitive tests included the Spanish English Verbal Learning Test, the Digit Symbol Substitution Test, and the letter and animal fluency tests. Results: Cognitive assessments were completed by 5018 (99.4%) of 5047 participants aged 56.7 ± 10.0 years, of whom 36.4% were female. Higher BMI and lower insulin sensitivity were related to better performance on memory and verbal fluency tests. In models including BMI and insulin sensitivity simultaneously, only higher BMI was related to better cognitive performance. Conclusions: In this study, higher BMI and lower insulin sensitivity in type 2 diabetes were cross‐sectionally associated with better cognitive performance. However, only higher BMI was related to cognitive performance when both BMI and insulin sensitivity were considered simultaneously. The causality and mechanisms for this association need to be determined in future studies. [ABSTRACT FROM AUTHOR]

Published
2023
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24. 100-LB: Glycemic Control Using Recommended Settings in Youth and Adults with Type 1 Diabetes (T1D) —Minimed 780G System with the Calibration-Free Guardian 4 Sensor Results

Author

VIGERSKY, ROBERT A., primary, BODE, BRUCE W., additional, BRAZG, RONALD L., additional, BUCKINGHAM, BRUCE A., additional, CARLSON, ANDERS L., additional, KAISERMAN, KEVIN B., additional, KIPNES, MARK, additional, LILJENQUIST, DAVID R., additional, PHILIS-TSIMIKAS, ATHENA, additional, PIHOKER, CATHERINE, additional, POP-BUSUI, RODICA, additional, REED, JOHN, additional, SHERR, JENNIFER, additional, SHULMAN, DOROTHY I., additional, SLOVER, ROBERT H., additional, THRASHER, JAMES, additional, CHEN, XIAOXIAO, additional, LIU, MARGARET, additional, CORDERO, TONI L., additional, VELLA, MELISSA, additional, RHINEHART, ANDREW S., additional, and SHIN, JOHN, additional

Published
2022
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28. Improved Glycemia with Hybrid Closed-Loop (HCL) Versus Continuous Subcutaneous Insulin Infusion (CSII) Therapy: Results from a Randomized Controlled Trial.

Author

Garg, Satish K., Grunberger, George, Weinstock, Ruth, Lawson, Margaret L., Hirsch, Irl B., DiMeglio, Linda A., Pop-Busui, Rodica, Philis-Tsimikas, Athena, Kipnes, Mark, Liljenquist, David R., Brazg, Ronald L., Kudva, Yogish C., Buckingham, Bruce A., McGill, Janet B., Carlson, Anders L., Criego, Amy B., Christiansen, Mark P., Kaiserman, Kevin B., Griffin, Kurt J., and Forlenza, Greg P.

Published
2023
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32. Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes

Author

Brown, Sue A., primary, Forlenza, Gregory P., primary, Bode, Bruce W., primary, Pinsker, Jordan E., primary, Levy, Carol J., primary, Criego, Amy B., primary, Hansen, David W., primary, Hirsch, Irl B., primary, Carlson, Anders L., primary, Bergenstal, Richard M., primary, Sherr, Jennifer L., primary, Mehta, Sanjeev N., primary, Laffel, Lori M., primary, Shah, Viral N., primary, Bhargava, Anuj, primary, Weinstock, Ruth S., primary, MacLeish, Sarah A., primary, DeSalvo, Daniel J., primary, Jones, Thomas C., primary, Aleppo, Grazia, primary, Buckingham, Bruce A., primary, and Ly, Trang T., primary

Published
2021
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33. 716-P: Transition from Multiple Daily Injections (MDI) to Omnipod 5 Automated Insulin Delivery System Improves A1C in Type 1 Diabetes (T1D)

Author

SHAH, VIRAL, primary, CRIEGO, AMY B., additional, CARLSON, ANDERS L., additional, BHARGAVA, ANUJ, additional, BODE, BRUCE W., additional, BROWN, SUE A., additional, FORLENZA, GREGORY P., additional, LEVY, CAROL J., additional, MEHTA, SANJEEV N., additional, LAFFEL, LORI M., additional, ALEPPO, GRAZIA, additional, BUCKINGHAM, BRUCE A., additional, DESALVO, DANIEL, additional, HIRSCH, IRL B., additional, MACLEISH, SARAH A., additional, PINSKER, JORDAN E., additional, and LY, TRANG T., additional

Published
2021
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34. 71-LB: Meta-analysis of Two Real-World Chart Review Studies to Determine the Effectiveness of FreeStyle Libre Flash Glucose Monitoring System on HbA1c in Adults with Type 2 Diabetes Managed with Basal Insulin

Author

CARLSON, ANDERS L., primary, DANIEL, TIMOTHY D., additional, DESANTIS, ANDREA, additional, JABBOUR, SERGE, additional, KARSLIOGLU-FRENCH, ESRA, additional, KRUGER, DAVIDA F., additional, MILLER, EDEN, additional, OZER, KEREM, additional, and ELLIOTT, TOM, additional

Published
2021
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37. Safety Evaluation of the Omnipod® 5 Automated Insulin Delivery System Over Three Months of Use in Adults and Adolescents With Type 1 Diabetes (T1D)

Author

Brown, Sue A, primary, Levy, Carol J, additional, Hirsch, Irl B, additional, Bode, Bruce W, additional, Carlson, Anders L, additional, Shah, Viral N, additional, Pinsker, Jordan E, additional, Weinstock, Ruth S, additional, Bhargava, Anuj, additional, Mehta, Sanjeev N, additional, Laffel, Lori M, additional, Jones, Thomas C, additional, Sherr, Jennifer L, additional, Aleppo, Grazia, additional, Forlenza, Gregory P, additional, and Ly, Trang T, additional

Published
2021
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41. Duration of Hybrid Closed-Loop Insulin Therapy to Achieve Representative Glycemic Outcomes in Adults With Type 1 Diabetes

Author

Leelarathna, Lalantha, Thabit, Hood, Willinska, Malgorzata E, Bally, Lia, Mader, Julia K, Arnolds, Sabine, Benesch, Carsten, Pieber, Thomas R, Shah, Viral N, Carlson, Anders L, Bergenstal, Richard M, Evans, Mark L, Hovorka, Roman, AP@Home04 And APCam11 Consortia, Leelarathna, Lalantha [0000-0001-9602-1962], Bally, Lia [0000-0003-1993-7672], Mader, Julia K [0000-0001-7854-4233], Shah, Viral N [0000-0002-3827-7107], Bergenstal, Richard M [0000-0002-9050-5584], and Apollo - University of Cambridge Repository

Subjects
AP@home04 and APCam11 consortia
Published
2020
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43. Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes.

Author

Carlson, Anders L., Sherr, Jennifer L., Shulman, Dorothy I., Garg, Satish K., Pop-Busui, Rodica, Bode, Bruce W., Lilenquist, David R., Brazg, Ron L., Kaiserman, Kevin B., Kipnes, Mark S., Thrasher, James R., Reed, John H. Chip, Slover, Robert H., Philis-Tsimikas, Athena, Christiansen, Mark, Grosman, Benyamin, Roy, Anirban, Vella, Melissa, Jonkers, Richard A.M., and Chen, Xiaoxiao

Subjects
*TYPE 1 diabetes, *CLOSED loop systems, *WILCOXON signed-rank test, *HYBRID systems, *ADULTS, *INSULIN therapy, *RESEARCH, *CLINICAL trials, *BLOOD sugar monitoring, *RESEARCH methodology, *BLOOD sugar, *HYPOGLYCEMIC agents, *EVALUATION research, *COMPARATIVE studies, *INSULIN pumps, *RESEARCH funding
Abstract

Introduction: This trial assessed safety and effectiveness of an advanced hybrid closed-loop (AHCL) system with automated basal (Auto Basal) and automated bolus correction (Auto Correction) in adolescents and adults with type 1 diabetes (T1D). Materials and Methods: This multicenter single-arm study involved an intent-to-treat population of 157 individuals (39 adolescents aged 14-21 years and 118 adults aged ≥22-75 years) with T1D. Study participants used the MiniMed™ AHCL system during a baseline run-in period in which sensor-augmented pump +/- predictive low glucose management or Auto Basal was enabled for ∼14 days. Thereafter, Auto Basal and Auto Correction were enabled for a study phase (∼90 days), with glucose target set to 100 or 120 mg/dL for ∼45 days, followed by the other target for ∼45 days. Study endpoints included safety events and change in mean A1C, time in range (TIR, 70-180 mg/dL) and time below range (TBR, <70 mg/dL). Run-in and study phase values were compared using Wilcoxon signed-rank test or paired t-test. Results: Overall group time spent in closed loop averaged 94.9% ± 5.4% and involved only 1.2 ± 0.8 exits per week. Compared with run-in, AHCL reduced A1C from 7.5% ± 0.8% to 7.0% ± 0.5% (<0.001, Wilcoxon signed-rank test, n = 155), TIR increased from 68.8% ± 10.5% to 74.5% ± 6.9% (<0.001, Wilcoxon signed-rank test), and TBR reduced from 3.3% ± 2.9% to 2.3% ± 1.7% (<0.001, Wilcoxon signed-rank test). Similar benefits to glycemia were observed for each age group and were more pronounced for the nighttime (12 AM-6 AM). The 100 mg/dL target increased TIR to 75.4% (n = 155), which was further optimized at a lower active insulin time (AIT) setting (i.e., 2 h), without increasing TBR. There were no severe hypoglycemic or diabetic ketoacidosis events during the study phase. Conclusions: These findings show that the MiniMed AHCL system is safe and allows for achievement of recommended glycemic targets in adolescents and adults with T1D. Adjustments in target and AIT settings may further optimize glycemia and improve user experience. Clinical Trial Registration number: NCT03959423. [ABSTRACT FROM AUTHOR]

Published
2022
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44. 97-LB: Safety and Glycemic Outcomes of the MiniMed Advanced Hybrid Closed-Loop (AHCL) System in Subjects with T1D

Author

CARLSON, ANDERS L., primary, BODE, BRUCE W., additional, BRAZG, RONALD L., additional, CHRISTIANSEN, MARK P., additional, GARG, SATISH K., additional, KAISERMAN, KEVIN, additional, KIPNES, MARK, additional, LILJENQUIST, DAVID R., additional, PHILIS-TSIMIKAS, ATHENA, additional, POP-BUSUI, RODICA, additional, SHERR, JENNIFER, additional, SHULMAN, DOROTHY I., additional, SINGH, KAMALPREET K., additional, SLOVER, ROBERT H., additional, THRASHER, JAMES, additional, CHEN, XIAOXIAO, additional, GROSMAN, BENYAMIN, additional, LEE, SCOTT W., additional, LINTEREUR, LOUIS J., additional, LIU, MARGARET, additional, PARIKH, NEHA, additional, RHINEHART, ANDREW S., additional, PENG, FEN, additional, ROY, ANIRBAN, additional, SHIN, JOHN, additional, WU, DI, additional, and VIGERSKY, ROBERT, additional

Published
2020
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48. HbA1c

Author

Carlson, Anders L., primary, Criego, Amy B., additional, Martens, Thomas W., additional, and Bergenstal, Richard M., additional

Published
2020
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49. Duration of Hybrid Closed-Loop Insulin Therapy to Achieve Representative Glycemic Outcomes in Adults With Type 1 Diabetes

Author

Leelarathna, Lalantha, primary, Thabit, Hood, additional, Willinska, Malgorzata E., additional, Bally, Lia, additional, Mader, Julia K., additional, Arnolds, Sabine, additional, Benesch, Carsten, additional, Pieber, Thomas R., additional, Shah, Viral N., additional, Carlson, Anders L., additional, Bergenstal, Richard M., additional, Evans, Mark L., additional, and Hovorka, Roman, additional

Published
2020
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50. In Response

Author

Smith, Charles L. and Carlson, Anders L.

Published
2009

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