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1. A Randomized Clinical Trial Assessing Continuous Glucose Monitoring (CGM) Use With Standardized Education With or Without a Family Behavioral Intervention Compared With Fingerstick Blood Glucose Monitoring in Very Young Children With Type 1 Diabetes.

Author

Laffel, Lori, Harrington, Kara, Hanono, Anat, Naik, Nisha, Ambler-Osborn, Louise, Schultz, Alan, DiMeglio, Linda, Woerne, Stephanie, Jolivette, Heather, Ismail, Heba, Tebbe, Megan, Newman, America, Legge, Megan, Tamborlane, William, Van Name, Michelle, Weyman, Kate, Finnegan, Jennifer, Steffen, Amy, Zgorski, Melinda, DeSalvo, Daniel, Hilliard, Marisa, DeLaO, Kylie, Xie, Cicilyn, Levy, Wendy, Wadwa, R Paul, Forlenza, Greg, Majidi, Shideh, Alonso, Guy, Weber, Isabel, Clay, Michelle, Simmons, Emily, Nathan, Brandon, Sunni, Muna, Sweet, Jessica, Pappenfus, Beth, Kogler, Anne, Ludwig, Marrissa, Nelson, Brittney, Street, Anne, Weingartner, Darcy, Albanese-O’Neill, Anastasia, Haller, Michael, Adams, Janey, Cintron, Miriam, Thomas, Nicole, Kelley, Jennifer, Simmons, Jill, William, George, Brendle, Faith, Goland, Robin, Williams, Kristen, Gandica, Rachelle, Pollak, Sarah, Casciano, Emily, Robinson, Elizabeth, Willi, Steven, Minnock, Pantea, Olivos, Diana, Carchidi, Cathy, Grant, Brian, Wong, Jenise C, Adi, Saleh, Corathers, Sarah, Sheanon, Nicole, Fox, Cathy, Weis, Tammy, MacLeish, Sarah, Wood, Jamie, Casey, Terri, Campbell, Wendy, McGuigan, Paul, Wintergerst, Kupper, Watson, Sara, Kingery, Suzanne, Pierce, Gwen, Ruch, Heather, Rayborn, Lauren, Rodriguez-Luna, Manuel, and Deuser, Amy

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Pediatric, Diabetes, Prevention, Metabolic and endocrine, Adolescent, Blood Glucose, Blood Glucose Self-Monitoring, Child, Child, Preschool, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Quality of Life, Strategies to Enhance New CGM Use in Early Childhood (SENCE) Study Group, Medical and Health Sciences, Endocrinology & Metabolism, Biomedical and clinical sciences, Health sciences
Abstract

ObjectiveThis study evaluated the effects of continuous glucose monitoring (CGM) combined with family behavioral intervention (CGM+FBI) and CGM alone (Standard-CGM) on glycemic outcomes and parental quality of life compared with blood glucose monitoring (BGM) in children ages 2 to

Published
2021

2. Cambridge hybrid closed-loop algorithm in children and adolescents with type 1 diabetes: a multicentre 6-month randomised controlled trial

Author

Hovorka, R, Acerini, C L, Thankamony, A, Allen, J M, Boughton, C K, Dovc, K, Dunger, D B, Ware, J, Musolino, G, Tauschmann, M, Wilinska, M E, Hayes, J F, Hartnell, S, Slegtenhorst, S, Ruan, Y, Haydock, M, Mangat, J, Denvir, L, Kanthagnany, SK, Law, J, Randell, T, Sachdev, P, Saxton, M, Coupe, A, Stafford, S, Ball, A, Keeton, R, Cresswell, R, Crate, L, Cripps, H, Fazackerley, H, Looby, L, Navarra, H, Saddington, C, Smith, V, Verhoeven, V, Bratt, S, Khan, N, Moyes, L, Sandhu, K, West, C, Wadwa, R P, Alonso, G, Forlenza, G, Slover, R, Towers, L, Berget, C, Coakley, A, Escobar, E, Jost, E, Lange, S, Messer, L, Thivener, K, Campbell, F M, Yong, J, Metcalfe, E, Allen, M, Ambler, S, Waheed, S, Exall, J, Tulip, J, Buckingham, B A, Ekhlaspour, L, Maahs, D, Norlander, L, Jacobson, T, Twon, M, Weir, C, Leverenz, B, Keller, J, Davis, N, Kumaran, A, Trevelyan, N, Dewar, H, Price, G, Crouch, G, Ensom, R, Haskell, L, Lueddeke, LM, Mauras, N, Benson, M, Bird, K, Englert, K, Permuy, J, Ponthieux, K, Marrero-Hernandez, J, DiMeglio, L A, Ismail, H, Jolivette, H, Sanchez, J, Woerner, S, Kirchner, M, Mullen, M, Tebbe, M, Besser, R EJ, Basu, S, London, R, Makaya, T, Ryan, F, Megson, C, Bowen-Morris, J, Haest, J, Law, R, Stamford, I, Ghatak, A, Deakin, M, Phelan, K, Thornborough, K, Shakeshaft, J, Weinzimer, S A, Cengiz, E, Sherr, J L, Van Name, M, Weyman, K, Carria, L, Steffen, A, Zgorski, M, Sibayan, J, Beck, R W, Borgman, S, Davis, J, Rusnak, J, Hellman, A, Cheng, P, Kanapka, L, Kollman, C, McCarthy, C, Chalasani, S, Hood, K K, Hanes, S, Viana, J, Lanning, M, Fox, D S, Arreaza-Rubin, G, Eggerman, T, Green, N, Janicek, R, Gabrielson, D, Belle, S H, Castle, J, Green, J, Legault, L, Willi, S M, Wysham, C, Ware, Julia, Boughton, Charlotte K, Allen, Janet M, Wilinska, Malgorzata E, Tauschmann, Martin, Denvir, Louise, Thankamony, Ajay, Campbell, Fiona M, Wadwa, R Paul, Buckingham, Bruce A, Davis, Nikki, DiMeglio, Linda A, Mauras, Nelly, Besser, Rachel E J, Ghatak, Atrayee, Weinzimer, Stuart A, Hood, Korey K, Fox, D Steven, Kanapka, Lauren, Kollman, Craig, Sibayan, Judy, Beck, Roy W, and Hovorka, Roman

Published
2022
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3. Health-Related Quality of Life in Parents and Partners of People With type 1 diabetes: Development and Validation of Type 1 Diabetes and Life (TIDAL) Measures

Author

Hilliard, Marisa E., Minard, Charles G., Marrero, David G., Wit, Maartje de, DuBose, Stephanie N., Verdejo, Alandra, Jaser, Sarah S., Kruger, Davida, Monzavi, Roshanak, Shah, Viral N., Wadwa, R. Paul, Weinstock, Ruth S., Thompson, Debbe, Cao, Viena T., and Anderson, Barbara J.

Subjects
Psychological aspects, Social aspects, Care and treatment, Health aspects, Family relations -- Health aspects -- Psychological aspects, Quality of life -- Social aspects -- Health aspects, Type 1 diabetes -- Social aspects -- Care and treatment, Domestic relations -- Health aspects -- Psychological aspects
Abstract

Patient-reported outcomes are important to assess and report in clinical trials and patient care (Lohr & Zebrack, 2009), especially for people with chronic conditions including type 1 diabetes (T1D) (Agiostratidou [...], Introduction: Despite the significant impact of type 1 diabetes (T1D) on family, few instruments are available to assess health-related quality of life (HRQOL) among family members of people with T1D. This study aimed to develop and evaluate the psychometric properties of new measures of diabetes-specific HRQOL for parents and partners of people with T1D. We report on the multistep development and validation process for the self-report Type 1 Diabetes and Life (TIDAL) measures, with versions for parents of youth age Public Significance Statement This study developed a set of validated questionnaires to measure health-related quality of life in parents and partners of people with type 1 diabetes. The experiences of family members are important and have implications for the health and well-being of people with diabetes, yet there have been few measures to accurately and reliably assess their quality of life. These new measures can be used in clinical practice and research settings. Keywords: patient-reported outcomes, quality of life, psychosocial, assessment, family Supplemental materials: https://doi.org/10.1037/fsh0000507.supp

Published
2021
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4. Insulin dose optimization using an automated artificial intelligence-based decision support system in youths with type 1 diabetes

Author

Nimri, Revital, Battelino, Tadej, Laffel, Lori M., Slover, Robert H., Schatz, Desmond, Weinzimer, Stuart A., Dovc, Klemen, Danne, Thomas, Phillip, Moshe, Shalitin, Shlomit, Bello, Rachel, Nevo-Shenker, Michal, Fisch-Shvalb, Naama, Shiovitch-Mantzuri, Galit, Choresh, Orit, Drutz, Irit, Nava, Yehiel, Hemo, Alona, Hermon, Orna, Nave, Rachel, Bratina, Natasa, Smigoe-Schweiger, Darja, Mali, Brigita, Gianini, Ana, Sever, Urska, Berkopec, Barbara Murn, Katz, Michelle, Isganaitis, Elvira, Mehta, Sanjeev, Quinn, Heidi, Naik, Nisha, Guo, Zijing, Volkening, Lisa, Forlenza, Gregory, Wadwa, R. Paul, Alfonso, G. Todd, Messer, Laurell, Towers, Lindsay, Thivener, Katie, Berget, Cari, Lange, Samantha, Jost, Emily, Rossick-Solis, Maria, Haller, Michael, Hiers, Paul, Jacobsen, Laura, Smith, Madison, O'Neill, Anastasia, Hosford, Jennifer, Perry, Alexis, Cengiz, Eda, Sherr, Jennifer, Gibbons, Kathryn, Carria, Lori, Zgorski, Melinda, Biester, Torben, Kordonouri, Olga, von dem Berge, Thekla, Biester, Sarah, and Remus, Kerstin

Subjects
Technology application, Care and treatment, Usage, Artificial intelligence, Artificial intelligence -- Usage, Youth -- Care and treatment, Insulin pumps -- Usage, Diabetes therapy -- Technology application, Type 1 diabetes -- Care and treatment, Teenagers -- Care and treatment
Abstract

Author(s): Revital Nimri [sup.1] , Tadej Battelino [sup.2] , Lori M. Laffel [sup.3] , Robert H. Slover [sup.4] , Desmond Schatz [sup.5] , Stuart A. Weinzimer [sup.6] , Klemen Dovc [...], Despite the increasing adoption of insulin pumps and continuous glucose monitoring devices, most people with type 1 diabetes do not achieve their glycemic goals.sup.1. This could be related to a lack of expertise or inadequate time for clinicians to analyze complex sensor-augmented pump data. We tested whether frequent insulin dose adjustments guided by an automated artificial intelligence-based decision support system (AI-DSS) is as effective and safe as those guided by physicians in controlling glucose levels. ADVICE4U was a six-month, multicenter, multinational, parallel, randomized controlled, non-inferiority trial in 108 participants with type 1 diabetes, aged 10-21 years and using insulin pump therapy (ClinicalTrials.gov no. NCT03003806). Participants were randomized 1:1 to receive remote insulin dose adjustment every three weeks guided by either an AI-DSS, (AI-DSS arm, n = 54) or by physicians (physician arm, n = 54). The results for the primary efficacy measure--the percentage of time spent within the target glucose range (70-180 mg dl.sup.-1 (3.9-10.0 mmol l.sup.-1))--in the AI-DSS arm were statistically non-inferior to those in the physician arm (50.2 [plus or minus] 11.1% versus 51.6 [plus or minus] 11.3%, respectively, P < 1 × 10.sup.-7). The percentage of readings below 54 mg dl.sup.-1 ( The randomized-controlled trial ADVICE4U demonstrates non-inferiority of an automated AI-based decision support system compared with advice from expert physicians for optimal insulin dosing in youths with type 1 diabetes.

Published
2020
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6. 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
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8. Nasal Glucagon Reverses Insulin-induced Hypoglycemia With Less Rebound Hyperglycemia: Pooled Analysis of Clinical Trials.

Author

Seaquist, Elizabeth, Giménez, Marga, Yan, Yu, Matsuhisa, Munehide, Kao, Christi Yuting, Wadwa, R Paul, Nagai, Yukiko, and Khunti, Kamlesh

Subjects
HYPOGLYCEMIA, TYPE 1 diabetes, HYPERGLYCEMIA, GLUCAGON, TYPE 2 diabetes, INSULIN pumps, BLOOD sugar monitors
Abstract

Background Rebound hyperglycemia may occur following glucagon treatment for severe hypoglycemia. We assessed rebound hyperglycemia occurrence after nasal glucagon (NG) or injectable glucagon (IG) administration in patients with type 1 diabetes (T1D) and type 2 diabetes (T2D). Methods This was a pooled analysis of 3 multicenter, randomized, open-label studies (NCT03339453, NCT03421379, NCT01994746) in patients ≥18 years with T1D or T2D with induced hypoglycemia. Proportions of patients achieving treatment success [blood glucose (BG) increase to ≥70 mg/dL or increase of ≥20 mg/dL from nadir within 15 and 30 minutes]; BG ≥70 mg/dL within 15 minutes; in-range BG (70-180 mg/dL) 1 to 2 and 1 to 4 hours postdose; and BG >180 mg/dL 1 to 2 and 1 to 4 hours postdose were compared. Incremental area under curve (iAUC) of BG >180 mg/dL and area under curve (AUC) of observed BG values postdose were analyzed. Safety was assessed in all studies. Results Higher proportions of patients had in-range BG with NG vs IG (1-2 hours: P =.0047; 1-4 hours: P =.0034). Lower proportions of patients had at least 1 BG value >180 mg/dL with NG vs IG (1-2 hours: P =.0034; 1-4 hours: P =.0068). iAUC and AUC were lower with NG vs IG (P =.025 and P <.0001). As expected, similar proportions of patients receiving NG or IG achieved treatment success at 15 and 30 minutes (97-100%). Most patients had BG ≥70 mg/dL within 15 minutes (93-96%). The safety profile was consistent with previous studies. Conclusion This study demonstrated lower rebound hyperglycemia risk after NG treatment compared with IG. Clinical Trial Registration NCT03421379, NCT03339453, NCT01994746 [ABSTRACT FROM AUTHOR]

Published
2024
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9. Increasing Use of Diabetes Devices: What Do Health Care Professionals Need?

Author

Messer, Laurel H., primary, Vigers, Tim, additional, Akturk, Halis K., additional, Forlenza, Gregory P., additional, Huss, Kelsey B., additional, Karami, Angela J., additional, Malecha, Emily, additional, Oser, Sean M., additional, Polsky, Sarit, additional, Pyle, Laura, additional, Shah, Viral N., additional, Wadwa, R. Paul, additional, and Oser, Tamara K., additional

Published
2023
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11. Continuous Glucose Monitoring Provides Durable Glycemic Benefit in Adolescents and Young Adults with Type 1 Diabetes: 12-Month Follow-Up Results.

Author

Miller, Kellee M., Bauza, Colleen, Kanapka, Lauren G., Clements, Mark A., DeSalvo, Daniel J., Hood, Korey, Messer, Laurel H., Sherr, Jennifer, Bergamo, Katherine, Criego, Amy, Freiner, Emily, Lyons, Sarah K., Monzavi, Roshanak, Moore, Wayne, Prahalad, Priya, Simmons, Jill H., Sulik, Mark, Wadwa, R. Paul, Weinstock, Ruth S., and Willi, Steven M.

Subjects
CONTINUOUS glucose monitoring, GLYCOSYLATED hemoglobin, SCIENTIFIC observation, BLOOD sugar monitoring, GLYCEMIC control, TYPE 1 diabetes, TREATMENT effectiveness, COMPARATIVE studies, DESCRIPTIVE statistics, HYPOGLYCEMIA, EVALUATION
Abstract

Objective. To further evaluate glycemic outcomes during the observational extension phase of the Continuous Glucose Monitoring (CGM) Intervention for Teens and Young Adults randomized clinical trial (RCT). Subjects and Methods. Following a 26-week RCT comparing CGM with blood glucose monitoring (BGM) in 153 adolescents and young adults aged 14 to <25 years old with suboptimally controlled type 1 diabetes, 70 (89%) participants in the BGM group initiated use of CGM (referred to as BGM–CGM cohort), and 70 (95%) participants in the CGM group continued to use of CGM (CGM–CGM cohort) for an additional 26 weeks. Results. In the CGM–CGM cohort, mean hemoglobin A1c (HbA1c) decreased from 8.9% ± 0.9% (74 ± 9.8 mmol/mol) at randomization to 8.3% ± 1.3% (67 ± 14.2 mmol/mol) at 52 weeks (p < 0.001); however, significant improvement in time in target range (TIR) 70–180 mg/dL was not observed from prerandomization (38% ± 13%) to 52 weeks (41% ± 18%). Median percent time <70 mg/dL decreased from 3.0% before randomization to 1.1% at 52 weeks (p < 0.001). In the BGM–CGM cohort, mean HbA1c decreased from 8.9% ± 1.2% (74 ± 13.1 mmol/mol) before CGM initiation to 8.5% ± 1.3% (69 ± 14.2 mmol/mol) after 26 weeks of CGM use (p < 0.001) and mean TIR increased from 34% ± 12% to 38% ± 15% (p = 0.01). The median percent time <70 mg/dL decreased from 3.3% before CGM initiation to 1.2% after 26 weeks of CGM use (p < 0.001). No participants discontinued CGM use during the extension phase. Conclusions. This further evaluation of CGM supports the findings of the preceding RCT that use of CGM improves glycemic control and reduces hypoglycemia in adolescents and young adults with type 1 diabetes. This trial is registered with NCT03263494. [ABSTRACT FROM AUTHOR]

Published
2023
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12. Health Care Transition to Adult Care in Type 1 Diabetes: Associations With Student and Employment Status—The SEARCH for Diabetes in Youth Study.

Author

Majidi, Shideh, Roberts, Alissa J., Suerken, Cynthia K., Reboussin, Beth A., Malik, Faisal S., Marcovina, Santica M., Corathers, Sarah, Reynolds, Kristi, Imperatore, Giuseppina, Wadwa, R. Paul, and Pihoker, Catherine

Subjects
RESEARCH, ANALYSIS of variance, CONFIDENCE intervals, TRANSITIONAL care, TIME, TYPE 1 diabetes, EMPLOYMENT, STUDENTS, DESCRIPTIVE statistics, QUESTIONNAIRES, CHI-squared test, RESEARCH funding, LOGISTIC regression analysis, ODDS ratio, ADULTS
Abstract

Successful transition from a pediatric to adult diabetes care provider is associated with reduced ambulatory diabetes care visits and increased acute complications. This study aimed to determine whether the degree of independence in diabetes care and the rate of acute complications after transition to adult diabetes care were associated with individuals' student or employment status. Nonstudents were found to be less likely than students to be independent with diabetes care, and employed nonstudents were at lower risk of diabetic ketoacidosis than unemployed nonstudents. Additional support may be needed for young adults who are not students or are unemployed to improve independence and reduce the risk for acute complications. [ABSTRACT FROM AUTHOR]

Published
2023
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13. 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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14. The Insulin-Only Bionic Pancreas Improves Glycemic Control in Non-Hispanic White and Minority Adults and Children With Type 1 Diabetes.

Author

Castellanos, Luz E., Russell, Steven J., Damiano, Edward R., Beck, Roy W., Shah, Viral N., Bailey, Ryan, Calhoun, Peter, Bird, Keisha, Mauras, Nelly, Bionic Pancreas Research Group, Wadwa, R. Paul, Forlenza, Greg, Slover, Robert, Messer, Laurel, Cobry, Erin, Shah, Viral, Polsky, Sarit, Jost, Emily, Berget, Cari, and Towers, Lindsey

Abstract

OBJECTIVE: We evaluated the performance of the iLet bionic pancreas (BP) in non-Hispanic White individuals (here referred to as "Whites") and in Black, Hispanic, and other individuals (here collectively referred to as "Minorities"). RESEARCH DESIGN AND METHODS: A multicenter, randomized controlled trial evaluated glycemic management with the BP versus standard of care (SC) in 161 adult and 165 pediatric participants with type 1 diabetes over 13 weeks. RESULTS: In Whites (n = 240), the mean baseline-adjusted difference in 13-week HbA1c between the BP and SC groups was −0.45% (95% CI −0.61 to −0.29 [−4.9 mmol/mol; −6.6 to −3.1]; P < 0.001), while this difference among Minorities (n = 84) was −0.53% (−0.83 to −0.24 [−6.0 mmol/mol; −9.2 to −2.8]; P < 0.001). In Whites, the mean baseline-adjusted difference in time in range between the BP and SC groups was 10% (95% CI 7–12; P < 0.001) and in Minorities was 14% (10–18; P < 0.001). CONCLUSIONS: The BP improves glycemic control in both Whites and Minorities and offers promise in decreasing health care disparities. [ABSTRACT FROM AUTHOR]

Published
2023
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23. 136-LB: Health Care Professional (HCP) Perspectives on Support Tools for Diabetes Devices

Author

MESSER, LAUREL H., primary, VIGERS, TIMOTHY B., additional, AKTURK, HALIS K., additional, FORLENZA, GREGORY P., additional, HUSS, KELSEY B., additional, KARAMI, ANGELA J., additional, MALECHA, EMILY, additional, OSER, SEAN, additional, POLSKY, SARIT, additional, PYLE, LAURA, additional, SHAH, VIRAL, additional, WADWA, R. PAUL, additional, and OSER, TAMARA, additional

Published
2022
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24. Cambridge hybrid closed-loop algorithm in children and adolescents with type 1 diabetes: a multicentre 6-month randomised controlled trial

Author

Ware, Julia, primary, Boughton, Charlotte K, additional, Allen, Janet M, additional, Wilinska, Malgorzata E, additional, Tauschmann, Martin, additional, Denvir, Louise, additional, Thankamony, Ajay, additional, Campbell, Fiona M, additional, Wadwa, R Paul, additional, Buckingham, Bruce A, additional, Davis, Nikki, additional, DiMeglio, Linda A, additional, Mauras, Nelly, additional, Besser, Rachel E J, additional, Ghatak, Atrayee, additional, Weinzimer, Stuart A, additional, Hood, Korey K, additional, Fox, D Steven, additional, Kanapka, Lauren, additional, Kollman, Craig, additional, Sibayan, Judy, additional, Beck, Roy W, additional, Hovorka, Roman, additional, Hovorka, R, additional, Acerini, C L, additional, Thankamony, A, additional, Allen, J M, additional, Boughton, C K, additional, Dovc, K, additional, Dunger, D B, additional, Ware, J, additional, Musolino, G, additional, Tauschmann, M, additional, Wilinska, M E, additional, Hayes, J F, additional, Hartnell, S, additional, Slegtenhorst, S, additional, Ruan, Y, additional, Haydock, M, additional, Mangat, J, additional, Denvir, L, additional, Kanthagnany, SK, additional, Law, J, additional, Randell, T, additional, Sachdev, P, additional, Saxton, M, additional, Coupe, A, additional, Stafford, S, additional, Ball, A, additional, Keeton, R, additional, Cresswell, R, additional, Crate, L, additional, Cripps, H, additional, Fazackerley, H, additional, Looby, L, additional, Navarra, H, additional, Saddington, C, additional, Smith, V, additional, Verhoeven, V, additional, Bratt, S, additional, Khan, N, additional, Moyes, L, additional, Sandhu, K, additional, West, C, additional, Wadwa, R P, additional, Alonso, G, additional, Forlenza, G, additional, Slover, R, additional, Towers, L, additional, Berget, C, additional, Coakley, A, additional, Escobar, E, additional, Jost, E, additional, Lange, S, additional, Messer, L, additional, Thivener, K, additional, Campbell, F M, additional, Yong, J, additional, Metcalfe, E, additional, Allen, M, additional, Ambler, S, additional, Waheed, S, additional, Exall, J, additional, Tulip, J, additional, Buckingham, B A, additional, Ekhlaspour, L, additional, Maahs, D, additional, Norlander, L, additional, Jacobson, T, additional, Twon, M, additional, Weir, C, additional, Leverenz, B, additional, Keller, J, additional, Davis, N, additional, Kumaran, A, additional, Trevelyan, N, additional, Dewar, H, additional, Price, G, additional, Crouch, G, additional, Ensom, R, additional, Haskell, L, additional, Lueddeke, LM, additional, Mauras, N, additional, Benson, M, additional, Bird, K, additional, Englert, K, additional, Permuy, J, additional, Ponthieux, K, additional, Marrero-Hernandez, J, additional, DiMeglio, L A, additional, Ismail, H, additional, Jolivette, H, additional, Sanchez, J, additional, Woerner, S, additional, Kirchner, M, additional, Mullen, M, additional, Tebbe, M, additional, Besser, R EJ, additional, Basu, S, additional, London, R, additional, Makaya, T, additional, Ryan, F, additional, Megson, C, additional, Bowen-Morris, J, additional, Haest, J, additional, Law, R, additional, Stamford, I, additional, Ghatak, A, additional, Deakin, M, additional, Phelan, K, additional, Thornborough, K, additional, Shakeshaft, J, additional, Weinzimer, S A, additional, Cengiz, E, additional, Sherr, J L, additional, Van Name, M, additional, Weyman, K, additional, Carria, L, additional, Steffen, A, additional, Zgorski, M, additional, Sibayan, J, additional, Beck, R W, additional, Borgman, S, additional, Davis, J, additional, Rusnak, J, additional, Hellman, A, additional, Cheng, P, additional, Kanapka, L, additional, Kollman, C, additional, McCarthy, C, additional, Chalasani, S, additional, Hood, K K, additional, Hanes, S, additional, Viana, J, additional, Lanning, M, additional, Fox, D S, additional, Arreaza-Rubin, G, additional, Eggerman, T, additional, Green, N, additional, Janicek, R, additional, Gabrielson, D, additional, Belle, S H, additional, Castle, J, additional, Green, J, additional, Legault, L, additional, Willi, S M, additional, and Wysham, C, additional

Published
2022
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25. Long-term Continuous Glucose Monitor Use in Very Young Children With Type 1 Diabetes: One-Year Results From the SENCE Study

Author

Van Name, Michelle A., primary, Kanapka, Lauren G., additional, DiMeglio, Linda A., additional, Miller, Kellee M., additional, Albanese-O’Neill, Anastasia, additional, Commissariat, Persis, additional, Corathers, Sarah D., additional, Harrington, Kara R., additional, Hilliard, Marisa E., additional, Anderson, Barbara J., additional, Kelley, Jennifer C., additional, Laffel, Lori M., additional, MacLeish, Sarah A., additional, Nathan, Brandon M., additional, Tamborlane, William V., additional, Wadwa, R. Paul, additional, Willi, Steven M., additional, Williams, Kristen M., additional, Wintergerst, Kupper A., additional, Woerner, Stephanie, additional, Wong, Jenise C., additional, and DeSalvo, Daniel J., additional

Published
2022
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27. Association of Insulin Regimen and Estimated Body Fat Over Time among Youths and Young Adults with Type 1 Diabetes: The SEARCH for Diabetes in Youth Study

Author

Kahkoska, Anna R., primary, Sarteau, Angelica Cristello, additional, Igudesman, Daria, additional, Reboussin, Beth A., additional, Dabelea, Dana, additional, Dolan, Lawrence M., additional, Jensen, Elizabeth, additional, Wadwa, R. Paul, additional, Pihoker, Catherine, additional, and Mayer-Davis, Elizabeth J., additional

Published
2022
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31. Corrigendum to 'Design and psychometrics for new measures of health-related quality of life in adults with type 1 diabetes: Type 1 Diabetes and Life (T1DAL)' [Diabetes Research and Clinical Practice 174 (2021) 108537] (Diabetes Research and Clinical Practice (2021) 174, (S0168822720307944), (10.1016/j.diabres.2020.108537))

Author

Hilliard, Marisa E., Marrero, David G., Minard, Charles G., Cao, Viena T., de Wit, Maartje, DuBose, Stephanie N., Verdejo, Alandra, Jaser, Sarah S., Kruger, Davida, Monzavi, Roshanak, Shah, Viral N., Wadwa, R. Paul, Weinstock, Ruth S., Thompson, Debbe, Anderson, Barbara J., Medical psychology, APH - Mental Health, and Amsterdam Reproduction & Development (AR&D)

Subjects
behavioral disciplines and activities
Abstract

The authors regret to inform of some small typographical errors in number of items reported for 2 factors of the T1DAL Adult-2 questionnaire, the total number of items reported for the T1DAL-Older Adult questionnaire, and the number of items reported for one factor of the T1DAL-Older Adult questionnaire. The correct numbers of items are as follows: T1DAL Adult-2 questionnaire has 4 items on the Financial Considerations factor and 4 items on the Handling Diabetes Well factor. The T1DAL-Older Adult has 22 items in total, and 11 items on the Emotional Experiences and Social Isolation factor. The errors have been corrected within the abstract, results section (3.0.2. Phase 2), and Fig. 1. The authors would like to apologize for any inconvenience caused.

Published
2021
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37. A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes

Author

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, University of Virginia [Charlottesville], Jaeb Center for Health Research, Stanford University, Barbara Davis Center for Childhood Diabetes (BDC), University of Colorado Anschutz [Aurora], Yale University School of Medicine, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), and Université de Montpellier (UM)

Subjects
medicine.medical_specialty, MESH: Hypoglycemia, MEDLINE, Insulin delivery, MESH: Insulin, 030204 cardiovascular system & hematology, Artificial pancreas, law.invention, 03 medical and health sciences, MESH: Insulin Infusion Systems, MESH: Diabetic Ketoacidosis, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Diabetes mellitus, MESH: Child, MESH: Hypoglycemic Agents, medicine, 030212 general & internal medicine, Glycemic, MESH: Adolescent, Type 1 diabetes, MESH: Humans, business.industry, MESH: Injections, Subcutaneous, General Medicine, medicine.disease, MESH: Male, 3. Good health, MESH: Glycated Hemoglobin A, medicine.anatomical_structure, MESH: Infusion Pumps, Implantable, MESH: Blood Glucose, Pancreas, business, MESH: Diabetes Mellitus, Type 1, MESH: Female, MESH: Pancreas, Artificial, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

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

Published
2020
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41. Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial.

Author

Sherr, Jennifer L., Bode, Bruce W., Forlenza, Gregory P., Laffel, Lori M., Schoelwer, Melissa J., Buckingham, Bruce A., Criego, Amy B., DeSalvo, Daniel J., MacLeish, Sarah A., Hansen, David W., Ly, Trang T., Weyman, Kate, Tichy, Eileen, VanName, Michelle, Brei, Michelle, Zgorski, Melinda, Steffen, Amy, Carria, Lori, Busby, Anna, and Wadwa, R. Paul

Subjects
INSULIN therapy, RESEARCH, CLINICAL trials, RESEARCH methodology, TYPE 1 diabetes, BLOOD sugar, HYPOGLYCEMIC agents, EVALUATION research, INSULIN, COMPARATIVE studies, HYPOGLYCEMIA, INSULIN pumps
Abstract

Objective: Very young children with type 1 diabetes often struggle to achieve glycemic targets, putting them at risk for long-term complications and creating an immense management burden for caregivers. We conducted the first evaluation of the Omnipod 5 Automated Insulin Delivery System in this population.Research Design and Methods: A total of 80 children aged 2.0-5.9 years used the investigational system in a single-arm study for 13 weeks following 14 days of baseline data collection with their usual therapy.Results: There were no episodes of severe hypoglycemia or diabetic ketoacidosis. By study end, HbA1c decreased by 0.55% (6.0 mmol/mol) (P < 0.0001). Time with sensor glucose levels in target range 70-180 mg/dL increased by 10.9%, or 2.6 h/day (P < 0.0001), while time with levels <70 mg/dL declined by median 0.27% (P = 0.0204).Conclusions: Use of the automated insulin delivery system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase compared with baseline. [ABSTRACT FROM AUTHOR]

Published
2022
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44. Extended Use of the Control-IQ Closed-Loop Control System in Children With Type 1 Diabetes

Author

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

Published
2021
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48. 978-P: Omnipod Personalized MPC Algorithm at Target Glucose of 110mg/dl Is Safe in Adults and Adolescents without Increasing Risk of Hypoglycemia

Author

FORLENZA, GREGORY P., primary, BUCKINGHAM, BRUCE A., additional, SHERR, JENNIFER, additional, WADWA, R. PAUL, additional, GALDERISI, ALFONSO, additional, EKHLASPOUR, LAYA, additional, BERGET, CARI, additional, HSU, LIANA, additional, ZGORSKI, MELINDA, additional, LEE, JOON BOK, additional, OCONNOR, JASON B., additional, DUMAIS, BONNIE, additional, VIENNEAU, TODD, additional, HUYETT, LAUREN M., additional, and LY, TRANG T., additional

Published
2020
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49. 195-OR: Safety and Performance of the Tandem T:slim X2 with Control-IQ Automated Insulin Delivery System in Preschoolers, Age 2-6 Years Old

Author

EKHLASPOUR, LAYA, primary, FORLENZA, GREGORY P., additional, SCHOELWER, MELISSA, additional, DEBOER, MARK D., additional, HSU, LIANA, additional, KINGMAN, RYAN S., additional, BORANIAN, EMILY, additional, EMORY, EMMA, additional, WADWA, R. PAUL, additional, BUCKINGHAM, BRUCE A., additional, and BRETON, MARC D., additional

Published
2020
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