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

Author

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, and Beck, Roy

Subjects
Adolescent, Blood Glucose, Child, Diabetes Mellitus, Type 1, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems
Abstract

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

Published
2021

4. Continuous glucose monitoring and metrics for clinical trials: an international consensus statement

Author

Battelino, Tadej, Alexander, Charles M, Amiel, Stephanie A, Arreaza-Rubin, Guillermo, Beck, Roy W, Bergenstal, Richard M, Buckingham, Bruce A, Carroll, James, Ceriello, Antonio, Chow, Elaine, Choudhary, Pratik, Close, Kelly, Danne, Thomas, Dutta, Sanjoy, Gabbay, Robert, Garg, Satish, Heverly, Julie, Hirsch, Irl B, Kader, Tina, Kenney, Julia, Kovatchev, Boris, Laffel, Lori, Maahs, David, Mathieu, Chantal, Mauricio, Dídac, Nimri, Revital, Nishimura, Rimei, Scharf, Mauro, Del Prato, Stefano, Renard, Eric, Rosenstock, Julio, Saboo, Banshi, Ueki, Kohjiro, Umpierrez, Guillermo E, Weinzimer, Stuart A, and Phillip, Moshe

Published
2023
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5. Sotagliflozin Added to Optimized Insulin Therapy Leads to Lower Rates of Clinically Relevant Hypoglycemic Events at Any HbA1c at 52 Weeks in Adults with Type 1 Diabetes

Author

Danne, Thomas, Pettus, Jeremy, Giaccari, Andrea, Cariou, Bertrand, Rodbard, Helena, Weinzimer, Stuart A, Bonnemaire, Mireille, Sawhney, Sangeeta, Stewart, John, Wang, Stella, de Cassia Castro, Rita, and Garg, Satish K

Subjects
Clinical Trials and Supportive Activities, Autoimmune Disease, Diabetes, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Metabolic and endocrine, Adult, Blood Glucose, Diabetes Mellitus, Type 1, Double-Blind Method, Drug Therapy, Combination, Female, Glycated Hemoglobin A, Glycosides, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Male, Middle Aged, Sodium-Glucose Transporter 2 Inhibitors, Treatment Outcome, Glycated Hemoglobin, Efficacy beyond HbA1c, HbA1c, SGLT1/SGLT2 inhibitors, Sotagliflozin, inTandem, Clinical Sciences, Medical Physiology, Endocrinology & Metabolism
Abstract

Background: Hypoglycemia rates usually increase when insulin treatment is intensified to improve glycemic control. We evaluated (post hoc) hypoglycemic rates in adult patients with type 1 diabetes (T1D) on sotagliflozin (a dual sodium-glucose cotransporter [SGLT] 1 and 2 inhibitor) in two phase 3, 52-week clinical trials (inTandem 1 and 2; NCT02384941 and NCT02421510). Materials and Methods: We analyzed rates of documented hypoglycemia (level 1, blood glucose ≥54 to

Published
2019

7. A Pilot randomized trial to examine effects of a hybrid closed-loop insulin delivery system on neurodevelopmental and cognitive outcomes in adolescents with type 1 diabetes

Author

Reiss, Allan L., Jo, Booil, Arbelaez, Ana Maria, Tsalikian, Eva, Buckingham, Bruce, Weinzimer, Stuart A., Fox, Larry A., Cato, Allison, White, Neil H., Tansey, Michael, Aye, Tandy, Tamborlane, William, Englert, Kimberly, Lum, John, Mazaika, Paul, Foland-Ross, Lara, Marzelli, Matthew, and Mauras, Nelly

Published
2022
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9. 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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11. Cost-Effectiveness of Closed-Loop Automated Insulin Delivery Using the Cambridge Hybrid Algorithm in Children and Adolescents with Type 1 Diabetes: Results from a Multicenter 6-Month Randomized Trial

Author

Fox, D. Steven, primary, Ware, Julia, additional, Boughton, Charlotte K, additional, Allen, Janet M., additional, Wilinska, Malgorzata E, additional, Tauschmann, Martin, additional, Denvir, Louise, additional, Thankamony, Ajay, additional, Campbell, Fiona, 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, Kanapka, Lauren, additional, Kollman, Craig, additional, Sibayan, Judy, additional, Beck, Roy W., additional, Hood, Korey K., additional, and Hovorka, Roman, additional

Published
2024
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12. Establishing a Global Standard for Wearable Devices in Sport and Exercise Medicine: Perspectives from Academic and Industry Stakeholders

Author

Ash, Garrett I., Stults-Kolehmainen, Matthew, Busa, Michael A., Gaffey, Allison E., Angeloudis, Konstantinos, Muniz-Pardos, Borja, Gregory, Robert, Huggins, Robert A., Redeker, Nancy S., Weinzimer, Stuart A., Grieco, Lauren A., Lyden, Kate, Megally, Esmeralda, Vogiatzis, Ioannis, Scher, LaurieAnn, Zhu, Xinxin, Baker, Julien S., Brandt, Cynthia, Businelle, Michael S., Fucito, Lisa M., Griggs, Stephanie, Jarrin, Robert, Mortazavi, Bobak J., Prioleau, Temiloluwa, Roberts, Walter, Spanakis, Elias K., Nally, Laura M., Debruyne, Andre, Bachl, Norbert, Pigozzi, Fabio, Halabchi, Farzin, Ramagole, Dimakatso A., Janse van Rensburg, Dina C., Wolfarth, Bernd, Fossati, Chiara, Rozenstoka, Sandra, Tanisawa, Kumpei, Börjesson, Mats, Casajus, José Antonio, Gonzalez-Aguero, Alex, Zelenkova, Irina, Swart, Jeroen, Gursoy, Gamze, Meyerson, William, Liu, Jason, Greenbaum, Dov, Pitsiladis, Yannis P., and Gerstein, Mark B.

Published
2021
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13. Personal and Social‐Built Environmental Factors of Glucose Variability Among Multiethnic Groups of Adults With Type 2 Diabetes: Research Protocol Using Ecological Momentary Assessment, Continuous Glucose Monitoring, and Actigraphy.

Author

Nam, Soohyun, Jeon, Sangchoon, Ash, Garrett I., Weinzimer, Stuart, Dunton, Genevieve F., Parekh, Niyati, Grey, Margaret, Chen, Kai, Lee, Minjung, Sajdlowska, Anna, and Whittemore, Robin

Subjects
LIFESTYLES, RISK assessment, SCIENTIFIC observation, ACTIGRAPHY, LONGITUDINAL method, TYPE 2 diabetes, CONTINUOUS glucose monitoring, ENVIRONMENTAL exposure, INDIVIDUALIZED medicine, WELL-being
Abstract

Glucose variability (GV)—the degree of fluctuation in glucose levels over a certain period of time—is emerging as an important parameter of dynamic glycemic control. Repeated glycemic oscillations have been reported to be the link to diabetes complications. This prospective observational study aims to: (1) identify multilevel risk factors (personal and social‐built environmental factors) associated with high GV; (2) identify "within‐person predictors" of high GV leveraging the intra‐person data to inform future personalized diabetes interventions; and (3) examine which lifestyle factors either mediate or moderate the relationship between emotional well‐being and GV among diverse adults with type 2 diabetes (T2D). We will recruit 200 adults with T2D from the community. All participants will complete baseline surveys assessing demographics, lifestyle, social‐built environmental, and clinical factors. Real‐time dynamic glucose levels will be measured using continuous glucose monitoring (CGM). Sleep, physical activity, diet/eating, and emotional well‐being will be measured with an actigraphy device and a real‐time self‐report tool (ecological momentary assessment [EMA]) across 14 days. Two 24‐h dietary recall data will be collected by online video calls. Generalized linear models, multilevel models, and structural equation models will be developed to achieve the study aims. The findings from the study will identify high‐risk groups of high GV who would benefit from CGM to improve diabetes outcomes and inform the future development of personalized just‐in‐time interventions targeting lifestyle behaviors with an increased understanding of GV and by supporting healthcare providers' clinical decisions. [ABSTRACT FROM AUTHOR]

Published
2024
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15. 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

16. Effect of Pramlintide on Prandial Glycemic Excursions During Closed-Loop Control in Adolescents and Young Adults With Type 1 Diabetes

Author

Weinzimer, Stuart A, Sherr, Jennifer L, Cengiz, Eda, Kim, Grace, Ruiz, Jessica L, Carria, Lori, Voskanyan, Gayane, Roy, Anirban, and Tamborlane, William V

Subjects
Biomedical and Clinical Sciences, Nutrition and Dietetics, Autoimmune Disease, Clinical Research, Diabetes, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Metabolic and endocrine, Adolescent, Adult, Blood Glucose, Diabetes Mellitus, Type 1, Female, Humans, Hypoglycemic Agents, Insulin, Islet Amyloid Polypeptide, Male, Meals, Pancreas, Artificial, Postprandial Period, Medical and Health Sciences, Endocrinology & Metabolism, Biomedical and clinical sciences, Health sciences
Abstract

ObjectiveEven under closed-loop (CL) conditions, meal-related blood glucose (BG) excursions frequently exceed target levels as a result of delays in absorption of insulin from the subcutaneous site of infusion. We hypothesized that delaying gastric emptying with preprandial injections of pramlintide would improve postprandial glycemia by allowing a better match between carbohydrate and insulin absorptions.Research design and methodsEight subjects (4 female; age, 15-28 years; A1C, 7.5 ± 0.7%) were studied for 48 h on a CL insulin-delivery system with a proportional integral derivative algorithm with insulin feedback: 24 h on CL control alone (CL) and 24 h on CL control plus 30-μg premeal injections of pramlintide (CLP). Target glucose was set at 120 mg/dL; timing and contents of meals were identical on both study days. No premeal manual boluses were given. Differences in reference BG excursions, defined as the incremental glucose rise from premeal to peak, were compared between conditions for each meal.ResultsCLP was associated with overall delayed time to peak BG (2.5 ± 0.9 vs. 1.5 ± 0.5 h; P < 0.0001) and reduced magnitude of glycemic excursion (88 ± 42 vs. 113 ± 32 mg/dL; P = 0.006) compared with CL alone. Pramlintide effects on glycemic excursions were particularly evident at lunch and dinner, in association with higher premeal insulin concentrations at those mealtimes.ConclusionsPramlintide delayed the time to peak postprandial BG and reduced the magnitude of prandial BG excursions. Beneficial effects of pramlintide on CL may in part be related to higher premeal insulin levels at lunch and dinner compared with breakfast.

Published
2012

21. Lived experience of CamAPS FX closed loop system in youth with type 1 diabetes and their parents

Author

Hood, Korey K, Garcia-Willingham, Natasha, Hanes, Sarah, Tanenbaum, Molly L, Ware, Julia, Boughton, Charlotte K, Allen, Janet M, Wilinska, Malgorzata E, Tauschmann, Martin, Denvir, Louise, Thankamony, Ajay, Campbell, Fiona, Wadwa, R Paul, Buckingham, Bruce A, Davis, Nikki, DiMeglio, Linda A, Mauras, Nelly, Besser, Rachel EJ, Ghatak, Atrayee, Weinzimer, Stuart A, Fox, D Steven, Kanapka, Lauren, Kollman, Craig, Sibayan, Judy, Beck, Roy W, Hovorka, Roman, DAN05 Consortium, Hood, Korey K [0000-0001-5730-7749], Boughton, Charlotte K [0000-0003-3272-9544], and Apollo - University of Cambridge Repository

Subjects
Blood Glucose, Parents, Diabetes Mellitus, Type 1, Treatment Outcome, Insulin Infusion Systems, Adolescent, Blood Glucose Self-Monitoring, Quality of Life, Humans, Insulin, Hypoglycemic Agents, Child
Abstract

AIM: To examine changes in the lived experience of type 1 diabetes after use of hybrid closed loop (CL), including the CamAPS FX CL system. MATERIALS AND METHODS: The primary study was conducted as an open-label, single-period, randomized, parallel design contrasting CL versus insulin pump (with or without continuous glucose monitoring). Participants were asked to complete patient-reported outcomes before starting CL and 3 and 6 months later. Surveys assessed diabetes distress, hypoglycaemia concerns and quality of life. Qualitative focus group data were collected at the completion of the study. RESULTS: In this sample of 98 youth (age range 6-18, mean age 12.7 ± 2.8 years) and their parents, CL use was not associated with psychosocial benefits overall. However, the subgroup (n = 12) using the CamAPS FX system showed modest improvements in quality of life and parent distress, reinforced by both survey (p < .05) and focus group responses. There were no negative effects of CL use reported by study participants. CONCLUSIONS: Closed loop use via the CamAPS FX system was associated with modest improvements in aspects of the lived experience of managing type 1 diabetes in youth and their families. Further refinements of the system may optimize the user experience.

Published
2022
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23. 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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35. CGM-measured glucose values have a strong correlation with C-peptide, HbA1c and IDAAC, but do poorly in predicting C-peptide levels in the two years following onset of diabetes

Author

Buckingham, Bruce, Cheng, Peiyao, Beck, Roy W., Kollman, Craig, Ruedy, Katrina J., Weinzimer, Stuart A., Slover, Robert, Bremer, Andrew A., Fuqua, John, Tamborlane, William, and for the Diabetes Research in Children Network (DirecNet) and Type 1 Diabetes TrialNet Study Groups

Published
2015
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37. 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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39. sj-pdf-1-dst-10.1177_19322968221116384 – Supplemental material for Feasibility and Preliminary Safety of Smartphone-Based Automated Insulin Delivery in Adolescents and Children With Type 1 Diabetes

Author

Deshpande, Sunil, Weinzimer, Stuart A., Gibbons, Kathryn, Nally, Laura M., Weyman, Kate, Carria, Lori, Zgorski, Melinda, Laffel, Lori M., Doyle, Francis J., and Dassau, Eyal

Subjects
111708 Health and Community Services, FOS: Clinical medicine, 111199 Nutrition and Dietetics not elsewhere classified, Medicine, FOS: Health sciences, 110306 Endocrinology
Abstract

Supplemental material, sj-pdf-1-dst-10.1177_19322968221116384 for Feasibility and Preliminary Safety of Smartphone-Based Automated Insulin Delivery in Adolescents and Children With Type 1 Diabetes by Sunil Deshpande, Stuart A. Weinzimer, Kathryn Gibbons, Laura M. Nally, Kate Weyman, Lori Carria, Melinda Zgorski, Lori M. Laffel, Francis J. Doyle and Eyal Dassau in Journal of Diabetes Science and Technology

Published
2022
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40. sj-docx-1-dst-10.1177_19322968221116384 – Supplemental material for Feasibility and Preliminary Safety of Smartphone-Based Automated Insulin Delivery in Adolescents and Children With Type 1 Diabetes

Author

Deshpande, Sunil, Weinzimer, Stuart A., Gibbons, Kathryn, Nally, Laura M., Weyman, Kate, Carria, Lori, Zgorski, Melinda, Laffel, Lori M., Doyle, Francis J., and Dassau, Eyal

Subjects
111708 Health and Community Services, FOS: Clinical medicine, 111199 Nutrition and Dietetics not elsewhere classified, Medicine, FOS: Health sciences, 110306 Endocrinology
Abstract

Supplemental material, sj-docx-1-dst-10.1177_19322968221116384 for Feasibility and Preliminary Safety of Smartphone-Based Automated Insulin Delivery in Adolescents and Children With Type 1 Diabetes by Sunil Deshpande, Stuart A. Weinzimer, Kathryn Gibbons, Laura M. Nally, Kate Weyman, Lori Carria, Melinda Zgorski, Lori M. Laffel, Francis J. Doyle and Eyal Dassau in Journal of Diabetes Science and Technology

Published
2022
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41. sj-docx-2-dst-10.1177_19322968221116384 – Supplemental material for Feasibility and Preliminary Safety of Smartphone-Based Automated Insulin Delivery in Adolescents and Children With Type 1 Diabetes

Author

Deshpande, Sunil, Weinzimer, Stuart A., Gibbons, Kathryn, Nally, Laura M., Weyman, Kate, Carria, Lori, Zgorski, Melinda, Laffel, Lori M., Doyle, Francis J., and Dassau, Eyal

Subjects
111708 Health and Community Services, FOS: Clinical medicine, 111199 Nutrition and Dietetics not elsewhere classified, Medicine, FOS: Health sciences, 110306 Endocrinology
Abstract

Supplemental material, sj-docx-2-dst-10.1177_19322968221116384 for Feasibility and Preliminary Safety of Smartphone-Based Automated Insulin Delivery in Adolescents and Children With Type 1 Diabetes by Sunil Deshpande, Stuart A. Weinzimer, Kathryn Gibbons, Laura M. Nally, Kate Weyman, Lori Carria, Melinda Zgorski, Lori M. Laffel, Francis J. Doyle and Eyal Dassau in Journal of Diabetes Science and Technology

Published
2022
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42. sj-pdf-3-dst-10.1177_19322968221116384 – Supplemental material for Feasibility and Preliminary Safety of Smartphone-Based Automated Insulin Delivery in Adolescents and Children With Type 1 Diabetes

Author

Deshpande, Sunil, Weinzimer, Stuart A., Gibbons, Kathryn, Nally, Laura M., Weyman, Kate, Carria, Lori, Zgorski, Melinda, Laffel, Lori M., Doyle, Francis J., and Dassau, Eyal

Subjects
111708 Health and Community Services, FOS: Clinical medicine, 111199 Nutrition and Dietetics not elsewhere classified, Medicine, FOS: Health sciences, 110306 Endocrinology
Abstract

Supplemental material, sj-pdf-3-dst-10.1177_19322968221116384 for Feasibility and Preliminary Safety of Smartphone-Based Automated Insulin Delivery in Adolescents and Children With Type 1 Diabetes by Sunil Deshpande, Stuart A. Weinzimer, Kathryn Gibbons, Laura M. Nally, Kate Weyman, Lori Carria, Melinda Zgorski, Lori M. Laffel, Francis J. Doyle and Eyal Dassau in Journal of Diabetes Science and Technology

Published
2022
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43. High success rates of sedation-free brain MRI scanning in young children using simple subject preparation protocols with and without a commercial mock scanner–the Diabetes Research in Children Network (DirecNet) experience

Author

Barnea-Goraly, Naama, Weinzimer, Stuart A., Ruedy, Katrina J., Mauras, Nelly, Beck, Roy W., Marzelli, Matt J., Mazaika, Paul K., Aye, Tandy, White, Neil H., Tsalikian, Eva, Fox, Larry, Kollman, Craig, Cheng, Peiyao, Reiss, Allan L., and on behalf of the Diabetes Research in Children Network (DirecNet)

Published
2014
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45. Navigating barriers to affording and obtaining insulin and diabetes supplies.

Author

Wilcox, Annabelle E., Lipska, Kasia J., Weinzimer, Stuart A., Gujral, Jasmine, Arakaki, Andrew, Kerandi, Linda, and Nally, Laura M.

Subjects
INSULIN, DIABETES, TYPE 1 diabetes, INTERNET pharmacies
Abstract

Thirty-six percent of participants reported using at least one measure to ration insulin or obtain insulin outside of their prescribing pharmacy due to insulin affordability; this was more than twice as common in the PWD independent group ( I p i < .001) (Table 2). B Highlights b Our study suggests that people with diabetes (PWD) face issues of affording and obtaining insulin and diabetes supplies, even in a population predominantly on private health insurance. [Extracted from the article]

Published
2023
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46. Lived experience of CamAPS FX closed loop system in youth with type 1 diabetes and their parents.

Author

Hood, Korey K., Garcia‐Willingham, Natasha, Hanes, Sarah, Tanenbaum, Molly L., Ware, Julia, Boughton, Charlotte K., Allen, Janet M., Wilinska, Malgorzata E., Tauschmann, Martin, Denvir, Louise, Thankamony, Ajay, Campbell, Fiona, Wadwa, R. Paul, Buckingham, Bruce A., Davis, Nikki, DiMeglio, Linda A., Mauras, Nelly, Besser, Rachel E. J., Ghatak, Atrayee, and Weinzimer, Stuart A.

Subjects
TYPE 1 diabetes, PSYCHOLOGICAL distress, CLOSED loop systems, INSULIN pumps, QUALITY of life, HYPOGLYCEMIA
Abstract

Aim: To examine changes in the lived experience of type 1 diabetes after use of hybrid closed loop (CL), including the CamAPS FX CL system. Materials and Methods: The primary study was conducted as an open‐label, single‐period, randomized, parallel design contrasting CL versus insulin pump (with or without continuous glucose monitoring). Participants were asked to complete patient‐reported outcomes before starting CL and 3 and 6 months later. Surveys assessed diabetes distress, hypoglycaemia concerns and quality of life. Qualitative focus group data were collected at the completion of the study. Results: In this sample of 98 youth (age range 6‐18, mean age 12.7 ± 2.8 years) and their parents, CL use was not associated with psychosocial benefits overall. However, the subgroup (n = 12) using the CamAPS FX system showed modest improvements in quality of life and parent distress, reinforced by both survey (p <.05) and focus group responses. There were no negative effects of CL use reported by study participants. Conclusions: Closed loop use via the CamAPS FX system was associated with modest improvements in aspects of the lived experience of managing type 1 diabetes in youth and their families. Further refinements of the system may optimize the user experience. [ABSTRACT FROM AUTHOR]

Published
2022
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48. Longitudinal Assessment of Neuroanatomical and Cognitive Differences in Young Children With Type 1 Diabetes: Association With Hyperglycemia

Author

Mauras, Nelly, Mazaika, Paul, Buckingham, Bruce, Weinzimer, Stuart, White, Neil H., Tsalikian, Eva, Hershey, Tamara, Cato, Allison, Cheng, Peiyao, Kollman, Craig, Beck, Roy W., Ruedy, Katrina, Aye, Tandy, Fox, Larry, Arbelaez, Ana Maria, Wilson, Darrell, Tansey, Michael, Tamborlane, William, Peng, Daniel, Marzelli, Matthew, Winer, Karen K., and Reiss, Allan L.

Published
2015
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49. Youth and parent perspectives on the acceptability of a group physical activity and coping intervention for adolescents with type 1 diabetes

Author

Adams, Mackenzie, Grey, Margaret, Joiner, Kevin, DeJonckheere, Melissa, Savoye, Mary, Sadler, Lois, Ash, Garrett, and Weinzimer, Stuart

Subjects
SportRxiv|Sport and Exercise Science, bepress|Life Sciences|Kinesiology, SportRxiv|Sport and Exercise Science|Physical Activity, human activities
Abstract

Introduction: To maintain optimal glycemic levels and prevent long-term complications, adolescents with type 1 diabetes (T1DM) should engage in regular moderate to vigorous activity (MVPA) in addition to other diabetes self-care behaviors. Though interventions to prepare adolescents safely increase MVPA have been developed and tested, barriers continue to limit dissemination and engagement in clinical and community settings. Objective: To examine youth and parent perspectives on the acceptability of a group physical activity and coping intervention for adolescents with T1DM.Subjects: 18 adolescents (11-19 years) with T1DM who completed the intervention and at least one of their parents.Methods: Adolescents completed an exit survey measuring satisfaction with the intervention (program components, comfort, and instructors) on a 5-point scale. Semi-structured interviews were conducted with adolescents and at least one parent. Qualitative description was used to develop themes that summarize participant experiences during the intervention. Results: The intervention was rated highly: program components (M=4.5), comfort (M=4.4), and instructors (M=4.3). Themes included: (1) Adolescents and parents valued being around others with T1DM and their families; (2) The intervention helped adolescents gain knowledge and reinforce diabetes self-management behaviors; (3) Challenges included convenience and sustaining participant engagement; and (4) Adolescents intended to sustain physical activity and diabetes self-management behaviors after the intervention.Conclusions: Adolescents with T1DM and their parents viewed a group physical activity and discussion intervention as a positive experience. Because participants highly valued the group aspect of the intervention, future MVPA interventions would likely benefit from integrating social interactions with others with T1DM.

Published
2021

50. Personalized Big Data for Type 1 Diabetes Exercise Support

Author

De Los Santos, Melissa, Jeon, Sangchoon, Fucito, Lisa, Nally, Laura, Baker, Julien, Stults-Kolehmainen, Matthew, Ash, Garrett, Spanakis, Elias, Brandt, Cynthia, Weinzimer, Stuart, and Gulanski, Barbara

Subjects
SportRxiv|Sport and Exercise Science, bepress|Life Sciences|Kinesiology, SportRxiv|Sport and Exercise Science|Physical Activity
Abstract

Objective: Evaluate feasibility, safety, acceptability, and estimate efficacy of an exercise promotion intervention for adults with type 1 diabetes (T1D) and sub-optimal baseline exercise patterns.Design: Single-group, 2-week baseline observation then 10-week intervention with follow-up observation.Setting: Community-based sample participating remotely with physician oversightParticipants: Volunteers 18-65 years old with T1D screened for medical readiness for exercise intervention offerings. N=20 enrolled, N=17 completing all outcomes with 88%-91% biosensor adherence. Intervention: Feedback on big data from continuous glucose monitoring (CGM), its intersection with other ecological datasets (exercise, mood, sleep), and other informational and motivational elements (exercise videos, text-based exercise coach, self-monitoring diary). Main Outcome Measures: Feasibility (use metrics, assessment completion), safety (mild and severe hypoglycemia, diabetic ketoacidosis), acceptability (system usability scale, single items, interview themes), standard clinical and psychosocial assessments.Results: Participants increased exercise from a median of 0 (IQR 0, 21) to 64 (20, 129) minutes per week (p=.004, d=0.71) with no severe hypoglycemia or ketoacidosis. Body mass index increased (29.5±5.1 to 29.8±5.4 kg/m2, p= .02, d= 0.57). Highest satisfaction ratings were for CGM use (89%) and data on exercise and its intersection with CGM and sleep (94%). Satisfaction was primarily due to improved exercise management behavioral skills, although derived motivation was transient.Conclusions: The use of personalized big data from biosensors to substantiate human-delivered, client-centered exercise support for T1D is feasible and acceptable for interventions involving big data collection. However, there is a need for more intensive, sustained support. The big data could support informatics-based, automated motivational tools.

Published
2021

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