Browsing by Author "Laffel, Lori M."
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Item 8076 Advancing Career Development of Physician-Scientists Engaged in Diabetes Research: Insights into the National K12 DiabDocs Program(Oxford University Press, 2024-10-05) Dasani, Komal D.; Bishop, Franziska K.; Golden, Sherita H.; Laffel, Lori M.; Mirmira, Raghavendra G.; Steck, Andrea K.; Willi, Steven M.; Maahs, David M.; DiMeglio, Linda A.; Pediatrics, School of MedicineBackground: In July 2022 the NIH established a multi-center National K12 “Diabetes-Docs: Physician-Scientist Career Development Program” (DiabDocs) to support mentored research experiences and tailored career development training for cohorts of physician scientists focused on diabetes research. DiabDocs scholars are board-certified or board-eligible physicians with training in pediatric or adult endocrinology or in another area tied to diabetes research and care. The program addresses the shortage of physicians engaged in diabetes research and is open to scholars at any eligible institution in the United States. Methods: The DiabDocs program was implemented by two multi-center Program Directors (MPD), in collaboration with an Executive Leadership Committee (ELC) comprised of experienced basic science and clinical/translational physician-scientists. Additional faculty from 19 different institutions have engaged in advisory and reviewer roles. The program solicits Letters of Intent (LOIs) annually from interested candidates followed by invitations for full applications; a program retreat features educational workshops and diversity training; and a Study Section selects Scholars. Currently, the program is in its third recruitment cycle for additional scholars to start Summer 2024. Additional career development programming is available through a series of interactive webinars. The program also has a strong commitment to diversity, equity, and inclusion, including a “DiabDiversity” program to support in-person engagement in DiabDocs experiences by under-represented in medicine trainees. Results: After two successful recruitment cycles in 2022-2023 that reviewed 24 LOIs, 11 scholars were selected. The funded scholars (6 Adult and 5 Pediatric Endocrinologists) include 3 individuals self-identifying as underrepresented in medicine and 7 females. For the 2023 application cycle, 24 LOIs were received (11 from Adult and 9 from Pediatric Endocrinology, 2 in combined Pediatric/Adult Endocrinology, and 2 from other specialties). Conclusions: The DiabDocs program aims to identify, recruit, and support outstanding early career physician scientists. The program provides a national network with resources for protected research time, career development programs, and national mentorship to develop cohorts of skilled professionals contributing to the advancement of diabetes research.Item Development and delivery of a brief family behavioral intervention to support continuous glucose monitor use in young children with type 1 diabetes(Wiley, 2022) Hilliard, Marisa E.; Commissariat, Persis V.; Kanapka, Lauren; Laffel, Lori M.; Levy, Wendy; Harrington, Kara; Anderson, Barbara J.; Miller, Kellee M.; DiMeglio, Linda A.; Pediatrics, School of MedicineBackground: Despite potential glycemic benefits of continuous glucose monitor (CGM) use in young children with type 1 diabetes, psychosocial and behavioral challenges may interfere with sustained use. We developed a 5-session family behavioral intervention (FBI) to support CGM use. Objective: We report on the multi-step development of the FBI, training interventionists, implementation in a 14-site clinical trial, and participant satisfaction. Methods: A multidisciplinary team created the FBI based on mixed-methods (i.e., survey data, qualitative research) preliminary work with parents of young children. Investigators trained non-physician staff to deliver the 5 sessions per an intervention manual. Trial participants received the FBI either during the first (FBI group, n = 50) or second 6-months (Crossover group, n = 44) of the 1-year trial. Investigators listened to session recordings to rate intervention fidelity, and participants rated satisfaction with the FBI. Results: The complete 5-session FBI was delivered to 89% of participants, in-person (73%) or by telephone (23%). Sessions lasted 23 min on average, and fidelity was high across sessions. Over 80% of participants rated very high satisfaction with all aspects of the FBI and offered few recommendations for improvement. Conclusions: Having been developed based on experiences and input of families of young children with type 1 diabetes, the FBI represented a novel behavioral approach to enhance sustained CGM use during a challenging developmental period. Evidence of strong feasibility and acceptability supports its potential for implementation in research and clinical care. As diabetes technologies evolve, the FBI may continue to be refined to address parents' most relevant concerns.Item ISPAD Clinical Practice Consensus Guidelines 2022: Diabetes technologies: Glucose monitoring(Wiley, 2022) Tauschmann, Martin; Forlenza, Gregory; Hood, Korey; Cardona-Hernandez, Roque; Giani, Elisa; Hendrieckx, Christel; DeSalvo, Daniel J.; Laffel, Lori M.; Saboo, Banshi; Wheeler, Benjamin J.; Laptev, Dmitry N.; Yarhere, Iroro; DiMeglio, Linda A.; Pediatrics, School of MedicineItem “I’m essentially his pancreas”: Parent perceptions of diabetes burden and opportunities to reduce burden in the care of children <8 years old with type 1 diabetes(Wiley, 2020-03) Commissariat, Persis V.; Harrington, Kara R.; Whitehouse, Amanda L.; Miller, Kellee M.; Hilliard, Marisa E.; Van Name, Michelle; DeSalvo, Daniel J.; Tamborlane, William V.; Anderson, Barbara J.; DiMeglio, Linda A.; Laffel, Lori M.; Medicine, School of MedicineBackground: Across all age groups, management of type 1 diabetes (T1D) places substantial responsibility and emotional burden upon families. This study explored parent perceptions of the burdens of caring for very young children with T1D. Methods: Semi-structured qualitative interviews were conducted with parents (85% mothers) of 79 children with T1D, aged 1 to <8 years old, from four diverse pediatric diabetes clinical centers. Interviews were transcribed, coded, and analyzed using hybrid thematic analysis to derive central themes. Results: Youth (77% White) had T1D for ≥6 months: age (M ± SD) 5.2 ± 1.5 years, diabetes duration 2.4 ± 1.3 years, and A1c 63 ± 10 mmol/mol (7.9 ± 0.9%); 66% used an insulin pump and 61% used CGM. Three major themes emerged related to diabetes burdens: (a) the emotional burden of diabetes on themselves and their children, (b) the burden of finding, training, and trusting effective secondary caregivers to manage the child's diabetes, and (c) suggestions for how more comprehensive, personalized diabetes education from healthcare providers for parents and secondary caregivers could help reduce parent burden and worry. Conclusions: In families with very young children with T1D, parental perceptions of the burden of managing diabetes are common and could be mitigated by tailored education programs that increase parent knowledge, bolster parents' confidence in themselves, and increase trust in their secondary caregivers to manage diabetes. Reduced parental burden and increased caregiver knowledge may positively impact child's glycemic control, as well as improve parent and child quality of life.Item Long-term Continuous Glucose Monitor Use in Very Young Children With Type 1 Diabetes: One-Year Results From the SENCE Study(Sage, 2023) Van Name, Michelle A.; Kanapka, Lauren G.; DiMeglio, Linda A.; Miller, Kellee M.; Albanese-O’Neill, Anastasia; Commissariat, Persis; Corathers, Sarah D.; Harrington, Kara R.; Hilliard, Marisa E.; Anderson, Barbara J.; Kelley, Jennifer C.; Laffel, Lori M.; MacLeish, Sarah A.; Nathan, Brandon M.; Tamborlane, William V.; Wadwa, R. Paul; Willi, Steven M.; Williams, Kristen M.; Wintergerst, Kupper A.; Woerner, Stephanie; Wong, Jenise C.; DeSalvo, Daniel J.; Pediatrics, School of MedicineObjectives: Achieving optimal glycemic outcomes in young children with type 1 diabetes (T1D) is challenging. This study examined the durability of continuous glucose monitoring (CGM) coupled with a family behavioral intervention (FBI) to improve glycemia. Study design: This one-year study included an initial 26-week randomized controlled trial of CGM with FBI (CGM+FBI) and CGM alone (Standard-CGM) compared with blood glucose monitoring (BGM), followed by a 26-week extension phase wherein the BGM Group received the CGM+FBI (BGM-Crossover) and both original CGM groups continued this technology. Results: Time in range (70-180 mg/dL) did not improve with CGM use (CGM+FBI: baseline 37%, 52 weeks 41%; Standard-CGM: baseline 41%, 52 weeks 44%; BGM-Crossover: 26 weeks 38%, 52 weeks 40%). All three groups sustained decreases in hypoglycemia (<70 mg/dL) with CGM use (CGM+FBI: baseline 3.4%, 52 weeks 2.0%; Standard-CGM: baseline 4.1%, 52 weeks 2.1%; BGM-Crossover: 26 weeks 4.5%, 52 weeks 1.7%, P-values <.001). Hemoglobin A1c was unchanged with CGM use (CGM+FBI: baseline 8.3%, 52 weeks 8.2%; Standard-CGM: baseline 8.2%, 52 weeks 8.0%; BGM-Crossover: 26 weeks 8.1%, 52 weeks 8.3%). Sensor use remained high (52-week study visit: CGM+FBI 91%, Standard-CGM 92%, BGM-Crossover 88%). Conclusion: Over 12 months young children with T1D using newer CGM technology sustained reductions in hypoglycemia and, in contrast to prior studies, persistently wore CGM. However, pervasive hyperglycemia remained unmitigated. This indicates an urgent need for further advances in diabetes technology, behavioral support, and diabetes management educational approaches to optimize glycemia in young children.Item Nighttime is the worst time: Parental fear of hypoglycemia in young children with type 1 diabetes(Wiley, 2018-02) Van Name, Michelle A.; Hilliard, Marisa E.; Boyle, Claire T.; Miller, Kellee M.; DeSalvo, Daniel J.; Anderson, Barbara J.; Laffel, Lori M.; Woerner, Stephanie E.; DiMeglio, Linda A.; Tamborlane, William V.; Pediatrics, School of MedicineBACKGROUND: Fear of hypoglycemia is common in parents of young children with type 1 diabetes (T1D), but little is known about the specific fears that parents most often experience. Hypoglycemia fear has been associated with poorer glycemic control in older children, though not yet studied in a large cohort of very young children. MATERIALS AND METHODS: Parents of 549 children <7 years (mean 5.2 ± 1.2 years [19% <3 years]) with a mean diabetes duration of 2.4 ± 1.0 years (range 1-6 years) and mean HbA1c 8.2% ± 1.1% (66 ± 12 mmol/mol) registered in the T1D Exchange completed the worry scale of the Hypoglycemia Fear Survey modified for parents (HFS-P). RESULTS: Mean parental fear of hypoglycemia worry score was 36.1 ± 23.1 (possible range 0-100), with most frequent worries related to the child having a low while asleep and the child not recognizing a low. The mean worry score was not associated with the child's age, glycemic control, or recent severe hypoglycemic event. Parental worries about lows while sleeping were significantly higher in pump users than non-users (61% vs. 45%; P < .001), and tended to be higher in CGM users than non-users (62% vs 51%; P = .02). CONCLUSIONS: The greatest worries of parents of young children with T1D were related to hypoglycemia during sleep and other times/circumstances during which it would be difficult to detect hypoglycemia. Using advanced diabetes technologies may be an effort to temper fears about hypoglycemia during sleep, though the directionality of this relationship is undetermined. Additional studies can clarify this association and leverage use of diabetes technologies to improve glycemic control.Item Second international consensus report on gaps and opportunities for the clinical translation of precision diabetes medicine(Springer Nature, 2023) Tobias, Deirdre K.; Merino, Jordi; Ahmad, Abrar; Aiken, Catherine; Benham, Jamie L.; Bodhini, Dhanasekaran; Clark, Amy L.; Colclough, Kevin; Corcoy, Rosa; Cromer, Sara J.; Duan, Daisy; Felton, Jamie L.; Francis, Ellen C.; Gillard, Pieter; Gingras, Véronique; Gaillard, Romy; Haider, Eram; Hughes, Alice; Ikle, Jennifer M.; Jacobsen, Laura M.; Kahkoska, Anna R.; Kettunen, Jarno L. T.; Kreienkamp, Raymond J.; Lim, Lee-Ling; Männistö, Jonna M. E.; Massey, Robert; Mclennan, Niamh-Maire; Miller, Rachel G.; Morieri, Mario Luca; Most, Jasper; Naylor, Rochelle N.; Ozkan, Bige; Patel, Kashyap Amratlal; Pilla, Scott J.; Prystupa, Katsiaryna; Raghavan, Sridharan; Rooney, Mary R.; Schön, Martin; Semnani-Azad, Zhila; Sevilla-Gonzalez, Magdalena; Svalastoga, Pernille; Takele, Wubet Worku; Tam, Claudia Ha-Ting; Thuesen, Anne Cathrine B.; Tosur, Mustafa; Wallace, Amelia S.; Wang, Caroline C.; Wong, Jessie J.; Yamamoto, Jennifer M.; Young, Katherine; Amouyal, Chloé; Andersen, Mette K.; Bonham, Maxine P.; Chen, Mingling; Cheng, Feifei; Chikowore, Tinashe; Chivers, Sian C.; Clemmensen, Christoffer; Dabelea, Dana; Dawed, Adem Y.; Deutsch, Aaron J.; Dickens, Laura T.; DiMeglio, Linda A.; Dudenhöffer-Pfeifer, Monika; Evans-Molina, Carmella; Fernández-Balsells, María Mercè; Fitipaldi, Hugo; Fitzpatrick, Stephanie L.; Gitelman, Stephen E.; Goodarzi, Mark O.; Grieger, Jessica A.; Guasch-Ferré, Marta; Habibi, Nahal; Hansen, Torben; Huang, Chuiguo; Harris-Kawano, Arianna; Ismail, Heba M.; Hoag, Benjamin; Johnson, Randi K.; Jones, Angus G.; Koivula, Robert W.; Leong, Aaron; Leung, Gloria K. W.; Libman, Ingrid M.; Liu, Kai; Long, S. Alice; Lowe, William L., Jr.; Morton, Robert W.; Motala, Ayesha A.; Onengut-Gumuscu, Suna; Pankow, James S.; Pathirana, Maleesa; Pazmino, Sofia; Perez, Dianna; Petrie, John R.; Powe, Camille E.; Quinteros, Alejandra; Jain, Rashmi; Ray, Debashree; Ried-Larsen, Mathias; Saeed, Zeb; Santhakumar, Vanessa; Kanbour, Sarah; Sarkar, Sudipa; Monaco, Gabriela S. F.; Scholtens, Denise M.; Selvin, Elizabeth; Sheu, Wayne Huey-Herng; Speake, Cate; Stanislawski, Maggie A.; Steenackers, Nele; Steck, Andrea K.; Stefan, Norbert; Støy, Julie; Taylor, Rachael; Tye, Sok Cin; Ukke, Gebresilasea Gendisha; Urazbayeva, Marzhan; Van der Schueren, Bart; Vatier, Camille; Wentworth, John M.; Hannah, Wesley; White, Sara L.; Yu, Gechang; Zhang, Yingchai; Zhou, Shao J.; Beltrand, Jacques; Polak, Michel; Aukrust, Ingvild; de Franco, Elisa; Flanagan, Sarah E.; Maloney, Kristin A.; McGovern, Andrew; Molnes, Janne; Nakabuye, Mariam; Njølstad, Pål Rasmus; Pomares-Millan, Hugo; Provenzano, Michele; Saint-Martin, Cécile; Zhang, Cuilin; Zhu, Yeyi; Auh, Sungyoung; de Souza, Russell; Fawcett, Andrea J.; Gruber, Chandra; Mekonnen, Eskedar Getie; Mixter, Emily; Sherifali, Diana; Eckel, Robert H.; Nolan, John J.; Philipson, Louis H.; Brown, Rebecca J.; Billings, Liana K.; Boyle, Kristen; Costacou, Tina; Dennis, John M.; Florez, Jose C.; Gloyn, Anna L.; Gomez, Maria F.; Gottlieb, Peter A.; Greeley, Siri Atma W.; Griffin, Kurt; Hattersley, Andrew T.; Hirsch, Irl B.; Hivert, Marie-France; Hood, Korey K.; Josefson, Jami L.; Kwak, Soo Heon; Laffel, Lori M.; Lim, Siew S.; Loos, Ruth J. F.; Ma, Ronald C. W.; Mathieu, Chantal; Mathioudakis, Nestoras; Meigs, James B.; Misra, Shivani; Mohan, Viswanathan; Murphy, Rinki; Oram, Richard; Owen, Katharine R.; Ozanne, Susan E.; Pearson, Ewan R.; Perng, Wei; Pollin, Toni I.; Pop-Busui, Rodica; Pratley, Richard E.; Redman, Leanne M.; Redondo, Maria J.; Reynolds, Rebecca M.; Semple, Robert K.; Sherr, Jennifer L.; Sims, Emily K.; Sweeting, Arianne; Tuomi, Tiinamaija; Udler, Miriam S.; Vesco, Kimberly K.; Vilsbøll, Tina; Wagner, Robert; Rich, Stephen S.; Franks, Paul W.; Pediatrics, School of MedicinePrecision medicine is part of the logical evolution of contemporary evidence-based medicine that seeks to reduce errors and optimize outcomes when making medical decisions and health recommendations. Diabetes affects hundreds of millions of people worldwide, many of whom will develop life-threatening complications and die prematurely. Precision medicine can potentially address this enormous problem by accounting for heterogeneity in the etiology, clinical presentation and pathogenesis of common forms of diabetes and risks of complications. This second international consensus report on precision diabetes medicine summarizes the findings from a systematic evidence review across the key pillars of precision medicine (prevention, diagnosis, treatment, prognosis) in four recognized forms of diabetes (monogenic, gestational, type 1, type 2). These reviews address key questions about the translation of precision medicine research into practice. Although not complete, owing to the vast literature on this topic, they revealed opportunities for the immediate or near-term clinical implementation of precision diabetes medicine; furthermore, we expose important gaps in knowledge, focusing on the need to obtain new clinically relevant evidence. Gaps include the need for common standards for clinical readiness, including consideration of cost-effectiveness, health equity, predictive accuracy, liability and accessibility. Key milestones are outlined for the broad clinical implementation of precision diabetes medicine.Item Sources and Valence of Information Impacting Parents' Decisions to Use Diabetes Technologies in Young Children <8 Years Old with Type 1 Diabetes(Mary Ann Liebert, Inc., 2020-09) Commissariat, Persis V.; Whitehouse, Amanda L.; Hilliard, Marisa E.; Miller, Kellee M.; Harrington, Kara R.; Levy, Wendy; DeSalvo, Daniel J.; Van Name, Michelle A.; Anderson, Barbara J.; Tamborlane, William V.; DiMeglio, Linda A.; Laffel, Lori M.; Pediatrics, School of MedicineThere are multiple information sources available to assist families in learning about rapidly advancing diabetes technologies as care options for their children. This study explored where and from whom families of young children with type 1 diabetes get information about diabetes technologies and the valence (positive vs. negative) of that information. Semi-structured interviews were conducted with parents (86% mothers) of 79 youth <8 years old with type 1 diabetes for ≥6 months, ([mean ± standard deviation] age 5.2 ± 1.5 years, diabetes duration 2.4 ± 1.3 years, 77% white, A1c 63 ± 10 mmol/mol [7.9 ± 0.9%], 66% pump-treated, 58% using continuous glucose monitors [CGMs]). Interviews were transcribed and underwent content analysis to derive central themes. Most parents reported learning about new technologies from three direct sources: diabetes care providers, people with diabetes, and caregivers of children with diabetes. Parents also cited three indirect sources of information: online forums, publications, and diabetes-specific conferences. Parents reported hearing primarily positive things about technologies. Families not using pump and/or CGM noted reluctance to use technology due to family-specific concerns (e.g., cost, child's unwillingness to wear device) rather than information from outside sources. In this subset of parents, many still expressed willingness to initiate use once family-specific concerns were resolved. Parents of young children received largely positive information about diabetes technologies, primarily from health care providers and others familiar with using devices personally or for their children. To maximize diabetes technology use in young children, it is incumbent upon providers to ensure families receive balanced realistic information about benefits and barriers.Item Time spent outside of target glucose range for young children with type 1 diabetes: a continuous glucose monitor study(Wiley, 2020-08) DiMeglio, Linda A.; Kanapka, Lauren G.; DeSalvo, Daniel J.; Anderson, Barbara J.; Harrington, Kara R.; Hilliard, Marisa E.; Laffel, Lori M.; Tamborlane, William V.; Van Name, Michelle A.; Wadwa, R. Paul; Willi, Steven M.; Woerner, Stephanie; Wong, Jenise C.; Miller, Kellee M.; Pediatrics, School of MedicineAim To assess the associations between demographic and clinical characteristics and sensor glucose metrics in young children with type 1 diabetes, using masked, continuous glucose monitoring data from children aged 2 to < 8 years. Research design and methods The analysis included 143 children across 14 sites in the USA, enrolled in a separate clinical trial. Eligibility criteria were: age 2 to <8 years; type 1 diabetes duration ≥3 months; no continuous glucose monitoring use for past 30 days; and HbA1c concentration 53 to <86 mmol/mol (7.0 to <10.0%). All participants wore masked continuous glucose monitors up to 14 days. Results On average, participants spent the majority (13 h) of the day in hyperglycaemia (>10.0 mmol/l) and a median of ~1 h/day in hypoglycaemia (<3.9 mmol/l). Participants with minority race/ethnicity and higher parent education levels spent more time in target range, 3.9–10.0 mmol/l, and less time in hyperglycaemia. More time in hypoglycaemia was associated with minority race/ethnicity and younger age at diagnosis. Continuous glucose monitoring metrics were similar in pump and injection users. Conclusions Given that both hypo- and hyperglycaemia negatively impact neurocognitive development, strategies to increase time in target glucose range for young children are needed.Item Twelve-month Psychosocial Outcomes of Continuous Glucose Monitoring with Behavioral Support in Parents of Young Children with Type 1 Diabetes(Wiley, 2023) Commissariat, Persis V.; DiMeglio, Linda A.; Kanapka, Lauren G.; Laffel, Lori M.; Miller, Kellee M.; Anderson, Barbara J.; Hilliard, Marisa E.; Strategies to Enhance New CGM Use in Early Childhood (SENCE) Study Group; Pediatrics, School of MedicineAim: Managing type 1 diabetes in young children can cause significant stress for parents. Continuous glucose monitoring (CGM) may reduce parental burden. The Strategies to Enhance CGM Use in Early Childhood (SENCE) trial randomized parents of children (ages 2 to <8 years) with type 1 diabetes to CGM with family behavioural intervention (CGM + FBI), CGM alone (Standard-CGM) or blood glucose monitoring for 26 weeks before receiving CGM + FBI (BGM-Crossover). This report assesses changes in psychosocial outcomes for all groups over 52 weeks. Methods: CGM + FBI (n = 45), Standard-CGM (n = 42) and BGM-Crossover (n = 44) participants completed psychosocial assessments at baseline, 26 weeks and 52 weeks. Repeated measures linear regression models evaluated change within and between treatment groups. Results: The BGM-Crossover group reported improved diabetes burden (Δ -6.9, 95% CI [-11.3, -2.6], p = 0.003), fear of hypoglycaemia (Δ -6.4, CI [-10.1, -2.6], p = 0.002) and technology satisfaction (Δ 7.3, CI [2.4, 12.2], p = 0.005) from 26 to 52 weeks, similar to published findings in the CGM + FBI group over the first 26 weeks. The Standard-CGM group reported increased technology satisfaction (Δ 7.3, CI [0.6, 14.0], p = 0.027) from baseline to 52 weeks. The CGM + FBI group reported less diabetes burden and fear of hypoglycaemia from baseline to 52 weeks, but changes were not statistically significant. Scores from 26 to 52 weeks did not deteriorate. Conclusions: Parents demonstrated psychosocial benefits following FBI that appeared to maintain without additional intervention. CGM-focused education with behavioural support likely helps parents of young children with type 1 diabetes reduce burden and worry in the short- and long-term.