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Article ; Online: Confronting Health Misinformation Surrounding COVID-19 Vaccines in the State of Florida.

Haller, Michael J / Rubin, Daniel A / Hitchings, Matt D T

2024

Abstract: COVID-19 vaccination is estimated to have averted more than 2.4 million deaths globally. In the United States (U.S.) alone, more than 120,000 deaths and 700,000 hospitalizations are reportedly estimated to have been prevented during the first six months ... ...

Abstract	COVID-19 vaccination is estimated to have averted more than 2.4 million deaths globally. In the United States (U.S.) alone, more than 120,000 deaths and 700,000 hospitalizations are reportedly estimated to have been prevented during the first six months of the vaccine campaign. Despite the overwhelming evidence regarding the safety and efficacy of vaccination, COVID-19 vaccine hesitancy continues to pose a significant threat to public health. Notably, an unexpected source of vaccine misinformation has been the Surgeon General of the State of Florida, Dr. Joseph Ladapo. While both a tenured faculty member of the University of Florida, College of Medicine and the Surgeon General of Florida, Dr. Ladapo has delivered official Florida Department of Health statements regarding COVID-19 vaccines that run contrary to those of the U.S. Centers for Disease Control and Prevention (CDC). While tenure is designed to protect those with contrarian views, we believe that the University has an ethical obligation to condemn misleading statements that put public health at risk. Herein, we explore the challenges of managing misinformation disseminated by someone who is simultaneously a tenured professor at a public, state-supported university, and a politically appointed public health official.
Language	English
Publishing date	2024-03-18
Publishing country	United States
Document type	Editorial
ZDB-ID	639008-0
ISSN	1525-1497 ; 0884-8734
ISSN (online)	1525-1497
ISSN	0884-8734
DOI	10.1007/s11606-024-08726-6
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Article: Time-Action Profile of Technosphere Insulin in Children with Type 1 Diabetes.

Haller, Michael J / Jones, Marisa C / Bhavsar, Sunil / Kaiserman, Kevin B

Diabetes therapy : research, treatment and education of diabetes and related disorders

2023 Volume 14, Issue 3, Page(s) 611–617

Abstract: Introduction: Technosphere insulin (TI) is an inhaled dry powder ultra-rapid-acting insulin. This report describes the results of the first study of TI in children with type 1 diabetes (T1D).: Methods: Pharmacokinetics (PK) of TI and the effect of TI ...

Abstract	Introduction: Technosphere insulin (TI) is an inhaled dry powder ultra-rapid-acting insulin. This report describes the results of the first study of TI in children with type 1 diabetes (T1D). Methods: Pharmacokinetics (PK) of TI and the effect of TI on circulating glucose concentrations were evaluated in a single-arm study that enrolled children ages 8-17 years with T1D for more than 1 year, on a stable multiple daily insulin injection (MDI) regimen, and meeting pre-defined pulmonary function testing criteria (at least 70% predicted). To assess PK, subjects received an individualized single preprandial dose of TI (4-12 U, in 4-U increments) via oral inhalation, based on their usual meal-time subcutaneously injected rapid-acting insulin dose and meal content. Serum insulin and blood glucose were measured at - 30 to 250 min relative to dosing. Results: Twenty-seven children with T1D participated in this single-dose PK study. Mean subject age was 13.3 years (59% female; 81.5% White). Mean serum insulin C Conclusion: Serum insulin rapidly increased post-dose and returned to baseline by 120 min. The data suggests the PK of TI in youth with T1D ages 8-17 years was similar to that seen in previous adult studies. Trial registration: ClinicalTrials.gov identifier, NCT02527265.
Language	English
Publishing date	2023-01-18
Publishing country	United States
Document type	Journal Article
ZDB-ID	2566702-6
ISSN	1869-6961 ; 1869-6953
ISSN (online)	1869-6961
ISSN	1869-6953
DOI	10.1007/s13300-023-01368-7
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Article ; Online: Are we ready to screen for type 1 diabetes? A structured worldwide survey among healthcare providers involved in paediatric diabetes care.

Neuman, Vit / Piona, Claudia / Cudizio, Laura / Drnkova, Lenka / Sumnik, Zdenek / Slavenko, Matvei G / Haller, Michael J / Maahs, David M / Chobot, Agata

Diabetic medicine : a journal of the British Diabetic Association

2024 , Page(s) e15329

Language	English
Publishing date	2024-04-02
Publishing country	England
Document type	Letter
ZDB-ID	605769-x
ISSN	1464-5491 ; 0742-3071 ; 1466-5468
ISSN (online)	1464-5491
ISSN	0742-3071 ; 1466-5468
DOI	10.1111/dme.15329
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Article: Challenges and Opportunities in Using Telehealth for Diabetes Care.

Crossen, Stephanie S / Bruggeman, Brittany S / Haller, Michael J / Raymond, Jennifer K

Diabetes spectrum : a publication of the American Diabetes Association

2022 Volume 35, Issue 1, Page(s) 33–42

Abstract: The ongoing coronavirus pandemic led to a rapid and dramatic increase in the use of telehealth for diabetes care. In the wake of this transition, we examine new opportunities and ongoing challenges for using telehealth within diabetes management, based ... ...

Abstract	The ongoing coronavirus pandemic led to a rapid and dramatic increase in the use of telehealth for diabetes care. In the wake of this transition, we examine new opportunities and ongoing challenges for using telehealth within diabetes management, based on data and experiences from the pre-pandemic and pandemic time frames.
Language	English
Publishing date	2022-02-08
Publishing country	United States
Document type	Journal Article
ZDB-ID	2211544-4
ISSN	1040-9165
ISSN	1040-9165
DOI	10.2337/dsi21-0018
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Article ; Online: Modeling the progression of Type 2 diabetes with underlying obesity.

Yang, Boya / Li, Jiaxu / Haller, Michael J / Schatz, Desmond A / Rong, Libin

PLoS computational biology

2023 Volume 19, Issue 2, Page(s) e1010914

Abstract: Environmentally induced or epigenetic-related beta-cell dysfunction and insulin resistance play a critical role in the progression to diabetes. We developed a mathematical modeling framework capable of studying the progression to diabetes incorporating ... ...

Abstract	Environmentally induced or epigenetic-related beta-cell dysfunction and insulin resistance play a critical role in the progression to diabetes. We developed a mathematical modeling framework capable of studying the progression to diabetes incorporating various diabetogenic factors. Considering the heightened risk of beta-cell defects induced by obesity, we focused on the obesity-diabetes model to further investigate the influence of obesity on beta-cell function and glucose regulation. The model characterizes individualized glucose and insulin dynamics over the span of a lifetime. We then fit the model to the longitudinal data of the Pima Indian population, which captures both the fluctuations and long-term trends of glucose levels. As predicted, controlling or eradicating the obesity-related factor can alleviate, postpone, or even reverse diabetes. Furthermore, our results reveal that distinct abnormalities of beta-cell function and levels of insulin resistance among individuals contribute to different risks of diabetes. This study may encourage precise interventions to prevent diabetes and facilitate individualized patient treatment.
MeSH term(s)	Humans ; Diabetes Mellitus, Type 2/complications ; Insulin Resistance/physiology ; Insulin ; Obesity/complications ; Glucose ; Blood Glucose
Chemical Substances	Insulin ; Glucose (IY9XDZ35W2) ; Blood Glucose
Language	English
Publishing date	2023-02-27
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, Non-U.S. Gov't
ZDB-ID	2193340-6
ISSN	1553-7358 ; 1553-734X
ISSN (online)	1553-7358
ISSN	1553-734X
DOI	10.1371/journal.pcbi.1010914
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Article: Sociodemographic factors associated with major depressive episodes and suicidal ideation among emerging adults with diabetes in the U.S.

Yadav, Sandhya / Hong, Young-Rock / Westen, Sarah / Marlow, Nicole M / Haller, Michael J / Walker, Ashby F

Frontiers in endocrinology

2023 Volume 14, Page(s) 1276336

Abstract: Background: Research focused on disparities related to mental health comorbidities, especially among emerging adults with diabetes, is limited. Identifying associated factors of disparities could inform policy decisions to make diabetes-related ... ...

Abstract	Background: Research focused on disparities related to mental health comorbidities, especially among emerging adults with diabetes, is limited. Identifying associated factors of disparities could inform policy decisions to make diabetes-related interdisciplinary care more accessible for vulnerable groups. Method: Using data from the National Survey on Drug Use and Health (2015-2019), we examined disparities in presence of major depressive episode (MDE) and suicidal ideation among emerging adults with diabetes. Survey design-adjusted bivariate and multivariable logistic regression models were used for statistical analyses. Results: The study included 1,125 emerging adults (18-25 years old), with a history of type 1 diabetes (T1D) or type 2 diabetes (T2D). After controlling for sociodemographic and health-related characteristics, we found lower odds of having past-year major MDE for non-Hispanic Black (AOR, 0.42, p=0.032) compared to their non-Hispanic White counterparts. Females were 3.02 times more likely to have past-year MDE than males (AOR, 3.02, p=0.004). The odds of having past-year MDE were 1.96 times higher among individuals who identified as LGB (lesbian, gay, bisexual) (AOR, 1.96, P=0.038). There were no statistically significant disparities in suicidal ideation related to race/ethnicity, sex, education, and family income. However, individuals who identified as LGB had significantly higher likelihood of suicidal ideation than their heterosexual counterparts (AOR, 2.47, P=0.004). Conclusion: Significant disparities related to MDE and suicidal ideation exist based on race/ethnicity, gender, and sexual orientation. Integration of a mental health professional into the multidisciplinary diabetes care team is critical for effective management of comorbid mental health conditions in younger patients with diabetes.
MeSH term(s)	Adult ; Humans ; Male ; Female ; Adolescent ; Young Adult ; Suicidal Ideation ; Diabetes Mellitus, Type 2/epidemiology ; Depressive Disorder, Major/epidemiology ; Sociodemographic Factors ; Sexual and Gender Minorities
Language	English
Publishing date	2023-12-07
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2592084-4
ISSN	1664-2392
ISSN	1664-2392
DOI	10.3389/fendo.2023.1276336
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Article ; Online: Blue Circle Health: A Novel Patient-Centered Model of Health Care Delivery for Low-Income Patients With Type 1 Diabetes.

Bruggeman, Brittany S / Walker, Ashby F / Peters, Anne L / D'Avolio, Leonard W / Haller, Michael J

Journal of diabetes science and technology

2023 Volume 17, Issue 4, Page(s) 925–934

Abstract: Analog insulins, insulin pumps, and continuous glucose monitors (CGM) have revolutionized type 1 diabetes (T1D) treatment over the last 50 years. Nevertheless, less than 20% of patients in the United States reach guideline-based HbA1c targets. The ... ...

Abstract	Analog insulins, insulin pumps, and continuous glucose monitors (CGM) have revolutionized type 1 diabetes (T1D) treatment over the last 50 years. Nevertheless, less than 20% of patients in the United States reach guideline-based HbA1c targets. The dysfunctional delivery of U.S. health care has further worsened glycemic outcomes among structurally disadvantaged groups such as non-Hispanic Black and low-income populations. Administrative complexities resulting from mixed insurance coverage and delivery systems, incongruity between effective policies and reimbursement, structural racism, and implicit biases have led to high diabetes care-related costs, provider scarcity and burnout, and patient diabetes distress. The Extension for Community Healthcare Outcomes (ECHO) Diabetes tele-education outreach model was created to increase self-efficacy among primary care providers through a combination of weekly didactic sessions led by a team of diabetes experts and access to community-based peer coaches. As an evolution of ECHO Diabetes, Blue Circle Health has been established as a philanthropically funded health care delivery system, using a whole-person, individualized approach to T1D care for adults living in underserved communities. The program will provide direct-to-patient telehealth services, including diabetes education, management, and related psychological care regardless of ability to pay. Community-based diabetes support coaches will serve as the primary point of contact, or guide on the "Blue Circle Health Member Journey." Access to needed insulins, supplies, and CGMs will be provided at no cost to the individual. Through a continuous learning and improvement model, a person-centered, equitable, accessible, and effective health care delivery model will be built for people living with T1D.
MeSH term(s)	Adult ; Humans ; United States ; Diabetes Mellitus, Type 1/therapy ; Blood Glucose ; Poverty ; Insulin/therapeutic use ; Delivery of Health Care ; Patient-Centered Care
Chemical Substances	Blood Glucose ; Insulin
Language	English
Publishing date	2023-01-29
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ISSN	1932-2968
ISSN (online)	1932-2968
DOI	10.1177/19322968221149008
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Article ; Online: Time for changes in type 1 diabetes intervention trial designs.

Atkinson, Mark A / Haller, Michael J / Schatz, Desmond A / Battaglia, Manuela / Mathieu, Chantal

The lancet. Diabetes & endocrinology

2023 Volume 11, Issue 11, Page(s) 789–791

MeSH term(s)	Humans ; Diabetes Mellitus, Type 1/therapy ; Research Design ; Diabetes Mellitus, Type 2
Language	English
Publishing date	2023-10-03
Publishing country	England
Document type	Journal Article
ISSN	2213-8595
ISSN (online)	2213-8595
DOI	10.1016/S2213-8587(23)00262-0
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Article ; Online: Apparent Clitoromegaly in Healthy Female Newborn.

Hiers, Paul S / Abi Younes, Rita Tatiana / Haller, Michael J

Pediatrics in review

2021 Volume 42, Issue Suppl 2, Page(s) 173–176

Abstract: Cysts of the external female genitalia are uncommon findings and can be either congenital or acquired. Congenital cysts of the external female genitalia may be discovered from the initial newborn examination and cause concern for clitoromegaly or ... ...

Abstract	Cysts of the external female genitalia are uncommon findings and can be either congenital or acquired. Congenital cysts of the external female genitalia may be discovered from the initial newborn examination and cause concern for clitoromegaly or ambiguous genitalia. We describe a clitoral cyst presenting as apparent clitoromegaly in a newborn; this is the third reported case in the literature. We also review the differential and evaluation for clitoromegaly in a newborn. We present a case of a 1-day-old newborn, with concern for clitoromegaly on initial newborn examination. Multiple anatomy ultrasounds were performed during pregnancy and no genital abnormality was noted. On physical examination, a 1 × 1 cm cyst was found on the clitoral hood obstructing the clitoris and vaginal opening. There were no signs of virilization or hyperandrogenism on examination. The cyst was aspirated, with clear, serous fluid removed. Normal female anatomy and normal clitoris size were noted after aspiration. She had no recurrence of the cyst in the months after discharge. Clitoral cysts of the female external genitalia are rare findings. Baring signs of virilization of hyperandrogenism, conservative management and watchful waiting or cyst drainage are reasonable approaches.
MeSH term(s)	Clitoris ; Female ; Humans ; Hyperandrogenism ; Infant, Newborn ; Neoplasm Recurrence, Local ; Pregnancy ; Ultrasonography ; Vulvar Diseases
Language	English
Publishing date	2021-09-01
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	774515-1
ISSN	1526-3347 ; 0191-9601
ISSN (online)	1526-3347
ISSN	0191-9601
DOI	10.1542/pir.2020-0043
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Article ; Online: How Do We Move Type 1 Diabetes Immunotherapies Forward During the Current COVID-19 Pandemic?

Haller, Michael J / Jacobsen, Laura M / Posgai, Amanda L / Schatz, Desmond A

Diabetes

2021 Volume 70, Issue 5, Page(s) 1021–1028

Abstract: Research-based immunotherapy trials seeking to prevent or reverse a number of autoimmune diseases, including type 1 diabetes, have seen near universal suspension due to the coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory ... ...

Abstract	Research-based immunotherapy trials seeking to prevent or reverse a number of autoimmune diseases, including type 1 diabetes, have seen near universal suspension due to the coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Diabetes and hyperglycemia are now appreciated as significant risk factors for COVID-19 morbidity and mortality; however, the vast majority of studies have reported on adults. Recent data in children and adolescents with type 1 diabetes suggest no increased risk of COVID-19. Even with immense appreciation for COVID-19 morbidity and mortality, we believe compelling arguments exist to carefully and thoughtfully resume certain type 1 diabetes phase 2-3 immunotherapy trials. In this Perspective, we consider the experience of trials that never halted or have resumed in the oncology and rheumatology fields, and advocate for staged type 1 diabetes immunotherapy trial resumption. With this, we present recommendations to achieve equipoise and mitigate risks for SARS-CoV-2 infection in the weeks surrounding infusion. Given the fact that the COVID-19 pandemic is expected to persist for some time, it is in the best interest of our patients that we find ways to safely move our field forward.
MeSH term(s)	Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal, Humanized/therapeutic use ; COVID-19/epidemiology ; COVID-19/mortality ; COVID-19/prevention & control ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; Diabetes Mellitus, Type 1/drug therapy ; Disease Progression ; Humans ; Immunosuppressive Agents/therapeutic use ; Immunotherapy ; Inflammatory Bowel Diseases/drug therapy ; Leukemia/drug therapy ; Risk Assessment ; SARS-CoV-2 ; Tumor Necrosis Factor Inhibitors/therapeutic use
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Immunosuppressive Agents ; Tumor Necrosis Factor Inhibitors ; golimumab (91X1KLU43E) ; teplizumab (S4M959U2IJ)
Language	English
Publishing date	2021-02-25
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Review
ZDB-ID	80085-5
ISSN	1939-327X ; 0012-1797
ISSN (online)	1939-327X
ISSN	0012-1797
DOI	10.2337/dbi20-0045
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