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Diabetes affects more than 37 million Americans. More than one-third of American adults (96 million) have prediabetes, so it is anticipated that the prevalence of diabetes will continue to climb in the generation to come. There have been major advances in the options for home glucose monitoring. Home glucose monitoring provides critical information and feedback for patients with diabetes to help them understand how daily activities affect their glucose levels and timely data to assist in behavior reinforcement and modification. Self-monitoring of blood glucose (SMBG) is of great value to those with type 1 diabetes and those with type 2 diabetes on insulin as it reduces HbA1c and rates of hypoglycemia. Currently, there is less support for long-term benefit of SMBG in those with type 2 diabetes not on insulin or insulin secretagogues. Continuous glucose monitoring (CGM) is becoming increasingly available to help manage diabetes. This form of monitoring provides benefits in terms of HbA1c, reduced time and rates of hypoglycemia, and increased time in range for those on insulin. CGM reports now include standardized reporting and target goals that will make widespread use easier to implement. This article will review the current data on home glucose monitoring for those with diabetes.

Discordance between physicians and patients’ health beliefs can impede health communication efforts. However, little research considers physicians’ perceptions of patient beliefs, despite the impor...

Diabetes is a complex condition that is largely self-managed. Decades of scientific evidence has proved that early glycemic control leads to improved microvascular and macrovascular outcomes in people with diabetes mellitus. Despite well-established management guidelines, only about half of the patients with diabetes achieve glycemic targets, and only one in five patients achieve metabolic control (blood pressure, lipid, and glucose targets), and both patients and physicians find themselves stuck in a rut called therapeutic inertia (TI). The authors present several practical strategies that can be tailored to different practice settings and facilitate reducing TI.

Type 2 diabetes mellitus (T2DM) is a chronic condition associated with substantial clinical and economic burden. As multiple therapeutic options are available, patient preferences on treatment characteristics are key in T2DM therapeutic decision-making. This study aimed to determine the preferences of US patients with T2DM for therapies recommended for first pharmacologic intensification after metformin.As part of a discrete choice experiment, an online survey was designed using literature review and qualitative interview findings. Eligibility was met by US patients with T2DM who were aged 18 years or older with an HbAEligible patients (n = 500) had a mean HbAPatients with T2DM in the USA are significantly more likely to prefer oral or injectable semaglutide-like profiles over those of key comparators from the glucagon-like peptide 1 receptor agonist, sodium-glucose cotransporter 2 inhibitor, dipeptidyl peptidase 4 inhibitor, and thiazolidinedione classes.

Diabetes mellitus has become a non-infectious pandemic. The incidence of T2D has risen dramatically and recent rates have increased in many countries including Muslim countries. As the number of people who participate in Ramadan increases, health care professionals will need to become familiar with the traditions and help people stay healthy during the holy month of Ramadan. A key part of Ramadan is the practice of one month of fasting from sunrise to sunset. While this is a religious practice, it has significant impacts on the management of people with diabetes. This article will discuss the traditions associated with Ramadan and how to help people safely manage their diabetes while participating in Ramadan.

Context Diabetes-related distress (DRD) is experienced by nearly 50% of people with diabetes at any given time in their diagnosis. The effects of low socioeconomic status (SES) and lacking access to resources can increase DRD. In addition, cardiovascular (CV) complications associated with diabetes are associated with higher DRD scores. Objectives This study evaluated the associations between DRD and predicted CV risks in participants with type 2 diabetes. Methods This cross-sectional study included 234 individuals with low SES who were Medi-Cal (California version of Medicaid) beneficiaries and sought medical care at a safety-net clinic system. The Problem Areas in Diabetes (PAID) questionnaire assessed DRD levels. The United Kingdom Prospective Diabetes Study Risk Engine was utilized to predict 10-year risks for coronary heart disease (CHD), fatal CHD, stroke, and fatal stroke. A multivariate linear regression model was constructed between the two variables, including other variables to control for potential confounding factors, for assessing the associations. Results After controlling for potential confounders, participants’ total PAID questionnaire scores were significantly associated with their 10-year predicted fatal CHD risks (B=0.060, 95% CI: [0.00084, 0.12], p=0.047). Conclusions After controlling for covariates, DRD levels exhibited a significant association with increased 10-year predicted fatal CHD risks in patients with type 2 diabetes and lower SES. Screening for DRD and provision of appropriate psychosocial interventions may reduce the risks of CHD in those with type 2 diabetes.

Diabetes is a common and complex disease affecting multiple organ systems throughout the body. With a consensus in care guidelines emphasizing the importance of glycemic control in determining the disease progression, people with diabetes worldwide have been placed on medication regimens targeting glucose stability from a variety of pathophysiologic pathways. Each of these medications also possesses its own potential for adverse events. In recent years, there has been increased reports of skin reactions to diabetes medications, adding to the more widely known eruptions such as insulin-induced lipohypertrophy and contact dermatitis of subcutaneous injections. The authors searched PubMed, Google, and Embase for articles including adverse reactions to anti-hyperglycemic medications. Key words and titles searched included, “antidiabetic drugs”, “skin reactions”, “adverse drug reactions”, “allergic reactions”, “diabetes”, “metformin”, “insulin”, “DPP4 inhibitors”, “thiazolindineones”, “sulfonylureas”, “SGLT2 inhibitors”, “GLP-1 agonists”, “diabetic medication”, “injection site reactions”. As a result, a total of 59 papers are included in this review. The great majority were case reports ranging from benign fixed drug eruptions to severe cutaneous reactions that threaten patients’ lives. Increasing physician awareness of both the potential for, and presentation of, such reactions to diabetes medications can reduce hospitalizations and optimize care in an already vulnerable patient population.

Patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are at high risk of CKD progression and cardiovascular (CV) disease. Prevalence of CKD in patients with T2D is currently around 40% and continues to grow. The increasing number of people with CKD and T2D will ultimately have a significant impact upon health resource use and costs of care for people with T2D. Management of CKD in patients with T2D aims to preserve kidney function to reduce the risk of end-stage kidney disease, CV events, and mortality. Evidence-based recommendations for the treatment of patients with CKD and T2D are provided by several international and national organizations and recommend several lifestyle and pharmacological approaches to help prevent or delay the progression of CKD in patients with T2D. Guidelines include regular screening of patients with T2D for CKD using spot urine albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (at least annually and at least twice a year if UACR >300 mg/g). Additionally, assessment of vascular complications, together with interventions designed to improve glycemic control and lipid levels, maintain healthy body weight, and optimize blood pressure should be performed. Medications shown to slow progression of CKD include renin-angiotensin system inhibitors, sodium-glucose cotransporter-2 inhibitors, glucagon-like peptide 1 receptor agonists, and, more recently, selective, non-steroidal mineralocorticoid receptor antagonists. This review highlights the ongoing challenges facing primary care providers in the management of CKD in patients with T2D including the consideration of comorbidities, adoption of new treatment options, and implementation of individualized care. Achieving consensus for optimal treatment of this disease is critical in providing consistent and appropriate care for all patients. Strategies to improve outcomes should also include use of clear referral criteria, use of a multi-disciplinary approach, and patient education.

BACKGROUND Visualization can be a powerful tool to comprehend data sets, especially when they can be represented via hierarchical structures. Enhanced comprehension can facilitate the development of scientific hypotheses. However, the inclusion of excessive data can make visualizations overwhelming. OBJECTIVE We developed a visual interactive analytic tool for filtering and summarizing large health data sets coded with hierarchical terminologies (VIADS). In this study, we evaluated the usability of VIADS for visualizing data sets of patient diagnoses and procedures coded in the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). METHODS We used mixed methods in the study. A group of 12 clinical researchers participated in the generation of data-driven hypotheses using the same data sets and time frame (a 1-hour training session and a 2-hour study session) utilizing VIADS via the think-aloud protocol. The audio and screen activities were recorded remotely. A modified version of the System Usability Scale (SUS) survey and a brief survey with open-ended questions were administered after the study to assess the usability of VIADS and verify their intense usage experience with VIADS. RESULTS The range of SUS scores was 37.5 to 87.5. The mean SUS score for VIADS was 71.88 (out of a possible 100, SD 14.62), and the median SUS was 75. The participants unanimously agreed that VIADS offers new perspectives on data sets (12/12, 100%), while 75% (8/12) agreed that VIADS facilitates understanding, presentation, and interpretation of underlying data sets. The comments on the utility of VIADS were positive and aligned well with the design objectives of VIADS. The answers to the open-ended questions in the modified SUS provided specific suggestions regarding potential improvements for VIADS, and the identified problems with usability were used to update the tool. CONCLUSIONS This usability study demonstrates that VIADS is a usable tool for analyzing secondary data sets with good average usability, good SUS score, and favorable utility. Currently, VIADS accepts data sets with hierarchical codes and their corresponding frequencies. Consequently, only specific types of use cases are supported by the analytical results. Participants agreed, however, that VIADS provides new perspectives on data sets and is relatively easy to use. The VIADS functionalities most appreciated by participants were the ability to filter, summarize, compare, and visualize data. INTERNATIONAL REGISTERED REPORT RR2-10.2196/39414

PurposeThis qualitative study utilizes the health belief model to explore how individuals with type 2 diabetes mellitus and low diabetes numeracy achieve and maintain good glycemic control. MethodsParticipants (n=10) participated in semi-structured interviews and completed the Patient Diabetes Knowledge Questionnaire, the Health Belief Questionnaire, and the Social Support Assessment Tool. ResultsResults indicate that participants had low levels of diabetes knowledge, high levels of perceived social support and strong self-efficacy related to type 2 diabetes management, despite low numeracy. Self-designed routines mitigated potential educational, socioeconomic, and knowledge barriers. Self-efficacy and social support were strong protective factors. ConclusionsThe healthcare team can help high-risk patients manage their type 2 diabetes by improving self-efficacy and identifying social support. Diabetes self-management education should encourage activities that promote higher levels of self-reflection and critical thinking.

Context Primary care physicians need a strong foundation in diabetes management, as they are the first line of care for patients with this complex disease, which is increasing in frequency in the United States. This foundational training begins in medical school, but its applications become more important during residency. Objectives To quantify osteopathic and allopathic family medicine residents’ amount of exposure to diabetes in residency training, investigate referral patterns related to diabetes management, and assess comfort levels with various diabetes treatment modalities. Methods An 18-item cross sectional survey was sent via email using Qualtrics to program directors and chief residents of 16 different training programs located in seven different health systems and four different states; the programs were focused on family medicine, internal medicine, pediatrics, and combined internal medicine/pediatrics programs. The link was also posted on Twitter using specific “handles” to “tag” professional associations and groups related to primary care. Emails and tweets were initiated on October 15, 2018 and responses were collected through April 15, 2019. Data collection was reinitiated via email only from May 1, 2020 through July 31, 2020 due to low initial response rate. The study, which included multiple choice and Likert scale questions with some skip logic, was designed by study investigators. Data was exported from Qualtrics to an Excel spreadsheet and analyzed using descriptive statistics, which are reported as percentages. Results A total of 61 residents responded to the survey, with most (52; 85.2%) enrolled in family medicine or internal medicine programs. Residents were mostly located in rural (28; 45.9%) and suburban (25; 41.0%) areas. Respondents reported being extremely comfortable with metformin (45; 73.8%), basal insulin (24; 39.3%), and healthy lifestyle education (32; 52.5%) for the treatment of diabetes. They reported being least comfortable with diabetes technology, with 51 (83.6%) uncomfortable or extremely uncomfortable with insulin pumps and 43 (70.5%) uncomfortable with continuous glucose monitoring systems for diabetes treatment. Referral rates to endocrinologists were low, with 47 (77%) reporting referral of diabetes patients 10–15% of the time. Residents reported interest in workshops and online continuing medical education for further training opportunities, but interest in additional formal training was low (3; 4.9%). Conclusions Residents in this study reported confidence in diabetes management and referral rates among this group were low. However, reported comfort levels with treatment modalities beyond metformin and lifestyle changes were not strong. Referral rates may have been low due to the low number of endocrinologists in rural areas and therapeutic inertia. Diabetes fellowships could increase resource availability for patient referral. Utilization of diabetologists in primary care programs may also add benefit and improve skills among trainees including more familiarity with diabetes technology and use of newer medications used in diabetes management.

Context Type 2 diabetes (T2D) mellitus, which was once considered a disease affecting adults, is a growing problem among youths. Research now shows that T2D in youths is more progressive and associated with earlier onset of complications than adult-onset T2D. Objectives To update practicing clinical physicians on what is currently known about pediatric T2D and share current guidelines to care for these patients. Methods The authors conducted a literature review through the MEDLINE/PubMed, Google Scholar, and clinicaltrials.gov databases in July 2019 using the following search phrases: “youth-onset type 2 diabetes,” “pediatric type 2 diabetes,” “diabetes in youth,” and “FDA-approved pediatric diabetes medications.” Items published between 2010 and 2019 and written in English were included. Results A total of 65 items were included after database review, including 44 articles, 10 FDA product inserts, six clinicaltrials.gov listings, three position statements/guideline documents, one website, and one FDA announcement. Conclusions There are very limited treatment options available to manage pediatric T2D. Prevention of pediatric T2D is paramount, which requires a high index of suspicion, routine screening of children and adolescents, and willingness to engage in family-based interventions for those at risk for prediabetes and T2D. Osteopathic physicians have a unique opportunity to help by applying the osteopathic principles to the whole person – including environmental, societal, and lifestyle factors – to help patients achieve their health and wellness goals.

OBJECTIVE We estimated the cost-effectiveness of the Program ACTIVE (Adults Coming Together to Increase Vital Exercise) II community-based exercise (EXER), cognitive behavioral therapy (CBT), and EXER+CBT interventions in adults with type 2 diabetes and depression relative to usual care (UC) and each other. RESEARCH DESIGN AND METHODS Data were integrated into the Michigan Model for Diabetes to estimate cost and health outcomes over a 10-year simulation time horizon from the health care sector and societal perspectives, discounting costs and benefits at 3% annually. Primary outcome was cost per quality-adjusted life-year (QALY) gained. RESULTS From the health care sector perspective, the EXER intervention strategy saved $313 (USD) per patient and produced 0.38 more QALY (cost saving), the CBT intervention strategy cost $596 more and gained 0.29 more QALY ($2,058/QALY), and the EXER+CBT intervention strategy cost $403 more and gained 0.69 more QALY ($585/QALY) compared with UC. Both EXER and EXER+CBT interventions dominated the CBT intervention. Compared with EXER, the EXER+CBT intervention strategy cost $716 more and gained 0.31 more QALY ($2,323/QALY). From the societal perspective, compared with UC, the EXER intervention strategy saved $126 (cost saving), the CBT intervention strategy cost $2,838/QALY, and the EXER+CBT intervention strategy cost $1,167/QALY. Both EXER and EXER+CBT interventions still dominated the CBT intervention. In comparison with EXER, the EXER+CBT intervention strategy cost $3,021/QALY. Results were robust in sensitivity analyses. CONCLUSIONS All three Program ACTIVE II interventions represented a good value for money compared with UC. The EXER+CBT intervention was highly cost-effective or cost saving compared with the CBT or EXER interventions.

Introduction Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are highly effective for glycaemic control and weight loss in patients with type 2 diabetes (T2D). In this retrospective, observational study, we analysed glycated haemoglobin (HbA1c) and weight following switching to semaglutide from any other GLP-1 RA, using US electronic health records and prescription data. Methods Adults (≥ 18 years old) with T2D required at least one prescription for injectable semaglutide at index date (treatment switch), at least one prescription for any other GLP-1 RA in the previous 365 days, a baseline HbA1c and/or weight measurement in the 90 days pre-index and a follow-up measurement at 180 and 365 days post-index. HbA1c and weight cohorts were analysed separately using an ANCOVA model. Sensitivity analyses were conducted in patients with at least two prescriptions for pre-switch GLP-1 RA. A secondary analysis compared subgroups receiving different GLP-1 RAs pre-switch. Results Patients with HbA1c (n = 710) and weight (n = 921) data had similar baseline characteristics. Significant reductions in HbA1c at 6 months (0.7%; 95% confidence interval [CI] − 0.8, − 0.6) were sustained at 12 months. Weight reductions were significant at 6 months (− 2.1 kg; 95% CI − 2.6, − 1.6) and greater at 12 months (− 2.8 kg; 95% CI − 3.9, − 1.8). These patterns were consistent with the two-prescription sensitivity analysis and independent of the pre-switch GLP-1 RA. Conclusion Switching to injectable semaglutide from any other GLP-1 RA was associated with significant improvements in glycaemic control and weight. Our findings support decision-making in clinical practice in patients with an indication to switch between GLP-1 RAs. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-021-01010-4.

Background: Time restricted eating (TRE) and Low Carbohydrate Diets (LCD) have become popular dietary patterns with potential metabolic benefits for T2DM patients. The objective of this study is to evaluate TRE on glucose control compared to LCD for individuals with T2DM after completing a 72 hour medically supervised induction fast. Methods: Participants completed a 72 hour medically supervised induction fast and were randomized to TRE (n=14, 8-hour daily feeding period) or LCD (n=10, Results: A total of 24 participants completed the protocol (mean age = 53.9, range 35-72) . GMI was reduced from 8.99% to 7.30% (p=0.002) in TRE and 7.99% to 6.77% in LCD (p=0.001) . Reductions in GMI range were greater in the first 2 weeks compared to last 2 weeks. The TRE group spent less time within the target range (67.7% vs. 74.8%, p=0.32) , more time hyperglycemic (29.4% vs. 21.0% p=0.25) , and less time hypoglycemic (2.8% vs. 4.2%, p=0.42) . Hypoglycemia was numerically less common in the TRE group (3/14 participants) compared to the LCD (6/participants) in CGM data beyond the induction fast. Glucose variability was similar in TRE (28.6%) and LCD (28.2%) . There were no SAEs experienced in either group. When surveyed, participants believed TRE and LCD were realistic nutritional therapies. Conclusion: These results suggest that both TRE and LCD supplemented by a medically supervised induction fast are efficacious and safe nutritional therapies to improve blood glucose in patients with T2DM. The participants will be followed for 12 months to analyze long-term effects. Disclosure A.Carbonel: None. E.Velis: None. T.L.Calinawan: None. R.Kiwan: None. C.Smith: None. C.Svid: None. J.H.Shubrook: Consultant; Abbott, AstraZeneca, Bayer AG, Eli Lilly and Company, Novo Nordisk.

BackgroundScientific hypothesis generation is a critical step in scientific research that determines the direction and impact of any investigation. Despite its vital role, we have limited knowledge of the process itself, hindering our ability to address some critical questions.ObjectiveTo what extent can secondary data analytic tools facilitate scientific hypothesis generation during clinical research? Are the processes similar in developing clinical diagnoses during clinical practice and developing scientific hypotheses for clinical research projects? We explore the process of scientific hypothesis generation in the context of clinical research. The study is designed to compare the role of VIADS, our web-based interactive secondary data analysis tool, and the experience levels of study participants during their scientific hypothesis generation processes.MethodsInexperienced and experienced clinical researchers are recruited. In this 2×2 study design, all participants use the same data sets during scientific hypothesis-generation sessions, following pre-determined scripts. The inexperienced and experienced clinical researchers are randomly assigned into groups with and without using VIADS. The study sessions, screen activities, and audio recordings of participants are captured. Participants use the think-aloud protocol during the study sessions. After each study session, every participant is given a follow-up survey, with participants using VIADS completing an additional modified System Usability Scale (SUS) survey. A panel of clinical research experts will assess the scientific hypotheses generated based on pre-developed metrics. All data will be anonymized, transcribed, aggregated, and analyzed.ResultsThis study is currently underway. Recruitment is ongoing via a brief online survey 1. The preliminary results show that study participants can generate a few to over a dozen scientific hypotheses during a 2-hour study session, regardless of whether they use VIADS or other analytic tools. A metric to assess scientific hypotheses within a clinical research context more accurately, comprehensively, and consistently has also been developed.ConclusionThe scientific hypothesis-generation process is an advanced cognitive activity and a complex process. Clinical researchers can quickly generate initial scientific hypotheses based on data sets and prior experience based on our current results. However, refining these scientific hypotheses is much more time-consuming. To uncover the fundamental mechanisms of generating scientific hypotheses, we need breakthroughs that capture thinking processes more precisely.

Insulin is an important treatment in diabetes, and understanding insulin pharmacokinetics is vital to clinical practice. The primary care physician should be knowledgeable about the decision for use, initiation of treatment and titration as well as common pitfalls such as hypoglycemia and cost.

BACKGROUND Scientific hypothesis generation is a critical step in scientific research that determines the direction and impact of any investigation. Despite its vital role, we have limited knowledge of the process itself, thus hindering our ability to address some critical questions. OBJECTIVE This study aims to answer the following questions: To what extent can secondary data analytics tools facilitate the generation of scientific hypotheses during clinical research? Are the processes similar in developing clinical diagnoses during clinical practice and developing scientific hypotheses for clinical research projects? Furthermore, this study explores the process of scientific hypothesis generation in the context of clinical research. It was designed to compare the role of VIADS, a visual interactive analysis tool for filtering and summarizing large data sets coded with hierarchical terminologies, and the experience levels of study participants during the scientific hypothesis generation process. METHODS This manuscript introduces a study design. Experienced and inexperienced clinical researchers are being recruited since July 2021 to take part in this 2×2 factorial study, in which all participants use the same data sets during scientific hypothesis–generation sessions and follow predetermined scripts. The clinical researchers are separated into experienced or inexperienced groups based on predetermined criteria and are then randomly assigned into groups that use and do not use VIADS via block randomization. The study sessions, screen activities, and audio recordings of participants are captured. Participants use the think-aloud protocol during the study sessions. After each study session, every participant is given a follow-up survey, with participants using VIADS completing an additional modified System Usability Scale survey. A panel of clinical research experts will assess the scientific hypotheses generated by participants based on predeveloped metrics. All data will be anonymized, transcribed, aggregated, and analyzed. RESULTS Data collection for this study began in July 2021. Recruitment uses a brief online survey. The preliminary results showed that study participants can generate a few to over a dozen scientific hypotheses during a 2-hour study session, regardless of whether they used VIADS or other analytics tools. A metric to more accurately, comprehensively, and consistently assess scientific hypotheses within a clinical research context has been developed. CONCLUSIONS The scientific hypothesis–generation process is an advanced cognitive activity and a complex process. Our results so far show that clinical researchers can quickly generate initial scientific hypotheses based on data sets and prior experience. However, refining these scientific hypotheses is a much more time-consuming activity. To uncover the fundamental mechanisms underlying the generation of scientific hypotheses, we need breakthroughs that can capture thinking processes more precisely. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/39414

Description The American Diabetes Association (ADA) updates the Standards of Medical Care in Diabetes annually to provide clinicians, patients, researchers, payers, and other interested parties with evidence-based recommendations for the diagnosis and management of diabetes. Methods To develop the 2020 Standards, the ADA Professional Practice Committee, comprising physicians, adult and pediatric endocrinologists, diabetes educators, registered dietitians, epidemiologists, pharmacists, and public health experts, continuously searched MEDLINE (English language only) from 15 October 2018 through August-September 2019 for pertinent studies, including high-quality trials that addressed pharmacologic management of type 2 diabetes. The committee selected and reviewed the studies, developed the recommendations, and solicited feedback from the larger clinical community. Recommendations This synopsis focuses on guidance relating to the pharmacologic treatment of adults with type 2 diabetes. Recommendations address oral and noninsulin injectable therapies, insulin treatment, and combination injectable therapies. Results of recent large trials with cardiovascular and renal outcomes are emphasized.

Gastroparesis is characterized by delayed gastric emptying in the absence of mechanical obstruction. This complication is associated with uncontrolled diabetes, contributing to approximately one-third of all gastroparesis cases (1–3). Gastroparesis is more prevalent in patients with type 1 diabetes than in those with type 2 diabetes (4). The 10-year cumulative incidence of diabetic gastroparesis has been estimated to be 5.2% in patients with type 1 diabetes and 1% in those with type 2 diabetes (5,6). The prevalence of diabetes-associated gastrointestinal symptoms is 5–12% (7,8). In a study by Jung et al. (9) conducted in Olmsted County, MN, the prevalence of gastroparesis was about 5% in patients with type 1 diabetes and 1% in type 2 diabetes (9). In the same study, the age-adjusted incidence rate of gastroparesis was 2.4/100,000 person-years in men and 9.8/100,000 person-years in women (9). Gastroparesis, a form of autonomic neuropathy, is most commonly seen in people who have had diabetes for >10 years and who have already developed other microvascular complications (10). Once the symptoms from gastroparesis begin, they typically persist and are stable over 12–25 years; this is true even when blood glucose levels have been controlled (11). The most common symptoms are early satiety, nausea, bloating, abdominal pain, and vomiting. In terms of prognosis, a recent study published by Chang et al. (12) found no association between delayed gastric emptying and increased mortality over a 25-year period. Although there is no evidence to date that diabetic gastroparesis increases mortality, this complication substantially impairs all aspects of life (13). Although still not fully elucidated, the suggested pathophysiology of diabetic gastroparesis includes poor glycemic control, sympathetic vagal neuropathy, Cajal interstitial cell abnormalities, and loss of neuronal nitric oxide synthase (nNOS) (3,14). The loss of interstitial cells …

As the cornerstone of type 2 diabetes (T2D) management within the community, primary care providers are now faced with the challenge of not only managing diabetes itself, but also preventing hypoglycemia and weight gain associated with intensive disease management, and reducing cardiovascular risk. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are well established as efficacious treatments for T2D, and the safety/tolerability profile of this drug class is well defined. However, despite their beneficial effects, GLP-1RAs are under-utilized, highlighting the need for novel approaches to increase their use in primary care. Oral semaglutide is the first oral GLP-1RA approved for the treatment of T2D, offering glucose lowering and body weight loss, a low risk of hypoglycemia, and no increase in cardiovascular risk. Oral semaglutide represents an additional treatment option for patients not achieving their glycemic goal despite treatment with metformin, either alone or with other hypoglycemic agents. Oral semaglutide has the potential to increase usage of GLP-1RAs in the primary care setting by addressing clinician and patient concerns about injections, and may facilitate earlier initiation of GLP-1RA therapy in T2D. Due to the formulation of oral semaglutide, clinicians need to be aware of specific considerations in order to ensure optimal use. Such considerations include dosing conditions and use of concomitant medications. This article provides practical guidance on the use of oral semaglutide in the primary care setting, based on evidence from clinical studies, including the phase 3a PIONEER program, and the authors' clinical experience.

It is well known that type 2 diabetes mellitus (T2D) is a globally increasing health burden. Despite recent therapeutic advances and the availability of many different classes of antihyperglycemic therapy, a large proportion of people do not achieve glycemic control. A decline in pancreatic beta-cell function has been defined as a key contributing factor to progression of T2D. In fact, a significant proportion of beta-cell secretory capacity is thought to be lost well before the diagnosis of T2D is made. Several models have been proposed to explain the reduction in beta-cell function, including reduced beta-cell number, beta-cell exhaustion, and dedifferentiation or transdifferentiation into other cell types. However, there have been reports that suggest remission of T2D is possible, and it is believed that beta-cell dysfunction may be, in part, reversible. As such, the question of whether beta cells are committed to failure in people with T2D is complex. It is now widely accepted that early restoration of normoglycemia may protect beta-cell function. Key to the successful implementation of this approach in clinical practice is the appropriate assessment of individuals at risk of beta-cell failure, and the early implementation of appropriate treatment options. In this review, we discuss the progression of T2D in the context of beta-cell failure and describe how C-peptide testing can be used to assess beta-cell function in primary care practice. In conclusion, significant beta-cell dysfunction is likely in individuals with certain clinical characteristics of T2D, such as long duration of disease, high glycated hemoglobin (≥9%), and/or long-term use of therapies that continuously stimulate the beta cell. In these people, measurement of beta-cell status could assist with choice of appropriate therapy to delay or potentially reverse beta-cell dysfunction and the progression of T2D.

In this highly digitalized era, sleep disorders are becoming more common and are associated with an increased burden of chronic disease. Shift workers are at an increased risk for both sleep disorders and metabolic syndrome. In this article, the authors outline the connection between circadian discordance, hormonal imbalance, and the development of metabolic syndrome in shift workers. Based on a literature review of animal model studies, observational studies, and clinical trials conducted between August and October of 2018, the authors offer several clinical interventions, including work schedules, light therapy, medications, and dietary habits to improve the circadian synchronicity of shift workers and reduce their risk of morbidity and mortality. It is important for physicians to be familiar with the consequences of shift work and ways to mitigate the risks for this patient population.

Understanding risk factors and glucose targets for gestational diabetes can help you identify at-risk patients and improve outcomes for mother and infant.

Background Visualization can be a powerful tool to comprehend data sets, especially when they can be represented via hierarchical structures. Enhanced comprehension can facilitate the development of scientific hypotheses. However, the inclusion of excessive data can make visualizations overwhelming. Objective We developed a visual interactive analytic tool for filtering and summarizing large health data sets coded with hierarchical terminologies (VIADS). In this study, we evaluated the usability of VIADS for visualizing data sets of patient diagnoses and procedures coded in the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). Methods We used mixed methods in the study. A group of 12 clinical researchers participated in the generation of data-driven hypotheses using the same data sets and time frame (a 1-hour training session and a 2-hour study session) utilizing VIADS via the think-aloud protocol. The audio and screen activities were recorded remotely. A modified version of the System Usability Scale (SUS) survey and a brief survey with open-ended questions were administered after the study to assess the usability of VIADS and verify their intense usage experience with VIADS. Results The range of SUS scores was 37.5 to 87.5. The mean SUS score for VIADS was 71.88 (out of a possible 100, SD 14.62), and the median SUS was 75. The participants unanimously agreed that VIADS offers new perspectives on data sets (12/12, 100%), while 75% (8/12) agreed that VIADS facilitates understanding, presentation, and interpretation of underlying data sets. The comments on the utility of VIADS were positive and aligned well with the design objectives of VIADS. The answers to the open-ended questions in the modified SUS provided specific suggestions regarding potential improvements for VIADS, and the identified problems with usability were used to update the tool. Conclusions This usability study demonstrates that VIADS is a usable tool for analyzing secondary data sets with good average usability, good SUS score, and favorable utility. Currently, VIADS accepts data sets with hierarchical codes and their corresponding frequencies. Consequently, only specific types of use cases are supported by the analytical results. Participants agreed, however, that VIADS provides new perspectives on data sets and is relatively easy to use. The VIADS functionalities most appreciated by participants were the ability to filter, summarize, compare, and visualize data. International Registered Report Identifier (IRRID) RR2-10.2196/39414

Pregestational diabetes is a condition in which a woman with diabetes (most commonly type 1 or type 2 diabetes) before the onset of pregnancy becomes pregnant and therefore vulnerable to increased risk for maternal and fetal adverse outcomes. Pregestational diabetes has been observed in 1–2% of all pregnancies, but rates are rising (1). Approximately one in nine women (14.9 million) have diabetes, and 35% of people with newly diagnosed diabetes are women of reproductive age (2). This means diabetes is increasingly affecting women of childbearing age. Furthermore, nearly one in five adolescents aged 12–18 years and one in four young adults aged 19–34 years are living with prediabetes, which has the potential to cross the threshold into diabetes (3). The increasing prevalence of diabetes among women of reproductive age is largely driven by an increase in type 2 diabetes, which in turn is driven by unhealthy nutrition, obesity, and increasingly sedentary lifestyles (4,5). Pregestational type 2 diabetes disproportionately affects women of ethnic minorities and disadvantaged socioeconomic status. For example, Pacific Islanders, Asian Indians, and Native Americans are more commonly affected by type 2 diabetes (6). In the United States, rates of pregestational diabetes have doubled since 1996, with ∼24% of women having preexisting type 1 diabetes and 76% having preexisting type 2 diabetes (7). The greatest increase is among Hispanic women. Moreover, women with pregestational type 2 diabetes are typically older (≥30 years of age) and more likely to be African American, Hispanic, or Asian (7). Thus, management of pregestational diabetes is not only a racial-ethnic equity issue, but is also important from a clinical impact standpoint. An estimated $327 million in direct medical costs and $90 billion in lost productivity could be saved by implementing comprehensive preconception care for all women diagnosed with diabetes (8). …

Human Papilloma Virus (HPV) has become a major public health concern in the United States. HPV has high subclinical infection rates and is a major cause of preventable cancers (cervical, vaginal, vulvar, anal, penile, and oropharyngeal). Despite availability of an effective vaccine against several common and carcinogenic strains of HPV, it remains the most common STI. Gardasil 9 is a widely available vaccine that protects against nine strains of HPV. Seven of those strains are known to cause a wide range of cancer, and the other two strains are the most common cause of condylomas (genital warts). Yet, patients are not completing this vaccination series. There is a constellation of reasons for this, including the failure of the provider to offer it to patients and patient refusal. Either way, this easy public health intervention is significantly underutilized. This review explores the infection process of HPV; its link to cancer; a comparison of vaccines offered in the past, such as Cervarix and Gardasil 4, compared to the currently offered Gardasil 9; and finally, an exploration of the beliefs and views around vaccination of the STI and cancer by looking at patient/physician stances against the vaccine tied with the ways to help patient compliance.

OBJECTIVE Depression (major depressive disorder [MDD]) in adults with type 2 diabetes mellitus (T2DM) is associated with worsened diabetes complications, increased health care costs, and early mortality. Program ACTIVE II was a randomized, controlled, multicenter treatment trial designed to test the comparative effectiveness of cognitive behavioral therapy (CBT) and/or community-based exercise (EXER) on diabetes and depression outcomes compared with usual care (UC). RESEARCH DESIGN AND METHODS Using a 2 × 2 factorial randomized controlled trial design, adults with T2DM for ≥1 year who met DSM-IV-TR criteria for MDD were randomized to CBT (10 sessions occurring over 12 weeks; N = 36), EXER (12 weeks of community-based exercise including six sessions with a personal trainer; N = 34), CBT+EXER (concurrent over a 12-week period; N = 34), and UC (N = 36). Primary outcomes were depression remission rate (assessed by psychiatric interviewers blind to assignment) and change in glycemic control (HbA1c). RESULTS The mean age was 56.0 years (SD 10.7). Participants were female (77%), white (71%), and married (52%). After controlling for education and antidepressant use, odds of achieving full MDD remission in the intervention groups were 5.0–6.8 times greater than UC (P < 0.0167). The CBT+EXER group demonstrated improved HbA1c compared with UC. For participants with a baseline HbA1c ≥7.0%, exploratory post hoc subgroup analysis showed that the CBT+EXER group had a 1.1% improvement in HbA1c (P < 0.0001) after controlling for covariates. CONCLUSIONS The Program ACTIVE behavioral treatment interventions demonstrated clinically meaningful improvements in depression outcomes in adults with T2DM and MDD. These community-based interventions are complementary to medical care and extend access to those in rural and urban areas.

Find AGA's NASH Clinical Care Pathway Appfor iOS and Android mobile devices at nash.gastro.org. Scan this QR code to be taken directly to the website.Nonalcoholic fatty liver disease (NAFLD) is becoming increasingly common, currently affecting approximately 37% of US adults. NAFLD is most often managed in primary care or endocrine clinics, where clinicians must determine which patients might benefit from secondary care to address hepatic manifestations, comorbid metabolic traits, and cardiovascular risks of the disease. Because NAFLD is largely asymptomatic, and because optimal timing of treatment depends on accurate staging of fibrosis risk, screening at the primary care level is critical, together with consistent, timely, evidence-based, widely accessible, and testable management processes. To achieve these goals, the American Gastroenterological Association assembled a multidisciplinary panel of experts to develop a Clinical Care Pathway providing explicit guidance on the screening, diagnosis, and treatment of NAFLD. This article describes the NAFLD Clinical Care Pathway they developed and provides a rationale supporting proposed steps to assist clinicians in diagnosing and managing NAFLD with clinically significant fibrosis (stage F2-F4) based on the best available evidence. This Pathway is intended to be applicable in any setting where care for patients with NAFLD is provided, including primary care, endocrine, obesity medicine, and gastroenterology practices.

Diabetes mellitus is a complex set of conditions that impacts 34 million Americans. While type 1 diabetes, type 2 diabetes, and gestational diabetes are most frequently encountered, there are many other types of diabetes with which healthcare providers are less familiar. These atypical forms of diabetes make up nearly 10% of diabetes cases and can masquerade as type 1 or 2 diabetes mellitus (T1DM or T2DM), and the treatment may not be optimized if the diagnosis is not accurate. Atypical forms include monogenic diabetes (formally known as maturity-onset diabetes of the young [MODY]), latent autoimmune diabetes of the adult (LADA), ketosis-prone diabetes, and secondary diabetes. This paper will detail the defining characteristics of each atypical form and demonstrate how they can masquerade as type 1 or 2 diabetes mellitus. Gestational diabetes mellitus will not be discussed in this article.

The number of Americans affected by diabetes continues to increase but the number of endocrinologists with specialty training to treat this population has not kept up with demand. Primary care outpatient visits can also not meet the projected diabetes population demands or the needs for other complex diabetes management issues. Treatments for diabetes including both medications and technologies continue to expand and become more complex. In response to these challenges there have been primary care physicians seeking specialized training to become diabetologists. This can fill some of the gaps left by a lack of resources in the U.S. healthcare system.

The rapid and constant increase in the number of people living with diabetes has outstripped the capacity of specialists to fully address this chronic disease alone. Furthermore, although most people with diabetes are treated in the primary care setting, most primary care providers feel under-prepared and under-resourced to fully address the needs of their patients with diabetes. Addressing this care gap will require a multifaceted approach centering on primary care training in diabetes and its complications. One-year diabetology fellowship programs are well situated to provide this training. Previous research has shown that the higher the diabetes-specific volume of patients seeing a primary care physician was, the better the quality outcomes were across six quality indicators (eye examinations, LDL cholesterol testing, A1C testing, prescriptions for ACE inhibitors or angiotensin receptor blockers, prescriptions for statins, and emergency department visits for hypoglycemia or hyperglycemia). Primary care diabetes fellowships have existed for many years, but the number of fellowships and fellowship positions has recently grown dramatically. This article proposes a standardized curriculum for such programs and makes the case for increasing their number in the United States.

BackgroundScientific hypothesis generation is a critical step in scientific research that determines the direction and impact of any investigation. Despite its vital role, we have limited knowledge of the process itself, thus hindering our ability to address some critical questions.ObjectiveThis study aims to answer the following questions: To what extent can secondary data analytics tools facilitate the generation of scientific hypotheses during clinical research? Are the processes similar in developing clinical diagnoses during clinical practice and developing scientific hypotheses for clinical research projects? Furthermore, this study explores the process of scientific hypothesis generation in the context of clinical research. It was designed to compare the role of VIADS, a visual interactive analysis tool for filtering and summarizing large data sets coded with hierarchical terminologies, and the experience levels of study participants during the scientific hypothesis generation process.MethodsThis manuscript introduces a study design. Experienced and inexperienced clinical researchers are being recruited since July 2021 to take part in this 2×2 factorial study, in which all participants use the same data sets during scientific hypothesis–generation sessions and follow predetermined scripts. The clinical researchers are separated into experienced or inexperienced groups based on predetermined criteria and are then randomly assigned into groups that use and do not use VIADS via block randomization. The study sessions, screen activities, and audio recordings of participants are captured. Participants use the think-aloud protocol during the study sessions. After each study session, every participant is given a follow-up survey, with participants using VIADS completing an additional modified System Usability Scale survey. A panel of clinical research experts will assess the scientific hypotheses generated by participants based on predeveloped metrics. All data will be anonymized, transcribed, aggregated, and analyzed.ResultsData collection for this study began in July 2021. Recruitment uses a brief online survey. The preliminary results showed that study participants can generate a few to over a dozen scientific hypotheses during a 2-hour study session, regardless of whether they used VIADS or other analytics tools. A metric to more accurately, comprehensively, and consistently assess scientific hypotheses within a clinical research context has been developed.ConclusionsThe scientific hypothesis–generation process is an advanced cognitive activity and a complex process. Our results so far show that clinical researchers can quickly generate initial scientific hypotheses based on data sets and prior experience. However, refining these scientific hypotheses is a much more time-consuming activity. To uncover the fundamental mechanisms underlying the generation of scientific hypotheses, we need breakthroughs that can capture thinking processes more precisely.International Registered Report Identifier (IRRID)DERR1-10.2196/39414

Nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) are common conditions with a rising burden. Yet, there are significant management gaps between clinical guidelines and practice in patients with NAFLD and NASH. Further, there is no single global guiding strategy for the management of NAFLD and NASH. The American Gastroenterological Association, in collaboration with seven professional associations, convened an international conference comprising 32 experts in gastroenterology, hepatology, endocrinology, and primary care providers from the U.S., Europe, Asia, and Australia. Conference content was informed by the results of a national NASH Needs Assessment Survey. The participants reviewed and discussed published literature on global burden, screening, risk stratification, diagnosis, and management of individuals with NAFLD, including those with NASH. Participants identified promising approaches for clinical practice and prepared a comprehensive, unified strategy for primary care providers and relevant specialists encompassing the full spectrum of NAFLD/NASH care. They also identified specific high-yield targets for clinical research and called for a unified, international public health response to NAFLD and NASH.