Management of Type 2 Diabetes Mellitus: Synopsis of the Department of Veterans Affairs and Department of Defense Clinical Practice Guideline.

The US Department of Veterans Affairs (VA) and the US Department of Defense (DoD) approved a joint clinical practice guideline for the management of type 2 diabetes. This was the product of a multidisciplinary guideline development committee composed of clinicians from both the VA and the DoD and was overseen by the VA/DoD Evidence Based Practice Work Group. The development process conformed to the standards for trustworthy guidelines as established by the National Academy of Medicine. The guideline development committee developed 12 key questions to guide an evidence synthesis. An independent third party identified relevant randomized controlled trials and systematic reviews that were published from January 2016 through April 2022. This evidence synthesis served as the basis for drafting recommendations. Twenty-six recommendations were generated and rated by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. Two algorithms were developed to guide clinical decision-making. This synopsis summarizes key aspects of the VA/DoD Clinical Practice Guideline for diabetes in 5 areas: prediabetes, screening for co-occurring conditions, diabetes self-management education and support, glycemic treatment goals, and pharmacotherapy. The guideline is designed to help clinicians and patients make informed treatment decisions to optimize health outcomes and quality of life and to align with patient-centered goals of care.

Priorities for efficacy trials of gender-affirming hormone therapy with estrogen: collaborative design and results of a community survey.

PURPOSE: Treatment guidelines for gender-affirming hormone therapy with estrogen (GAHT-E) recommend specific dosing regimens based on limited data. Well-controlled efficacy trials are essential to tailoring treatment to patient goals as the guidelines recommend. The goal of this study was to take a foundational step toward designing community-centered effectiveness trials for gender-diverse individuals seeking GAHT-E. METHODS: Our team developed a cross-sectional survey based on broad clinical experience and consultation with our community advisory board. The survey included 60 items covering demographics, transition history, goals and priorities for treatment, indicators of treatment success, sexual function goals, and future research priorities. The survey was distributed during the summer of 2021, primarily through social networks designed for gender-expansive individuals seeking treatment with estrogen. RESULTS: A total of 1270 individuals completed the survey. Overall treatment goals most frequently rated "extremely important" or "very important" were the following: (1) improved satisfaction with life (81%), (2) appearing more feminine (80%), (3) appearing less masculine (77%), (4) improved mental health (76%), and (5) being seen as your true gender by others (75%). The three body characteristics most frequently rated "highest priority" or "high priority" among changes were the following: (1) facial hair (85%), (2) breast shape or size (84%), and (3) body shape (80%). The highest-rated research priority was comparing feminization with different routes of estrogen administration. CONCLUSION: The goals and experiences of individuals seeking GAHT-E are diverse. Future clinical trials of GAHT-E should be grounded in the needs and priorities of community stakeholders.

Pembrolizumab-Induced Type 1 Diabetes in a 95-Year-Old Veteran With Metastatic Melanoma.

Low C-peptide levels should prompt a high suspicion for immune checkpoint inhibitor-induced type 1 diabetes, and initiation of insulin therapy should be strongly considered.

Results From a Trial of an Online Diabetes Prevention Program Intervention.

INTRODUCTION: Online Diabetes Prevention Programs (DPPs) can be scaled up and delivered broadly. However, little is known about real-world effectiveness and how outcomes compare with in-person DPP. This study examined online DPP weight loss and participation outcomes and secondarily compared outcomes among participating individuals with parallel in-person interventions. STUDY DESIGN: A large non-randomized trial supplemented by a comparative analysis of participating individuals from a concurrent trial of two parallel in-person programs: in-person DPP and the Veterans Administration's standard of care weight loss program (MOVE!). SETTING/PARTICIPANTS: Obese/overweight Veterans with prediabetes enrolled in online DPP (n = 268) between 2013 and 2014. Similar eligibility criteria were used to enroll in-person participants between 2012 and 2014 (n = 273 in-person DPP, n = 114 MOVE!) within a separate trial. INTERVENTION: Online DPP included a virtual group format, live e-coach, weekly modules delivered asynchronously, and wireless home scales. In-person programs included eight to 22 group-based, face-to-face sessions. MAIN OUTCOMES MEASURES: Weight change at 6 and 12 months using wirelessly uploaded home scale data or electronic medical record weights from clinical in-person visits. Outcomes were analyzed between 2015 and 2017. RESULTS: From 1,182 invitations, 268 (23%) participants enrolled in online DPP. Among these, 158 (56%) completed eight or more modules; mean weight change was -4.7kg at 6 months and -4.0kg at 12 months. In a supplemental analysis of participants completing one or more sessions/modules, online DPP participants were most likely to complete eight or more sessions/modules (87% online DPP vs 59% in-person DPP vs 55% MOVE!, p < 0.001). Online and in-person DPP participants lost significantly more weight than MOVE! participants at 6 and 12 months; there was no significant difference in weight change between online and in-person DPP. CONCLUSIONS: An intensive, multifaceted online DPP intervention had higher participation but similar weight loss compared to in-person DPP. An intensive, multifaceted online DPP intervention may be as effective as in-person DPP and help expand reach to those at risk.

Concurrent Milk Ingestion Decreases Absorption of Levothyroxine.

BACKGROUND: Levothyroxine is the most commonly prescribed medication in the United States. Many foods and medications, including calcium supplements, can interfere with levothyroxine absorption. No studies have investigated the effect of cow's milk, a common breakfast staple, on the absorption of oral levothyroxine. Cow's milk contains approximately 450 mg of elemental calcium per 12 oz (355 mL) serving. METHODS: A pharmacokinetic study was conducted in healthy euthyroid subjects to assess levothyroxine absorption with and without concurrent cow's milk consumption. Following an overnight fast, serum total thyroxine (TT4) concentrations were measured at baseline and at one, two, four, and six hours after ingestion of 1000 µg of oral levothyroxine alone or when co-administered with 12 oz (355 mL) of 2% milk. There was a four-week washout period between the two assessments in each subject. RESULTS: Ten subjects (Mage ± SD = 33.7 ± 10.2 years; 60% male) completed the study. The area under the curve (AUC) of TT4 concentrations was significantly lower when levothyroxine was ingested along with 12 oz (355 mL) of 2% cow's milk (M ± SD = 67.3 ± 12.1) compared to that with levothyroxine alone (73.5 ± 17.0; p = 0.02). Also, peak serum TT4 concentrations were significantly lower when cow's milk was co-administered with levothyroxine (M ± SD = 14.1 ± 0.8 µg/dL) than with levothyroxine alone (13.0 ± 0.9 µg/dL; p = 0.04). CONCLUSIONS: This is the first study to demonstrate that concurrent cow's milk ingestion reduces oral levothyroxine absorption. The findings support previous literature showing the interference of elemental calcium and food with thyroid hormone absorption. Patients managed with thyroid hormone should be advised to avoid taking their levothyroxine simultaneously with cow's milk.

Transgender Care in the Primary Care Setting: A Review of Guidelines and Literature.

For patients who desire transgender care, providers must use appropriate language, know the basics of cross-sex hormone therapy, and understand the risks and adverse effects of treatment options.

Implementation findings from a hybrid III implementation-effectiveness trial of the Diabetes Prevention Program (DPP) in the Veterans Health Administration (VHA).

BACKGROUND: The Diabetes Prevention Program (DPP) is an effective lifestyle intervention to reduce incidence of type 2 diabetes. However, there are gaps in knowledge about how to implement DPP. The aim of this study was to evaluate implementation of DPP via assessment of a clinical demonstration in the Veterans Health Administration (VHA). METHODS: A 12-month pragmatic clinical trial compared weight outcomes between the Veterans Affairs Diabetes Prevention Program (VA-DPP) and the usual care MOVE!® weight management program (MOVE!). Eligible participants had a body mass index (BMI) ≥30 kg/m2 (or BMI ≥ 25 kg/m2 with one obesity-related condition), prediabetes (glycosylated hemoglobin (HbA1c) 5.7-6.5% or fasting plasma glucose (FPG) 100-125 mg/dL), lived within 60 min of their VA site, and had not participated in a weight management program within the last year. Established evaluation and implementation frameworks were used to guide the implementation evaluation. Implementation barriers and facilitators, delivery fidelity, participant satisfaction, and implementation costs were assessed. Using micro-costing methods, costs for assessment of eligibility and scheduling and maintaining adherence per participant, as well as cost of delivery per session, were also assessed. RESULTS: Several barriers and facilitators to Reach, Adoption, Implementation, Effectiveness and Maintenance were identified; barriers related to Reach were the largest challenge encountered by site teams. Fidelity was higher for VA-DPP delivery compared to MOVE! for five of seven domains assessed. Participant satisfaction was high in both programs, but higher in VA-DPP for most items. Based on micro-costing methods, cost of assessment for eligibility was $68/individual assessed, cost of scheduling and maintaining adherence was $328/participant, and cost of delivery was $101/session. CONCLUSIONS: Multi-faceted strategies are needed to reach targeted participants and successfully implement DPP. Costs for assessing patients for eligibility need to be carefully considered while still maximizing reach to the targeted population.

Diabetes Prevention Program Translation in the Veterans Health Administration.

INTRODUCTION: This clinical demonstration trial compared the effectiveness of the Veterans Affairs Diabetes Prevention Program (VA-DPP) with an evidence-based usual care weight management program (MOVE!®) in the Veterans Health Administration health system. DESIGN: Prospective, pragmatic, non-randomized comparative effectiveness study of two behavioral weight management interventions. SETTING/PARTICIPANTS: Obese/overweight Veterans with prediabetes were recruited from three geographically diverse VA sites between 2012 and 2014. INTERVENTION: VA-DPP included 22 group-based intensive lifestyle change sessions. MAIN OUTCOME MEASURES: Weight change at 6 and 12 months, hemoglobin A1c (HbA1c) at 12 months, and VA health expenditure changes at 15 months were assessed using VA electronic health record and claims data. Between- and within-group comparisons for weight and HbA1c were done using linear mixed-effects models controlling for age, gender, race/ethnicity, baseline outcome values, and site. Analyses were conducted in 2015-2016. RESULTS: A total of 387 participants enrolled (273 VA-DPP, 114 MOVE!). More VA-DPP participants completed at least one (73.3% VA-DPP vs 57.5% MOVE! p=0.002); four (57.5% VA-DPP vs 42.5% MOVE!, p=0.007); and eight or more sessions (42.5% VA-DPP vs 31% MOVE!, p=0.035). Weight loss from baseline was significant at both 6 (p<0.001) and 12 months (p<0.001) for VA-DPP participants, but only significant at 6 months for MOVE! participants (p=0.004). Between groups, there were significant differences in 6-month weight loss (-4.1 kg VA-DPP vs -1.9 kg MOVE!, p<0.001), but not 12-month weight loss (-3.4 kg VA-DPP vs -2.0 kg MOVE!, p=0.16). There were no significant differences in HbA1c change or outpatient, inpatient, and total VA expenditures. CONCLUSIONS: VA-DPP participants had higher participation rates and weight loss at 6 months, but similar weight, HbA1c, and health expenditures at 12 months compared to MOVE! PARTICIPANTS: Features of VA-DPP may help enhance the capability of MOVE! to reach a larger proportion of the served population and promote individual-level weight maintenance.

Implementation of a prediabetes identification algorithm for overweight and obese Veterans.

Type 2 diabetes prevention is an important national goal for the Veteran Health Administration (VHA): one in four Veterans has diabetes. We implemented a prediabetes identification algorithm to estimate prediabetes prevalence among overweight and obese Veterans at Department of Veterans Affairs (VA) medical centers (VAMCs) in preparation for the launch of a pragmatic study of Diabetes Prevention Program (DPP) delivery to Veterans with prediabetes. This project was embedded within the VA DPP Clinical Demonstration Project conducted in 2012 to 2015. Veterans who attended orientation sessions for an established VHA weight-loss program (MOVE!) were recruited from VAMCs with geographically and racially diverse populations using existing referral processes. Each site implemented and adapted the prediabetes identification algorithm to best fit their local clinical context. Sites relied on an existing referral process in which a prediabetes identification algorithm was implemented in parallel with existing clinical flow; this approach limited the number of overweight and obese Veterans who were assessed and screened. We evaluated 1,830 patients through chart reviews, interviews, and/or laboratory tests. In this cohort, our estimated prevalence rates for normal glycemic status, prediabetes, and diabetes were 29% (n = 530), 28% (n = 504), and 43% (n = 796), respectively. Implementation of targeted prediabetes identification programs requires careful consideration of how prediabetes assessment and screening will occur.

Implementation and evaluation of the VA DPP clinical demonstration: protocol for a multi-site non-randomized hybrid effectiveness-implementation type III trial.

BACKGROUND: The Diabetes Prevention Program (DPP) study showed that lifestyle intervention resulted in a 58% reduction in incidence of type 2 diabetes among individuals with prediabetes. Additional large randomized controlled trials have confirmed these results, and long-term follow-up has shown sustained benefit 10-20 years after the interventions ended. Diabetes is a common and costly disease, especially among Veterans, and despite strong evidence supporting the feasibility of type 2 diabetes prevention, the DPP has not been widely implemented. The first aim of this study will evaluate implementation of the Veterans Affairs (VA) DPP in three VA medical centers. The second aim will assess weight and hemoglobin A1c (A1c) outcomes, and the third aim will determine the cost-effectiveness and budget impact of implementation of the VA DPP from a health system perspective. METHODS/DESIGN: This partnered multi-site non-randomized systematic assignment study will use a highly pragmatic hybrid effectiveness-implementation type III mixed methods study design. The implementation and administration of the VA DPP will be funded by clinical operations while the evaluation of the VA DPP will be funded by research grants. Seven hundred twenty eligible Veterans will be systematically assigned to the VA DPP clinical demonstration or the usual care VA MOVE!® weight management program. A multi-phase formative evaluation of the VA DPP implementation will be conducted. A theoretical program change model will be used to guide the implementation process and assess applicability and feasibility of the DPP for VA. The Consolidated Framework for Implementation Research (CFIR) will be used to guide qualitative data collection, analysis, and interpretation of barriers and facilitators to implementation. The RE-AIM framework will be used to assess Reach, Effectiveness, Adoption, Implementation, and Maintenance of the VA DPP. Twelve-month weight and A1c change will be evaluated for the VA DPP compared to the VA MOVE! PROGRAM: Mediation analyses will be conducted to identify whether program design differences impact outcomes. DISCUSSION: Findings from this pragmatic evaluation will be highly applicable to practitioners who are tasked with implementing the DPP in clinical settings. In addition, findings will determine the effectiveness and cost-effectiveness of the VA DPP in the Veteran population.

Prevalence of comorbid obstructive sleep apnea and metabolic syndrome: syndrome Z and maxillofacial surgery implications.

PURPOSE: To determine the prevalence of the recently identified syndrome Z (SZ), which is the co-occurrence of obstructive sleep apnea (OSA; hypoxia, systemic and pulmonary hypertension, nocturnal arrhythmias) and metabolic syndrome (MetS; increased abdominal girth, hypertriglyceridemia, decreased high-density lipoprotein, hypertension, increased fasting glucose), which places the surgical patient at heightened risk of perioperative complications (myocardial infarction, stroke, pneumonia, wound infection). MATERIALS AND METHODS: Electronic medical records of 296 male veterans were assessed for the presence of SZ using the American Academy of Sleep Medicine definition of OSA and a modified Adult Treatment Panel III definition of MetS, where obesity was defined by a body mass index of at least 30 kg/m(2) rather than by waist circumference. RESULTS: SZ was diagnosed in 59% of patients. These individuals commonly exhibited severe OSA and least commonly mild OSA. The more severe the OSA, the more likely (60%) that patients manifested moderate (4 risk markers) or severe (5 risk markers) MetS. Furthermore, with increasing apnea-hypopnea index values, the more severe were the MetS elements. CONCLUSIONS: The results of this study demonstrate the high prevalence rate of MetS in patients with OSA seeking treatment. Given the risk of perioperative complications, it is suggested that all patients scheduled for maxillofacial surgical procedures to treat OSA be evaluated for SZ.

The role of cognitive impairment and caregiver support in diabetes management of older outpatients.

OBJECTIVES: To examine the role of cognitive impairment and caregiver support in diabetes care adherence and glycemic control. METHODS: Fifty-one veteran male outpatients (27 with caregivers) aged 60 years and older with type 2 diabetes were evaluated for cognitive impairment with the Cognitive Abilities Screening Instrument. Patients or caregivers completed diabetes self-care and depression scales. Medical morbidity information and HbA1c plasma levels at baseline and 1 year later were obtained from electronic medical records. RESULTS: Greater cognitive impairment (F = 5.1, p < .05), and presence of a caregiver (F = 5.3, p < .05), were independently associated with worse diabetes care adherence (adjusting for age, education, medical comorbidity, and depression). In addition, Mean HbA1c levels were worse in the cognitively impaired group with caregivers relative to the three other groups (F = 4.10, p < .05, eta2 = .09). One year later, mean HbA1c levels rose from 7.7 to 8.2% in the cognitively impaired group with caregivers. CONCLUSION: Cognitive impairment is associated with worse diabetes care management. Surprisingly, the presence of a caregiver is not protective. Further research is necessary to examine the healthcare needs of cognitively impaired, diabetic patients and their caregivers.

Self-monitoring of blood glucose levels in patients with type 2 diabetes mellitus not taking insulin: a meta-analysis.

OBJECTIVE: To perform a meta-analysis of randomized controlled trials (RCTs) and systematic reviews evaluating the efficacy of self-monitoring of blood glucose (SMBG) levels among patients with diabetes mellitus (DM). STUDY DESIGN: Meta-analysis of RCTs among patients with DM not taking insulin comparing patients with SMBG versus those without SMBG and reporting results as change in glycosylated hemoglobin (A1C) values. METHODS: Prior systematic reviews and a PubMed search were used to identify studies. Data were extracted by trained physician reviewers working in duplicate. Trials were classified according to duration of the intervention, and random-effects meta-analysis was used to pool results. RESULTS: Three trials of SMBG of 3 months' duration were too heterogeneous to pool. Nine other trials were identified. Five trials of SMBG of 6 months' duration yielded a pooled effect estimate of a decrease in mean A1C values of -0.21% (95% confidence interval [CI], -0.38% to -0.04%). Four trials that reported outcomes of 1 year or longer yielded a pooled effect estimate of a decrease in mean A1C values of -0.16% (95% CI, -0.38% to 0.05%). Three trials reported hypoglycemic outcomes, which were increased in the patients using SMBG, although this mostly involved asymptomatic or mild episodes. CONCLUSIONS: At most, SMBG produces a statistically significant but clinically modest effect in controlling blood glucose levels in patients with DM not taking insulin. It is of questionable value in helping meet target values of glucose control.

Metabolic syndrome: pathogenesis, medical care and dental implications.

BACKGROUND: The dental literature contains little information about metabolic syndrome (MetS) and its dental implications. TYPES OF STUDIES REVIEWED: The authors conducted a MEDLINE search for the period 2000 through 2005, using the term "metabolic syndrome" to define its pathophysiology, medical treatment and dental implications. RESULTS: MetS is the co-occurrence of abdominal obesity, hyper-triglyceridemia, reduced high-density lipoprotein cholesterol levels, hypertension and impaired fasting glucose, which results from consumption of a high-calorie diet and decreased levels of physical activity superimposed on the appropriate genetic setting. Components of MetS synergistically promote the development of atherosclerosis, resulting in myocardial infarction and stroke. CLINICAL IMPLICATIONS: Deteriorating oral health status is associated with worsening of the atherogenic profile. Tooth loss often results in chewing difficulties because of inadequate occlusive surfaces and may lead to alterations in food selection and dietary quality. This, in turn, adversely affects body composition and nutritional status, both of which are related to vascular health. Dentists should develop treatment plans that preserve and restore the dentition, thus ensuring maximum masticatory efficiency and affording patients the optimum opportunity to consume food that will not foster atherogenesis.

Intensive insulin therapy in critical care: a review of 12 protocols.

OBJECTIVE: To review performance characteristics of 12 insulin infusion protocols. RESEARCH DESIGN AND METHODS: We systematically identify and compare 12 protocols and then apply the protocols to generate insulin recommendations in the management of a patient with hyperglycemia. The main focus involves a comparison of insulin doses and patterns of insulin administration. RESULTS: There is great variability in protocols. Areas of variation include differences in initiation and titration of insulin, use of bolus dosing, requirements for calculation in adjustment of the insulin infusion, and method of insulin protocol adjustments. Insulin recommendations for a sample patient are calculated to highlight differences between protocols, including the patterns and ranges of insulin dose recommended (range 27-115 units [mean +/- SD 66.7 +/- 27.9]), amount recommended for glucose readings >200 mg/dl, and adjustments nearing target glucose. CONCLUSIONS: The lack of consensus in the delivery of intravenous insulin infusions is reflected in the wide variability of practice noted in this survey. This mandates close attention to the choice of a protocol. One protocol may not suffice for all patients.

What is the proper use of hemoglobin A1c monitoring in the elderly?

Diabetes mellitus (DM) is a major health problem for the aging population. Glycemic control is fundamental to the management of diabetes, as glycemic levels are closely linked to development of diabetes-related complications. Measurement of the hemoglobin A1c (A1c) to assess chronic glycemic control is an integral component of diabetes care. Currently, there is no clear evidence that age alters the relationship between A1c and average blood glucose. The Diabetes Control and Complications trial and the United Kingdom Prospective Diabetes Study are the 2 main studies that have provided evidence leading to the widespread recommendation of A1c monitoring. The American Diabetes Association recommends achieving an A1c level of 7% or lower. However, older diabetics represent a heterogeneous population ranging from frail nursing home residents to active community-dwelling elderly with variable life expectancies. One needs to look at the individual in order to best balance risk versus benefit associated with tight glycemic control. Benefits of intensive therapy in an effort to lower A1c must always be weighed against the greater risk of disabling and unpredictable hypoglycemia, as the geriatric population is less likely to benefit from reducing the risk of microvascular complications and more likely to suffer serious adverse effects from hypoglycemia.