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.

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.

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.

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.