Exploring the influence of behavioral factors on depression and anxiety scores during the COVID-19 pandemic: insights from the Virginia statewide COVIDsmart longitudinal study.

BACKGROUND: Amidst the COVID-19 pandemic, there has been growing concern about the declining mental health and healthy behaviors compared to pre-pandemic levels. Despite this, there is a lack of longitudinal studies that have examined the relationship between health behaviors and mental health during the pandemic. In response, the statewide COVIDsmart longitudinal study was launched. The study's main objective is to better understand the effects of the pandemic on mental health. Findings may provide a foundation for the identification of public health strategies to mitigate future negative impacts of the pandemic. METHODS: Following online recruitment in spring of 2021, adults, ages 18 to 87, filled out social, mental, economic, occupational, and physical health questionnaires on the digital COVIDsmart platform at baseline and through six monthly follow-ups. Changes in the participant's four health behaviors (e.g., tobacco and alcohol consumption, physical activity, and social media use), along with sex, age, loneliness score, and reported social and economic (SE) hardships, were analyzed for within-between group associations with depression and anxiety scores using Mixed Models Repeated Measures. RESULTS: In this study, of the 669 individuals who reported, the within-between group analysis indicated that younger adults (F = 23.81, p < 0.0001), loneliness (F = 234.60, p < 0.0001), SE hardships (F = 31.25, p < 0.0001), increased tobacco use (F = 3.05, p = 0.036), decreased physical activity (F = 6.88, p = 0.0002), and both positive and negative changes in social media use (F = 7.22, p = 0.0001) were significantly associated with worse depression scores. Additionally, females (F = 6.01, p = 0.015), younger adults (F = 32.30, p < 0.0001), loneliness (F = 154.59, p < 0.0001), SE hardships (F = 22.13, p < 0.0001), increased tobacco use (F = 4.87, p = 0.004), and both positive and negative changes in social media use (F = 3.51, p = 0.016) were significantly associated with worse anxiety scores. However, no significant changes were observed in the within-between group measurements of depression and anxiety scores over time (p > 0.05). Physical activity was not associated with anxiety nor was alcohol consumption with both depression and anxiety (p > 0.05). CONCLUSIONS: This study demonstrates the longitudinal changes in behaviors within the context of the COVID-19 pandemic. These findings may facilitate the design of preventative population-based health approaches during the COVID-19 pandemic or future pandemics.

A Digital Health Initiative (COVIDsmart) for Remote Data Collection and Study of COVID-19's Impact on the State of Virginia: Prospective Cohort Study.

BACKGROUND: The COVID-19 pandemic has affected people's lives beyond severe and long-term physical health symptoms. Social distancing and quarantine have led to adverse mental health outcomes. COVID-19-induced economic setbacks have also likely exacerbated the psychological distress affecting broader aspects of physical and mental well-being. Remote digital health studies can provide information about the pandemic's socioeconomic, mental, and physical impact. COVIDsmart was a collaborative effort to deploy a complex digital health research study to understand the impact of the pandemic on diverse populations. We describe how digital tools were used to capture the effects of the pandemic on the overall well-being of diverse communities across large geographical areas within the state of Virginia. OBJECTIVE: The aim is to describe the digital recruitment strategies and data collection tools applied in the COVIDsmart study and share the preliminary study results. METHODS: COVIDsmart conducted digital recruitment, e-Consent, and survey collection through a Health Insurance Portability and Accountability Act-compliant digital health platform. This is an alternative to the traditional in-person recruitment and onboarding method used for studies. Participants in Virginia were actively recruited over 3 months using widespread digital marketing strategies. Six months of data were collected remotely on participant demographics, COVID-19 clinical parameters, health perceptions, mental and physical health, resilience, vaccination status, education or work functioning, social or family functioning, and economic impact. Data were collected using validated questionnaires or surveys, completed in a cyclical fashion and reviewed by an expert panel. To retain a high level of engagement throughout the study, participants were incentivized to stay enrolled and complete more surveys to further their chances of receiving a monthly gift card and one of multiple grand prizes. RESULTS: Virtual recruitment demonstrated relatively high rates of interest in Virginia (N=3737), and 782 (21.1%) consented to participate in the study. The most successful recruitment technique was the effective use of newsletters or emails (n=326, 41.7%). The primary reason for contributing as a study participant was advancing research (n=625, 79.9%), followed by the need to give back to their community (n=507, 64.8%). Incentives were only reported as a reason among 21% (n=164) of the consented participants. Overall, the primary reason for contributing as a study participant was attributed to altruism at 88.6% (n=693). CONCLUSIONS: The COVID-19 pandemic has accelerated the need for digital transformation in research. COVIDsmart is a statewide prospective cohort to study the impact of COVID-19 on Virginians' social, physical, and mental health. The study design, project management, and collaborative efforts led to the development of effective digital recruitment, enrollment, and data collection strategies to evaluate the pandemic's effects on a large, diverse population. These findings may inform effective recruitment techniques across diverse communities and participants' interest in remote digital health studies.

Neighborhood socioeconomic inequality based on everyday mobility predicts COVID-19 infection in San Francisco, Seattle, and Wisconsin.

Race and class disparities in COVID-19 cases are well documented, but pathways of possible transmission by neighborhood inequality are not. This study uses administrative data on COVID-19 cases for roughly 2000 census tracts in Wisconsin, Seattle/King County, and San Francisco to analyze how neighborhood socioeconomic (dis)advantage predicts cumulative caseloads through February 2021. Unlike past research, we measure a neighborhood's disadvantage level using both its residents' demographics and the demographics of neighborhoods its residents visit and are visited by, leveraging daily mobility data from 45 million mobile devices. In all three jurisdictions, we find sizable disparities in COVID-19 caseloads. Disadvantage in a neighborhood's mobility network has greater impact than its residents' socioeconomic characteristics. We also find disparities by neighborhood racial/ethnic composition, which can be explained, in part, by residential and mobility-based disadvantage. Neighborhood conditions measured before a pandemic offer substantial predictive power for subsequent incidence, with mobility-based disadvantage playing an important role.

Wealth, Race, and Place: How Neighborhood (Dis)advantage From Emerging to Middle Adulthood Affects Wealth Inequality and the Racial Wealth Gap.

Do neighborhood conditions affect wealth accumulation? This study uses the National Longitudinal Survey of Youth 1979 cohort and a counterfactual estimation strategy to analyze the effect of prolonged exposure to neighborhood (dis)advantage from emerging adulthood through middle adulthood. Neighborhoods have sizable, plausibly causal effects on wealth, but these effects vary significantly by race/ethnicity and homeownership. White homeowners receive the largest payoff to reductions in neighborhood disadvantage. Black adults, regardless of homeownership, are doubly disadvantaged in the neighborhood-wealth relationship. They live in more-disadvantaged neighborhoods and receive little return to reductions in neighborhood disadvantage. Findings indicate that disparities in neighborhood (dis)advantage figure prominently in wealth inequality and the racial wealth gap.

Comparing Patch vs Pen Bolus Insulin Delivery in Type 2 Diabetes Using Continuous Glucose Monitoring Metrics and Profiles.

OBJECTIVE: CeQur Simplicity™ (CeQur, Marlborough, MA) is a 3-day insulin delivery patch designed to meet mealtime insulin requirements. A recently reported 48-week, randomized, multicenter, interventional trial compared efficacy, safety and self-reported outcomes in 278 adults with type 2 diabetes (T2D) on basal insulin therapy who initiated and managed mealtime insulin therapy with a patch pump versus insulin pen. We assessed changes in key glycemic metrics among a subset of patients who wore a continuous glucose monitoring (CGM) device. METHODS: Study participants (patch, n = 49; pen, n = 48) wore a CGM device in masked setting during the baseline period and prior to week 24. Glycemic control was assessed using international consensus guidelines for percentage of Time In Range (%TIR: >70% at 70-180 mg/dL), Time Below Range (%TBR: <4% at <70 mg/dL; <1% at <54 mg/dL), and Time Above Range (%TAR: <25% at >180 mg/dL; <5% at >250 mg/dL). RESULTS: Both the patch and pen groups achieved recommended targets in %TIR (74.1% ± 18.7%, 75.2 ± 16.1%, respectively) and marked reductions in %TAR >180 mg/dL (21.1% ± 19.9%, 19.7% ± 17.5%, respectively) but with increased %TBR <70 mg/dL (4.7% ± 5.2%, 5.1 ± 5.8, respectively), all P < .0001. No significant between-group differences in glycemic improvements or adverse events were observed. CONCLUSIONS: CGM confirmed that the patch or pen can be used to safely initiate and optimize basal-bolus therapy using a simple insulin adjustment algorithm with SMBG. Preference data suggest that use of the patch vs pen may enhance treatment adherence.

Implementation of Basal-Bolus Therapy in Type 2 Diabetes: A Randomized Controlled Trial Comparing Bolus Insulin Delivery Using an Insulin Patch with an Insulin Pen.

Background: Barriers to mealtime insulin include complexity, fear of injections, and lifestyle interference. This multicenter, randomized controlled trial evaluated efficacy, safety, and self-reported outcomes in adults with type 2 diabetes, inadequately controlled on basal insulin, initiating and managing mealtime insulin with a wearable patch versus an insulin pen. Methods: Adults with type 2 diabetes (n = 278, age: 59.2 ± 8.9 years), were randomized to patch (n = 139) versus pen (n = 139) for 48 weeks, with crossover at week 44. Baseline insulin was divided 1:1 basal: bolus. Using a pattern-control logbook, subjects adjusted basal and bolus insulin weekly using fasting and premeal glucose targets. Results: Glycated hemoglobin (HbA1c) change (least squares mean ± standard error) from baseline to week 24 (primary endpoint) improved (P < 0.0001) in both arms, -1.7% ± 0.1% and -1.6% ± 0.1% for patch and pen (-18.6 ± 1.1 and -17.5 ± 1.1 mmol/mol), and was maintained at 44 weeks. The coefficient of variation of 7-point self-monitoring blood glucose decreased more (P = 0.02) from baseline to week 44 for patch versus pen. There were no differences in adverse events, including hypoglycemia (three severe episodes per arm), and changes in weight and insulin doses. Subject-reported treatment satisfaction, quality of life, experience ratings at week 24, and device preferences at week 48 significantly favored the patch. Most health care providers preferred patch for mealtime insulin. Conclusions: Bolus insulin delivered by patch and pen using an algorithm-based weekly insulin dose titration significantly improved HbA1c in adults with type 2 diabetes, with improved subject and health care provider experience and preference for the patch.

Measures of Accuracy for Continuous Glucose Monitoring and Blood Glucose Monitoring Devices.

Currently, patients with diabetes may choose between two major types of system for glucose measurement: blood glucose monitoring (BGM) systems measuring glucose within capillary blood and continuous glucose monitoring (CGM) systems measuring glucose within interstitial fluid. Although BGM and CGM systems offer different functionality, both types of system are intended to help users achieve improved glucose control. Another area in which BGM and CGM systems differ is measurement accuracy. In the literature, BGM system accuracy is assessed mainly according to ISO 15197:2013 accuracy requirements, whereas CGM accuracy has hitherto mainly been assessed by MARD, although often results from additional analyses such as bias analysis or error grid analysis are provided. The intention of this review is to provide a comparison of different approaches used to determine the accuracy of BGM and CGM systems and factors that should be considered when using these different measures of accuracy to make comparisons between the analytical performance (ie, accuracy) of BGM and CGM systems. In addition, real-world implications of accuracy and its relevance are discussed.

Health Care Professionals' Clinical Perspectives on Glycemic Control and Satisfaction With a New Blood Glucose Meter With a Color Range Indicator: Online Evaluation in India, Russia, China, and the United States.

BACKGROUND: We previously demonstrated in patients with diabetes that displaying blood glucose results in association with color improved their ability to interpret glucose results. OBJECTIVE: The objective of this study was to investigate the perceptions of health care professionals (HCPs) in specific countries about the value of color on a new glucose meter and to determine if HCP perspectives among countries differ on the value of this approach in clinical practice. METHODS: A total of 180 HCPs, including 105 endocrinologists, 34 primary care physicians, 25 diabetes educators, and 16 pharmacists, were recruited from India (n=50), Russia (n=50), China (n=50), and the United States (n=30). These HCPs experienced the OneTouch Select Plus Simple glucose meter online from their own office computer using interactive demonstrations (webpages, meter simulator, and video clips). After providing demographic and current clinical practice insights, HCPs responded to questions about the utility of the color-enhanced glucose meter. RESULTS: Mean age and years in their current professional role for the 180 HCPs was 41.3 (SD 8.1) and 13.3 (SD 6.8) years for endocrinologists, 41.3 (SD 8.3) and 14.1 (SD 6.8) years for primary care physicians, 37.5 (SD 8.7) and 12.7 (SD 6.8) years for diabetes educators, and 35.9 (SD 5.3) and 9.5 (SD 5.2) years for pharmacists. In all, 88% (44/50) of Russian and 83% (25/30) of American HCPs said their patients find it easy to recognize low, in-range, or high blood glucose results compared to 56% (28/50) of HCPs in China and 42% (21/50) in India. Regardless of country, HCPs had less confidence that their patients act on blood glucose results with 52% (26/50) in Russia, 63% (19/30) in the United States, 60% (30/50) in China, and 40% (20/50) in India responding positively. During the interactive online meter experience, HCPs from all countries responded positively to questions about a meter with color features. After reflecting on the value of this meter, most HCPs strongly agreed or agreed their patients would be more inclined to act on results using a meter with color features (Russia: 92%, 46/50; United States: 70%, 21/30; China: 98%, 49/50; India: 94%, 47/50). They also said that color was particularly useful for patients with lower numeracy or education who may struggle with interpreting results (Russia: 98%, 49/50; United States: 77%, 23/30; China: 100%, 50/50; India: 82%, 41/50). CONCLUSIONS: This multicountry online study provides evidence that HCPs had high overall satisfaction with the OneTouch Select Plus glucose meter, which uses color-coded information to assist patients with interpreting blood glucose results. This may be especially helpful in patient populations with low numeracy or literacy and limited access to health care and direct interaction with HCPs.

Use of Blood Glucose Meters Featuring Color Range Indicators Improves Glycemic Control in Patients With Diabetes in Comparison to Blood Glucose Meters Without Color (ACCENTS Study).

BACKGROUND: The ability of patients to improve glycemic control depends partly on their ability to interpret and act on blood glucose results. We investigated whether switching people with diabetes to blood glucose meters (BGMs) featuring a color range indicator (CRI) could improve glycemic control compared to remaining on their current BGM without color. METHODS: 163 adults with type 1 (T1D) or type 2 diabetes (T2D) and a hemoglobin A1c (A1c) of 7.5-11% were randomized to: One Touch Verio™ (Verio), OneTouch Verio Flex™ (Flex), or controls remaining on their current BGM. Diabetes nurses had standard conversations about diabetes management with all subjects at baseline. No changes in medication, insulin dosing, or SMBG frequency were recommended. RESULTS: After 12 weeks, subjects who switched to Verio or Flex meters with CRI (n = 108) had a mean change in A1c 0.36% lower than controls (n = 55) ( P = .017). A1c reductions were greatest in T1D subjects (n = 45), with a decrease of 0.50% ( P = .004). T1D subjects using Verio meters (n = 25) contributed a 0.59% reduction compared to controls ( P < .008), whereas T1D subjects using Flex meters (n = 20) had a clinical meaningful reduction in A1c of 0.40% without reaching statistical significance ( P > .05). Verio and Flex users reported taking more action and easier understanding of diabetes management compared to previous BGMs. CONCLUSIONS: This study demonstrated that switching patients to BGMs featuring a CRI resulted in improvements in glycemic control compared to subjects using currently marketed BGMs that do not use a CRI. Registration: Clinicaltrials.gov NCT02929654 https://clinicaltrials.gov/ct2/show/NCT02929654.

Seven-Year Clinical Surveillance Program Demonstrates Consistent MARD Accuracy Performance of a Blood Glucose Test Strip.

BACKGROUND: MARD (mean absolute relative difference) is increasingly used to describe performance of glucose monitoring systems, providing a single-value quantitative measure of accuracy and allowing comparisons between different monitoring systems. This study reports MARDs for the OneTouch Verio® glucose meter clinical data set of 80 258 data points (671 individual batches) gathered as part of a 7.5-year self-surveillance program Methods: Test strips were routinely sampled from randomly selected manufacturer's production batches and sent to one of 3 clinic sites for clinical accuracy assessment using fresh capillary blood from patients with diabetes, using both the meter system and standard laboratory reference instrument. RESULTS: Evaluation of the distribution of strip batch MARD yielded a mean value of 5.05% (range: 3.68-6.43% at ±1.96 standard deviations from mean). The overall MARD for all clinic data points (N = 80 258) was also 5.05%, while a mean bias of 1.28 was recorded. MARD by glucose level was found to be consistent, yielding a maximum value of 4.81% at higher glucose (≥100 mg/dL) and a mean absolute difference (MAD) of 5.60 mg/dL at low glucose (<100 mg/dL). MARD by year of manufacture varied from 4.67-5.42% indicating consistent accuracy performance over the surveillance period. CONCLUSIONS: This 7.5-year surveillance program showed that this meter system exhibits consistently low MARD by batch, glucose level and year, indicating close agreement with established reference methods whilste exhibiting lower MARD values than continuous glucose monitoring (CGM) systems and providing users with confidence in the performance when transitioning to each new strip batch.

Why Did People Move During the Great Recession?: The Role of Economics in Migration Decisions.

Labor migration offers an important mechanism to reallocate workers when there are regional differences in employment conditions. Whereas conventional wisdom suggests migration rates should increase during recessions as workers move out of areas that are hit hardest, initial evidence suggested that overall migration rates declined during the Great Recession, despite large regional differences in unemployment and growth rates. In this paper, we use data from the American Community Survey to analyze internal migration trends before and during the economic downturn. First, we find only a modest decline in the odds of adults leaving distressed labor market areas during the recession, which may result in part from challenges related to the housing price crash. Second, we estimate conditional logit models of destination choice for individuals who migrate across labor market areas and find a substantial effect of economic factors such as labor demand, unemployment, and housing values. We also estimate latent class conditional logit models that test whether there is heterogeneity in preferences for destination characteristics among migrants. Over all, the latent class models suggest that roughly equal percentages of migrants were motivated by economic factors before and during the recession. We conclude that fears of dramatic declines in labor migration seem to be unsubstantiated.

Examining the Impact of a Novel Blood Glucose Monitor With Color Range Indicator on Decision-Making in Patients With Type 1 and Type 2 Diabetes and its Association With Patient Numeracy Level.

BACKGROUND: Many patients struggle to interpret and respond appropriately to the numerical blood glucose results displayed on their meter, with many regularly taking no action or self-care adjustment for out-of-range results. We recently reported that a glucose meter that provides automatic onscreen information using a color range indicator (ColorSure Technology) improved the ability of patients to categorize their blood glucose results. OBJECTIVE: The objective of this study was to examine how ColorSure Technology (or color) affected patient decision making on blood glucose results and how patient numeracy levels influenced such decisions. METHODS: We invited 103 subjects (56 with type 2 diabetes and 47 with type 1 diabetes) to a face-to-face in-clinic visit in a diabetes care center and showed them glucose results with or without color via interactive computer or paper logbook exercises. Before participating in these exercises, subjects completed surveys on numeracy and their understanding of blood glucose information. RESULTS: Subjects preferentially acted on high glucose results shown with color (55%, 57/103) compared to results without color (45%, 46/103; P=.001). When shown identical pairs of results, subjects preferentially acted on results shown with color (62%, 64/103) compared to results without color (16%, 16/103) (P<.001). Subjects more accurately identified days of the week in which results were low, in range, or high when reviewing logbooks with color (83%, 85/103) than without color (68%, 70/103; P=.012). Subjects with lower numeracy were more likely to consider taking action for high glucose results shown with color (59%, 18/31) than without color (41%, 13/31) and preferentially would take action on results shown with color (71%, 22/31) compared to results without color (16%, 5/31). CONCLUSIONS: Insulin- and noninsulin-using subjects were each more inclined to act when glucose results were shown with color, and associating glucose results with color was viewed as particularly beneficial by subjects with lower numeracy.

Diabetes App-Related Text Messages From Health Care Professionals in Conjunction With a New Wireless Glucose Meter With a Color Range Indicator Improves Glycemic Control in Patients With Type 1 and Type 2 Diabetes: Randomized Controlled Trial.

BACKGROUND: Mobile diabetes apps enable health care professionals (HCPs) to monitor patient progress, offer remote consultations, and allow more effective and informed treatment decisions between patients and HCPs. The OneTouch Reveal app aggregates data from a blood glucose meter and provides analytics to help patients and HCPs visualize glycemic trends and patterns, enabling more informed treatment and lifestyle decisions. The app also allows patients and HCPs to keep connected by exchanging text messages (short message service [SMS]) or progress reports via email. OBJECTIVE: The primary objective of our study was to assess changes in glycemic control and overall experiences of patients and HCPs using the app in conjunction with the wireless OneTouch Verio Flex blood glucose meter. METHODS: We randomly assigned 137 adults with type 1 (T1DM) or type 2 diabetes mellitus (T2DM) and a glycated hemoglobin (HbA1c) level of ≥7.5% and ≤11.0% to use the glucose meter alone or glucose meter plus the app for 24 weeks. The meter + app group were scheduled to receive diabetes-related text messages from their HCP every 2 weeks (total of 12 texts). Clinical measures and self-reported outcomes were assessed during face-to-face clinic visits between the participant and a diabetes nurse at baseline, week 12, and week 24. RESULTS: In 128 completed participants, HbA1c decreased after 12 and 24 weeks in both the meter-only (n=66) (0.56% and 0.55%, respectively) and meter + app groups (n=62) (0.78% and 0.67%, respectively) compared with baseline (each P<.001). The difference in HbA1c reduction between the 2 groups was not statistically significant at 12 or 24 weeks (P=.12 and P=.45, respectively). However, the decrease in HbA1c was greater in T2DM participants using the meter + app after 12 weeks (1.04%) than in T2DM participants using the meter alone (0.58%; P=.09). In addition, decrease in HbA1c in participants using the meter + app who received at least 10 diabetes-related text messages (1.05%) was significantly greater than in meter-only participants (P<.01). CONCLUSIONS: Use of the OneTouch Verio Flex glucose meter alone or in combination with the OneTouch Reveal diabetes app was associated with significant improvements in glycemic control after 12 and 24 weeks. Improvements using the app were greatest in participants with T2DM and those participants who received the highest number of HCP text messages. This study suggests that real-time availability of patient data and the ability to send personalized diabetes-related text messages can assist HCPs to improve glycemic control in patients between scheduled visits. TRIAL REGISTRATION: Clinicaltrials.gov NCT02429024; https://clinicaltrials.gov/ct2/show/NCT02429024 (Archived by WebCite at http://www.webcitation.org/6sCTDRa1l).

When love meets hate: The relationship between state policies on gay and lesbian rights and hate crime incidence.

Do public policies on gay and lesbian rights affect the incidence of hate crimes based on sexual orientation? We propose that legal inequalities increase hate crimes because they provide discursive opportunities for bias, discrimination, and violence. Legal equality, however, will reduce violence. Using annual panel data from 2000 to 2012, a period of substantial policy change, we analyze how three state policies affect reported hate crimes: same-sex partnerships, employment non-discrimination, and hate crime laws. Hate crime and employment non-discrimination laws that include sexual orientation reduce hate crime incidence. Partnership recognition increases reported hate crimes, though it may not increase actual crime incidence. Because incidence is spatially correlated, policy changes in one state yield spillover benefits in other states. These results provide some of the first quantitative evidence that public policies affect hate crimes based on sexual orientation. Findings confirm the roles of institutional heterosexism and discursive opportunities in producing hate crimes.

Comparison of rechargeable versus battery-operated insulin pumps: temperature fluctuations.

The role of continuous subcutaneous insulin infusion (insulin pumps) has become increasingly important in diabetes management, and many different types of these systems are currently available. This exploratory study focused on the reported heating issues that lithium-ion battery-powered pumps may have during charging compared with battery-operated pumps. It was found that pump temperature increased by 6.4°C during a long charging cycle of a lithiumion battery-operated pump under ambient temperatures. In an environmental-chamber kept at 35°C, the pump temperature increased by 4.4°C, which indicates that the pump temperature was above that of the recommended safety limit for insulin storage of 37°C. When designing new pumps, and when using currently available rechargeable pumps in warmer climates, the implications of these temperature increases should be taken into consideration. Future studies should also further examine insulin quality after charging.

A Comprehensive Evaluation of a Novel Color Range Indicator in Multiple Blood Glucose Meters Demonstrates Improved Glucose Range Interpretation and Awareness in Subjects With Type 1 and Type 2 Diabetes.

AIMS: We previously demonstrated that people with type 2 diabetes (T2DM) can improve their ability to categorize blood glucose (BG) results into low, in range, or high glycemic ranges after experiencing a color range indicator (CRI or ColorSure™ Technology) in a single meter. This study examined whether a CRI was effective in people with type 1 (T1) or T2DM when used in 3 glucose meters. METHODS: A total of 179 subjects (139 T2DM and 40 T1DM) classified BG values as low, in range, or high based on individual current knowledge. Subjects then experienced the CRI which showed whether different BG values were low, in range, or high. After CRI interaction, subjects repeated the classification. RESULTS: Following interaction with the CRI, subjects significantly improved their ability to categorize BG results into low, in range, and high glycemic ranges by 27.9% (T2DM) and 27.2% (T1DM) (each P < .001). Improvement was not accompanied by an increase in time spent categorizing results. There was no difference in classification ability between subjects with T1 or T2DM. There was also no correlation between HbA1c, numeracy level, test frequency, or duration of diabetes and the ability to correctly classify results. Subjects agreed the CRI feature helped them easily interpret glucose values and improved their awareness of glucose ranges. CONCLUSION: Interaction with a CRI improved the ability of subjects with T1 and T2DM to interpret and categorize BG values into recommended glycemic ranges, irrespective of the glucose meter providing the CRI insights.

Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report.

Research on and commercial development of the artificial pancreas (AP) continue to progress rapidly, and the AP promises to become a part of clinical care. In this report, members of the JDRF Artificial Pancreas Project Consortium in collaboration with the wider AP community 1) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA1c, and 2) identify a short set of basic, easily interpreted outcome measures to be reported in AP studies whenever feasible. Consensus on a broader range of measures remains challenging; therefore, reporting of additional metrics is encouraged as appropriate for individual AP studies or study groups. Greater consistency in reporting of basic outcome measures may facilitate the interpretation of study results by investigators, regulatory bodies, health care providers, payers, and patients themselves, thereby accelerating the widespread adoption of AP technology to improve the lives of people with type 1 diabetes.

Remote Health Consultations Supported by a Diabetes Management Web Application With a New Glucose Meter Demonstrates Improved Glycemic Control.

BACKGROUND: Cloud-connected diabetes applications enable health care professionals (HCPs) to monitor patient progress and offer the potential for remote consultations. OneTouch Reveal (OTR) is a cloud-based web application that aggregates data from blood glucose (BG) meters or insulin pumps and provides analytics to help patients and HCPs make more informed treatment and lifestyle decisions. This study assessed the experience of patients using OTR and the OneTouch Verio (OTV) BG meter and determined the extent of changes in glycemic control. METHODS: Subjects with T1DM (23) or T2DM (17) uploaded BG meter results to OTR for 12 weeks. HCPs remotely reviewed progress using OTR and delivered telephone consultations at 4 and 8 weeks based on OTR insights. RESULTS: After 12 weeks, mean HbA1c decreased by 0.4% (P < .001) and 25% of subjects had a reduction of ≥1.0%. Reduction in HbA1c was similar in subjects with T1DM and T2DM, although subjects with T1DM started with higher baselines. In subjects with T2DM, mean BG decreased significantly from 175 to 161 mg/dl (P < .001) with the percentage of above-range BG results decreasing from 33% to 24%. 80% of subjects confirmed OTR detected out-of-range glucose patterns and 84% of these subjects were able to correct the underlying pattern to get BG back in-range. CONCLUSIONS: OTR web application in combination with the OTV meter helped subjects with T1DM and T2DM effectively manage their diabetes and was associated with improved BG control over 12 weeks. Real-time visibility to subject data may help HCPs deliver focused and effective remote consultations.