Randomized Controlled Trial of Telementoring During Resource-Limited Patient Care Simulation Improves Caregiver Performance and Patient Survival.

OBJECTIVES: To determine the impact of telementoring on caregiver performance during a high-fidelity medical simulation model (HFMSM) of a critically ill patient in a resource-limited setting. DESIGN: A two-center, randomized, controlled study using a HFMSM of a patient with community-acquired pneumonia complicated by acute respiratory distress syndrome. SETTING: A notional clinic in a remote location staffed by a single clinician and nonmedical assistant. PARTICIPANTS: Clinicians with limited experience managing critically ill patients. INTERVENTIONS: Telemedicine (TM) support. MEASUREMENTS: The primary outcome was clinical performance as measured by accuracy, reliability, and efficiency of care. Secondary outcomes were patient survival, procedural quality, subjective assessment of the HFMSM, and perceived workload. MAIN RESULTS: TM participants (N = 11) performed better than non-TM (NTM, N = 12) in providing expected care (accuracy), delivering care more consistently (reliability), and without consistent differences in efficiency (timeliness of care). Accuracy: TM completed 91% and NTM 42% of expected tasks and procedures. Efficiency: groups did not differ in the mean (± sd) minutes it took to obtain an advanced airway successfully (TM 15.2 ± 10.5 vs. NTM 22.8 ± 8.4, p = 0.10) or decompress a tension pneumothorax with a needle (TM 0.7 ± 0.5 vs. NTM 0.6 ± 0.9, p = 0.65). TM was slower than NTM in completing thoracostomy (22.3 ± 10.2 vs. 12.3 ± 4.8, p = 0.03). Reliability: TM performed 13 of 17 (76%) tasks with more consistent timing than NTM. TM completed 68% and NTM 29% of procedural quality metrics. Eighty-two percent of the TM participants versus 17% of the NTM participants simulated patients survived (p = 0.003). The groups similarly perceived the HFMSM as realistic, managed their patients with personal ownership, and experienced comparable workload and stress. CONCLUSIONS: Remote expertise provided with TM to caregivers in resource-limited settings improves caregiver performance, quality of care, and potentially real patient survival. HFMSM can be used to study interventions in ways not possible with real patients.

Mobile app activity engagement by cancer patients and their caregivers informs remote monitoring.

Mobile phone applications ("apps") are potentially an effective, low-burden method to collect patient-reported outcomes outside the clinical setting. Using such apps consistently and in a timely way is critical for complete and accurate data capture, but no studies of concurrent reporting by cancer patient-caregiver dyads have been published in the peer-reviewed literature. This study assessed app engagement, defined as adherence, timing, and attrition with two smartphone applications, one for adult cancer patients and one for their informal caregivers. This was a single-arm, pilot study in which adult cancer patients undergoing IV chemotherapy or immunotherapy used the DigiBioMarC app, and their caregivers used the TOGETHERCare app, for approximately one month to report weekly on the patients' symptoms and wellbeing. Using app timestamp metadata, we assessed user adherence, overall and by participant characteristics. Fifty patient-caregiver dyads completed the study. Within the one-month study period, both adult cancer patients and their informal caregivers were highly adherent, with app activity completion at 86% for cancer patients and 84% for caregivers. Caregivers completed 86% of symptom reports, while cancer patients completed 89% of symptom reports. Cancer patients and their caregivers completed most activities within 48 h of availability on the app. These results suggest that the DigiBioMarC and TOGETHERCare apps can be used to collect patient- and caregiver-reported outcomes data during intensive treatment. From our research, we conclude that metadata from mobile apps can be used to inform clinical teams about study participants' engagement and wellbeing outside the clinical setting.

Correction: Correlation Between Remote Symptom Reporting by Caregivers and Adverse Clinical Outcomes: Mixed Methods Study.

[This corrects the article DOI: 10.2196/49100.].

Correlation Between Remote Symptom Reporting by Caregivers and Adverse Clinical Outcomes: Mixed Methods Study.

BACKGROUND: Timely collection of patient-reported outcomes (PROs) decreases emergency department visits and hospitalizations and increases survival. However, little is known about the outcome predictivity of unpaid informal caregivers' reporting using similar clinical outcome assessments. OBJECTIVE: The aim of this study is to assess whether caregivers and adults with cancer adhered to a planned schedule for electronically collecting patient-reported outcomes (PROs) and if PROs were associated with future clinical events. METHODS: We developed 2 iPhone apps to collect PROs, one for patients with cancer and another for caregivers. We enrolled 52 patient-caregiver dyads from Kaiser Permanente Northern California in a nonrandomized study. Participants used the apps independently for 4 weeks. Specific clinical events were obtained from the patients' electronic health records up to 6 months following the study. We used logistic and quasi-Poisson regression analyses to test associations between PROs and clinical events. RESULTS: Participants completed 97% (251/260) of the planned Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) surveys and 98% (254/260) of the Patient-Reported Outcomes Measurement Information System (PROMIS) surveys. PRO-CTCAE surveys completed by caregivers were associated with patients' hospitalizations or emergency department visits, grade 3-4 treatment-related adverse events, dose reductions (P<.05), and hospice referrals (P=.03). PROMIS surveys completed by caregivers were associated with hospice referrals (P=.02). PRO-CTCAE surveys completed by patients were not associated with any clinical events, but their baseline PROMIS surveys were associated with mortality (P=.03), while their antecedent or final PROMIS surveys were associated with all clinical events examined except for total days of treatment breaks. CONCLUSIONS: In this study, caregivers and patients completed PROs using smartphone apps as requested. The association of caregiver PRO-CTCAE surveys with patient clinical events suggests that this is a feasible approach to reducing patient burden in clinical trial data collection and may help provide early information about increasing symptom severity.

Usability evaluation of mobile phone technologies for capturing cancer patient-reported outcomes and physical functions.

Background: By eliminating the requirement for participants to make frequent visits to research sites, mobile phone applications ("apps") may help to decentralize clinical trials. Apps may also be an effective mechanism for capturing patient-reported outcomes and other endpoints, helping to optimize patient care during and outside of clinical trials. Objectives: We report on the usability of Digital BioMarkers for Clinical Impact (DigiBioMarC™ (DBM)), a novel smartphone-based app used by cancer patients in conjunction with a wearable device (Apple Watch®). DBM is designed to collect patient-reported outcomes and record physical functions. Methods: In a fully decentralized "bring-your-own-device" smartphone study, we enrolled 54 cancer patient and caregiver dyads from Kaiser Permanente Northern California (KPNC) from October 2020 through March 2021. Patients used the app for at least 28 days, completed weekly questionnaires about their symptoms, physical functions, and mood, and performed timed physical tasks. Usability was determined through a subset of the Mobile App Rating Scale (MARS), the full System Usability Scale (SUS), the Net Promoter Score (NPS), and semi-structured interviews. Results: We obtained usability survey data from 50 of 54 patients. Median responses to the selected MARS questions and the mean SUS scores indicated above average usability. The NPS from the semi-structured interviews at the end of the study was 24, indicating a favorable score. Conclusions: Cancer patients reported above average usability for the DBM app. Qualitative analyses indicated that the app was easy to use and helpful. Future work will emphasize implementing further patient recommendations and evaluating the app's clinical efficacy in multiple settings.

A novel smartphone application for the informal caregivers of cancer patients: Usability study.

Informal caregivers are a critical source of support for cancer patients. However, their perspectives are not routinely collected, despite health impacts related to the burden of caregiving. We created the TOGETHERCare smartphone application (app) to collect observer-reported outcomes regarding the cancer patient's health and caregiver's perceptions of their own mental and physical health, and to provide tips and resources for self-care and patient care. We enrolled 54 caregivers between October 2020 and March 2021 from Kaiser Permanente Northern California (KPNC), an integrated healthcare system. Fifty caregivers used the app for approximately 28 days. Usability and acceptability were assessed using questions from the Mobile App Rating Scale (MARS), the System Usability Scale (SUS), the Net Promoter Score (NPS), and semi-structured interviews. The caregivers' mean age was 54.4 years, 38% were female and 36% were non-White. The SUS total mean score was 83.4 (SD = 14.2), for a percentile rank of 90-95 ("excellent"). Median MARS responses to the functionality questions were also high. The NPS score of 30 at the end of the study indicated that most caregivers would recommend the app. Themes from semi-structured interviews were consistent across the study period and indicated that the app was easy to use and helpful. Caregivers indicated a need for feedback from the app, suggested some changes to the wording of questions, the app's visuals, and timing of notifications. This study demonstrated that caregivers are willing to complete frequent surveys about themselves and their patients. The app is unique because it provides a remote method to collect caregivers' observations about the patient that may be useful for clinical care. To our knowledge, TOGETHERCare is the first mobile app developed specifically to capture adult cancer patient symptoms from the informal caregiver's perspective. Future research will examine whether use of this app can help improve patient outcomes.

Incidence and Progression of Diabetic Retinopathy in American Indian and Alaska Native Individuals Served by the Indian Health Service, 2015-2019.

Importance: Estimates of diabetic retinopathy (DR) incidence and progression in American Indian and Alaska Native individuals are based on data from before 1992 and may not be informative for strategizing resources and practice patterns. Objective: To examine incidence and progression of DR in American Indian and Alaska Native individuals. Design, Setting, and Participants: This was a retrospective cohort study conducted from January 1, 2015, to December 31, 2019, and included adults with diabetes and no evidence of DR or mild nonproliferative DR (NPDR) in 2015 who were reexamined at least 1 time during the 2016 to 2019 period. The study setting was the Indian Health Service (IHS) teleophthalmology program for diabetic eye disease. Exposure: Development of new DR or worsening of mild NPDR in American Indian and Alaska Native individuals with diabetes. Main Outcomes and Measures: Outcomes were any increase in DR, 2 or more (2+) step increases, and overall change in DR severity. Patients were evaluated with nonmydriatic ultra-widefield imaging (UWFI) or nonmydriatic fundus photography (NMFP). Standard risk factors were included. Results: The total cohort of 8374 individuals had a mean (SD) age of 53.2 (12.2) years and a mean (SD) hemoglobin A1c level of 8.3% (2.2%) in 2015, and 4775 were female (57.0%). Of patients with no DR in 2015, 18.0% (1280 of 7097) had mild NPDR or worse in 2016 to 2019, and 0.1% (10 of 7097) had PDR. The incidence rate from no DR to any DR was 69.6 cases per 1000 person-years at risk. A total of 6.2% of participants (441 of 7097) progressed from no DR to moderate NPDR or worse (ie, 2+ step increase; 24.0 cases per 1000 person-years at risk). Of patients with mild NPDR in 2015, 27.2% (347 of 1277) progressed to moderate NPDR or worse in 2016 to 2019, and 2.3% (30 of 1277) progressed to severe NPDR or worse (ie, 2+ step progression). Incidence and progression were associated with expected risk factors and evaluation with UWFI. Conclusions and Relevance: In this cohort study, the estimates of DR incidence and progression were lower than those previously reported for American Indian and Alaska Native individuals. The results suggest extending the time between DR re-evaluations for certain patients in this population, if follow-up compliance and visual acuity outcomes are not jeopardized.

Advanced Digital Health Technologies for COVID-19 and Future Emergencies.

Background: Coronavirus disease 2019 (COVID-19) has led to a national health care emergency in the United States and exposed resource shortages, particularly of health care providers trained to provide critical or intensive care. This article describes how digital health technologies are being or could be used for COVID-19 mitigation. It then proposes the National Emergency Tele-Critical Care Network (NETCCN), which would combine digital health technologies to address this and future crises. Methods: Subject matter experts from the Society of Critical Care Medicine and the Telemedicine and Advanced Technology Research Center examined the peer-reviewed literature and science/technology news to see what digital health technologies have already been or could be implemented to (1) support patients while limiting COVID-19 transmission, (2) increase health care providers' capability and capacity, and (3) predict/prevent future outbreaks. Results: Major technologies identified included telemedicine and mobile care (for COVID-19 as well as routine care), tiered telementoring, telecritical care, robotics, and artificial intelligence for monitoring. Several of these could be assimilated to form an interoperable scalable NETCCN. NETCCN would assist health care providers, wherever they are located, by obtaining real-time patient and supplies data and disseminating critical care expertise. NETCCN capabilities should be maintained between disasters and regularly tested to ensure continual readiness. Conclusions: COVID-19 has demonstrated the impact of a large-scale health emergency on the existing infrastructures. Short term, an approach to meeting this challenge is to adopt existing digital health technologies. Long term, developing a NETCCN may ensure that the necessary ecosystem is available to respond to future emergencies.

The Indian Health Service Primary Care-Based Teleophthalmology Program for Diabetic Eye Disease Surveillance and Management.

Background: Historically, fewer than half of American Indians and Alaska Natives (AI/AN) with diabetes received the annual diabetic retinopathy (DR) examination that is considered the minimum standard of care; this rate is similar to that of the general United States (U.S.) population with diabetes. Solution: The Indian Health Service-Joslin Vision Network (IHS-JVN) Teleophthalmology Program in 2000 to increase compliance with DR standards of care among AI/AN through validated, primary care-based telemedicine. The IHS-JVN provides remote diagnosis of DR severity, with a report including management recommendations that is returned to the patient's primary care provider. The program conforms with the American Telemedicine Association (ATA) Practice Guidelines for Ocular Telehealth-Diabetic Retinopathy. Outcomes: The IHS-JVN has been expanding incrementally since the first patients were recruited in 2000; this expansion coincides with large improvements in the annual DR examination rates reported as part of local, regional, and national regulatory compliance under the Government Performance and Results Act (GPRA). Currently, with 99 clinical implementations in 23 states, IHS-JVN is the largest primary care-based ATA validation category three telemedicine program in the U.S. Summary: This article describes the program's workflow, imaging and reading technologies, diagnostic protocols, reports to providers, training, quality assurance processes, and geographical distribution. In addition to its clinical use, the program has been utilized in research on utilization of diabetic eye care, cost-effectiveness, technology development, and DR epidemiology of the AI/AN population. Potential next steps for this program are discussed.

Prevalence of diabetic retinopathy and diabetic macular edema in a primary care-based teleophthalmology program for American Indians and Alaskan Natives.

BACKGROUND: Diabetes and its complications are more common in American Indians and Alaska Natives (AI/AN) than other US racial/ethnic populations. Prior reports of diabetic retinopathy (DR) prevalence in AI/AN are dated, and research on diabetic macular edema (DME) is limited. This study characterizes the recent prevalence of DR and DME in AI/AN using primary care-based teleophthalmology surveillance. METHODS: This is a multi-site, clinic-based, cross-sectional study of DR and DME. The sample is composed of AI /AN patients with diabetes (n = 53,998), served by the nationally distributed Indian Health Service-Joslin Vision Network Teleophthalmology Program (IHS-JVN) in primary care clinics of US Indian Health Service (IHS), Tribal, and Urban Indian health care facilities (I/T/U) from 1 November 2011 to 31 October 2016. Patients were recruited opportunistically for a retinal examination using the IHS-JVN during their regular diabetes care. The IHS-JVN used clinically validated, non-mydriatic, retinal imaging and retinopathy assessment protocols to identify the severity levels of non-proliferative diabetic retinopathy (NPDR), proliferative diabetic retinopathy (PDR), DME, and sight threatening retinopathy (STR; a composite measure). Key social-demographic (age, gender, IHS area), diabetes-related health (diabetes therapy, duration of diabetes, A1c), and imaging technology variables were examined. The analysis calculated frequencies and percentages of severity levels of disease. RESULTS: Prevalence of any NPDR, PDR, DME, and STR among AI/AN patients undergoing DR teleophthalmology surveillance by IHS-JVN was 17.7%, 2.3%, 2.3%, and 4.2%, respectively. Prevalence was lowest in Alaska and highest among patients with A1c >/ = 8%, duration of diabetes > 10 years, or using insulin. CONCLUSIONS: Prevalence of DR in this cohort was approximately half that in previous reports for AI/AN, and prevalence of DME was less than that reported in non-AI/AN populations. A similar reduction in diabetes related end-stage renal disease in the same population and time period has been reported by other researchers. Since these two diabetic complications share a common microvasculopathic mechanism, this coincident change in prevalence may also share a common basis, possibly related to improved diabetes management.

Does Mobile Care ('mCare') Improve Quality of Life and Treatment Satisfaction Among Service Members Rehabilitating in the Community? Results from a 36-Wk, Randomized Controlled Trial.

Introduction: Research has shown that mobile phones can help with management of numerous health problems. As an adjunct to care management provided to injured service members rehabilitating in their communities, particularly those with mild traumatic brain injury (mTBI), post-traumatic stress (PTS), and/or behavioral health problems, the Army developed a mobile phone application called "mCare." This study examined whether service members who received mCare had higher well-being, were more satisfied with their care, and viewed mCare as a valuable part of their care management as compared with their counterparts who received standard care management alone, and whether those with mTBI, PTS, and/or behavioral health problems benefited differently from mCare. Materials and Methods: In-processing service members at four community-based warrior transition units were recruited for participation in a 36-wk, randomized, controlled trial and allocated to receive standard care management plus mCare (n = 95) or standard care management alone (n = 87). Participants in the mCare group received daily questionnaires, tips, and appointment reminders. All participants were asked to complete the General Well-being Schedule (GWS) at baseline, 12, 24, and 36 wk, and the Case Management Quality Questionnaire (CMQQ) at 12, 24, and 36 wk. All participants and care managers were approached to complete interviews about the usability/likeability of mCare or standard care management. The analyses tested for group differences in completion of the intervention, graphed means for the GWS and CMQQ by group/subgroup, and statistically compared the longitudinal trends in these outcomes using mixed models in which group, time, and group*time were included as regression variables. The analyses also tallied interview responses and identified thematic quotes. The study protocol was reviewed and approved by the Walter Reed National Military Medical Center's Institutional Review Board. Results: Estimated rate of change in GWS scores was -2.2 (standard error = 1.0; t = -2.1; p = 0.0382). Estimated rate of change in CMQQ scores was -0.8 (standard error = 0.5; t = -1.52; p = 0.1299). Neither change was meaningful. Rates of change in the GWS and CMQQ scores did not differ by group or by behavioral health, mTBI, and PTS subgroups within the groups. The interviews found that 83% of mCare participants liked the communication with their care managers versus 73% of standard care management participants. Participants in both the mCare group and the care managers said that they liked the application's appointment tracking and reminders. Care managers thought mCare was particularly useful for people with mTBI, PTS, and cognitive problems. Conclusion: mCare did not result in differences in general well-being and satisfaction with care management among service members rehabilitating in their communities, some with mTBI, PTS, and/or behavioral health problems. But participants and care managers who used mCare said that they found it useful. Study limitations included the diversity of clinical issues of the participants, greater missing data among mCare participants, and the high baseline quality of care management in the settings observed. The fact that patients and care managers liked mCare, apart from no changes in outcomes, is important because health care is increasingly adopting mobile solutions.

The Cost-Effectiveness of Real-Time Continuous Glucose Monitoring (RT-CGM) in Type 2 Diabetes.

BACKGROUND: This analysis models the cost-effectiveness of real-time continuous glucose monitoring (RT-CGM) using evidence from a randomized controlled trial (RCT) that demonstrated RT-CGM reduced A1C, for up to 9 months after using the technology, among patients with type 2 diabetes not on prandial insulin. RT-CGM was offered short-term and intermittently as a self-care tool to inform patients' behavior. METHOD: The analyses projected lifetime clinical and economic outcomes for RT-CGM versus self-monitoring of blood glucose by fingerstick only. The base-case analysis was consistent with the RCT (RT-CGM for 2 weeks on/1 week off over 3 months). A scenario analysis simulated outcomes of an RT-CGM "refresher" after the active intervention of the RCT. Analyses used the IMS CORE Diabetes Model and were conducted from a US third-party payer perspective, including direct costs obtained from published sources and inflated to 2011 US dollars. Costs and health outcomes were discounted at 3% per annum. RESULTS: Life expectancy (LE) and quality-adjusted life expectancy (QALE) from RT-CGM were 0.10 and 0.07, with a cost of $653/patient over a lifetime. Incremental LE and QALE from a "refresher" were 0.14 and 0.10, with a cost of $1312/patient over a lifetime, and incremental cost-effectiveness ratios were $9319 and $13 030 per LY and QALY gained. CONCLUSIONS: RT-CGM, as a self-care tool, is a cost-effective disease management option in the US for people with type 2 diabetes not on prandial insulin. Repeated use of RT-CGM may result in additional cost-effectiveness.

Glycemic variability in nondiabetic morbidly obese persons: results of an observational study and review of the literature.

Glycemic variability (GV) is correlated with oxidative stress which may lead to increased cardiovascular risk and poor clinical outcomes in people with prediabetes and diabetes. We sought to understand whether morbidly obese persons without diabetes by standard criteria have dysglycemia as measured by GV. We performed an observational study of GV metrics and carotid intima media thickness (CIMT) in 21 morbidly obese normoglycemic and 15 morbidly obese prediabetic applicants to The Biggest Loser television show. The results were compared to previously published studies in normoglycemic nonobese and obese individuals. Glucose was measured with a masked continuous glucose monitor (CGM) over 3 to 8 days and carotid intima media thickness (CIMT) was determined by ultrasound. CGM-derived GV metrics for GV were coefficient of variation (CV), standard deviation (SD), mean amplitude of glycemic excursions (MAGE), continuous overall net glycemic action-1 hour (CONGA1), and mean of daily differences (MODD). We found that morbidly obese subjects (n = 21) who were normoglycemic by standard criteria had higher GV (CV = 22%, SD = 24.2 mg/dl and MAGE = 48.6 mg/dl) than previous reports of normoglycemic, nonobese individuals (CV = 12-18%, SD = 11.5-15.0 mg/dl, and MAGE = 26.3-28.3 mg/dl). Morbidly obese prediabetic subjects (n = 15) had GV metrics indistinguishable from those morbidly obese subjects who were normoglycemic. CIMT was higher in both morbidly obese groups compared with historical age- and sex-matched controls. Normoglycemic and prediabetic morbidly obese individuals have higher GV compared with normal weight, nondiabetic individuals. We speculate that this may increase the risk for macrovascular disease through excessive oxidative stress.

Minding the gaps in continuous glucose monitoring: a method to repair gaps to achieve more accurate glucometrics.

Estimation of glycemic variability requires frequent measures of glucose and is greatly aided by continuous glucose monitoring (CGM); however, under real-world conditions, missing data or "gaps" of ≥ 10 minutes can occur in CGM data, affecting the reliability of certain estimates. Thus, we determined the magnitude of the gap problem as observed in a cohort of patients with type 2 diabetes and demonstrated an approach to fill the gaps. The approach takes the difference between readings before and after a gap and distributes the difference equally across the number of missing readings, as determined by the sensor's setting for reading frequency. The approach is easy to implement, conservative, and improves estimation of variability measures that reference time, namely, mean of daily differences and continuous overlapping net glycemic action.

Effect of an accelerometer on body weight and fitness in overweight and obese active duty soldiers.

This study evaluated whether using a web-linked accelerometer, plus mandatory physical training, is associated with various weight- and fitness-related outcomes in overweight/obese active duty soldiers. Soldiers who failed the height/weight standards of the Army Physical Fitness Test (APFT) were randomized to use a Polar FA20 accelerometer device (polar accelerometer group [PA], n = 15) or usual care (UC, n = 13) for 6 months. Both groups received 1.5 hours of lifestyle instruction. We collected data at baseline, 2, 4, and 6 months, and evaluated group differences in temporal changes in study outcomes. At 6 months, 1/28 subjects (UC) passed the APFT height/weight standards. There were no group differences in changes in weight (PA: -0.1 kg vs. UC: +0.3 kg; p = 0.9), body fat (PA: -0.9% vs. UC: -1.1%; p = 0.9), systolic blood pressure (PA: +1.3 mm Hg vs. UC: -2.1 mm Hg; p = 0.2), diastolic blood pressure (PA: +3.8 mm Hg vs. UC: -2.4 mm Hg; p = 0.3), or resting heart rate in beats per minute (bpm) (PA: +7.8 bpm vs. UC: +0.1 bpm; p = 0.2). These results suggest that using an accelerometer with web-based feedback capabilities plus mandatory physical training does not assist in significant weight loss or ability to pass the APFT height/weight standards among overweight/obese soldiers.

Heterogeneity of responses to real-time continuous glucose monitoring (RT-CGM) in patients with type 2 diabetes and its implications for application.

OBJECTIVE: To characterize glucose response patterns of people who wore a real-time continuous glucose monitor (RT-CGM) as an intervention to improve glycemic control. Participants had type 2 diabetes, were not taking prandial insulin, and interpreted the RT-CGM data independently. RESEARCH DESIGN AND METHODS: Data were from the first 12 weeks of a 52-week, prospective, randomized trial comparing RT-CGM (n = 50) with self-monitoring of blood glucose (n = 50). RT-CGM was used in 8 of the first 12 weeks. A1C was collected at baseline and quarterly. This analysis included 45 participants who wore the RT-CGM ≥4 weeks. Analyses examined the RT-CGM data for common response patterns-a novel approach in this area of research. It then used multilevel models for longitudinal data, regression, and nonparametric methods to compare the patterns of A1C, mean glucose, glycemic variability, and views per day of the RT-CGM device. RESULTS: There were five patterns. For four patterns, mean glucose was lower than expected as of the first RT-CGM cycle of use given participants' baseline A1C. We named them favorable response but with high and variable glucose (n = 7); tight control (n = 14); worsening glycemia (n = 6); and incremental improvement (n = 11). The fifth was no response (n = 7). A1C, mean glucose, glycemic variability, and views per day differed across patterns at baseline and longitudinally. CONCLUSIONS: The patterns identified suggest that targeting people with higher starting A1Cs, using it short-term (e.g., 2 weeks), and monitoring for worsening glycemia that might be the result of burnout may be the best approach to using RT-CGM in people with type 2 diabetes not taking prandial insulin.

A randomized comparison of online- and telephone-based care management with internet training alone in adult patients with poorly controlled type 2 diabetes.

AIMS: Care management may improve the quality of diabetes care by enhancing contact between high-risk patients and their providers. This prospective, longitudinal, randomized trial sought to investigate whether telephone or online care management improves diabetes-related outcomes over time compared with usual care supplemented with Internet access and training. SUBJECTS AND METHODS: One hundred fifty-one adult subjects with type 2 diabetes mellitus and an elevated hemoglobin A1c (A1c) level (≥8.5%) were randomly assigned to online care management (n=51), telephone-based care management (n=51), or Web training (n=49) groups. Online and telephone participants interacted with a care manager through a diabetes education and care management Web site and by telephone, respectively. The Web training group was provided with online diabetes self-management resources but no care management support. The primary outcome measure was A1c measured every 3 months for a year. RESULTS: A1c declined significantly and substantially in all groups over 12 months. A1c declined linearly at a rate of 0.32% (P<0.0001) per quarter for the online group, 0.36% (P<0.0001) for the telephone group, and 0.41% for the Web training group (P<0.0001). The rate of change over time did not differ significantly among groups. The groups converged at 12 months with average absolute A1c difference of -1.5%. The number of interactions with care providers was not significantly associated with the change in A1c. Blood pressure, weight, lipid levels, and diabetes distress did not differ among groups over time. CONCLUSIONS: Online, telephone-based care management, and Web training for diabetes patients with elevated A1c were each associated with a substantial improvement in A1c over a 1-year period. Internet access and training alone may be as effective as care management in patients with poorly controlled diabetes.

Mobile phone-based video messages for diabetes self-care support.

BACKGROUND: This study examined whether mobile phone-based, one-way video messages about diabetes self-care improve hemoglobin A1c (A1C) and self-monitoring of blood glucose (SMBG). METHODS: This was a 1-year prospective randomized trial with two groups. The active intervention lasted 6 months. The study enrolled 65 people with A1C >8.0% who were established (>6 months) patients in the endocrinology clinics of the Walter Reed Health Care System. Participants were randomized to receive "usual care" or self-care video messages from their diabetes nurse practitioner. Video messages were sent daily to cell phones of study participants. Hemoglobin A1c and SMBG data were collected at 0, 3, 6, 9, and 12 months. RESULTS: Participants who received the messages had a larger rate of decline in A1C than people who received usual care (0.2% difference over 12 months, adjusting for covariates; p = .002 and p = .004 for the interaction between time and group and for the quadratic effect of time by group, respectively). Hemoglobin A1c decline was greatest among participants who received video messages and viewed >10 a month (0.6% difference over 12 months, adjusting for covariates; p < .001 for the interaction between time and group and the quadratic effect). Self-monitoring of blood glucose metrics were not related to the intervention. CONCLUSIONS: A one-way intervention using mobile phone-based video messages about diabetes self-care can improve A1C. Engagement with the technology is an important predictor of its success. This intervention is simple to implement and sustain.

Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes.

OBJECTIVE: To determine whether short-time, real-time continuous glucose monitoring (RT-CGM) has long-term salutary glycemic effects in patients with type 2 diabetes who are not on prandial insulin. RESEARCH DESIGN AND METHODS: This was a randomized controlled trial of 100 adults with type 2 diabetes who were not on prandial insulin. This study compared the effects of 12 weeks of intermittent RT-CGM with self-monitoring of blood glucose (SMBG) on glycemic control over a 40-week follow-up period. Subjects received diabetes care from their regular provider without therapeutic intervention from the study team. RESULTS: There was a significant difference in A1C at the end of the 3-month active intervention that was sustained during the follow-up period. The mean, unadjusted A1C decreased by 1.0, 1.2, 0.8, and 0.8% in the RT-CGM group vs. 0.5, 0.5, 0.5, and 0.2% in the SMBG group at 12, 24, 38, and 52 weeks, respectively (P = 0.04). There was a significantly greater decline in A1C over the course of the study for the RT-CGM group than for the SMBG group, after adjusting for covariates (P < 0.0001). The subjects who used RT-CGM per protocol (≥48 days) improved the most (P < 0.0001). The improvement in the RT-CGM group occurred without a greater intensification of medication compared with those in the SMBG group. CONCLUSIONS: Subjects with type 2 diabetes not on prandial insulin who used RT-CGM intermittently for 12 weeks significantly improved glycemic control at 12 weeks and sustained the improvement without RT-CGM during the 40-week follow-up period, compared with those who used only SMBG.

The effect of real-time continuous glucose monitoring on glycemic control in patients with type 2 diabetes mellitus.

BACKGROUND: Real-time continuous glucose monitoring (RT-CGM) improves hemoglobin A1c (A1C) and hypoglycemia in people with type 1 diabetes mellitus and those with type 2 diabetes mellitus (T2DM) on prandial insulin; however, it has not been tested in people with T2DM not taking prandial insulin. We evaluated the utility of RT-CGM in people with T2DM on a variety of treatment modalities except prandial insulin. METHODS: We conducted a prospective, 52-week, two-arm, randomized trial comparing RT-CGM (n = 50) versus self-monitoring of blood glucose (SMBG) (n = 50) in people with T2DM not taking prandial insulin. Real-time continuous glucose monitoring was used for four 2-week cycles (2 weeks on/1 week off). All patients were managed by their usual provider. This article reports on changes in A1C 0-12 weeks. RESULTS: Mean (± standard deviation) decline in A1C at 12 weeks was 1.0% (± 1.1%) in the RT-CGM group and 0.5% (± 0.8%) in the SMBG group (p = .006). There were no group differences in the net change in number or dosage of hypoglycemic medications. Those who used the RT-CGM for ≥ 48 days (per protocol) reduced their A1C by 1.2% (± 1.1%) versus 0.6% (± 1.1%) in those who used it <48 days (p = .003). Multiple regression analyses statistically adjusting for baseline A1C, an indicator for usage, and known confounders confirmed the observed differences between treatment groups were robust (p = .009). There was no improvement in weight or blood pressure. CONCLUSIONS: Real-time continuous glucose monitoring significantly improves A1C compared with SMBG in patients with T2DM not taking prandial insulin. This technology might benefit a wider population of people with diabetes than previously thought.