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Background: Glycemic control in the hospital setting is imperative for improving outcomes among patients with diabetes. Bedside point-of-care (POC) glucose monitoring has remained the gold standard for decades, while only providing momentary glimpses into a patient’s glycemic control. Continuous glucose monitoring (CGM) has been shown to improve glycemic control in the ambulatory setting. However, a paucity of inpatient experience and data remains a barrier to US Food and Drug Administration (FDA) approval and expanded/non-research use in the hospital setting. Method: Amid the COVID-19 pandemic, the FDA exercised its enforcement discretion to not object to the use of CGM systems for the treatment of patients in hospital settings to support COVID-19 health care–related efforts to reduce viral exposure of health care workers. Following this announcement, Scripps Health, a large not-for-profit health care system in San Diego, California, implemented CGM as the new “standard of care” (CGM as SOC) for glucose monitoring and management in the hospital. Results: The present report serves to (1) detail the implementation procedures for employing this new SOC; (2) describe the patients receiving CGM as SOC, their glycemic control, and hospital outcomes; and (3) share lessons learned over two years and nearly 900 hospital encounters involving CGM. Conclusions: Here, we conclude that CGM is feasible in the hospital setting by using a dedicated diabetes care team and the CGM technology with remote monitoring.

Type 2 diabetes disproportionately impacts ethnic minorities and individuals from low socioeconomic status. Diabetes self-management education and support has been shown to improve clinical outcomes in these populations, and mobile health (mHealth) interventions can reduce barriers to access. Dulce Digital-Me (DD-Me) was developed to integrate adaptive mHealth technologies to enhance self-management and reduce disparities in the high-risk, underserved Hispanic population. The objective of the present study was to evaluate reach, adoption, and implementation of an mHealth diabetes self-management education and support intervention in this underrepresented population. The present analysis is a multimethod process evaluation using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The study was effective in reaching a sample that was representative of the intended population; only modest but significant differences were observed in sex and age. The DD-Me health coach (HC) cited several important facilitators of intervention adoption, including outreach frequency and personalization, and the automated HC report. Implementation fidelity was high, with participants receiving >90% of intended interventions. Participants who received DD-Me with support from a HC were most engaged, suggesting utility and acceptability of integrating HCs with mHealth interventions. Perceptions of implementation among study participants were positive and consistent across study arms. This evaluation revealed the target population was successfully reached and engaged in the digital health interventions, which was implemented with high fidelity. Further studies should evaluate the efficacy and maintenance of the study following the RE-AIM model to determine whether this intervention warrants expansion to additional settings and populations.

Team-based models that use medical assistants (MAs) to provide self-management support for adults with type 2 diabetes (T2D) have not been pragmatically tested in diverse samples. This cluster-randomized controlled trial compares MA health coaching with usual care in adults with T2D and poor clinical control (“MAC Trial”). The purpose was to conduct a multi-method process evaluation of the MAC Trial using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Reach was assessed by calculating the proportion of enrolled participants out of the eligible pool and examining representativeness of those enrolled. Key informant interviews documented adoption by MA Health Coaches. We examined implementation from the research and patient perspectives by evaluating protocol adherence and the Patient Perceptions of Chronic Illness Care (PACIC-SF) measure, respectively. Findings indicate that the MAC Trial was efficient and effective in reaching patients who were representative of the target population. The acceptance rate among those approached for health coaching was high (87%). Both MA Health Coaches reported high satisfaction with the program and high levels of confidence in their role. The intervention was well-implemented, as evidenced by the protocol adherence rate of 79%; however, statistically significant changes in PACIC-SF scores were not observed. Overall, if found to be effective in improving clinical and patient-reported outcomes, the MAC model holds potential for wider-scale implementation given its successful adoption and implementation and demonstrated ability to reach patients with poorly controlled T2D who are at-risk for diabetes complications in diverse primary care settings.

While good cardiometabolic control can reduce complications in type 2 diabetes (T2D) , many individuals do not achieve clinical targets. This real-world trial compared medical assistant health coaching (MAC) to usual care (UC) in improving outcomes among adults with T2D and ≥ 1 of the following in the past 90 days: HbA1c ≥ 8%, LDL ≥ 100 mg/dL, SBP ≥ 140 mm/Hg. This N=600 study was conducted from 2016-2021 at four cluster-randomized clinics within two diverse health systems in Southern CA: a large, private insurance-based system [n = 298, majority non-Hispanic White, English-speaking, mid/upper socioeconomic status (SES) ]; M age = 70.2 ± 12.6] and a Federally-Qualified Health Center (n = 302, majority Hispanic, Spanish-speaking, lower SES; M age = 56.9 ± 12.0) . MAC and UC received diabetes care as usual in primary care, with referral to diabetes education and/or specialists as indicated. MAC also received in-clinic and telephone-based health coaching for up to one year (1-14 sessions; M = 5.2 ± 2.8) . Baseline mean HbA1c = 8.8 ± 2.2%, LDL = 101.8 ± 44.8 mg/dL, and SBP = 137.9 ± 19.4 mm/Hg. From baseline to 12-months, the percentage of individuals meeting quality metrics increased in both groups: HbA1c < 8% (MAC: 74.8 to 79.9%; UC: 64.0 to 80.4%) , LDL < 100 mg/dL (MAC: 75.7 to 84.9%; UC: 72.6 to 82.4%) , SBP < 140 mm/Hg (MAC: 75.0 to 86.9%; UC: 80.2 to 86.4%) . When outcomes were analyzed continuously using multi-level modeling, both MAC and UC demonstrated statistically significant improvements on all clinical outcomes; however, the rate of improvement was largely equivalent across groups (time-by-group ps > .05) . Due to the pragmatic nature of this trial, there was marked variation (by design) in intervention duration and intensity across participants, and in clinical and sociodemographic characteristics of participants across health systems. Additional analyses examining under what conditions and/or for whom the MAC intervention may prove more/less effective will be presented. Disclosure A.L.Fortmann: Consultant; Ascensia Diabetes Care, Employee; Dexcom, Inc. A.Philis-tsimikas: Advisory Panel; Bayer AG, Novo Nordisk, Research Support; Lilly Diabetes, National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk, Viking Therapeutics. T.Clark: None. S.R.Spierling bagsic: None. H.Sandoval: None. K.L.Savin: None. S.Roesch: None. L.Gallo: None. Funding NIH/NIDDK 1R18DK104250

Mobile health delivery of diabetes self-management education and support (DSME/S) can reduce barriers among racial/ethnic minority populations (e.g., Hispanics) , but little is known about how participant characteristics shape adherence and engagement with mHealth interventions. The current study examined this using data from Dulce Digital-Me, a randomized trial that tested an adaptive mHealth DSME/S intervention among 3Hispanic adults with poorly managed type 2 diabetes from a Federally Qualified Health Center in San Diego, CA. In addition to core educational content, participants in three intervention arms received text messages with ecological momentary assessment (EMA) of health behaviors and prompts to check their blood glucose (BG) over 24 weeks. Linear regression models examined associations of age, sex, diabetes duration, health literacy (Single Item Literacy Scale) , and diabetes distress (Diabetes Distress Scale-17) at baseline with the percentage of EMA and BG checks completed, controlling for study arm. Average participant age was 52.6 years ± 11.5; 70% were female. Younger age (B=-.88) , longer diabetes duration (B=.51) , lower health literacy (B=-4.7) , and lower diabetes distress (B=-6.7) predicted significantly higher EMA completion, while only lower distress (B=-4.5) predicted higher BG check completion (all ps Disclosure T.Clark: None. A.L.Fortmann: Consultant; Ascensia Diabetes Care, Employee; Dexcom, Inc. A.Philis-tsimikas: Advisory Panel; Bayer AG, Novo Nordisk, Research Support; Lilly Diabetes, National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk, Viking Therapeutics. K.L.Savin: None. H.Sandoval: None. S.R.Spierling bagsic: None. L.Gallo: None. Funding National Institutes of Health (NCT03130699)

Diabetes, high blood pressure, and obesity are major risk factors for cardiovascular disease (CVD) . Access to and awareness of health education programming is often low in ethnic/racial minorities and individuals of low socioeconomic status experience a higher prevalence of T2D, hypertension, CVD and stroke. Additionally, underserved, at-risk patients face barriers to accessing traditional in-person diabetes self-management education and support (DSME/S) due to transportation, caregiving, and work conflicts. To address this gap, the ADA’s Know Diabetes by Heart (KDBH) initiative partnered with Project Dulce, an evidence-based culturally and linguistically modified DSME/S program to overlay an innovative digital approach to diabetes support programming and resources in the community. In response to COVID-restrictions, Project Dulce sessions integrating KDBH content were delivered via telehealth group sessions and text messaging to encourage heart healthy self-management behaviors. Pre/post surveys assessed knowledge and self-management, and clinical metrics were evaluated via electronic health records. The KDBH/Project Dulce DSME/S program was delivered to 5 health systems in California: 2 Federally Qualified Health Centers, 2 County health clinics and 1 large community-based health system near the US/Mexico border. Of the N=553 who received KDBH/Project Dulce education, 47% were White, 36% Hispanic, 14% African American, Asian, Native American, Pacific Islander, and 3% other. Of all enrollees, 58% were female, and 15% were /= 66 y/o. Participant feedback indicated acceptance of both the group virtual and texting programs. Findings demonstrate the feasibility of disseminating important heart healthy interventions to diverse ethnic/racial minority groups via a variety of digital and telehealth methods. Disclosure M.Ruiz: n/a. A.L.Fortmann: Consultant; Ascensia Diabetes Care, Employee; Dexcom, Inc. H.Sandoval: None. A.Philis-tsimikas: Advisory Panel; Bayer AG, Novo Nordisk, Research Support; Lilly Diabetes, National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk, Viking Therapeutics. M.Chichmarenko: None. S.R.Bagsic: None. J.Boyer: None. Funding American Diabetes Association/KDBH

Dulce Digital (DD) , a simple low-cost text message program designed to enhance clinical diabetes care with educational, motivational and glucose reminder messages when delivered 2-3 times/day over 6 months has been shown to be highly acceptable in diverse racial/ethnic minorities and low SES communities and results in a mean 1% reduction in HbA1c compared to usual care. During the COVID pandemic, barriers to in-person care, including quarantines, stay-at-home work schedules, childcare, and transportation, make digital messaging a practical means of improving patient health. To maximize reach in the T2DM population, a large Southern California health care provider integrated DD into their DSME/S offering. This study aims to learn the reach, acceptability, and effectiveness of Dulce Digital in a real-world patient care setting to motivate patients with daily self-care behaviors. An existing diabetes registry identified N=1423 patients with T2DM and HbA1c>7.5% in the last 6 months. There was enthusiastic adoption of the DD texting program byprimary care clinic sites with 78 providers across the County. Patient recruitment was conducted via a patient portal message (EPIC My Chart) sent from healthcare providers encouraging participation in the program. Within one week of portal outreach, 116 patients (8.2%) enrolled (mean age = 57.3 y/o +/- 14.4, range 24-92; 50% female; mean HbA1c= 9.9 % +/- 1.5, range 8.1-16.2) . Program workflows include using support staff to monitor blood glucose responses in the texting platform, assess possible reasons for hyper/hypoglycemia, and encourage follow up with a provider as needed. Adoption by patients and providers to date demonstrate a digital texting program is acceptable and desired equally by men and women across a wide range of ages in patients with T2D and elevated HbA1c. Outreach to enroll patients using a patient EMR portal can be successful and can serve as an enhanced approach to support DSME/S. Disclosure M.Ruiz: n/a. A.Philis-tsimikas: Advisory Panel; Bayer AG, Novo Nordisk, Research Support; Lilly Diabetes, National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk, Viking Therapeutics. H.Sandoval: None. A.L.Fortmann: Consultant; Ascensia Diabetes Care, Employee; Dexcom, Inc. M.A.Stechschulte: None. S.R.Bagsic: None. K.Patel: None. K.Mendez: None.

OBJECTIVEThe current standard for hospital glucose management is point-of-care (POC) testing. We conducted a randomized controlled trial of real-time continuous glucose monitoring (RT-CGM) compared with POC in a non–intensive care unit (ICU) hospital setting.RESEARCH DESIGN AND METHODSA total of 110 adults with type 2 diabetes on a non-ICU floor received RT-CGM with Dexcom G6 versus usual care (UC). RT-CGM data were wirelessly transmitted from the bedside. Hospital telemetry monitored RT-CGM data and notified bedside nursing of glucose alerts and trends. Standardized protocols were used for interventions.RESULTSThe RT-CGM group demonstrated significantly lower mean glucose (M∆ = −18.5 mg/dL) and percentage of time in hyperglycemia >250 mg/dL (−11.41%) and higher time in range 70–250 mg/dL (+11.26%) compared with UC (P values CONCLUSIONSRT-CGM can be used successfully in community-based hospital non-ICU settings to improve glucose management. Continuously streaming glucose readings may truly be the fifth vital sign.

OBJECTIVE: The current standard for hospital glucose management is point-of-care (POC) testing. We conducted a randomized controlled trial comparing real-time CGM (RT-CGM) to POC in a non-ICU hospital setting. RESEARCH DESIGN AND METHODS: N=110 adults with type 2 diabetes (T2D) on a non-ICU floor received RT-CGM with Dexcom G6 vs usual care (UC). RT-CGM data were wirelessly transmitted from the bedside. Hospital telemetry monitored RT-CGM data and notified bedside nursing of glucose alerts and trends. Standardized protocols were used for interventions. RESULTS: The RT-CGM group demonstrated significantly lower mean glucose (M∆= -18.5 mg/dL) and percentage of time in hyperglycemia >250 mg/dL (-11.41%), and higher median TIR 70-250 mg/dL (+11.26%) compared with UC (ps CONCLUSION: RT-CGM can be used successfully in community-based hospital non-ICU settings to improve glucose management; continuously streaming glucose readings may truly be the 5th vital sign.

Hispanics have a 66% higher risk of developing type 2 diabetes (T2D), and exhibit worse outcomes than non-Hispanic whites. Many Hispanics lack access to diabetes self-management education and support (DSME/S) due to practical, cultural, and other barriers. Mobile health (mHealth) technology has the potential to circumvent such barriers and expand the reach of DSME/S. A 3-group, randomized controlled trial is currently underway to evaluate the effectiveness of mHealth DSME/S approaches in improving diabetes outcomes among predominantly low income, Hispanic adults with T2D and HbA1c ≥ 8% at a Federally Qualified Health Center in Southern California. Dulce Digital-Me (DD-Me) is an adaptive mHealth intervention that integrates educational text messaging with personalized goal-setting and feedback. Over 6 months, participants receive 2-3 messages/day, and are provided with a glucometer and pillbox that wirelessly transmit real-time data to a cloud. Ecological momentary assessment (EMA) gauges progress in healthful eating, exercise, and emotional well-being. Participants’ progress in lifestyle changes, medication adherence, and BG monitoring frequency and control is compared to pre-defined targets. Real-time feedback is delivered via automated, algorithm-driven messaging or by medical assistant Health Coach (n = 104 in each group). The control group (n = 207) receives educational text messages alone. Preliminary analyses (N = 163) showed higher BG monitoring frequency in the DD-Me Health Coach group (M = 7.02 ± 0.45 checks/week) versus the DD-Me algorithm-driven (M = 4.80 ± 0.49) and control groups (M = 5.25 ± 0.65), p Disclosure A.L. Fortmann: None. A. Philis-Tsimikas: Advisory Panel; Self; Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. S.R.S. Bagsic: None. D.G. Vital: None. J.A. Jones: None. H. Sandoval: None. K.L. Savin: None. T. Clark: None. K. Luu: None. J.G. Godino: None. L. Gallo: None. Funding National Institutes of Health (1R01DK112322)

In the US, nearly 11% of adults were living with diagnosed diabetes in 2017, and significant type 2 diabetes (T2D) disparities are experienced by socioeconomically disadvantaged, racial/ethnic minority populations, including Hispanics. The standard 15-minute primary care visit does not allow for the ongoing self-management support that is needed to meet the complex needs of individuals with diabetes. “Team-based” chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or “health coaching.” While rigorous trials have shown MA health coaching to improve diabetes outcomes, less is known about if and how such a model can be integrated within real world, primary care clinic workflows. Medical Assistant Health Coaching for Type 2 Diabetes in Diverse Primary Care Settings – A Pragmatic, Cluster-Randomized Controlled Trial will address this gap. Specifically, this study compares MA health coaching versus usual care in improving diabetes clinical control among N=600 at-risk adults with T2D, and is being conducted at four primary care clinics that are part of two health systems that serve large, ethnically/racially, and socioeconomically diverse populations in Southern California. Electronic medical records are used to identify eligible patients at both health systems, and to examine change in clinical control over one year in the overall sample. Changes in behavioral and psychosocial outcomes are being evaluated by telephone assessment in a subset (n=300) of participants, and rigorous process and cost evaluations will assess potential for sustainability and scalability. ClinicalTrials.gov: NCT02643797 (registered November 30, 2015: https://clinicaltrials.gov/ct2/show/NCT02643797?term=philis-tsimikas&rank=10) Trial registration: NCT02643797

Background Multimorbidity affects four of ten US adults and eight of ten adults ages 65 years and older, and frequently includes both cardiometabolic conditions and behavioral health concerns. Hispanics/Latinos (hereafter, Latinos) and other ethnic minorities are more vulnerable to these conditions, and face structural, social, and cultural barriers to obtaining quality physical and behavioral healthcare. We report the protocol for a randomized controlled trial that will compare Mi Puente (My Bridge), a cost-efficient care transitions intervention conducted by a specially trained Behavioral Health Nurse and Volunteer Community Mentor team, to usual care or best-practice discharge approaches, in reducing hospital utilization and improving patient reported outcomes in Latino adults with multiple cardiometabolic conditions and behavioral health concerns. The study will examine the degree to which Mi Puente produces superior reductions in hospital utilization at 30 and 180 days (primary aim) and better patient-reported outcomes (quality of life/physical health; barriers to healthcare; engagement with outpatient care; patient activation; resources for chronic disease management), and will examine the cost effectiveness of the Mi Puente intervention relative to usual care. Methods Participants are enrolled as inpatients at a South San Diego safety net hospital, using information from electronic medical records and in-person screenings. After providing written informed consent and completing self-report assessments, participants randomized to usual care receive best-practice discharge processes, which include educational materials, assistance with outpatient appointments, referrals to community-based providers, and other assistance (e.g., with billing, insurance) as required. Those randomized to Mi Puente receive usual-care materials and processes, along with inpatient visits and up to 4 weeks of follow-up phone calls from the intervention team to address their integrated physical-behavioral health needs and support the transition to outpatient care. Discussion The Mi Puente Behavioral Health Nurse and Volunteer Community Mentor team intervention is proposed as a cost-effective and culturally appropriate care transitions intervention for Latinos with multimorbidity and behavioral health concerns. If shown to be effective, close linkages with outpatient healthcare and community organizations will help maximize uptake, dissemination, and scaling of the Mi Puente intervention. Trial registration ClinicalTrials.gov: NCT02723019. Registered on 30 March 2016.

To address the burgeoning primary care demand-capacity imbalance, team-based models using medical assistants (MAs) to provide evidence-based, disease self-management support have been proposed. Randomized controlled trials (RCT) have shown MA health coaching improves clinical outcomes in chronic disease populations; however, pragmatic research is needed to evaluate effectiveness and feasibility in real-world health settings. Thus, we adopted a unique, cluster RCT to compare MA health coaching with usual care in N=600 adults with T2D, plus HbA1c ≥8.0% and/or SBP ≥140 mmHg, and/or LDL-C ≥100 mg/dL. Importantly, this in-progress trial examines implementation and outcomes across two very distinct settings: a federally qualified health center (Site A; majority Hispanic/Spanish-speaking, low SES patients; M age = 58.2) and a large, private insurance-based health system (Site B; majority non-Hispanic white/English-speaking, middle/upper SES; M age = 73.4). To facilitate integration with routine clinic processes, existing MAs are trained to perform at top of license, and EMR-based risk stratification identifies qualifying patients presenting to clinic each day. MA health coaches join primary care visits to understand the care plan and provide self-management support in conjunction with medical visits and by phone for 1 year. Dosage and intervention components (medication reconciliation, assessment, goal setting, lab review) are tailored to patient needs. A process evaluation revealed differences between Sites A and B in session frequency (M = 7 ± 3 vs. 4 ± 2), duration (M = 20 ± 15 vs. 14 ± 10 minutes), and focus (healthful eating vs. blood pressure monitoring) (all ps Disclosure T. Clark: None. L. Gallo: None. J.A. Euyoque: None. K.L. Savin: None. J.I. Bravin: None. H. Sandoval: None. D. Lara Ledesma: None. A. Philis-Tsimikas: Advisory Panel; Self; AstraZeneca, Lilly Diabetes, Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc. Research Support; Self; Dexcom, Inc., Glooko, Inc., National Institute of Diabetes and Digestive and Kidney Diseases. Stock/Shareholder; Spouse/Partner; Ionis Pharmaceuticals, Inc., Novo Nordisk Inc. A.L. Fortmann: None. Funding National Institutes of Health