Scripps Health

CONTINUOUS GLUCOSE MONITORING FOR HIGH-RISK TYPE 2 DIABETES IN THE HOSPITAL: CLOUD-BASED REAL-TIME GLUCOSE EVALUATION AND MANAGEMENT SYSTEM (CYBER GEMS) - 7. PROJECT SUMMARY/ABSTRACT THERE IS STRONG EVIDENCE THAT POOR GLYCEMIC CONTROL IN THE HOSPITAL IS COMMON. GIVEN THE KNOWN CONSEQUENCES OF UNCONTROLLED BLOOD SUGARS DURING A HOSPITALIZATION (E.G., INFECTION, SERIOUS NEUROLOGICAL AND CARDIAC COMPLICATIONS, MORTALITY, LONGER LENGTHS OF STAY, READMISSIONS, HIGHER HEALTHCARE COSTS), HEALTH SYSTEMS DEVOTE SIGNIFICANT RESOURCES TO DEVELOPING PROTOCOLS FOR IMPROVING GLUCOMETRICS. SURPRISINGLY, DESPITE THE WIDESPREAD USE AND DEMONSTRATED EFFECTIVENESS OF CONTINUOUS GLUCOSE MONITORING (CGM) FOR AMBULATORY GLUCOSE MANAGEMENT, CGMS ARE NOT CURRENTLY USED IN ANY US HOSPITAL. THEREFORE, THE LONG-TERM GOAL TO DEVELOP CLOUD-BASED REAL-TIME GLUCOSE EVALUATION AND MANAGEMENT SYSTEM (CYBER GEMS) IS TO PROVIDE AN EFFECTIVE, REAL-TIME SOLUTION TO AUGMENT EXISTING PROCESSES, TO PROVIDE A VALUABLE TEST OF REAL-WORLD EFFECTIVENESS, WHILE CAPITALIZING ON STANDARDIZED ALGORITHMS TO FACILITATE SUSTAINABILITY AND SCALABILITY TO OTHER SYSTEMS AND AT-RISK POPULATIONS. THE INNOVATIVE INTERVENTION WILL ENABLE HOSPITAL CARE TEAMS TO TAKE IMMEDIATE STEPS BASED ON THE WIRELESS TRANSMISSION OF GLUCOSE DATA FROM THE DEXCOM G6 DEVICE, SENT TO A DIGITAL DASHBOARD, WHERE INTEGRATION WITH EXISTING REAL-WORLD HOSPITAL PROCESSES CAN PROVIDE IMMEDIATE PRIORITIZATION TO PREVENT OR CORRECT IMPENDING HYPOGLYCEMIA AND SEVERE HYPERGLYCEMIC EVENTS. THE FIRST STEP TOWARD THIS LONG-TERM GOAL IS A RANDOMIZED CONTROLLED TRIAL, DEFINED AS A PHASE III/IV DEFINITIVE CLINICAL TRIAL THAT IN TURN ESTABLISHES EFFICACY AND EFFECTIVENESS OF THIS INTERVENTION. AIM 1 WILL ESTABLISH THE EFFECTIVENESS OF CYBER GEMS VERSUS USUAL CARE (UC) IN INCREASING THE % TIME PATIENTS ARE IN-RANGE AND DECREASING % TIME IN HYPOGLYCEMIA AND SEVERE HYPERGLYCEMIA DURING HOSPITALIZATION. SIMULTANEOUSLY, AIM 2 WILL EVALUATE THE EFFECTIVENESS OF CYBER GEMS VERSUS UC IN DECREASING HOSPITAL-ACQUIRED INFECTION RISK. THE DESCRIBED DIGITAL DASHBOARD IS PROGRESSIVE, AS IT FACILITATES REAL-TIME, WIRELESS TRANSMISSION OF GLUCOSE DATA OF A LARGE VOLUME OF PATIENTS SIMULTANEOUSLY; AUTOMATICALLY IDENTIFIES AND PRIORITIZES PATIENTS FOR INTERVENTION; AND DETECTS POTENTIALLY DANGEROUS HYPOGLYCEMIC EPISODES – ALL AT A REDUCED BURDEN THAN CURRENT METHODS OF STRATIFICATION AND REVIEW. THE UNINTERRUPTED COVERAGE BY TELEMETRY, COUPLED WITH EFFICIENT AND REMOTE DIABETES SPECIALIST OVERSIGHT IN CYBER GEMS IS A SCALABLE, NOVEL, TEAM-BASED APPROACH TO MAXIMIZE THE USE OF CONTINUOUSLY STREAMING CGM DATA FOR OPTIMAL GLUCOSE MANAGEMENT. THE WORK PROPOSED PUSHES THE LIMITS OF THESE CHALLENGES BY PROVIDING EVIDENCE, IDENTIFIED BY A TEAM-BASED APPROACH TO GLUCOSE MANAGEMENT IN AN UNDERSERVED AND UNDERSTUDIED POPULATION, SUPPLEMENTING PRIOR DATA DESIGNED TO IMPROVE OUTCOMES AMONG HIGH-RISK PATIENTS WITH T2D AND RELATED CARDIOMETABOLIC CONDITIONS.

ACT1VATE: ADDRESSING EMOTIONAL DISTRESS TO IMPROVE OUTCOMES AMONG DIVERSE ADULTS WITH TYPE 1 DIABETES

DULCE DIGITAL-ME: AN ADAPTIVE MHEALTH INTERVENTION FOR UNDERSERVED HISPANICS WITH DIABETES

PRIMARY CARE TRAINING AND ENHANCEMENT-COMMUNITY PREVENTION AND MATERNAL HEALTH

MI PUENTE: MY BRIDGE TO BETTER CARDIOMETABOLIC HEALTH AND WELL-BEING

MEDICAL ASSISTANT HEALTH COACHING FOR DIABETES IN DIVERSE PRIMARY CARE SETTINGS

SCRIPPS GENOME ADVISER: ANNOTATION AND DISTRIBUTED VARIANT INTERPRETATION SERVER

SCRIPPS TRANSLATIONAL SCIENCE INSTITUTE, VISMOBILE, RYTHM DIAGNOSITC SYSTEMS, AND PHYSIQ: SENSOR TEC

ENHANCING DULCE DIGITAL WITH CGM-DRIVEN PERSONALIZATION, PEER SUPPORT, GAMIFICATION, AND ENGAGEMENT (EDGE) TO IMPROVE T2D SELF-MANAGEMENT - PROJECT SUMMARY/ABSTRACT DIABETES AFFECTS 12% OF THE U.S. POPULATION, WITH OVER HALF OF INDIVIDUALS FAILING TO MEET HBA1C TARGETS, CONTRIBUTING TO SIGNIFICANT MORBIDITY AND MORTALITY. DESPITE ADVANCES IN DIGITAL HEALTH AND SELF-MANAGEMENT TOOLS, THERE REMAINS A CRITICAL GAP IN INTEGRATING PERSONALIZED, REAL-TIME GLUCOSE FEEDBACK AND TAILORED MESSAGING TO SUSTAIN ENGAGEMENT AND IMPROVE GLYCEMIC TARGETS, PARTICULARLY IN NON-INSULIN-USING ADULTS WITH TYPE 2 DIABETES (T2D). THE LONG-TERM GOAL OF THIS RESEARCH IS TO DEVELOP A SCALABLE, PATIENT-CENTERED DIGITAL INTERVENTION THAT COMBINES REAL-TIME GLUCOSE MONITORING, DIGITALLY DELIVERED EDUCATION, AND VIRTUAL COACHING TO TRANSFORM DIABETES SELF-MANAGEMENT AND IMPROVE HEALTH OUTCOMES. THIS STUDY EVALUATES THE ENHANCING DULCE DIGITAL WITH CGM-DRIVEN PERSONALIZATION, PEER SUPPORT, GAMIFICATION, AND ENGAGEMENT (EDGE) INTERVENTION, WHICH INTEGRATES CONTINUOUS GLUCOSE MONITORING (CGM)-DRIVEN PERSONALIZED MESSAGING, VIRTUAL PEER HEALTH COACHING, AND GAMIFICATION TO ADDRESS THE GAP IN SUSTAINED ENGAGEMENT AND REAL-TIME GLYCEMIC FEEDBACK. THIS RESEARCH SERVES AS THE FIRST STEP TOWARD ACHIEVING THE LONG-TERM GOAL BY RIGOROUSLY TESTING EDGE’S EFFECTIVENESS IN IMPROVING CLINICAL AND BEHAVIORAL OUTCOMES AND UNDERSTANDING ITS IMPLEMENTATION POTENTIAL IN PRIMARY CARE SETTINGS. IN AIM 1A, WE WILL ASSESS THE EFFECTIVENESS OF EDGE COMPARED TO DULCE DIGITAL IN IMPROVING CLINICAL OUTCOMES, INCLUDING HBA1C, CGM METRICS, AND MEDICATION DOSAGE, THROUGH A RANDOMIZED CONTROLLED TRIAL OF 262 NON-INSULIN-USING ADULTS WITH T2D, WITH DATA COLLECTED AT BASELINE, 6 MONTHS, AND 12 MONTHS. IN AIM 1B, WE WILL EVALUATE PATIENT-REPORTED OUTCOMES, SUCH AS DIABETES DISTRESS, SELF-CARE BEHAVIORS, AND QUALITY OF LIFE, USING VALIDATED SURVEYS TO MEASURE CHANGES AT THE SAME TIME POINTS. IN AIM 2 WE WILL ASSESS THE IMPLEMENTATION AND SUSTAINABILITY OF EDGE USING THE RE-AIM FRAMEWORK, WHILE LEVERAGING MULTIMODAL DATA (CGM, EMA, WEARABLES, EHRS) ANALYZED WITH MACHINE LEARNING METHODS TO IDENTIFY BEHAVIORAL PATTERNS AND PREDICTORS OF GLYCEMIC IMPROVEMENT. TOGETHER, THESE AIMS WILL PROVIDE STRONG EVIDENCE THAT PERSONALIZED, DATA-DRIVEN INTERVENTIONS CAN IMPROVE CLINICAL OUTCOMES, PATIENT ENGAGEMENT, AND SCALABILITY OF DIABETES SELF-MANAGEMENT PROGRAMS. THE FINDINGS ARE EXPECTED TO IMPROVE DIABETES CARE AND HEALTH SYSTEM PERFORMANCE ON HEDIS METRICS, AND DELIVER INNOVATIVE, SCALABLE SOLUTIONS FOR PRIMARY CARE SETTINGS. IN ADDITION TO IMPROVING GLYCEMIC TARGETS, EDGE’S INTEGRATION OF PEER COACHING, GAMIFICATION, AND AI-DRIVEN ANALYTICS OFFERS UNIQUE ADVANTAGES IN ADDRESSING BARRIERS TO PATIENT ENGAGEMENT AND PERSONALIZATION IN DIABETES CARE. BY DEMONSTRATING THE EFFECTIVENESS OF EDGE, THIS RESEARCH WILL ADVANCE THE FIELD OF DIGITAL HEALTH BY LAYING THE FOUNDATION FOR FUTURE LARGE-SCALE, DATA-DRIVEN INTERVENTIONS THAT OPTIMIZE DIABETES OUTCOMES AND CARE DELIVERY. THIS STUDY PUSHES THE BOUNDARIES OF DIABETES MANAGEMENT BY COMBINING PROVEN DIGITAL EDUCATION WITH ADVANCED TECHNOLOGIES AND MULTIMODAL MACHINE LEARNING DATA ANALYTICS, OFFERING NEW ALTERNATIVES TO TRADITIONAL APPROACHES AND TRANSFORMING THE WAY SELF-MANAGEMENT IS DELIVERED IN INDIVIDUALS WITH T2D.

DEVELOPMENT OF SMART IMPLANTS FOR SHOULDER ARTHROPLASTY - PROJECT SUMMARY IN THE UNITED STATES, IT IS ESTIMATED THAT MORE THAN 800,000 INDIVIDUALS WERE LIVING WITH TOTAL SHOULDER ARTHROPLASTY (TSA) IN 2017. THE NUMBER OF SHOULDER ARTHROPLASTY PROCEDURES HAVE CONTINUED TO INCREASE IN RECENT YEARS WITH PROJECTIONS AS HIGH AS 235% (350,000+ PROCEDURES) BY 2025. WITH THE INCREASE IN THE AGING POPULATION AND THE DEMAND FOR BETTER MOBILITY AND QUALITY OF LIFE, SHOULDER ARTHROPLASTY IS ALSO COMMONLY USED FOR THE MANAGEMENT OF CUFF TEAR ARTHROPATHY AND FOR PROXIMAL HUMERUS FRACTURES OFFERING A TREATMENT OPTION TO IMPROVE RANGE OF MOTION, STRENGTH, AND PAIN RELIEF. HOWEVER, BIOMECHANICAL PROBLEMS ARE OFTEN ASSOCIATED WITH TSA, AND INSTABILITY AND LOOSENING ARE COMMON CAUSES FOR REVISION SURGERY. UNDERSTANDING AND PREVENTING INSTABILITY AND LOOSENING REQUIRES MORE INFORMATION ABOUT THE POST-OPERATIVE LOADING CONDITIONS DURING DAILY LIFE THROUGHOUT THE LIFE OF THE PROSTHESIS. THUS, THERE IS A NEED FOR LOAD SENSING COMPONENTS THAT CAN BE ROUTINELY IMPLANTED DURING TSA AND REMAIN WITHIN THE JOINT FOR THE LIFE OF THE IMPLANT. TO ADDRESS THIS GAP, SCRIPPS HEALTH PROPOSES TO DEVELOP SMART IMPLANTS CAPABLE OF CONTINUOUSLY MONITORING PROSTHESIS LOADING CONDITIONS IN REAL-TIME THROUGHOUT THE IMPLANT'S LIFESPAN, AIMING TO REVOLUTIONIZE THE FIELD OF BIOMEDICAL IMPLANTS BY PROVIDING VALUABLE FEEDBACK TO PATIENTS AND HEALTHCARE PROVIDERS. WE WILL DESIGN, MANUFACTURE, AND TEST SMART, SELF-POWERED IMPLANT PROTOTYPES FOR TOTAL SHOULDER REPLACEMENT. TO THE BEST OF OUR KNOWLEDGE, WE WILL BE DEVELOPING A PROSTHESIS THAT CAN MEASURE IN VIVO SHOULDER BIOMECHANICS (FORCES AND KINEMATICS), PROVIDE BIOFEEDBACK TO THE PATIENT IN REAL-TIME, AND SEND DATA TO THE HEALTHCARE PROVIDER. OUR IMPLANTS WILL ENABLE SENSORS TO CONTINUOUSLY SAMPLE LOADING DATA IN A SELF- POWERED OPERATION MODE, AND PROVIDE ALERTS WHEN ABNORMALITIES ARE DETECTED. THIS R21 WILL FOCUS ON THE FOLLOWING SPECIFIC AIMS FOR PROOF OF CONCEPT. AIM 1: DEVELOPMENT AND TESTING OF SMART HUMERAL STEM PROTOTYPES FOR PARTIAL, ANATOMIC, OR REVERSE SHOULDER ARTHROPLASTY. AIM 2: DEVELOPMENT AND TESTING OF SMART GLENOSPHERE IMPLANT PROTOTYPES FOR REVERSE SHOULDER ARTHROPLASTY. BY LEVERAGING PREVIOUS SUCCESSES IN KNEE JOINT TECHNOLOGY, THE PROJECT AIMS TO CREATE SELF-POWERED SMART IMPLANTS FOR BOTH HUMERAL STEM AND GLENOSPHERE COMPONENTS, OFFERING VERSATILE MONITORING SOLUTIONS FOR VARIOUS SHOULDER REPLACEMENT PROCEDURES AND POTENTIALLY REDUCING THE NEED FOR REVISION SURGERIES. OUR TECHNOLOGY CAN REVOLUTIONIZE THE BIOMEDICAL IMPLANT FIELD AS AN AFFORDABLE, LOW- COST METHOD FOR PATIENT SELF-CARE THAT CAN BE USED WORLDWIDE.

REAL-TIME MONITORING OF KNEE FORCES AND KINEMATICS IN VIVO

RESPONSE TO TESTING AMONG INDIVIDUAL CONSUMERS OF DTC PERSONAL GENOMICS SERVICES

INTEGRATING CONTINUOUS GLUCOSE MONITORING IN DIABETES SELF‐MANAGEMENT EDUCATION AND SUPPORT TOIMPROVE GLYCEMIC CONTROL IN LATINO ADULTS WITH TYPE 2 DIABETES -   PROJECT SUMMARY/ABSTRACT: DR. SAN DIEGO IS A SOCIAL AND BEHAVIORAL SCIENTIST WITH A STRONG FOUNDATION IN USING COMMUNITY-BASED PARTICIPATORY RESEARCH (CBPR) AND CLINICAL AND TRANSLATIONAL SCIENCES. AS AN EARLY-STAGE INVESTIGATOR, HER RESEARCH IS FOCUSED ON USING A SOCIOECOLOGICAL PERSPECTIVE TO ADAPT TYPE 2 DIABETES (T2D) SELF-MANAGEMENT PROGRAMS TO ADDRESS INDIVIDUAL, SOCIAL, AND ENVIRONMENTAL FACTORS THAT INFLUENCE HEALTH OUTCOMES. AS SUCH SHE IS PURSUING A RESEARCH CAREER COMBINING CBPR AND IMPLEMENTATION SCIENCE TO IMPROVE DIGITAL HEALTH OUTCOMES IN POPULATIONS EXPERIENCING HIGH PREVALENCE OF T2D COMPLICATIONS AND MAY BENEFIT FROM NEWER TREATMENT APPROACHES. THE PROPOSED RESEARCH AIMS TO: 1) UNDERSTAND BARRIERS AND FACILITATORS TO CGM DEVICE UPTAKE AND MAINTAINED USE BY CONDUCTING A NEEDS ASSESSMENT WITH PATIENTS, DIABETES EDUCATORS, CLINICIANS, AND HEALTH PLAN ADMINISTRATORS; 2) INTEGRATE EDUCATION OF CGM DEVICE IN THE PROJECT DULCE DIABETES EDUCATION CURRICULUM (CGM + PD) AND DEVELOP IMPLEMENTATION STRATEGIES USING IMPLEMENTATION MAPPING; AND 3) PILOT TEST CGM + PD IN IMPROVING CGM METRICS IN INSULIN-TREATED ADULTS (N=72) WITH T2D ACROSS 6 MONTHS. THE K01 CAREER DEVELOPMENT PLAN SUPPORTS THE RESEARCH AIMS AND DR. SAN DIEGO’S TRANSITION TO INDEPENDENCE WITH TRAINING IN 1) BUILDING SUSTAINABLE NETWORK AND COMMUNITY PARTNERSHIPS; 2) IMPLEMENTATION SCIENCE; 3) CGM IMPLEMENTATION AND DATA EVALUATION; 4) RIGOROUS QUALITATIVE AND ADVANCED QUANTITATIVE STATISTICAL METHODOLOGIES; 5) LEADERSHIP SKILLS TO EXECUTE MULTI-CENTER STUDIES; AND 6) GRANT WRITING FOR A LARGE, MULTI-SITE STUDY. SHE WILL BE SUPPORTED BY A STRONG MENTORING TEAM, INCLUDING DR. ATHENA PHILIS-TSIMIKAS (PRIMARY MENTOR), AN EXPERT IN TEAM-BASED DIABETES CARE, COMMUNITY-ENGAGED RESEARCH, AND INTEGRATING DIABETES TECHNOLOGIES INTO REAL-WORLD HEALTHCARE SETTINGS; DR. AMISHA WALLIA, A PHYSICIAN SCIENTIST WITH EXPERTISE IN HEALTH RESEARCH, DIABETES TECHNOLOGIES, AND MULTI-SITE TRIALS; DR. MICHAEL I. GORAN, AN EXPERT IN CLINICAL, BEHAVIORAL, AND COMMUNITY APPROACHES TO T2D TREATMENT AND RISK REDUCTION; DR. BETH PYATAK, AN OCCUPATIONAL SCIENTIST WITH EXPERTISE IN QUALITATIVE METHODS AND IMPLEMENTATION SCIENCE RESEARCH; DR. JILL WAALEN, A BIOSTATISTICIAN WITH EXPERTISE IN CGM DATA ANALYSIS; AND DR. BARBARA J. TURNER, AN EXPERT IN DISSEMINATION AND IMPLEMENTATION SCIENCE AND COMMUNITY-ENGAGED RESEARCH. DR. SAN DIEGO’S OVERARCHING GOAL IS TO IMPROVE THE QUALITY AND QUANTITY OF LIFE OF POPULATIONS BURDENED BY T2D. SCRIPPS HEALTH IS AN IDEAL ENVIRONMENT FOR HER TO ACCOMPLISH HER TRAINING AND CAREER GOALS GIVEN ITS CLINICAL SETTINGS THAT OFFER HEALTH CARE AND ACCESS TO VARIOUS POPULATIONS IN SAN DIEGO, CA, AND IS COMMITTED TO PROVIDING HER WITH PROTECTED TIME AND RESOURCES NEEDED TO SUCCESSFULLY COMPLETE HER STUDY. IMPORTANTLY, THIS AWARD WILL PROVIDE HER WITH PROTECTED TRAINING TIME TO BUILD ON HER EXISTING SKILLS IN CBPR AND ADVANCE HER KNOWLEDGE IN IMPLEMENTATION SCIENCE AND DIABETES TECHNOLOGIES SO THAT SHE CAN CONDUCT STUDIES THAT PROMOTE THE ADOPTION AND INTEGRATION OF DIGITAL HEALTH DEVICES IN REAL-WORLD SETTINGS.