Baseline A1C Research Articles

Role of the liver in the sustained normalisation of A1c over 2 years following short-term insulin therapy in early type 2 diabetes.

When administered in early type 2 diabetes (T2DM), the strategy of 'induction' with short-term intensive insulin therapy (IIT) followed by 'maintenance' with metformin thereafter can yield outstanding glycaemic control, with some patients achieving A1c in the normal range of its assay. We thus sought to identify determinants of sustained normalisation of A1c in response to this treatment strategy. In this study, adults with T2DM of mean duration 1.7 ± 1.4 years received induction IIT (glargine, lispro) for 3 weeks, followed by metformin maintenance either with or without periodic 2-week courses of IIT every 3 months for 2 years. Sustained glycaemic normalisation was defined by A1c <6.0% at 2 years. Of 101 participants, 26 achieved A1c <6.0% at 2 years. At baseline, these individuals had lower A1c and fasting glucose than the other participants, along with better beta-cell function. During maintenance therapy from 3 weeks to 2 years, they had greater reduction of adiposity (body mass index: p = 0.02; waist circumference: p = 0.02), hepatic insulin resistance (HOMA-IR: p = 0.02) and ALT (p = 0.005), coupled with relative stabilisation of beta-cell function and glycaemia. On logistic regression analyses, significant independent predictors of normalisation of A1c at 2 years were baseline A1c (adjusted odds ratio [aOR] = 0.01 [95% CI 0.001-0.16], p = 0.001) and the changes in waist circumference (aOR = 0.77 [0.63-0.94], p = 0.012) and ALT (aOR = 0.90 [0.82-0.98], p = 0.019) during maintenance therapy from 3 weeks to 2 years. While lower baseline A1c and greater reduction in central adiposity predicted A1c <6.0% at 2 years as anticipated, the emergence of greater reduction in ALT as a concomitant determinant highlights the role of the liver in the achievement of sustained glycaemic normalisation.

Nurse-Led Mobile Phone Intervention to Promote Self-Management in Type 2 Diabetes in Ghana: A Randomized Controlled Trial.

The purpose of the study was to test the effectiveness of a nurse-led mobile phone intervention (NMPI) on glycemic variability and self-management among people living with type 2 diabetes (T2DM) in Ghana. In this randomized controlled trial, the intervention group received a 3-month NMPI program plus standard care, and the control group received standard care alone in a tertiary health care setting. Ninety-eight participants (baseline A1C > 7%) were randomized 1:1 to either NMPI or standard care group. The primary study outcomes were changes in A1C testing and self-management assessed using the Summary of Diabetes Self-Care Activities tool at baseline and end of the study. The intervention group had statistically significant improvement in their mean A1C level from baseline to the end of the study. In comparison, the control group also had improvement in their mean A1C level but was not statistically significant. Consistently, the intervention participants had better statistically significant improvements in self-management behaviors than the control group. There was a medium, negative correlation between A1C changes and overall self-care changes for the intervention group, whereas that of the control group was smaller. Study findings have shown that a tailored NMPI program in addition to standard care could improve glycemic variability and self-management among people living with poorly managed T2DM in Ghana better than standard care alone.

Factors associated with attendance at a pharmacist-led group diabetes self-management education class and impact on health outcomes

BackgroundGroup education has demonstrated benefits among people with diabetes, including reduced A1C and improved self-monitoring practices. Despite this, attendance rates are low for a variety of reasons, including lack of understanding of potential benefits among patients. ObjectivesThe pharmacist-led diabetes self-management education program at a community hospital has low attendance. This project assesses characteristics associated with attendance and compares outcomes among attendees and non-attendees. MethodsRetrospective data was collected between July 2022 and December 2023. Variables included: age, sex, class attendance, pre- and ≥ 90-day post-class A1C, pre- and post-class BMI, attending pharmacist-led clinic prior to scheduled class, social determinants of health screening survey responses, and diagnosis of depression or anxiety. Results103 patients were identified. 53 % attended at least one class out of a series of four. Attendance at the pharmacist-led diabetes clinic (70 % among attendees versus 30 % among non-attendees, p < 0.001) was associated with attendance. Age, gender, concurrent mental health diagnoses (depression and anxiety), and SDOH related needs were not associated with attendance. Baseline A1C was similar for attendees and non-attendees (9.6 vs. 9.7 %, respectively). Post-class A1C was 7.4 % for attendees of at least one class and 8 % for non-attendees. Patients who attended all four classes achieved a mean A1C <7 %. DiscussionThere are many factors that lead to lack of engagement with group education for diabetes. Referral to group education by a pharmacist who has established rapport with the patient and can speak to specific details about benefits of the classes may improve attendance at diabetes group education.

12314 Effectiveness Of Continuous Glucose Monitors In Patients With Type 2 Diabetes On Washington Medicaid Or Financial Assistance

Abstract Disclosure: A. Deng: None. A. Thirumalai: None. J. Lin: None. M. Weber: None. S. Zuo: None. Continuous glucose monitors (CGMs) have become more accessible for patients with type 2 diabetes mellitus (T2DM) on one insulin injection per day who have either commercial or Medicare plans. However, there are still strict requirements for patients with Washington State Medicaid, creating disparities in diabetes care for vulnerable populations. The aim of this study is to assess the effectiveness and adherence of CGMs in patients with T2DM on Washington State Medicaid plans or institutional financial assistance who are prescribed at least one insulin injection daily, similar to Medicare requirements. This ongoing prospective cohort study enrolled 40 adult patients with T2DM, baseline A1C greater than 7%, and prescribed at least one insulin injection per day from three Harborview Medical Center clinics. Through grant funding, patients were provided with Freestyle Libre 2 CGMs for 6 months. Since this is an ongoing study, we present preliminary results of patients who completed 3 months of CGM use. Effectiveness was measured by the change in A1C from baseline to 3 months after initiation of the CGM (primary outcome) and change in CGM glycemic metrics on ambulatory glucose profile (AGP) from baseline to 3 months after initiation of CGM (secondary outcomes). Assessment of adherence to the CGMs involved tracking the percentage of CGM data captured from the AGP reports recorded at each visit and monitoring dispense history. Twenty patients reached the 3-month follow-up with a median age of 59 years; 60% female, 70% non-English speaking; 45% with Medicaid, and 55% with Harborview Financial Assistance as insurance coverage. Median baseline A1C was 9.2%, duration of diabetes was 10 years, number of diabetes medications was 3, daily insulin injections of 2, and number of blood glucose checks per day was 1. At first CGM download (2 weeks), the median time in range (TIR, glucose 70-180 mg/dL) was 53.5%, coefficient of variation was 35.3% and percent of data captured was 80%. At 3-month follow-up, the median reduction in A1c was –1.2% (IQR -1.8, -0.5). On CGM, the median TIR had increased to 60.5%, coefficient of variation had improved to 31.5% and percent of data captured was 79%. In this ongoing study, preliminary findings show encouraging early evidence of improved glycemic control after CGMs were initiated and patients sustained greater than 70% CGM data captured at 3 months. These results should be interpreted with caution given the small number of participants with results at 3 months. Nonetheless, once the study is complete, the outcomes may be used to inform eligibility requirements for continuous glucose monitors in patients with Washington Medicaid or Harborview Financial Assistance. Presentation: 6/3/2024

12420 Effects Of A Continuous Glucose Monitoring (CGM) Optimization Program On Prescribing Behavior And Glycemic Outcomes

Abstract Disclosure: A. Sterbenz: None. J. Fuentes Rosales: None. S. Abraham: None. P. Siroya: None. R. Middelbeek: None. J. Mitri: None. F. Rossitto: None. E. Cabana: None. A. Gharse: None. L. Collins: None. L. Aliaga: None. A. Millan Ferro: None. J. Cifuni: None. A. Schwartz: None. E. Kelley: None. C. Gomez: None. M. Aballay: None. Introduction: Continuous glucose monitoring (CGM) improves glucose control in patients with diabetes, as demonstrated in clinical trials. There is limited information available on the real-world application of CGM adoption in a resource-limited setting or safety net outpatient hospital setting. This intervention's aim was to assess the impact of a multifaceted approach on improving CGM utilization and on glycemic control among patients with diabetes. Methods: Wyckoff Heights Medical Center, located in Brooklyn, NY is a resource-limited setting that in partnership with the Joslin Diabetes Center, Boston, MA launched a CGM Clinical Care Optimization Program. This quality improvement (QI) initiative included establishing a diabetes technology team (DTT) which met weekly (n=24 sessions) to establish a highly specialized interprofessional group. The DTT activities included: 1) Establishing a CGM workflow; 2) Expanding Medical Assistant responsibilities related to diabetes technology and training; 3) Creating five bilingual (English-Spanish) patient handouts; 4) Building CGM vendor relationships; 5) Developing a CGM manual for data download, billing and coding, and education to increase CGM knowledge across the system. Data were collected prior to CGM initiation and at most recent visit. Results: The intervention occurred between February and November 2023. Prior to this intervention, 49 patients had a CGM prescription. After 9 months, CGM prescriptions were written for 333 patients (680% increase) with the following baseline characteristics (mean ± SD): age (61.2 ± 14.7 yrs.); 56% female; 44% male; 71% Latino; Race: 67% Other (63% Hispanic or Latino), 25% Black or African American, 4% White, Asian 2%, American Indian or Alaska Native 2%; 38% Spanish-speaking, 59% English-Speaking, 3% Other; 81% government insurance (63% Medicaid, 18% Medicare), 19% commercial insurance. The majority of patients had been diagnosed with type 2 diabetes (91%) and 9% had type 1 diabetes. Baseline HbA1C was 9.7 ± 1.5%. Of note, prior to CGM, 34% of patients had A1C&amp;gt;9%. The impact of CGM use was evaluated on 116 patients that met the following criteria: baseline A1C value within 60 days before or up-to 30 days after prescription, and a A1C &amp;gt;90 days after. After an average duration of 154 days of CGM use, HbA1c decreased significantly by -0.51% (p=0.001), demonstrating improved glycemic control post-CGM use. In those with A1c &amp;gt;9%, HbA1c decreased from 10.5% to 8.8% (p&amp;lt;0.01). Conclusion: Creating a CGM optimization program in a resource-limited setting is critical in improving patient self-awareness and provider insight in glycemic control in patients diagnosed with type 1 and type 2 diabetes. These data demonstrate the feasibility of implementing a CGM optimization program in a resource-limited setting, which is critically important in improving clinical care for people with diabetes. Presentation: 6/2/2024

6488 Factors associated with the response to SGLT2 inhibitors and GLP-1 Receptor Agonists in Veterans with Type 2 Diabetes

Abstract Disclosure: S. Hashmi: None. K. Samson: None. G. Arora: None. S. Azad: None. D. Awad: None. C.V. Desouza: None. Background: SGLT2 inhibitors and GLP1 agonists are recommended as first line pharmacological therapy (along with metformin) for type 2 DM, particularly in patients with CKD, CVD, or HF. Despite their effectiveness, there is limited evidence available to predict which patient subsets will respond favorably to SGLT2 inhibitors or GLP1 agonist. Purpose of study: To determine if baseline characteristics can predict response to therapy and to compare the differences in characteristics between SGLT2 inhibitor and GLP1 agonist groups. Methodology: Retrospective study of veterans ages 19-89 yr with T2DM initiated on treatment from Jan 1, 2015, to Dec 31, 2022, with either SGLT2 inhibitor or GLP 1 agonist for at least 6 months. The cohort comprised 866 patients, of which 544 individuals met the inclusion criteria (332 in the GLP-1 agonist group and 212 in the SGLT2 inhibitor group). Baseline characteristics assessed included age, sex, race, comorbidities, weight, BMI, HbA1c, eGFR, BP and lipids. Treatment response thresholds were defined as an HbA1c reduction of more than 0.5 percentage points and more than 3% of pretreatment weight loss, evaluated 6-12 months after initiating treatment. A complete response was defined as both treatment thresholds being met. Statistical analysis involved Chi-Square tests and independent samples t-test between variables of interest. Logistic regression was conducted with the dichotomous complete response outcome, for variables with bivariate p-values less than 0.10, in addition to variables preselected for inclusion based on the clinical relevance. Results: Three variables were statistically significant in the final logistic regression with complete response outcome. Patients on GLP1 had an increased adjusted odds of having a complete outcome (AOR: 2.45 (95% CI: 1.45, 4.15) relative to patients on SGLT2. In addition, older patients (AOR: 1.34 (95% CI: 1.02, 1.74)) and patients with a higher baseline HbA1c (AOR: 1.18 (95% CI: 1.02, 1.36)) had increased adjusted odds of having a complete response relative to patients 10 years younger and patients with an A1c 1 unit lower, respectively. 72.6% of patients on GLP1 agonists achieved the A1c response goal, in contrast to 48.6% on SGLT2 inhibitors (p &amp;lt; 0.001). Also, 47.6 % of individuals achieved weight loss goals on GLP1 agonist as compared to 41 % on SGLT2 inhibitor. A greater proportion of females (66.7%) achieved the A1c reduction goal compared to males (45.9%) on SGLT2 inhibitors (p = 0.04). Conclusion: Individuals receiving GLP-1 agonists had a twofold increased odds of achieving A1c reduction and weight loss goals after a 6-12 month treatment period compared to those prescribed SGLT2 inhibitors. Older patients and patients with higher baseline A1c levels had greater odds of reaching A1c and weight loss threshold whereas other baseline variables were not significantly associated with the outcome. Presentation: 6/3/2024

Effect of Pharmacist-Led Interventions on Diabetes Distress Among People With Type 2 Diabetes.

The purpose of this study was to determine the effectiveness of pharmacist-led interventions on diabetes distress and glucose management among people with type 2 diabetes (T2DM) in a community care clinic. Adults with T2DM were recruited during routine visits at the pharmacist-run clinic. Participants completed a baseline A1C, demographic survey, Diabetes Distress Scale (DDS), and Patient Health Questionnaire-2 (PHQ-2). Depending on DDS subscale-specific responses, participants qualified for pharmacist-led educational interventions based on the ADCES7 Self-Care Behaviors™. After 6 months, participants completed another A1C, satisfaction survey, DDS, and PHQ-2. Data analysis included descriptive statistics and paired t tests. Among 53 participants at baseline, diabetes distress was present in 77.4%; emotional burden was most common in 64.2%, followed by regimen distress in 45.3%, interpersonal distress in 34.0%, and physician distress in 20.8%. After the intervention, significant reductions occurred in mean overall DDS score (2.0 to 1.7), emotional burden (2.4 to 1.8), regimen distress (2.3 to 1.7), A1C (7.0% to 6.5%; 53.0 to 47.5 mmol/mol), and PHQ-2 score (1.6 to 1.0). Participants were highly satisfied with the service, their knowledge, and self-management skills following completion of the study. Diabetes distress was present in most participants despite glucose management that was largely achieving treatment goals. Pharmacist-led educational interventions significantly reduced overall DDS score, emotional burden, regimen distress, A1C, and PHQ-2 score. The results of this study suggest that people with T2DM should receive routine screening for diabetes distress and that pharmacists can positively affect diabetes management and emotional well-being through tailored education.

Association of Changes in A1C Following Continuous Glucose Monitoring Acquisition in People with Sub-Optimally Treated Type 2 Diabetes Taking GLP-1 RA Therapy.

Both glucagon-like peptide-1 receptor agonists (GLP-1 RA) and continuous glucose monitoring (CGM) improve glycemia in patients with type 2 diabetes (T2D). However, it is unknown whether adding CGM to GLP-1 RA therapy further improves A1c. We evaluated changes in A1c levels 6months after initiation of FreeStyle Libre (FSL) in adults with sub-optimally controlled T2D already on GLP-1 RA therapy. This retrospective, observational study used Optum's de-identified Market Clarity Data, a linked electronic health record-claims database to assess changes in A1c after FSL acquisition. Inclusion criteria were T2D diagnosis, ≥ 18years, baseline A1c ≥ 8%, with the first FSL acquisition between 2018 and 2022. Patients were required to be on GLP-1 RA prior to FSL with at least one GLP-1 RA prescription within 90days of FSL acquisition. GLP-1 RA initiation was defined as the earliest GLP-1 RA prescription from 2017 onwards. Paired changes in A1c were assessed at 6months after initial FSL acquisition. The study cohort included 1454 adults with T2D (age 55 ± 10years, 52% male, 38% with intensive insulin therapy, median 471days from GLP-1 RA initiation to FSL, and baseline A1c 9.8 ± 1.5%). After FSL acquisition, patients experienced an A1c decrease of 1.5 ± 1.9% (p < 0.001). Patients with a baseline A1c > 10% had the largest reduction (n = 497, - 2.7 ± 2.2%, p < 0.001). Significant improvements were observed in subgroups based on insulin therapy and GLP-1 RA formulation. Those initiating GLP-1 RA therapy > 24months before FSL acquisition also showed improvements in A1c (n = 478; - 1.3 ± 1.7%, p < 0.001). In a large, real-world study of adults with T2D, those on prior GLP-1 RA therapy experienced significant A1c improvements after acquiring FSL, irrespective of GLP-1 RA duration, GLP-1 RA formulation, or insulin therapy type. These findings support the use of FSL in adults with T2D treated with GLP-1 RA.

Clinical Outcomes of Rural Patients with Diabetes Treated by ECHO-Trained Providers Versus an Academic Medical Center

BackgroundDespite clinical practice guidelines prioritizing cardiorenal risk reduction, national trends in diabetes outcomes, particularly in rural communities, do not mirror the benefits seen in clinical trials with emerging therapeutics and technologies.ObjectiveProject ECHO supports implementation of guidelines in under-resourced areas through virtual communities of practice, sharing of best practices, and case-based learning. We hypothesized that diabetes outcomes of patients treated by ECHO-trained primary care providers (PCPs) would be similar to those of patients treated by specialists at an academic medical center.DesignSpecialists from the University of New Mexico (UNM) launched a weekly diabetes ECHO program to mentor dyads consisting of a PCP and community health worker at ten rural clinics.ParticipantsWe compared cardiorenal risk factor changes in patients with diabetes treated by ECHO-trained dyads to patients treated by specialists at the UNM Diabetes Comprehensive Care Center (DCCC). Eligible participants included adults with type 1 diabetes, type 2 diabetes on insulin, or diabetes of either type with A1c > 9%.Main MeasuresThe primary outcome was change from baseline in A1c in the ECHO and DCCC cohorts. Secondary outcomes included changes in body mass index (BMI), blood pressure, cholesterol, and urine albumin to creatinine ratio (UACR).Key ResultsCompared to the DCCC cohort (n = 151), patients in the ECHO cohort (n = 856) experienced greater A1c reduction (−1.2% vs −0.6%; p = 0.02 for difference in difference). BMI decreased in the Endo ECHO cohort and increased in the DCCC cohort (−0.2 vs. +1.3 kg/m2; p = 0.003 for difference in difference). Diastolic blood pressure declined in the Endo ECHO cohort only. Improvements of similar magnitude were observed in low-density lipoprotein cholesterol in both groups. UACR remained stable in both groups.ConclusionsECHO may be a suitable intervention for improving diabetes outcomes in rural, under-resourced communities with limited access to a specialist.

Changes in Basal and Bolus Insulin Requirements with Tirzepatide as an Adjunctive Therapy in Adults with Type 1 Diabetes Using Tandem Control-IQ.

This study was aimed at investigating changes in insulin requirements and glycemic outcomes in adults with type 1 diabetes (T1D) using Control IQ (Tandem Diabetes) automated insulin delivery system (AID) over 8months of tirzepatide treatment. In this single-center, observational study, we collected demographic, A1c, weight, sensor glucose, and insulin dose data for adults with T1D who were using AID and initiated tirzepatide adjunct therapy for clinical indications (n = 11, median age 37, 64% female and mean body mass index of 39.6kg/m2). Data were compared from baseline and over 8months. Within 2months of tirzepatide treatment, there were significant reductions in total daily insulin [median (IQR) 73.9 (47.6-95.8) to 51.7 (46.7-66.8) units/day, p < 0.001], basal insulin [47 (28.2-51.8) to 32.4 (25.5-46.3) units/day, p < 0.001], and bolus insulin [31.4 (19.9-38.3) to 17.9 (14.9-22.2) units/day, p < 0.001] requirements. Insulin dose reduction from 2 to 8months was modest. The frequency of user-initiated boluses did not differ throughout the study. Despite reductions in total insulin requirement, time in range (70-180mg/dl) increased by 7%, A1c reduced by 0.5%, weight reduced by 9%, without increase in time below 70mg/dl. This pilot study provides clinical guidance on insulin titration for adults with T1D who may initiate tirzepatide therapy. Based on the findings of this study, we recommend reducing 25% of total daily insulin dose at tirzepatide initiation in adults with T1D using AID with baseline A1c of less than 7.5%. Higher doses of tirzepatide were associated with greater weight loss, however, the reduction in insulin requirement was minimal.

Continuous glucose monitoring and rates of hyperglycemia during chemotherapy for early-stage breast cancer.

e24134 Background: Diabetes (DM) and hyperglycemia (HG) during chemotherapy increase the risk of treatment-related toxicities. The prevalence of HG and daily patterns of HG over the course of chemotherapy in patients with early-stage breast cancer (ESBC) are currently unknown. Methods: We conducted a prospective single-arm pilot study of continuous glucose monitoring in patients with ESBC receiving chemotherapy from 12/2020 – 2/2022. Eligibility criteria included: diagnosis of Stage I-III BC, age ≥18, and planned chemotherapy with concurrent corticosteroid supportive care use. Patients were excluded if they were receiving other systemic corticosteroids or insulin. Patients wore FreeStyle Libre Pro continuous glucose monitoring sensors from the time of chemotherapy initiation (± 7 days) through completion. The sensors detected interstitial glucose levels every 15 minutes and were reapplied by the study team every 2-3 weeks. Primary endpoints were: (1) prevalence of HG, defined as number of patients with ≥1 glucose reading ≥140 mg/dL and (2) among those who developed HG, the proportion of time spent hyperglycemic, defined as number of readings ≥140 mg/dL divided by total number of readings. Key secondary endpoints included prevalence of prediabetes (pre-DM) and diabetes (DM) at baseline and changes in A1c from baseline to weeks 12 and 24. The analysis was stratified by baseline A1c (euglycemia [A1c &lt; 5.7%], pre-DM [A1c 5.7%-6.4%], or DM [A1c ≥6.5% and clinical diagnosis of DM prior to study enrollment]). Results: Among 20 evaluable patients, the median age at baseline was 59 (range 34-78) and median body mass index (BMI) was 29.5 kg/m2 (range 19.5-41.6). The most common chemotherapy regimens included docetaxel/cyclophosphamide (25%), weekly paclitaxel ± trastuzumab (20%), paclitaxel followed by doxorubicin/cyclophosphamide (15%), docetaxel/carboplatin/trastuzumab/pertuzumab (15%), and cyclophosphamide/methotrexate/fluorouracil (15%). All 20 patients developed HG. Of 124,165 total readings, 17% were ≥140 mg/dL and mean glucose was 112.7 mg/dL. At baseline, n = 10 were euglycemic, n = 7 had pre-DM, and n = 3 had DM. By cohort, the proportion of time spent hyperglycemic was 3.9% (euglycemia group), 10% (pre-DM group), and 73.3% (DM group) (p &lt; .0001). Mean glucose values were 95.5 mg/dL (euglycemia group), 104.5 mg/dL (pre-DM group), and 183.0 mg/dL (DM group) (p &lt; .0001). Change in mean A1c from baseline to weeks 12 and 24 varied significantly across groups. Conclusions: Among patients receiving chemotherapy for ESBC, we found evidence of HG in all patients, and the proportion of time spent hyperglycemic during chemotherapy varied significantly by baseline A1c. Further interventions should evaluate the benefits of improved glucose control among patients with baseline A1c &gt; 5.7%. Clinical trial information: NCT04473378 .

Metabolic factors affecting response to adjuvant anti-PD1 therapy for melanoma.

9589 Background: Given the intersection between metabolism and the immune system, and with the increasing use of immune checkpoint inhibitors (ICIs) in the treatment of solid tumors, it is important to determine whether metabolic factors are associated with outcomes for patients treated with ICIs. Obesity is often associated with improved response to immunotherapy for patients with melanoma. However, the impact of other metabolic disorders, such as type 2 diabetes (T2DM), hypertension (HTN), and hyperlipidemia (HLD), on immunotherapy response is not as well understood. The purpose of this study is to determine the impact of these metabolic disorders on immunotherapy treatment. Methods: Patients with stage II or III melanoma who were treated with adjuvant anti-PD-1 therapy and consented to the University of Pittsburgh Melanoma Center repository were included in this study. A retrospective chart review was conducted of the eligible 281 patients. Results: HTN, T2DM, HLD, and body mass index (BMI) &gt; 35 were analyzed together in two multivariate Cox proportional hazard models, one considering overall survival (OS) and the other recurrence free survival (RFS). T2DM (n=49) was significantly associated with both a decreased OS (HR=2.51, 95% CI 1.14-5.52; p=0.0219) and RFS (HR=1.92, 95% CI 1.16-3.164; p=0.011). No significant differences were observed for patients with HTN (n=156) in OS (HR=1.45, 95% CI 0.73-2.87; p=0.29) or RFS (HR=1.22, 95% CI 0.80-1.86; p=0.35), HLD (n=140) in OS (HR=0.62, 95% CI 0.30-1.29; p=0.20) or RFS (HR=0.69, 95% CI 0.44-1.07; p=0.098), or BMI &gt; 35 in OS (HR=1.01, 95% CI 0.48-2.13; p=0.99) or RFS (HR=0.78, 95% CI 0.47-1.29; p=0.34). After adjusting for common pre-treatment comorbidities (coronary artery disease, chronic kidney disease, and smoking), age, and sex, T2DM was no longer significantly associated with reduced OS (HR=1.78, 95% CI 0.83-3.8; p=0.14), but the association with RFS remained significant (HR=1.69, 95% CI 1.04-2.76; p=0.034). In patients with T2DM alone, metformin use (n=24) during immunotherapy treatment was associated with improved OS in univariate (HR=0.28, 95% CI 0.08-0.9; p=0.0385) and multivariate (HR=0.18, 95% CI 0.05-0.7; p=0.0098) analyses controlling for age, sex, and the comorbidities listed above. It was also near significant for increased RFS in a univariate (HR=0.46, 95% CI 0.20-1.06; p=0.067) and multivariate (HR=0.42, 95% CI 0.17-1.06; p=0.065) model. Baseline A1C (n=15) values were not significantly associated with OS (HR=0.18, 95% CI 0.001-24.7; p=0.49) or RFS (HR=0.60, 95% CI 0.21-1.76; p=0.35) in univariate models. Conclusions: T2DM is associated with decreased RFS for patients with melanoma treated with adjuvant anti-PD-1 therapy. Within the T2DM cohort, metformin use was associated with significantly improved RFS and OS. A1C did not correlate with either OS or RFS, suggesting that the effects of both T2DM and metformin may be independent of glycemic control.

HSD72 Baseline A1C and BMI Trends for People with Type 2 Diabetes Receiving First-Time GLP-1 Ra Prescriptions

HSD72 Baseline A1C and BMI Trends for People with Type 2 Diabetes Receiving First-Time GLP-1 Ra Prescriptions

A nurse driven care management program to engage older diabetes patients in personalized goal setting and disease management.

Multiple diabetes care guidelines have called for the personalization of risk factor goals, medication management, and self-care plans among older patients. Study of the implementation of these recommendations is needed. This study aimed to test whether a patient survey embedded in the Electronic Healthcare Record (EHR), coupled with telephonic nurse care management, could engage patients in personalized goal setting and chronic disease management. We conducted a single-center equal-randomization delayed comparator trial at the primary care clinics of the University of Chicago Medicine from 2018.6 to 2019.12. Patients over the age of 65 years with type 2 diabetes with an active patient portal account were recruited and randomized to receive an EHR embedded goal setting and preference survey immediately in the intervention arm or after 6 months in the delayed intervention control arm. In the intervention arm, nurses reviewed American Diabetes Association recommendations for A1C goals based on health status class, established personalized goals, and provided monthly telephonic care management phone calls for a maximum of 6 months. Our primary outcome was the documentation of a personalized A1C goal in the EHR. A total of 100 patients completed the trial (mean age, 72.51 [SD, 5.22] years; mean baseline A1C, 7.14% [SD, 1.06%]; 68% women). The majority were in the Healthy (59%) followed by Complex (30%) and Very Complex (11%) health status classes. Documentation of an A1C goal in the EHR increased from 42% to 90% (p < 0.001) at 6 months in the intervention group and from 54% to 56% in the control group. Across health status classes, patients set similar A1C goals. Older patients can be engaged in personalized goal setting and disease management through an embedded EHR intervention. The clinical impact of the intervention may differ if deployed among older patients with more complex health needs and higher glucose levels. ClinicalTrials.gov Identifier: NCT03692208.

Implementation of an Interprofessional Diabetes Management Clinic in the Rural Primary Care Setting.

Background: Access to a primary care provider is not guaranteed for many living in rural settings. Notably, rural populations experience a higher degree of burden from chronic diseases compared to urban-dwellers. For example, diabetes can go undiagnosed and undertreated with lack of primary care. To address these care gaps at a large, rural family medicine practice in western North Carolina, a multidisciplinary pharmacist-led diabetes clinic was developed. Objectives: This article describes the implementation, evolution, and impact of the diabetes management clinic and explores future directions for improving the experience of patients and health care providers. Practice Description and Innovation: The diabetes management clinic at Mountain Area Health Education Center (MAHEC) is a pharmacy resident-led interdisciplinary clinic incorporating nutrition and pharmacy learners to provide patient care in both telehealth and in-office settings. Since its inception in 2018, the clinic has facilitated meaningful learning opportunities for students and residents and helped patients manage their diabetes in a multifaceted approach. Evaluation Methods: A retrospective, cross-sectional study evaluated diabetes-related outcomes for 80 patients seen in the diabetes management clinic during twelve months of appointments. The primary outcome measure was change in A1c from baseline. Results: Among patients with a follow-up A1c during the study (n=64), there was a mean reduction in A1c by 0.79% from baseline. Additionally, among those with a second follow-up A1c available (n=32), there was a mean reduction from baseline in A1c of 1.42%. Conclusion: The utilization of pharmacy residents as part of an interdisciplinary diabetes management clinic can extend access to care for underserved patients. The clinic also serves as a structured teaching clinic for interdisciplinary learners, and it has contributed to positive clinical outcomes, strong interprofessional collaboration, and expansion of experiential education opportunities since its inception in 2018.

Evaluation of a pharmacist-led personal continuous glucose monitor workflow to improve glycemic management in an internal medicine clinic

BackgroundThe use of personal continuous glucose monitors (CGMs) in patients with diabetes has increased substantially and is expected to continue to increase as CGMs become more affordable and insurance plans improve coverage. The utilization of CGMs has improved diabetes management and reduced hypoglycemic events. ObjectivesTo create pharmacist-led personal CGM workflow and evaluate its impact on glycemic management in patients with diabetes. Practice DescriptionThe study took place at an Internal Medicine Clinic. The practice providers include 2 medical doctors, 5 physician assistants, 2 nurse practitioners, and 1 clinical pharmacist. Practice InnovationTo create and implement a sustainable pharmacy led CGM workflow for enhanced CGM use within an internal medicine clinic. Evaluation MethodsThis was a prospective, investigator-initiated pilot study conducted at an Atrium Health Internal Medicine clinic over 28 weeks. In this pilot, 42 patients were qualifying candidates with diabetes and personal CGM use. In addition, 30 patients were followed until study completion and included into final analysis. ResultsThe average baseline A1c was reduced from 8.3% to 7.1% over a 3- to 6-month period. The pharmacist-led CGM workflow revealed a statistically significant reduction in A1c from baseline by an average of 1.2% (95% CI −0.6 to −1.8, P = 0.0006). On average, patients were enrolled for 19.9 weeks and had an average of 5 visits during this time. During the study duration, 100 medications changes were implemented under the existing clinical pharmacist practitioner agreement between the pharmacists and the provider. Overall, 58 Current Procedural Terminology 95251 codes were billed yielding $7052.00 in billed CGM services for the clinic. This project generated 40.6 provider relative value units. ConclusionThe utilization of a pharmacist-led personal CGM workflow can improve diabetes outcomes.

Impact of Risk Stratification in Patients With Diabetes Mellitus in a Health System Specialty Pharmacy Setting

Background: Integrated pharmacist care into health systems results in significant A1c reduction and improved outcomes in patients with diabetes. However, little is known about the adoption of Health System Specialty Pharmacy (HSSP) chronic disease management (CDM) services within diabetes clinics. Risk stratification is proven to enhance care in various patient populations. Objective: The objective of this study is to describe how the implementation of risk stratification in the HSSP setting results in optimized patient outcomes in diabetes. Method: This is a retrospective descriptive study reporting the results of expanding the HSSP care model to implement risk stratified CDM services for patients with diabetes. A total of 285 patients were enrolled in the HSSP CDM pharmacy services and were stratified into high- or low-risk groups. Results: Eighty-eight patients were stratified as high-risk with an average baseline A1c of 11.47% and a most recent average of 8.84%. The remaining 285 patients were stratified into the low-risk group. Their average baseline A1c was 7.48% and the last recorded average A1c was 7.15%. Patients not enrolled in HSSP CDM services (N = 100) had a lower reduction in average A1c compared to patients enrolled in the program. Conclusion: Patients stratified into high- and low-risk groups had greater reductions in A1c compared to patients who did not use HSSP CDM services. These results showcase the success of risk stratification and demonstrate the impact HSSP has on patients needing CDM services and outlines a strategy to provide the greatest impact in a high-volume patient population.

Outcomes of New York City Care Calls: A Prospective Randomized Controlled Effectiveness Trial of Telephone-Delivered Type 2 Diabetes Self-Management Support.

The purpose of the 12-month randomized controlled trial was to evaluate the effectiveness of a Telephonic Self-Management Support (T-SMS) program among adults with type 2 diabetes (T2D). Eight hundred twelve adults with T2D participated in NYC Care Calls (mean age = 59.2, SD = 10.8; female = 57%; mean A1C = 9.3, SD = 1.8; Latino = 86%) and were randomly assigned to T-SMS or enhanced usual care (EUC). A1C (primary outcome), blood pressure, and body mass index (secondary outcomes) were extracted from electronic medical records. Secondary patient-reported outcomes, including depressive symptoms, diabetes distress, medication adherence, and self-management activities, were assessed by telephone in English or Spanish. For T-SMS, the number of assigned phone calls was based on baseline A1C, depressive symptoms, and/or diabetes distress. Analyses were conducted under the intention-to-treat principle. A1C decreased over 12 months in both T-SMS (0.72% percentage points; 95% CI, 0.53-0.91) and EUC (0.66% percentage points; 95% CI, 0.46-0.85; Ps < .001). Diabetes distress and self-management also improved over time in both arms (Ps < .05). Compared to EUC, participants in the T-SMS arm did not differ in outcomes. The T-SMS and EUC groups were found not to have an appreciable outcome difference. It is unclear whether improvements in A1C across both conditions represent a secular trend or indicate that print-based educational intervention may have a positive impact on self-management and well-being.

Application of Closed-loop Theory in Deep Learning Training Guided by High-strength Intelligent Machinery

Artificial intelligence (AI) algorithms and continuous monitoring technologies have the potential to transform the way chronic illnesses are managed. We will also talk about the problems and potential that AI technology presents for CGM in individualised and preventive medicine. Furthermore, we assessed the AHCL system's usefulness in patients with impaired awareness of hypoglycemia (IAH) and those who correctly recognised hypoglycemia symptoms. The participants' ages varied from 37 to 15, and they had received diabetes medication for an average of 20 to 10 years. IAH was seen in 12 individuals (27%) with a Clarke's score of less than 3. Patients with IAH were older than those who did not have IAH. The baseline CGM readings and A1c were the same, but the estimated glomerular filtration rate (eGFR) was lower. Despite prior insulin treatment, the AHCL system resulted in an overall drop in A1c (from 6.9 0.5% to 6.7 0.6%, P 0.001). Only three patients (7%) received Clarke's three scores after six months on the AHCL system, resulting in a 20% absolute risk decrease for IAH (95% confidence interval: 7-32).

Association of food insecurity with changes in diet quality, weight, and glycemia over two years in adults with prediabetes and type 2 diabetes on medicaid

Little is known about longitudinal associations between food insecurity (FI) and diet, weight, and glycemia in people with prediabetes and type 2 diabetes (T2D). In a secondary analysis of Medicaid-enrolled health center patients with prediabetes or T2D in Boston, Massachusetts (N = 188), we examined associations between food security (FS) and measures of diet quality, weight, and hyperglycemia. FS (10-item USDA FS module) was ascertained at baseline, 1-year, and 2-year follow-up and categorized as persistently secure, intermittently insecure, or persistently insecure. Associations between FS category and changes in Healthy Eating Index-2020 (HEI-20), body mass index (BMI), and hemoglobin A1c (A1c) from baseline to year 2 were assessed using multivariate generalized linear models. Participants had median (p25, p75) age of 52 (42, 57); 71.8% were female and 62.8% Hispanic. Over follow-up, 32.4% were persistently food secure, 33.0% intermittently insecure, and 34.5% persistently insecure. Baseline mean (SD) HEI-20, BMI, and A1c were 55.8 (14.5), 35.9 (8.7) kg/m2, 7.1% (1.6) and did not differ by FS category. FS category was not associated with changes in HEI-20, BMI, and A1c at 2 years (all p > 0.05). Results suggest that Medicaid-enrolled adults with prediabetes or T2D, regardless of FS status, would benefit from dietary and weight management interventions.