Change In Hemoglobin A1c Research Articles

Assessing the Effectiveness of mHealth Interventions for Diabetes and Hypertension Management in Africa: Systematic Review and Meta-Analysis.

Mobile health (mHealth) interventions are effective in improving chronic disease management, mainly in high-income countries. However, less is known about the efficacy of mHealth interventions for the reduction of cardiovascular risk factors, including for hypertension and diabetes, which are rapidly increasing in low- and middle-income countries. This study aimed to assess the efficacy of mHealth interventions for diabetes and hypertension management in Africa. We searched PubMed, Cochrane Library, Google Scholar, African Journals Online, and Web of Science for relevant studies published from inception to July 2022. The main outcomes of interest were changes in hemoglobin A1c (HbA1c), systolic blood pressure, and diastolic blood pressure. The random or fixed effect model was used for the meta-analysis, and the I2 statistic was used to gauge study heterogeneity. Z tests and P values were used to evaluate the effect of mHealth interventions on HbA1c and blood pressure levels. This review included 7 studies (randomized controlled trials) with a total of 2249 participants. Two studies assessed the effect of mHealth on glycemic control, and 5 studies assessed the effect of mHealth on blood pressure control. The use of mHealth interventions was not associated with significant reductions in HbA1c levels (weighted mean difference [WMD] 0.20, 95% CI -0.40 to 0.80; P=.51) among patients with diabetes and systolic blood pressure (WMD -1.39, 95% CI -4.46 to 1.68; P=.37) and diastolic blood pressure (WMD 0.36, 95% CI -1.37 to 2.05; P=.69) among patients with hypertension. After conducting sensitivity analyses using the leave-one-out method, the Kingue et al study had an impact on the intervention, resulting in a 2 mm Hg reduction in systolic blood pressure (WMD -2.22, 95% CI -3.94 to -0.60; P=.01) but was nonsignificant for diastolic blood pressure and HbA1c levels after omitting the study. Our review provided no conclusive evidence for the effectiveness of mHealth interventions in reducing blood pressure and glycemic control in Africa among persons with diabetes and hypertension. To confirm these findings, larger randomized controlled trials are required.

The Effectiveness of Continuous Glucose Monitoring Devices in Managing Uncontrolled Diabetes Mellitus: A Retrospective Study.

This retrospective study aimed to assess the effectiveness of continuous glucose monitoring (CGM) devices in managing uncontrolled diabetes mellitus (DM). The study cohort comprised 25 patients with uncontrolled diabetes who received treatment at an internal medicine resident clinic. The objective was to evaluate the impact of transitioning from self-monitoring of blood glucose (SMBG) to CGM devices on glycemic control, as measured by changes in hemoglobin A1c (HbA1c) levels, average blood glucose levels, hypoglycemic events, time spent within the target blood sugar range, and glucose variability. The findings indicated significant improvements in glycemic control with the adoption of CGM devices, highlighting their potential benefits for optimizing diabetes management. The study is particularly interesting because it was done in an internal medicine continuity clinic with the main participation of the internal medicine residents under the supervision of an endocrinologist. It was not done as the majority of the other studies used CGM in specialized endocrinology clinics.

Safety and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Solid Organ Transplant Recipients.

Background: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) may be effective in reducing body weight and hemoglobin A1c (HbA1c) post-kidney transplantation. Limited literature exists on use of these agents outside of kidney transplant. The purpose of this program evaluation was to evaluate the safety and efficacy of SGLT2i in kidney, liver, and lung transplant recipients. Methods: This was a retrospective program evaluation of adult kidney, liver, and lung transplant recipients between August 31, 2016 and July 31, 2021. Patients initiated on SGLT2i for diabetes for a minimum of 90 days with at least 1 follow-up appointment were screened for inclusion. Outcomes were compared between SGLT2i initiation to nadir values 3-12-months post-initiation. Outcomes included change in hemoglobin A1c, fasting blood glucose, actual body weight, and body mass index. Safety outcomes included adverse effects, cardiovascular events, death-censored graft loss, and all-cause mortality. Results: Forty-nine patients met inclusion criteria, (26 liver, 18 kidney, 4 lung, and 1 simultaneous liver-kidney recipient). The median time from transplant to SGLT2i initiation was 1216 days (IQR 524-2256). Glycemic and weight loss outcomes showed a statistically significant benefit from SGLT2i use. Total safety outcome incidence was minimal at 12 months. No patient experienced myocardial infarctions, graft loss, or mortality at 3-12 months. One incidence of urinary tract infection and stroke occurred each. The most common adverse effects included hypotension and hypoglycemia. Conclusion: This program evaluation demonstrated that SGLT2i can be used safely in solid organ transplant recipients. These agents can provide an additional non-insulin agent for post-transplant diabetes mellitus management in solid organ transplant.

607-P: The Impact of Telenutrition vs. In-Person Nutrition Consultations on Glycemic Control in People with Type 1 Diabetes—Data from Saudi Arabia

Background: Telehealth has the potential to improve accessibility to nutrition clinics, particularly in parts of the world where the number of certified nutritionists is limited. Here, we evaluate the impact of utilizing telehealth for nutrition consultations on glycemic control and patients satisfaction when managing people with type 1 diabetes (PwT1D). Methods: A retrospective analysis of data from 137 PwT1D referred to the nutrition clinic at King Saud University to learn carb counting (2021-2022). Participants were divided into 2 groups: 1) Telenutrition group (those who had 4 virtual & 2-3 in-person visits) (n=107) and 2) In-person group (those who had 6-7 in-person & no virtual visits) (n=30). Changes in hemoglobin A1C and CGM metrics from baseline to month 3 (i.e. end of the study (EOS)) were compared between the groups. At the EOS, participants were asked to fill out a satisfaction survey. Results: The reduction in A1c from baseline to EOS was comparable in both groups (1.2% and 1.1%, in the Telenutrition and In-person groups, respectively, both p<0.01). Likewise, the glucose time in range (TIR) increased from 53.9% at baseline to 58.5% at the EOS (p<0.01) in the telenutrition group and from 49.1% at baseline to 54.7% at the EOS (p=0.13) in the in-person group. This was accompanied by a significant reduction in the prandial insulin doses from baseline to EOS by 32% in the telenutrition group and 28% in the in-person group (both p<0.01). Majority (98%) of those who attended the telenutrition clinic reported satisfaction with the quality of healthcare provided and 97% reported that their experience with the telenutrition clinic was as satisfying or more satisfying than that in the in-person clinic. Conclusion: Telenutrition clinic is as effective in improving glycemic control in people with T1D as the traditional “in-person” nutrition clinics, and its utilization may improve patients' satisfaction and accessibility to certified nutritionists Disclosure M.Al-sofiani: Consultant; Eli Lilly and Company, Speaker's Bureau; Sanofi, Medtronic, Vitalair. S.Almuammar: None.

661-P: Associations of Food Security Status with Diet Quality and Glycemic Control over Two Years in Adults with Type 2 Diabetes on Medicaid

Background: Little is known about the association of food insecurity (FI) with changes in diet quality and hemoglobin A1c (HbA1c) over time in people with type 2 diabetes (T2D). Methods: In an analysis of adults with Medicaid and T2D enrolled in a longitudinal cohort study in 2020, demographics, depression (Patient Health Questionnaire-8 [PHQ-8]), food security status (USDA Food Security Module), Healthy Eating Index-2015 (HEI-15) diet quality scores, and other social determinants of health were assessed with annual surveys. Primary outcomes were HEI-15 and HbA1c, obtained from electronic health records. Separate propensity-score adjusted linear mixed models with a random intercept were used to test associations of baseline FI with changes in HEI-15 and A1c over 2 years. Results: Of 846 participants, 133 (16%) had T2D at baseline; 79 (59.4%) of those with T2D had FI. Those with baseline FI vs. food security had higher PHQ-8 scores and prevalence of housing instability, financial stress, and cost-related barriers to care (p<0.05). Over 2 years, changes in HEI-15 (p=0.45) and HbA1c (p=0.86) did not differ by baseline food security status (Table 1). Conclusion: In adults with T2D on Medicaid, diet quality remained low and HbA1c high over 2 years regardless of food security status, highlighting the importance of addressing nutrition when managing T2D in Medicaid patients. Disclosure K.D.Gu: None. J.Cheng: None. S.H.Mcgovern: None. J.L.Mccurley: None. D.E.Levy: None. V.Fung: Other Relationship; Vertex Pharmaceuticals Incorporated, Stock/Shareholder; Vertex Pharmaceuticals Incorporated. C.Clark: None. A.N.Thorndike: None. Funding National Institutes of Health (T32DK007028, 5T32HL098048, R01DK124145)

162-LB: ¡Más Fresco! More Fresh—Impact of a Fruit and Vegetable Prescription Program in a Pediatric Type 2 Diabetes Clinic

Fruit and vegetable prescription (FVRx) programs have shown to improve fruit and vegetable intake and glycemic control in adults with diabetes; however, pediatric data is lacking. The aim of this study was to assess if a FVRx program improved fresh fruit and vegetable intake and health outcomes of children with type 2 diabetes mellitus (T2D). Families with a child with T2D and enrolled in Medi-Cal were recruited from our pediatric diabetes clinic. Families were randomized to either receive vouchers immediately (intervention group) or after a 6-month waiting period (delayed-control group). Monthly vouchers were given for 1 year to purchase fresh fruits and vegetables. Families completed surveys including the Dietary Screening Questionnaire and U.S. Household Food Security Survey every 6 months. Physiologic data and standardized laboratory tests were also collected. Of the 57 families with baseline surveys, the majority identified as Latino/Hispanic (84%) and the mean age of children was 14.3 years. Of the 49 parents who completed the baseline U.S. Household Food Security Survey, 46.9% reported low household food security and 16.3% reported very low food security. There were 29 families who completed our baseline and 6-month surveys. For the intervention group (n=14), there was an increase in parent-reported fruit and vegetable intake from baseline to 6-months for parents (2.4 vs 3.6 cups per day, p=0.0034) and children (2.6 vs 4.4 cups per day, p=0.0264). Children self-reported increased fresh vegetable intake between baseline and 6-months (0.17 vs 0.53 cups per day, p=0.014). There was no statistically significant difference in these measures for the delayed-control group (n=15). There was no significant change in BMI Z-score or hemoglobin A1c for the two groups after 6 months. A FVRx program is a viable intervention to improve fruit and vegetable intake for families with a child with T2D. Further research is needed to assess its impact on BMI and glycemic control. Disclosure K. Chan: None. S. P. Hiller-venegas: None. J. J. Kim: None. K. O. Klein: Consultant; AbbVie Inc., Tolmar Pharm, Azurity. K. Rhee: None. Funding U.S. Department of Agriculture-National Institute of Food and Agriculture (2021-06512)

860-P: Evaluation of Efficacy and Safety of Glucokinase Activators—A Systematic Review and Meta-analysis

Aims: Glucokinase activators (GKAs) promote the activity of glucokinase (GK) and is under development for the treatment of diabetes. The efficacy and safety of GKAs require evaluation. Methods: This meta-analysis included randomized controlled trials (RCTs) with a duration of at least 12 weeks conducted in patients with diabetes. The primary objective of this meta-analysis was the difference of hemoglobin A1c (HbA1c) change from baseline to study end between GKA groups and placebo groups. Risk of hypoglycemia and laboratory indicators were also evaluated. Weighted mean differences (WMDs) and 95% confidence intervals (CIs) were calculated for the continuous outcomes, odd ratios (ORs) and 95% CI were calculated for the risk of hypoglycemia. Results: Data from 13 RCTs with 2,748 participants treated with GKAs and 2,681 control participants were analyzed. Overall, the level of HbA1c decreased significantly in patients with GKA treatment compared with placebo (WMD=-0.316%, 95% CI -0.426 to -0.206%, P<0.001). The OR comparing GKA versus placebo was 1.88 for risk of hypoglycemia (95% CI 1.51 to 2.33, P<0.001). The WMD comparing GKA versus placebo was 0.308mmol/L for triglyceride (TG) levels (95% CI 0.153 to 0.464mmol/L, P<0.001). The sensitivity analysis demonstrated difference when stratified by drug type, selectivity, and study duration. Conclusion: In patients with diabetes, GKA treatment was associated with a better glycemic control, but a significant increased risk of hypoglycemia and elevation in TG concentration in general. The efficacy and safety varied with drug type and selectivity. Disclosure W.Yang: None. Funding National Natural Science Foundation of China (81903711, 81970698, 81970708); Beijing Natural Science Foundation (7202216)

Food Diary Completion Does Not Significantly Impact Glycemic Control in an Observational Single-Institution Pilot Study of Patients with Type 2 Diabetes Mellitus.

Hemoglobin A1c is frequently used to monitor glycemic control in patients with type 2 diabetes mellitus (T2DM). There is an association between dietary habits and hemoglobin A1c. Food diaries are often used to assist in dietary management and have been associated with modification of dietary habits. We aimed to investigate the impact of completing a seven-day food diary on hemoglobin A1c in subjects with T2DM. We hypothesized that patients who completed a food diary might independently modify their dietary habits, resulting in a clinically significant change in hemoglobin A1c. Forty-five subjects with T2DM who completed a seven-day food diary were included in this observational study. Subjects had a mean hemoglobin A1c at baseline of 7.56 ± 1.43 and a body mass index of 33.6 ± 7.6 kg/m². A majority were female (57.8%) and insulin-dependent (71.1%). The primary outcome of interest was a clinically significant change in hemoglobin A1c (≥0.5%). Outcomes were assessed before and within six months after the food diary completion. Chi-square, independent-sample t-tests, and logistic regression were used to analyze the data. Twelve patients demonstrated a clinically significant decrease in hemoglobin A1c; however, this was not statistically significant regardless of gender (p = 0.5), baseline body mass index (p = 0.5), insulin use (p = 0.3), or community needs index (p = 0.7). Although some patients had clinically significant improvements in their hemoglobin A1c, our findings suggest that the use of food diaries alone without goal-directed initiatives is insufficient to achieve differences in hemoglobin A1c in patients with T2DM and an average A1c within the range of 6%-8%.

Strains of Faecalibacterium prausnitzii and its extracts reduce blood glucose levels, percent HbA1c, and improve glucose tolerance without causing hypoglycemic side effects in diabetic and prediabetic mice

IntroductionThe commensal bacterium Faecalibacterium prausnitzii is a prominent member of the microbiome of animals and humans, and it plays an important role in several physiological processes. Numerous studies have correlated...

Tirzepatide versus insulin glargine as second-line or third-line therapy in type 2 diabetes in the Asia-Pacific region: the SURPASS-AP-Combo trial.

Tirzepatide is a once-weekly GIP/GLP-1 receptor agonist. In this phase 3, randomized, open-label trial, insulin-naive adults (≥18 years of age) with type 2 diabetes (T2D) uncontrolled on metformin (with or without a sulphonylurea) were randomized 1:1:1:1 to weekly tirzepatide 5 mg, 10 mg or 15 mg or daily insulin glargine at 66 hospitals in China, South Korea, Australia and India. The primary endpoint was non-inferiority of mean change in hemoglobin A1c (HbA1c) from baseline to week 40 after treatment with 10 mg and 15 mg of tirzepatide. Key secondary endpoints included non-inferiority and superiority of all tirzepatide doses in HbA1c reduction, proportions of patients achieving HbA1c < 7.0% and weight loss at week 40. A total of 917 patients (763 (83.2%) in China) were randomized to tirzepatide 5 mg (n = 230), 10 mg (n = 228) or 15 mg (n = 229) or insulin glargine (n = 230). All doses of tirzepatide were non-inferior and superior to insulin glargine for least squares mean (s.e.) reduction in HbA1c from baseline to week 40: tirzepatide 5 mg, 10 mg and 15 mg, -2.24% (0.07), -2.44% (0.07) and -2.49% (0.07), respectively, and insulin glargine, -0.95% (0.07), with a treatment difference ranging from -1.29% to -1.54% (all P < 0.001). Proportions of patients achieving HbA1c < 7.0% at week 40 were greater in tirzepatide 5-mg (75.4%), 10-mg (86.0%) and 15-mg (84.4%) groups compared to insulin glargine (23.7%) (all P < 0.001). All tirzepatide doses led to superior body weight reduction at week 40: tirzepatide 5 mg, 10 mg and 15 mg, -5.0 kg (-6.5%), -7.0 kg (-9.3%) and -7.2 kg (-9.4%), respectively, compared to insulin glargine, 1.5 kg (+2.1%) (all P < 0.001). The most common adverse events with tirzepatide were mild to moderate decreased appetite, diarrhea and nausea. No severe hypoglycemia was reported. Tirzepatide demonstrated superior reductions in HbA1c versus insulin glargine in an Asia-Pacific, predominately Chinese, population with T2D and was generally well tolerated. ClinicalTrials.gov registration: NCT04093752 .

A very low-carbohydrate diabetes prevention program for veterans with prediabetes: a single-arm mixed methods pilot study.

All Veterans Affairs (VA) Medical Centers offer the MOVE! Weight Management Program to help patients achieve and maintain a healthy weight through a calorie-restricted, low-fat diet and increased physical activity. Yet, most MOVE! participants do not achieve clinically significant weight loss of ≥5%. A carbohydrate-restricted diet may help more Veterans to achieve ≥5% weight loss. This was a single-arm explanatory sequential mixed methods pilot study conducted in one VA health care system. Veterans with prediabetes and body mass index ≥25 kg/m2 were invited to participate in a group-based, virtual, very low-carbohydrate Diabetes Prevention Program (VLC-DPP) consisting of 23 sessions over 12 months. Participants were taught to follow a very low-carbohydrate eating pattern, defined as 20-35 grams of net carbohydrates per day. The primary outcomes were measures of feasibility and acceptability, including program uptake and session attendance. Secondary outcomes included change in weight, hemoglobin A1c, lipids, and patient-reported measures of food cravings, stress eating, perceived health status, and motivation. Interviews were conducted at 6 months to identify factors that facilitated or hindered participants' achievement of ≥5% weight loss. Among 108 screened Veterans, 21 enrolled in the study (19%), and 18 were included in the analytic cohort. On average, participants attended 12.4/16 weekly sessions and 3.6/8 bimonthly or monthly sessions. At 12 months, mean percent weight loss was 9.4% (SD = 10.7) with 9 participants (50%) achieving ≥5% weight loss. Three factors facilitated achievement of ≥5% weight loss among 10/16 interviewees: (1) enjoyment of low-carbohydrate foods; (2) careful monitoring of carbohydrate intake; and (3) reduced hunger and food cravings. Three factors hindered achievement of ≥5% weight loss among 6/16 interviewees: (1) food cravings, particularly for sweets; (2) challenges with maintaining a food log; and (3) difficulty with meal planning. A VLC-DPP is feasible and acceptable and shows preliminary efficacy among Veterans with prediabetes. The program's weight loss effectiveness compared to standard MOVE! should be evaluated in a larger-scale trial. Such a program may be offered in addition to the standard MOVE! program to expand the menu of evidence-based lifestyle counseling options for Veterans. https://clinicaltrials.gov/ct2/show/NCT04881890, identifier NCT04881890.

Mobile Applications to Support Diabetes Self-Management Education: Patient Experiences and Provider Perspectives.

Diabetes self-management education and support (DSMES) is a critical component of diabetes care, but time for it is often limited. Digital tools, such as mobile applications (apps), show promise in extending efforts and supporting self-management education, but have not been fully used. Objectives of this multi-phase study were to (1) evaluate an app designed to support patients with insulin therapy and (2) examine provider perspectives on DSMES apps. Phase 1: Thirty-two adult patients with type 2 diabetes new to or having difficulties with insulin therapy were introduced to the BDTM Diabetes Care App. Three-month app use and satisfaction and changes in hemoglobin A1c (HbA1c) and diabetes distress were assessed. Phase 2: Sixty diabetes providers completed a survey about their experiences with and perspectives on DSMES apps. Phase 1: Patients reported satisfaction with the app, and significant improvements in HbA1c and diabetes distress were observed. Phase 2: Most providers viewed apps as adjuncts to diabetes education. Only 33% had previous app experience; however, 100% would consider recommending apps to their patients. Most would spend 5-15 minutes introducing apps to patients. All respondents agreed that the following DSMES app features-evidence-based educational content, data logging and tracking features, customizable user experience, digital coaching via goal setting or reminders, and ability to share data with providers-are key components to consider. Findings suggest DSMES apps can play a role in self-management support and provide guidance on factors to consider when introducing digital tools into clinical practice. Clinicaltrials.gov, #NCT03999268.

Design and rationale of behavioral nudges for diabetes prevention (BEGIN): A pragmatic, cluster randomized trial of text messaging and a decision aid intervention for primary care patients with prediabetes

BackgroundAmong 96 million U.S. adults with prediabetes, adoption of evidence-based treatment to prevent diabetes remains low. Primary care represents an essential venue for preventing diabetes, yet providers in this setting have limited time to address prevention. This highlights the need for low-touch interventions that promote diabetes prevention and are not delivered by primary care providers. Text messaging and decision aids displaying disease risk and treatment information have improved outcomes in prior research. However, these approaches have not been definitively studied for managing prediabetes. MethodsThe Behavioral Nudges for Diabetes Prevention (BEGIN) trial is a pragmatic, cluster randomized trial testing the effectiveness of text messaging about diabetes prevention and a prediabetes decision aid. These interventions are being studied in 8 primary care clinics using a 2 × 2 factorial design, in which pairs of clinics are randomized in a 1:1:1:1 ratio to receive usual care, text messaging alone, prediabetes decision aid alone, or both interventions. A total of 656 patients are recruited to participate, receive the study interventions, and contribute data at baseline and 12 months. The primary outcome is 12-month weight change, and the secondary outcome is adoption of evidence-based treatment to prevent diabetes. Change in hemoglobin A1c is an exploratory outcome that will be assessed among participants with available values. ConclusionFindings from the BEGIN trial will provide evidence about the effectiveness of two novel, low-touch interventions focused on diabetes prevention in primary care, where patients are diagnosed with prediabetes and there is little prior research.TRIAL REGISTRY: NCT04869917

Evaluation of efficacy and safety of glucokinase activators-a systematic review and meta-analysis.

Glucokinase activators (GKAs) promote the activity of glucokinase (GK) and is under development for the treatment of diabetes. The efficacy and safety of GKAs require evaluation. This meta-analysis included randomized controlled trials (RCTs) with a duration of at least 12 weeks conducted in patients with diabetes. The primary objective of this meta-analysis was the difference of hemoglobin A1c (HbA1c) change from baseline to study end between GKA groups and placebo groups. Risk of hypoglycemia and laboratory indicators were also evaluated. Weighted mean differences (WMDs) and 95% confidence intervals (CIs) were calculated for the continuous outcomes, and odds ratios (ORs) and 95% CI were calculated for the risk of hypoglycemia. Data from 13 RCTs with 2,748 participants treated with GKAs and 2,681 control participants were analyzed. In type 2 diabetes, the level of HbA1c decreased greater in patients with GKA treatment compared with placebo (WMD = -0.339%, 95% CI -0.524 to -0.154%, P < 0.001). The OR comparing GKA versus placebo was 1.448 for risk of hypoglycemia (95% CI 0.808 to 2.596, P = 0.214). The WMD comparing GKA versus placebo was 0.322 mmol/L for triglyceride (TG) levels (95% CI 0.136 to 0.508 mmol/L, P = 0.001). When stratified by drug type, selectivity, and study duration, a significant difference was found between groups. In type 1 diabetes, the result of HbA1c change and lipid indicators showed no significant difference between the TPP399 group and the placebo group. In patients with type 2 diabetes, GKA treatment was associated with a better glycemic control but a significant elevation in TG concentration in general. The efficacy and safety varied with drug type and selectivity. International Prospective Register of Systematic Reviews, identifier CRD42022378342.

Fitterfly Diabetes CGM Digital Therapeutics Program for Glycemic Control and Weight Management in People With Type 2 Diabetes Mellitus: Real-world Effectiveness Evaluation.

Digital therapeutic platforms facilitate health care through patient-centered strategies based on multidisciplinary teams and shared decision-making. Such platforms can be used for developing a dynamic model of diabetes care delivery, which can help in improving glycemic control by promoting long-term behavior changes in people with diabetes. This study aims to evaluate the real-world effectiveness of the Fitterfly Diabetes CGM digital therapeutics program for improving glycemic control in people with type 2 diabetes mellitus (T2DM) after the completion of 90 days in the program. We analyzed deidentified data of 109 participants in the Fitterfly Diabetes CGM program. This program was delivered through the Fitterfly mobile app coupled with continuous glucose monitoring (CGM) technology. This program consists of 3 phases: the first phase is observation, wherein the patient's CGM readings are observed for 7 days (week 1); the second phase is the intervention; and the third phase aims at sustaining the lifestyle modification introduced during the second phase. The primary outcome of our study was the change in the participants' hemoglobin A1c (HbA1c) levels after program completion. We also evaluated the changes in participant weight and BMI after the program, changes in the CGM metrics in the initial 2 weeks of the program, and the effects of participant engagement in the program on improving their clinical outcomes. At the end of the 90 days of the program, the mean HbA1c levels, weight, and BMI of the participants were significantly reduced by 1.2% (SD 1.6%), 2.05 (SD 2.84) kg, and 0.74 (SD 1.02) kg/m2 from baseline values of 8.4% (SD 1.7%), 74.45 (SD 14.96) kg, and 27.44 (SD 4.69) kg/m2 in week 1, respectively (P<.001). The average blood glucose levels and time above range values showed a significant mean reduction by 16.44 (SD 32.05) mg/dL and 8.7% (SD 17.1%) in week 2 from week 1 baseline values of 152.90 (SD 51.63) mg/dL and 36.7% (SD 28.4%), respectively (P<.001 for both). Time in range values significantly improved by 7.1% (SD 16.7%) from a baseline value of 57.5% (SD 25%) in week 1 (P<.001). Of all the participants, 46.9% (50/109) showed HbA1c reduction ≥1% and 38.5% (42/109) showed weight loss ≥4%. The average number of times the mobile app was opened by each participant during the program was 108.80 (SD 127.91) times. Our study shows that participants in the Fitterfly Diabetes CGM program showed a significant improvement in their glycemic control and reduction in weight and BMI. They also showed a high level of engagement with the program. Weight reduction was significantly associated with higher participant engagement with the program. Thus, this digital therapeutic program can be considered as an effective tool for improving glycemic control in people with T2DM.

A Multidisciplinary Quality Improvement Program to Improve Diabetes Care at a Free Clinic.

To evaluate the effectiveness of an intensive, multidisciplinary patient-centered approach involving a pharmacist and a dietician in a population of uninsured free clinic patients with diabetes and hypertension. A single-center retrospective chart review of a quality improvement project. All patients had diagnoses of diabetes and hypertension and a most recent hemoglobin A1c ≥ 9.0%. Patients met individually with a pharmacist and a dietician during 6 encounters over 12 months. The pharmacist made medication changes, encouraged lifestyle reflections, and helped patients create and track self-management goals. The dietician helped patients plan strategies for diet and exercise. The primary outcome was a change in mean hemoglobin A1c. Of 30 enrolled patients, 17 completed three months of treatment, and seven completed 12 months. The 17 patients who completed three months of treatment had the following characteristics: mean age 55.5 years; mean hemoglobin A1c 11.5%; 82% were taking two or more antidiabetic medications; 59% were taking two or more antihypertensive medications. Significant reductions in mean hemoglobin A1c values were observed at three months (-3.4%, P<0.0001) and twelve months (-4.0%, P=0.0156). Reductions in systolic blood pressure were also observed at three months (-6 mmHg, P=0.1060) and twelve months (-17 mmHg, P=0.2188). Large and significant hemoglobin A1c reductions were observed in free clinic patients with diabetes refractory to traditional medical management. Goal-oriented patient empowerment effectively improves a wide range of patient outcomes in the free clinic setting. Other free clinics can implement this collaborative, multidisciplinary model with access to similar personnel.

Changes in clinical markers observed from pharmacist-managed cardiovascular risk reduction clinics in federally qualified health centers: A retrospective cohort study.

Reductions in hemoglobin A1c (HbA1C) have been associated with improved cardiovascular outcomes and savings in medical expenditures. One public health approach has involved pharmacists within primary care settings. The objective was to assess change in HbA1C from baseline after 3-5 months of follow up in pharmacist-managed cardiovascular risk reduction (CVRR) clinics. This retrospective cohort chart review occurred in eight pharmacist-managed CVRR federally qualified health clinics (FQHC) in Indiana, United States. Data were collected from patients seen by a CVRR pharmacist within the timeframe of January 1, 2015 through February 28, 2020. Data collected include: demographic characteristics and clinical markers between baseline and follow-up. HbA1C from baseline after 3 to 5 months was assessed with pared t-tests analysis. Other clinical variables were assessed and additional analysis were performed at 6-8 months. Additional results are reported between 9 months and 36 months of follow up. The primary outcome evaluation included 445 patients. Over 36 months of evaluation, 3,803 encounters were described. Compared to baseline, HbA1C was reduced by 1.6% (95%CI -1.8, -1.4, p<0.01) after 3-5 months of CVRR care. Reductions in HbA1C persisted at 6-8 months with a reduction of 1.8% ([95%CI -2.0, -1.5] p<0.01). The follow-up losses were 29.5% at 3-5 months and 93.2% at 33-36 months. Our study augments the existing literature by demonstrating the health improvement of pharmacist-managed CVRR clinics. The great proportion of loss to follow-up is a limitation of this study to be considered. Additional studies exploring the expansion of similar models may amplify the public health impact of pharmacist-managed CVRR services in primary care sites.

Association between PNPLA3 rs738409 variant and 5-year estimated glomerular filtration rate decline in post-menopausal women with type 2 diabetes: A panel-data analysis

Background and aimsLittle is known about the relationship between patatin-like phospholipase domain-containing protein-3 (PNPLA3) rs738409 variant and decline in estimated glomerular filtration rate (eGFR) over time in individuals with type 2 diabetes (T2DM). Methods and resultsWe enrolled an outpatient sample of 46 post-menopausal women with T2DM and preserved kidney function at baseline (in 2017), who were followed through 2022. eGFR and albuminuria were measured annually. Genotyping of PNPLA3 rs738409 was performed by TaqMan-based RT-PCR system. Overall, 25 (54.3%) patients had PNPLA3 rs738409 CC (homozygous wild-type) genotype and 21 had CG or GG genotypes. During the 5-year follow-up, the presence of rs738409 CG/GG genotypes was associated with faster eGFR decline (coefficient: −6.55; 95% CI −11.0 to −2.08; p = 0.004 by random-effects panel data analysis). This association remained significant even after adjustment for 5-year changes in age, hemoglobin A1c, hypertension status, albuminuria and use of sodium-glucose co-transporter-2 inhibitors or glucagon-like peptide-1 receptor agonists. ConclusionsThis pilot study suggests that in post-menopausal T2DM women with preserved kidney function at baseline, the risk allele (G) of PNPLA3 rs738409 is associated with a faster eGFR decline during a 5-year follow-up, independent of annual changes in common renal risk factors and use of certain glucose-lowering medications.

The Beneficial Effects of a Multispecies Probiotic Supplement on Glycaemic Control and Metabolic Profile in Adults with Type 1 Diabetes: A Randomised, Double-Blinded, Placebo-Controlled Pilot-Study.

In this pilot-study, the effects of a multispecies probiotic supplement on glycaemic control and metabolic parameters in adults with type 1 diabetes (T1DM) were explored. A total of 50 T1DM patients were enrolled and randomly placed into a group receiving capsules containing multi-probiotic strains (Bifidobacterium longum, Lactobacterium bulagricumi, Streptococcus thermophilus) and insulin (probiotics group, n =27) or a group receiving a placebo and insulin (placebo group, n = 23). All patients underwent continuous glucose monitoring at baseline and 12 weeks after intervention. The primary outcomes were determined by comparing factors such as changes in fasting blood glucose (FBG) and haemoglobin A1c (HbA1c) between the groups. Probiotic supplementation significantly reduced FBG (-1.0±4.7 vs 1.8±4.7mmol/L, p = 0.048), 30 min postprandial glucose (-0.5 ± 4.6 vs 1.9 ± 3.3 mmol/L, p = 0.0495), and low-density lipoprotein cholesterol (-0.07 ± 0.45 vs 0.32±0.78mmol/L, p =0.0413), compared with the placebo. Althoughnotstatisticallysignificant, probiotic supplementation also lowered HbA1c levels by 0.49% (-5.33 mmol/mol, p = 0.310). Besides, no significant difference was observed in the continuous glucose monitoring (CGM) parameters between the two groups. Further subgroup analysis revealed a significant reduction in mean sensor glucose (MSG; -0.75 (-2.11, 0.48) mmol/L vs 1.51 (-0.37, 2.74)mmol/L, p = 0.010) and time above range (TAR; -5.47 (-20.1, 3.04)% vs 18.9 (-1.11, 35.6)%, p =0.006), as well as an greater improvement in the time in range (TIR; 9.32 (-4.84, 16.6)% vs -19.9 (-31.4, 0.69)%, p =0.005) in male patients than female patients in the probiotics group. Multispecies probiotics exerted beneficial effects on fasting and postprandial glucose and lipid profiles in adult T1DM patients, especially for male patients and those with higher baseline FBG levels.

Abstract P142: Mediation of Effects of a Low-Carbohydrate Dietary Intervention on Hemoglobin A1c Through Weight: A Randomized Clinical Trial

Introduction: Low-carbohydrate diets lead to weight loss and improvement in hemoglobin A1c and other cardiometabolic outcomes. However, there is limited research on how much of the glycemic effects of low-carbohydrate diets are mediated by weight loss. Hypothesis: The effect of a low-carbohydrate dietary intervention on hemoglobin A1c would be mediated by weight loss. Methods: We conducted a 6-month randomized clinical trial on the effects of a low-carbohydrate diet intervention (target &lt;40 net grams of carbohydrates during first 3 months; &lt;60 net grams for months 3-6) compared with usual diet on hemoglobin A1c. Participants were 40-70 years with untreated HbA1c of 6.0-6.9%. In post hoc mediation analyses, we examined whether the effect of the intervention on 6-month change in hemoglobin A1c was mediated by 3-month weight, after adjustment for age, sex, race, education, and baseline levels of behavioral and cardiometabolic risk factors. We used the causal framework approach described by and the SAS macro developed by Valeri and VanderWeele. Results: 150 participants (mean [SD] age 59 [8] years; 108 [72%] female; 88 [59%] Black) were randomized to either the low-carbohydrate diet intervention (75 participants) or usual diet (75 participants) arm. Mean (SD) HbA1c was 6.16% (0.30%) at baseline. Six-month data was collected on 142 participants (95%). Compared with the usual diet arm, the low-carbohydrate diet intervention arm had significantly greater 6-month reduction in HbA1c (net difference, -0.23% [95% CI, -0.32 to -0.14%]) and body weight (-5.9 kg [95% CI, -7.4 to -4.4 kg]). In mediation analyses, 59% of the total effect of intervention on 6-month change in hemoglobin A1c was mediated by weight measured at 3 months (Table). Conclusions: In mediation analyses, a substantial proportion (59%) of the total effect of intervention on 6-month change in hemoglobin A1c was mediated through weight measured at 3 months. Future research should further explore contributions of weight loss to reductions in glycemia in other populations.