Change In A1c Research Articles

Efficacy and Safety of Sodium Glucose Cotransporter-2 (SGLT2) Inhibitors in Patients With Diabetes and Chronic Kidney Disease (CKD): A Meta-analysis of Randomized Control Trials.

The current meta-analysis aims to assess the efficacy and safety of sodium glucose cotransporter 2 (SGLT2) inhibitors in individuals with diabetes and chronic kidney disease (CKD). The current meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A systematic search was conducted to identify all relevant studies related to the efficacy and safety of SGLT2 inhibitors in individuals with diabetes and CKD. The search was undertaken in PubMed, EMBASE, and Cochrane Library from January 2000 to September 2022. The primary efficacy outcome assessed in the current meta-analysis included major adverse cardiovascular events (MACE). Other efficacy outcomes included all-cause mortality and change in hemoglobin A1c (HbA1c) (%). Safety outcomes included serious adverse events, acute kidney injury, hypoglycemia, and hyperkalemia. In total 11 articles met the inclusion criteria and were included in the final analysis enrolling 27520 patients (14491 in the SGLT2 inhibitors and 13029 in the placebo group). The findings of this meta-analysis have shown that the risk of MACE and all-cause mortality was significantly lower in patients receiving SGLT2 inhibitors. Additionally, Hb1AC change was also significantly greater in SGLT2 inhibitors group. In relation to safety outcomes, serious adverse events, risk of acute kidney injury, and hyperkalemia were significantly lower in the SGLT2 inhibitors group. The SGLT2 inhibitors significantly decreased the risk of major cardiovascular events and all-cause mortality in patients with CKD and diabetes. Furthermore, SGLT2 inhibitor is also effective in reducing Hb1Ac levels in patients.

A feasibility pilot trial of a peer-support educational behavioral intervention to improve diabetes medication adherence in African Americans

BackgroundAfrican Americans are twice as likely to die from diabetes, compared to other racial and ethnic groups in the USA. Poor adherence to diabetes medications is common among African Americans and contributes to these disproportionally worse outcomes. A pilot study was conducted to determine the feasibility and acceptability of a peer-supported intervention targeting diabetes and medication beliefs, communication, and self-efficacy skills to enhance medication adherence among African Americans with type 2 diabetes.MethodsBased on the extended self-regulatory model and information-motivation-behavioral skills model, this intervention was piloted using a single group pre/post-intervention study design at two sites. Seventeen African Americans who self-reported as adherent to diabetes medicines (ambassadors) were paired with 22 African Americans with self-reported poor medication adherence (buddies). Feasibility outcomes evaluated recruitment, retention, and intervention adherence. Measures assessed at baseline and 1-month post-intervention included glycemic control (hemoglobin A1c), self-reported medication adherence, diabetes beliefs, concerns about diabetes medicines, and diabetes self-efficacy. Wilcoxon signed-rank tests assessed for differences in mean scores of outcome variables at baseline compared with a 3-month follow-up. Semi-structured 60-min interviews were conducted with each buddy to explore their acceptability of the intervention. To ensure the rigor of the qualitative data, we focused on analytic criteria such as credibility, confirmability, and transferability.ResultsMost buddies and ambassadors were female and about 56 years old. Feasibility outcomes included recruitment success rates of 73% for buddies and 85% for ambassadors relative to our goals. Retention rate for hemoglobin A1c and medication adherence outcome assessment was 95% for buddies. Both buddies and ambassadors had excellent intervention adherence, with buddies having a mean attendance of 7.76 out of 8 sessions/phone calls and ambassadors completing > 99% of the 105 intervention calls with Buddies. Results showed a signal of change in hemoglobin A1c (effect size = 0.14) and medication adherence (effect size = 0.35) among buddies, reduction in buddies’ negative beliefs about diabetes and an increase in necessity beliefs of diabetes medicines. Summative interviews with buddies showed they valued ambassador’s encouragement of self-management behaviors.ConclusionsResults support conduct of an efficacy trial to address medication adherence for African Americans with type 2 diabetes using a peer-supported tailored intervention.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT04028076.

Association of community-level food insecurity and glycemic control among pregnant individuals with pregestational diabetes

AimTo evaluate whether pregnant individuals with pregestational diabetes who live in a food-insecure community have worse glycemic control compared to those who do not live in a food-insecure community. MethodsA retrospective analysis of pregnant individuals with pregestational diabetes enrolled in a multidisciplinary prenatal and diabetes care program. The exposure was community-level food insecurity per the Food Access Research Atlas. The outcomes were hemoglobin A1c (A1c) < 6.0 % in early and late pregnancy, and an absolute decrease in A1c ≥ 2.0 % and mean change in A1c across pregnancy. ResultsAmong 418 assessed pregnant individuals with pregestational diabetes, those living in a food-insecure community were less likely to have an A1c < 6.0 % in early pregnancy compared to those living in a community without food insecurity [16 % vs. 30 %; adjusted risk ratio (aRR): 0.55; 95 % CI: 0.33–0.92]. Individuals living in a food-insecure community were more likely to achieve a decrease in A1c ≥ 2.0 % [35 % vs. 21 %; aRR: 1.55; 95 % CI: 1.06–2.28] and a larger mean decrease in A1c across pregnancy [mean: 1.46 vs. 1.00; adjusted beta: 0.47; 95 % CI: 0.06–0.87)]. ConclusionsPregnant individuals with pregestational diabetes who lived in a food-insecure community were less likely to enter pregnancy with glycemic control, but were more likely to have a reduction in A1c and achieve similar A1c status compared to those who lived in a community without food insecurity. Whether interventions that address food insecurity improve glycemic control and consequent perinatal outcomes remains to be studied.

Metabolic Improvements and Remission of Prediabetes and Type 2 Diabetes: Results From a Multidomain Lifestyle Intervention Clinic

ObjectivesAlthough lifestyle interventions are first-line treatment for individuals living with prediabetes and type 2 diabetes (T2D), they are rarely implemented effectively in routine clinical care. MethodsWe present a retrospective analysis of a 12-month, single-centre, structured multidomain lifestyle intervention clinic offered to individuals living with prediabetes and type 2 diabetes. The intervention consisted of expert-guided educational and nutritional counselling combined with a personalized physical exercise prescription, with the main goal of improving metabolic health and reaching remission. Anthropometric parameters, glucose, basal insulin, glycated hemoglobin (A1C), and lipid levels were measured at baseline and at 3, 6, and 12 months after the lifestyle intervention initiation. Remission of prediabetes and T2D were defined as a return of A1C at 6 months to <6.5% (or <5.7% for prediabetes) and persisting for at least 3 months in the absence of glucose-lowering pharmacotherapy. ResultsAfter a multidomain, expert-guided lifestyle intervention, 117 individuals living with prediabetes and T2D had significantly improved metabolic profiles: Mean weight change at 12 months was −4.9 kg (95% confidence interval [CI], −4.0 to −5.7; p<0.001), and mean change in A1C at 12 months was −0.6% (95% CI, −0.4 to −0.7; p<0.001). A substantial proportion of individuals reached the criteria for remission (20% among participants with prediabetes and 12% among those with T2D). ConclusionsThe results of this study suggest that prioritizing lifestyle changes in a multifaceted, progressive, 12-month intervention in this population improves anthropometric and insulin resistance measures, and has the potential to normalize metabolic values, even to the point of reaching the criteria of remission.

PSUN181 Diabetes-related outcomes following use of basal-bolus insulin vs. premixed insulin in a VA population with Type 2 diabetes: A retrospective chart review.

Abstract Background Treatment of diabetes mellitus (DM) with basal bolus insulin analogs (BB) requires up to five injections a day. The complexity of BB therapy may adversely influence patient compliance. A simpler and cheaper regimen with premixed insulin (PM) typically involves two injections a day but is perceived to be less effective in managing DM. The purpose of this research project was to compare DM-related outcomes between BB regimens (insulin detemir or glargine plus aspart, lispro or regular insulin) and PM insulin regimens (70/30 insulin NPH/regular) among our veteran population with type 2 DM. Research design and Methods This is a retrospective chart review that included 140 veterans (70 in BB group and 70 in PM group) with type2 DM. Subjects aged 18 years or above and those having A1C level ≥ 8% were included. Subjects with type 1 diabetes or who switched their insulin regimen during the follow-up period were excluded. The included subjects were followed for a year, after the start of respective insulin therapies to examine change in A1c (primary outcome) levels across groups. Data were analyzed using Chi-square/Fisher exact tests and logistic regression. All analyses were conducted using SPSS version 27 and SAS9.4. Results Out of 140 enrolled subjects, 94% were males with average age of 65.7 ± 10.1 years and DM duration of 12.9±9 years. There was no significant difference in age, gender, baseline A1c, BMI or duration of DM between the two groups. Following treatment initiation, there was no statistically significant difference between the BB and PM insulin groups for change in A1c (-1.9±1.8 vs -2.1±1.9%, p = 0.3) or for the rate of hypoglycemia (30% vs 21.4%, p = 0.3) respectively. Although the average BMI increased in both groups, the change was similar for both BB and PM groups (0.84±3.1 vs 0.4±2.2 kg/m2 respectively, p = 0.2). A logistic regression controlling for the confounders of hypoglycemia, found that the type of insulin used did not predict the development of hypoglycemia [OR 0.594, (0.251, 1.404)]. Conclusion There were no significant differences in A1c change, rate of hypoglycemia, and change in body mass index in patients treated with either BB or PM insulin among our study population. These results suggest that PM insulin is equally effective as the BB and its use can potentially improve patient compliance and reduce the cost of care. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.

ODP164 Asynchronous Diabetes Virtual Interventions, Support, &amp; Empowerment (ADVISE) Program to Improve Glycemic Control in High-Risk Youth and Adults with Type 1 Diabetes

Abstract Background The use of personalized text messages to support and empower people with type 1 diabetes(T1D) has the potential to improve glycemic control, particularly in the parts of the world where access to high-quality diabetes care remains limited. Here, we examine the impact of the "Asynchronous Diabetes Virtual Interventions, Support, &amp; Empowerment" (ADVISE) program on glycemic control in high-risk youth and young adults with T1D in Saudi Arabia. Methods We retrospectively coded all text messages, exchanged between healthcare professionals(HCPs) and patients with T1D enrolled in the ADVISE program between January and October 2020. Messages were categorized according to their direction ("outgoing" from HCPs to patients versus "incoming" from patients to HCPs) and type (problem-solving, coaching, encouraging, rapport building, strategic questioning, or appointment scheduling-related texts). Then, we examined: a) the change in patients’ A1C and CGM metrics from pre- to post-enrollment in the ADVISE program and b) the association between the type, direction, and frequency of the texts and change in glycemic control. Results The ADVISE program enrolled 74 high-risk youth and young adults with T1D [58% women, with a median(IQR) age of 20(16,27) years old and duration of diabetes of 8(4,14) years and an average pre-enrollment A1C of 10.1%]. Out of the 3,457 texts, exchanged between HCPs and patients with T1D, 2642 (76%) were outgoing from HCPs to patients, 815(24%) were incoming from patients to HCPs, and 2,203(83% of the outgoing texts) were coaching-related. Overall, A1C, TIR, and TAR have significantly improved throughout the study period. Patients who received virtual adjustments of insulin doses as part of the ADVISE program had significant improvements in TIR (from baseline: 41% to Month-3: 53% to Month-6: 55%) and TAR (Baseline: 52% to Month-3: 39% to Month-6: 37%). Whereas patients who received no virtual adjustments of insulin dose had no significant changes in any of the glycemic metrics. When examined by frequency of incoming texts, patients who sent ≥1 text/month to their HCPs noted significant improvements in TIR, TAR, and A1C, whereas those who sent &amp;lt;1 text/month noted no significant changes in any of the glycemic metrics. Similarly, A1C has significantly improved (from 9.6% to 8.6%, p&amp;lt;0. 01) in patients who received ≥8 texts/month from their HCPs, whereas those who received &amp;lt;8 texts/month had no significant change in A1C (9. 05% to 9%, p=0.24). Conclusion Our ADVISE program applies the four principles "Ps" of precision medicine to diabetes care (Predictive, Preventive, Personalized, and Participative) and is associated with significant improvements in various glycemic metrics in high-risk youth and young adults with T1D. Our findings have implications to mitigate the health- and economic- burden of diabetes, particularly in parts of the world where diabetes is highly prevalent and access to high-quality care is limited. Presentation: No date and time listed

LBSUN151 The Impact Of The COVID-19 Pandemic On Diabetes &amp; Weight Management

Abstract COVID-19 was declared a pandemic on 03/11/2020 by the WHO and the State of Minnesota issued a stay-at-home mandate on 03/27/2020. While individuals with diabetes mellitus (DM) and severe obesity were identified as more likely to be infected and at higher risk of complications from COVID-19, access to outpatient clinics was limited during this time, with a shift towards telemedicine. In June 2020, the WHO reported that in 49% of 155 surveyed countries, diabetes treatment was disrupted. However, the impact on diabetes care in the US was poorly characterized, particularly among underserved groups. Aim To study the impact of the pandemic and telemedicine on medical treatment of patients with DM at Hennepin County Medical Center (HCMC), a teaching hospital in Minneapolis, Minnesota serving a diverse inner-city population. Methods Retrospective cohort study design with 710 participants. We compared A1C and weight changes before and after the pandemic. The study group (n=344) included patients, 18 years of age or older, with DM Type 1 or Type 2 who presented for an HCMC diabetes clinic visit between 12/2019-02/2020 and a follow up visit between 6/2020 -10/2020. The control group (n=366) included patients with DM who presented for an HCMC diabetes clinic visit between 12/2018 - 02/2019 and a follow up visit between 6/2019 - 10/2019. Results There was a significantly lower A1C reduction in the cases as compared to the control group (-0.34 [CI -0.59, -0. 09] p value 0. 007), adjusted for inpatient admission, continuous glucose monitor use, diabetes type 1, insurance status, insulin use, GLP-1 agonist use, smoking status and hypertension. Weight reduction during the pandemic was lower as compared to the control but did not achieve statistical significance (-0.96 [CI -3. 02, 1. 09] p value 0.36). Telemedicine use among the study group resulted in an insignificant A1c reduction of -0.24 (p value 0.23). There was statistically significant weight gain of 0.42 among the group who used telemedicine, while nonusers had weight loss of -3.24 (p value 0. 04). Telemedicine users had higher insulin utilization (92.6% vs 83.3%, p value 0. 017) and lower self-pay and Medicaid enrollment (1.7% vs 5.9% and 33.8% vs 40.6% respectively, p value 0. 011) as compared to nonusers. Conclusion The COVID-19 pandemic led to a significant deterioration of glycemic control but had no effect on weight. Telemedicine use led to A1c reduction but did not reach statistical significance potentially due to the small sample size and short duration of follow up. Significant weight gain was observed in telemedicine users influenced by greater insulin use and insurance coverage as compared to weight loss amongst nonusers which may be attributed to socioeconomic barriers such as food scarcity among those without the means to access telemedicine. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.

Impact of pharmacist‐led chronic disease management in a Federally Qualified Health Center

AbstractIntroductionThere is growing interest in pharmacist‐led chronic disease management (CDM) for underserved populations such as those treated within Federally Qualified Health Centers (FQHCs).ObjectivesTo assess the impact of adding a pharmacist to the healthcare team within an FQHC for CDM.MethodsThis is a non‐randomized, 6‐month prospective pilot study whereby any member of the healthcare team could refer a patient to receive CDM from a pharmacist. The primary outcome is change in disease control as measured by primary clinical endpoint. Primary clinical endpoints for the most common disease states include glycated hemoglobin (A1C) for type 2 diabetes mellitus (T2DM), systolic blood pressure (SBP) for hypertension, Generalized Anxiety Disorder‐7 (GAD‐7) score for anxiety, and Patient Health Questionnaire‐9 (PHQ‐9) score for depression. Primary clinical endpoints are compared using a paired t test for the modified intention‐to‐treat population. Secondary outcomes include change in self‐reported health and healthcare utilization and difference in satisfaction with care between the primary care provider (PCP) and pharmacist.ResultsThree hundred patients were enrolled of whom 199 were included. Most patients were referred by their PCP. Statistically significant differences in the mean primary endpoint were observed for all disease states with at least 20 participants, including T2DM (n = 96, change in A1C ‐2.1%, P &lt; 0.001), hypertension (n = 32, change in SBP ‐29.7 mmHg, P &lt; 0.001), anxiety (n = 25, change in GAD‐7 score − 7, P &lt; 0.001), and depression (n = 22, change in PHQ‐9 score −11.1, P &lt; 0.0001). While statistically significant changes in self‐reported healthcare and healthcare utilization were not observed, patients were more satisfied with care.ConclusionWhen provided with prescriptive authority and working within an interdisciplinary primary care team, pharmacists were able to impact clinical and humanistic outcomes in the FQHC, leading to improved CDM for a variety of illnesses. More studies should be conducted to validate these results in other settings.

Efficacy of Control-IQ Technology in a General Endocrine Clinic

ObjectiveRecent advances in technology have allowed for the expanded use of hybrid closed-loop insulin pump therapy and automated insulin delivery systems for the management of diabetes mellitus. We assessed the outcomes of introducing Tandem t:slim X2 with the Control-IQ technology in a general endocrine clinic. MethodsData from 66 adults with type 1 (n = 61) and type 2 (n = 5) diabetes mellitus were aggregated for analysis. Patients were either transitioned from traditional insulin pump therapy or multiple daily injection therapy to Tandem t:slim X2 with the Control-IQ technology from January 2020 to June 2021. The assessed clinical end points included changes in time below range, time above range, and time in target range. Changes in hemoglobin A1C before and after Control-IQ technology implementation were noted. The primary outcome was a change in time in target range with the Control-IQ technology. ResultsThere was a significant increase in time in target range when comparing pre- and post–Control-IQ technology (49.5% vs 63.3%, P < .0003) values. There was a reduction in time above range (46.8% vs 34.9%, P < .0013), a decrease in time below range (4.0% vs 1.7%, P = .017), and a decrease in hemoglobin A1C after transitioning to the Control-IQ technology (7.7% [61 mmol/mol] vs 7.1% [54 mmol/mol], P < .017). The patient dropout rate was low (7%). ConclusionThe Control-IQ technology system was effective in reducing hyperglycemia while increasing time in target range and decreasing hypoglycemia. This technology is a useful and effective addition to the growing number of automated insulin delivery systems. The clinical outcomes mirror the results found in the key adult pivotal trials.

Feasibility of a comprehensive medication review to improve medication use for patients with cancer and comorbid conditions

PurposeA focus on oral medications for patients receiving care from both oncologists and primary care providers elicits an opportunity for improvement in patient outcomes. The purpose of this pilot study was to explore the feasibility and appropriateness of a comprehensive medication review (CMR) by a primary care pharmacist in a population of patients with cancer and chronic conditions.MethodsAdult patients who received both cancer and primary care at Michigan Medicine, received active systemic cancer treatment, and had a comorbid condition of diabetes, hypertension, chronic heart failure, depression, and/or anxiety were eligible to receive a CMR by the primary care clinical pharmacist. Data collected included number eligible for the CMR (feasibility), patient demographics, medication-related problems (MRPs) and medication interventions (appropriate), number of patients requiring follow-up with the clinical pharmacist or physician, and pre/post-intervention changes in A1c and BP, as applicable.ResultsOf the 96 patients that met inclusion criteria, 55 patients (57%) received a CMR. Pharmacists provided 66 instances of patient education and identified 22 medication-related problems (MRPs) in 15 (27%) of patients. After CMRs were completed, 22 patients (40%) were referred to primary care pharmacists or physician providers for ongoing care.ConclusionA CMR was feasible and appropriate for patients with chronic conditions receiving treatment for cancer.

Meeting the needs of rural veterans through rapid implementation of pharmacist-provided telehealth management of diabetes during the COVID-19 pandemic.

BackgroundThe rapid implementation of telehealth care due to the COVID-19 pandemic allowed clinical pharmacist practitioners (CPPs) within the Veterans Health Administration (VA) to continue to provide diabetes management to Veterans with healthcare disparities, including rural Veterans.ObjectivesThis project aimed to describe the change in hemoglobin A1c (HbA1c) in telehealth naïve Veterans with types 1 or 2 diabetes mellitus (DM) before and after the rapid implementation of CPP-provided telehealth DM management due to the COVID-19 pandemic. The project also sought to describe potential healthcare disparities which may be addressed by the increase in telehealth use and the impact of metformin sustained action (SA) recalls.MethodsAnalysis included patients receiving face-to-face DM-focused visits with a CPP prior to the COVID-19 pandemic (06/01/2019 – 12/01/2019) who transitioned to telehealth care via telephone or VA Video Connect (VVC) during the COVID-19 pandemic (06/01/2020 – 12/01/2020). One or more HbA1c readings within each timeframe was required for inclusion. Patients were excluded if previously enrolled in VA telehealth DM management.ResultsThe rapidly implemented telehealth management of DM provided by VA CPPs was observed to maintain or improve HbA1c control in 84.2% of patients. During the same timeframe, 10.9% of patients were taken off metformin SA secondary to national drug recalls. In total, 76% of patients were from rural communities and over 52% of patients traveled greater than 50 miles round-trip to receive face-to-face DM care prior to the pandemic.ConclusionGlycemic control was improved or maintained for a majority of patients who were rapidly converted to pharmacist-provided telehealth DM management during the COVID-19 pandemic. A large majority of rural patients were reached as a result of CPP-provided telehealth care. This provides evidence to support the continued widespread telehealth utilization to effectively manage DM and reach Veterans with healthcare disparities, particularly rural communities.

Comparison of A1c Reduction, Weight Loss, and Changes in Insulin Requirements With Addition of GLP-1 Agonists vs SGLT-2 Inhibitors in Patients Using Multiple Daily Insulin Injections

Objective: To determine whether Glucagon-Like Peptide 1 (GLP-1) agonists or Sodium Glucose Transporter 2 (SGLT-2) inhibitors result in greater A1c reduction, weight loss, and reduction of insulin requirements in veterans using multiple daily doses of insulin. Methods: This retrospective, single-site, cohort study included patients of VA Eastern Kansas Health Care System with a diagnosis of Type II Diabetes utilizing multiple daily dose insulin and an SGLT-2 inhibitor or GLP-1 agonist. SAS Enterprise Guide was utilized to complete a multivariate analysis of variance to evaluate all outcomes. Key Findings: 150 patients met selection criteria. The GLP-1 group averaged a .65% reduction in A1c compared to a 1.05% reduction in the SGLT-2 group (P = .1397). The Basal insulin dose was reduced by 5.5 units in the GLP-1 group vs 2.45 units in the SGLT-2 group (P = .3132), and 7.12 units vs 8.14 units respectively for short-acting insulin (P = .8170). The resulting weight reduction was 4.1 Kg in the GLP-1 group compared to 3.6 Kg in the SGLT-2 group (P = .6993). Conclusion: The results suggest there is not a statistically significant difference in changes to A1c, insulin requirements, or weight after 1 year of treatment with an SGLT-2 vs GLP-1 in patients using multiple daily insulin injections.

Feasibility and effectiveness of self-monitoring of blood glucose among insulin-dependent patients with type 2 diabetes: open randomized control trial in three rural districts in Rwanda

BackgroundThe prevalence of type 2 diabetes in sub Saharan Africa (SSA) has been on the rise. Effective control of blood glucose is key towards reducing the risk of diabetes complications. Findings mainly from high-income countries have demonstrated the effectiveness of self-monitoring of blood-glucose (SMBG) in controlling blood glucose levels. However, there are limited studies describing the implementation of SMBG in rural SSA. This study explores the feasibility and effectiveness of implementing SMBG among patients diagnosed with insulin-dependent type 2 diabetes in rural Rwanda.MethodsParticipants were randomized into intervention (n = 42) and control (n = 38) groups. The intervention group received a glucose-meter, blood test-strips, log-book, waste management box and training on SMBG in addition to usual care. The control group continued with their usual care consisting of, routine monthly medical consultation and health education. The primary outcomes were adherence to the implementation of SMBG (testing schedule and recording data in the log-book) and change in hemoglobin A1c. Descriptive statistics and a paired t-test were used to analyze the primary outcomes.ResultsIn both the intervention and control arms, majority of the participants were female (59.5% vs 52.6%) and married (71.4% vs 73.7%). Most had at most a primary level education (83.3% vs. 89.4%) and were farmers (54.8% vs. 50.0%). Among those in the intervention group, 63.4% showed good adherence to implementing SMBG based on the number of tests recorded in the glucose meter. Only 20.3% demonstrated accurate recording of the glucose level tests in log-books. The mean difference of the HbA1C from baseline to six months post-intervention was significantly better among the intervention group -0.94% (95% CI -1.46, -0.41) compared to the control group 0.73% (95% CI -0.09, 1.54) p < 0.001.ConclusionOur study showed that among patients with insulin-dependent type 2 diabetes residing in rural Rwanda, SMBG was feasible and demonstrated positive outcomes in improving blood glucose control. However, there is need for strategies to enhance accuracy in recording blood glucose test results in the log-book.Trial registrationThe trial was registered retrospectively on the Pan African Clinical Trial Registry, on 17th May 2019. The registration number is PACTR201905538846394.

Evaluating implementation of Diabetes Self-Management Education in Maryland County, Liberia: protocol for a pilot prospective cohort study

IntroductionAchieving glycaemic targets for people living with diabetes (PLWD) is challenging, especially in settings with limited resources. Programmes need to address gaps in knowledge, skills and self-management. Diabetes Self-Management Education...

Association between hemoglobin A1C response to glucagon-like peptide-1 receptor agonists and hemoglobin A1C and weight outcomes post-bariatric surgery

Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are a common treatment for type 2 diabetes mellitus (T2D). Endogenous glucagon-like peptide-1 secretion is a proposed mediator of T2D remission following bariatric surgery. We evaluated the association between preoperative response to GLP-1RAs and T2D outcomes following bariatric surgery. Our institution's bariatric surgery database was queried for patients with T2D who had taken a GLP-1RA prior to Roux-en-Y gastric bypass (N = 38) or vertical sleeve gastrectomy (N = 9). Response to GLP-1RAs was defined as change in hemoglobin A1C from initiation of therapy to ∼6 months. Postoperative outcomes included A1C and weight loss at 6 months (N = 44), 1 year (N = 44) and 2 years (N = 38) following surgery. The association between GLP-1RA response and postoperative outcomes was evaluated using multivariable generalized linear mixed models adjusted for postoperative time point, A1C prior to initiation of GLP-1RA, weight and surgery type. Mean A1C at initiation of therapy was 8.3 ± 1.4% and decreased by 1.1 ± 1.5% on GLP-1RA treatment. Greater response to GLP-1RA adjusted for initial A1C was correlated with reduced A1C at 6 months (r = 0.38, p = 0.02) and 2 years (r = 0.42, p = 0.03) but not weight loss following bariatric surgery. Every 1% decrease in A1C on GLP-1RA was associated with 0.30 ± 0.10% reduction in postoperative A1C and doubled odds of normoglycemia with A1C<5.7% (odds ratio: 2.00, 95% confidence interval: 1.12–3.45). Our findings offer preliminary evidence for a potential use of GLP-1RAs in predicting glycemic outcomes following bariatric surgery in patients with T2D. Further studies are needed to continue investigating this relationship. • GLP-1 is a potential mediator of post-bariatric surgery diabetes remission. • Preoperative GLP-1R agonist response is associated with A1C reduction post-bariatric surgery. • No association between GLP-1R agonist response and postoperative weight loss was found. • GLP-1R agonist response may be a predictor of diabetes remission following surgery.

Testing a very low-carbohydrate adaption of the Diabetes Prevention Program among adults with prediabetes: study protocol for the Lifestyle Education about prediabetes (LEAP) trial

BackgroundThe Center for Disease Control and Prevention’s National Diabetes Prevention Program (NDPP) aims to help individuals with prediabetes avoid progression to type 2 diabetes mellitus (T2DM) through weight loss. Specifically, the NDPP teaches individuals to follow a low-fat, calorie-restricted diet and to engage in regular physical activity to achieve ≥ 5% body weight loss. Most NDPP participants, however, do not achieve this weight loss goal, and glycemic control remains largely unchanged. One promising opportunity to augment the NDPP’s weight loss and glycemic effectiveness may be to teach participants to follow a very low-carbohydrate diet (VLCD), which can directly reduce post-prandial glycemia and facilitate weight loss by reducing circulating insulin and enabling lipolysis. To date, there have been no high-quality, randomized controlled trials to test whether a VLCD can prevent progression to T2DM among individuals with prediabetes. The aim of this study is to test the effectiveness of a VLCD version the NDPP (VLC-NDPP) versus the standard NDPP. We hypothesize the VLC-NDPP will demonstrate greater improvements in weight loss and glycemic control.MethodsWe propose to conduct a 12-month, 1:1, randomized controlled trial that will assign 300 adults with overweight or obesity and prediabetes to either the NDPP or VLC-NDPP. The primary outcome will be glycemic control as measured by change in hemoglobin A1c (HbA1c) from baseline to 12 months. Secondary outcomes will include percent body weight change and changes in glycemic variability, inflammatory markers, lipids, and interim HbA1c. We will evaluate progression to T2DM and initiation of anti-hyperglycemic agents. We will conduct qualitative interviews among a purposive sample of participants to explore barriers to and facilitators of dietary adherence. The principal quantitative analysis will be intent-to-treat using hierarchical linear mixed effects models to assess differences over time.DiscussionThe NDPP is the dominant public health strategy for T2DM prevention. Changing the program’s dietary advice to include a carbohydrate-restricted eating pattern as an alternative option may enhance the program’s effectiveness. If the VLC-NDPP shows promise, this trial would be a precursor to a multi-site trial with incident T2DM as the primary outcome.Trial registrationNCT05235425. Registered February 11, 2022.

Addressing Therapeutic Inertia: Development and Implementation of an Electronic Health Record-Based Diabetes Intensification Tool.

To assess whether an electronic health record (EHR)-based diabetes intensification tool can improve the rate of A1C goal attainment among patients with type 2 diabetes and an A1C ≥8%. An EHR-based tool was developed and sequentially implemented in a large, integrated health system using a four-phase, stepped-wedge design (single pilot site [phase 1] and then three practice site clusters [phases 2-4]; 3 months/phase), with full implementation during phase 4. A1C outcomes, tool usage, and treatment intensification metrics were compared retrospectively at implementation (IMP) sites versus nonimplementation (non-IMP) sites with sites matched on patient population characteristics using overlap propensity score weighting. Overall, tool utilization was low among patient encounters at IMP sites (1,122 of 11,549 [9.7%]). During phases 1-3, the proportions of patients achieving the A1C goal (<8%) were not significantly improved between IMP and non-IMP sites at 6 months (range 42.9-46.5%) or 12 months (range 46.5-53.1%). In phase 3, fewer patients at IMP sites versus non-IMP sites achieved the goal at 12 months (46.7 vs. 52.3%, P = 0.02). In phases 1-3, mean changes in A1C from baseline to 6 and 12 months (range -0.88 to -1.08%) were not significantly different between IMP and non-IMP sites. Times to intensification were similar between IMP and non-IMP sites. Utilization of a diabetes intensification tool was low and did not influence rates of A1C goal attainment or time to treatment intensification. The low level of tool adoption is itself an important finding highlighting the problem of therapeutic inertia in clinical practice. Testing additional strategies to better incorporate, increase acceptance of, and improve proficiency with EHR-based intensification tools is warranted.

Time in range following flash glucose monitoring: Relationship with glycaemic control, diabetes-related distress and resource utilisation in the Association of British Clinical Diabetologists national audit.

The aim of this study was to understand the relationship between time in range (TIR) achieved using the isCGM with changes in glycaemic control, diabetes-related distress (DRD) and resource utilisation in people living with diabetes. Clinicians from 106 National Health System (NHS) UK hospitals submitted isCGM user baseline and follow-up data in a web-based tool held within the UK NHS network. Linear regression analysis was used to identify the relationship between follow-up glucose TIR (3.9-10 mmol/L) categories (TIR% 50-70 and TIR% >70) with change in haemoglobin A1c (HbA1c), DRD and Gold score (measure of hypoglycaemia unawareness, where a score ≥4 suggests impaired awareness of hypoglycaemia). Of 16,427 participants, 1241 had TIR follow-up data available. In this cohort, the mean TIR was 44.8% (±22.5). With the use of isCGM, at 7.9months mean follow-up, improvements were observed in HbA1c (-6.9 [13.5]mmol/mol, p < 0.001), Gold score (-0.35 [1.5], p < 0.001) and Diabetes Distress Screening (-0.73 [1.23], p < 0.001). In the regression analysis restricted to people living with type 1 diabetes, TIR% 50-70 was associated with a -8.9 mmol/mol (±0.6, p < 0.001) reduction in HbA1c; TIR% >70 with a -14 mmol/mol (±0.8, p < 0.001) reduction in HbA1c. Incremental improvement in TIR% was also associated with significant improvements in Gold score and DRD. TIR% >70 was associated with no hospital admissions due to hypoglycaemia, hyperglycaemia/diabetic ketoacidosis, and a 60% reduction in the paramedic callouts and 77% reduction in the incidence of severe hypoglycaemia. In a large cohort of UK isCGM users, we demonstrate a significant association of higher TIR% with improvement in HbA1c, hypoglycaemia awareness, DRD and resource utilisation.

Impact of SMART Goals on Diabetes Management in a Pharmacist-Led Telehealth Clinic

Background: Although there is evidence demonstrating successful implementation of SMART (specific, measurable, achievable, relevant, time-bound) goals in clinical settings, their impact on improving diabetes control has not been well-established. Objective: The primary objective was to determine the association between setting SMART goals and change in A1c among a Veteran population. Methods: This was an IRB-approved retrospective, case-control study. Patients with Type 2 diabetes mellitus (DM) managed virtually by a Clinical Pharmacy Specialist at a VA Community-Based Outpatient Clinic were eligible for inclusion. The electronic medical record was used to identify patients that set a SMART goal for DM management during the study timeframe. These patients were matched to a similar cohort of patients that did not set a SMART goal. Results: There were 100 patients included in the study. Goal A1c was achieved in 30% of patients in the SMART goal group compared with 24% of patients in the control group. There was a 1.2% reduction in A1c from baseline to 3 months in the SMART goal group vs .85% in the control group (P = .287). The mean number of medication changes per patient was 1.7 in the SMART goal group vs 2.1 in the control group (P = .174). Patients in the SMART goal group set an average of 1.5 SMART goals during the study period. Conclusion: Overall, patients that set SMART goals had clinically meaningful A1c lowering. Setting SMART goals for DM management in agreeable patients during diabetes telehealth visits may lead to fewer medication changes and improved diabetes control.

P8.082: Incidence and Associated Factors With Uncontrolled Hypertension at 12- Months Post-renal Transplantation

Background: Uncontrolled hypertension (HTN) after renal transplantation is not uncommon. However, our center has not studied its incidence and risk factors post kidney transplantation before. Method: A single-center retrospective study of the renal transplant recipients who underwent kidney transplantation between January 2017 to May 2020 with12 months of follow-up. The goal target of hypertension treatment during this retrospective study was <140/90 mmHg as per the published guidelines at that time. We divided patients according to their blood pressure (BP) control at 12 months post kidney transplantation into two groups: controlled BP (≤140/90) and uncontrolled BP(> 140/90). We studied the association between the patients’ demographics and baseline cardiovascular risk factors and uncontrolled HTN 12 months post kidney transplantation. We also studied the association between pretransplant (baseline) cardiovascular imagings and uncontrolled HTN at 12 months. These tests included:(ejection fraction, wall motion abnormalities on echo, calcium scoring, perfusion stress test, cardiac angiogram, and the degree of calcifications on CT of pelvic arteries). Additionally, we studied the changes seen during the first 12 months post kidney transplantation. These included: creatinine change, rejection, weight change, A1C change, post-transplant diabetes, LDL change, PTH change from baseline, and persistent hyperthyroidism. Results: A total of 254 renal transplant recipients were included. 74% were ≥ 30 years, 58% were men, and 80% were living-donor kidney recipients. Preemptive transplantation was 10.1%, PD: 11.5% and HD: 78.4%. At one year, 76 (29.9%) of the patients did not attain the BP goal of 140/90. SBP decreased from baseline to 12 months by -7.2±18.6 mmHg in the group with controlled BP and whereas it increased by 3.5±16.9 mmHg in the group with uncontrolled BP. (P:<0.001). DBP decreased from baseline to 12 months by -4.1±12 mmHg in the group with controlled BP, whereas it increased by 2±13.7 mmHg in the group with uncontrolled BP (P<0.001). Among characteristics and baseline cardiovascular risk factors, factors associated with uncontrolled HTN included age (47 VS 41 years, P:0.008) and DM (P:0.012). Whereas gender, dialysis vintage, preemptive transplantation, type of dialysis (hemodialysis VS peritoneal dialysis), type of transplant (living donor kidney transplant VS deceased donor kidney transplant), and smoking were not different among the two groups. None of the pre-transplant (baseline) cardiovascular imaging findings were associated with having uncontrolled BP >140/90 at 12 months. Similarly, there was no association between uncontrolled HTN and creatinine change from baseline, rejection, weight change, A1C change, post-transplant diabetes, LDL change, PTH change from baseline, and persistent hyperthyroidism. However, higher BMI at 12 months was associated with a higher incidence of uncontrolled HTN (BMI 27.2±5.9 vs. 29.2±5.4, P: 0.013). Multivariate analysis showed that the predictors of uncontrolled blood pressure (>149/90 mmHg) included a higher creatinine (OR=1.016, CI=1.004-1.028. p=0.01) and smoking (OR=3.58, CI=1.001-12.8. p=0.05). Conclusion: At one-year post renal transplantation, about one-third (29.9%) of the renal transplant recipients had uncontrolled hypertension despite multiple BP medications. SBP and DBP significantly trended up from baseline after transplantation in those with uncontrolled hypertension. In contrast, SBP and DBP significantly decreased from baseline after transplantation in those with controlled hypertension. This interesting finding requires further confirmation by a controlled prospective study.