A1C Reduction Research Articles

Factors associated with A1C reduction with GLP-1 agonist or SGLT-2 inhibitor use.

While use of glucagon-like peptide-1 (GLP-1) agonists and sodium-glucose cotransporter-2 (SGLT-2) inhibitors reduces the risk of atherosclerotic cardiovascular disease outcomes and lowers glycosylated haemoglobin (A1C), evidence on patient characteristics associated with clinically relevant A1C reduction is lacking. The objective of this retrospective cohort study was to identify patient characteristics associated with A1C reduction with initial GLP-1 or SGLT-2 use. Patients with type 2 diabetes and a baseline A1C ≥7% who were dispensed a GLP-1 or SGLT-2 between 01/01/10 and 12/31/17 were included. Patients were categorized as having a ≥1% or <1% A1C reduction during the 90-365 days after GLP-1/SGLT-2 initiation. Patient characteristics were collected during the 180 days prior to initiation. Multivariable logistic and linear regression modelling was performed to identify characteristics associated with a ≥1% A1C reduction and absolute change in A1C, respectively. Five hundred and seventy-two patients were included with 261 (46%) and 311 (54%) having and not having an ≥1% A1C reduction. Patients were primarily middle-aged, female, white, non-Hispanic and had a high burden of chronic disease. Characteristics associated with a ≥1% A1C reduction included: GLP-1/SGLT-2 persistence, congestive heart failure comorbidity, phentermine dispensing, care management team (CMT) enrollee and higher baseline A1C. Characteristics associated with absolute A1C reduction included: age, baseline A1C, CMT enrollee, GLP-1/SGLT-2 persistence and a phentermine dispensing. The results of this study provide practitioners with guidance on the patients who are most likely to have a clinically relevant A1C reduction with GLP-1 or SGLT-2 use.

A historical cohort study of glycemic control in patients with concurrent type 2 diabetes and substance use disorder treated in a primary care setting.

Substance use disorder (SUD) is a known barrier to patient-self-management, which can hinder efforts to achieve treatment goals in type 2 diabetes (T2D) when the conditions coexist. Identify the association between SUD and glycemic control in patients with T2D treated in a primary care setting. This retrospective cohort study included patients with T2D treated by providers at family medicine clinics at an academic medical center and its affiliated regional sites from January 2014 to October 2019. Study index date was the first A1c recorded when T2D and SUD diagnoses had both been documented in the medical record. Glycemic control, measured by hemoglobin A1c (A1c), was identified at baseline and over a 12-month follow-up period and was compared between SUD and non-SUD patients. Of 9568 included patients with T2D, 468 (4.9%) had a SUD diagnosis. In 237 SUD and 4334 non-SUD patients with A1c data, mean (SD) baseline A1c was 8.2% (2.5) and 7.9% (2.1), respectively (P = 0.043). A1c reduction was statistically greater in SUD patients than non-SUD patients (-0.31% versus -0.06%, respectively; P = 0.015), although the clinical significance is modest. In a multivariable linear regression analysis, follow-up A1c was lower in the SUD versus non-SUD patients (coefficient -0.184, 95% CI -0.358, -0.010; P = 0.038). Patients with T2D and SUD had higher baseline A1c but this difference was minimized over a 12-month follow-up period. Additional research is warranted to determine long-term glycemic control and barriers to attaining and maintaining glycemic control in patients with T2D and SUD.

Are Chinese Patients with Type 2 Diabetes and a Body Mass Index of 27.5-32.5kg/m2 Suitable for Metabolic Surgery? A One-Year Post-Surgery Study.

IntroductionThe aim of this study was to clarify the efficacy and safety of metabolic surgery in Chinese patients with type 2 diabetes mellitus (T2DM) and a body mass index (BMI) of 27.5–32.5 kg/m2.MethodsA total of 99 patients with T2DM were enrolled in this retrospective cohort study. Of these patients, 53 had a BMI of 27.5–32.5 kg/m2 and had undergone metabolic surgery (n = 21) or were on conventional antidiabetic therapy (n = 32)]; 46 had a BMI ≥ 32.5 kg/m2 and all had undergone metabolic surgery. Primary endpoints included the triple endpoint [hemoglobin A1c < 6.5%, low-density lipoprotein cholesterol (LDL-C) < 2.6 mmol/L, and systolic blood pressure (SBP) < 130 mmHg] and successful weight loss 1 year later. Remission of diabetes, glucose and lipid metabolism, medication usage, and adverse events were evaluated.ResultsOf patients with BMI 27.5–32.5 kg/m2 undergoing metabolic surgery, 33.33% achieved the composite endpoints, and 100% achieved successful weight loss. This result was similar to that in patients with BMI ≥ 32.5 and better than those with BMI 27.5–32.5 kg/m2 receiving conventional antidiabetic therapy. A significant and similar reduction in BMI, waist circumference, SBP, serum LDL-C, hemoglobin A1c, and uric acid, as well as similar frequency postoperative adverse events, were confirmed in both metabolic surgery groups. Patients with BMI 27.5–32.5 kg/m2 who had undergonemetabolic surgery showed more metabolic improvement than those only receiving medications but they experienced more adverse events.ConclusionA BMI cutoff of 27.5 kg/m2 for metabolic surgery may be suitable for Chinese patients with T2DM.

Evaluation of the Addition of Pharmacist Management to a Medication Assistance Program in Patients with Hypertension and Diabetes Resistant to Usual Care

Objective: To evaluate the effect of a medication assistance program and the addition of pharmacist management on clinical outcomes in patients with hypertension and diabetes through an Advanced Pharmaceutical Care program. Methods: This was a prospective quality improvement study on patients with hypertension and/or diabetes resistant to usual care. The primary outcomes were change in A1C, blood glucose, and blood pressure between 3 phases: usual care, free medications, and free medications plus pharmacist management. Secondary outcomes included achievement of A1C, blood glucose, and blood pressure goals as well as pharmacist interventions. Results: Seven patients were included in the study. The mean A1C decreased from 11.3% to 8.3% with free medications (p = 0.28) and from 8.3% to 6.4% with pharmacist management (p = 0.119). Mean blood pressure during usual care, free medications, and pharmacist intervention was 150/87 mm Hg, 148/85 mm Hg, and 125/78 mm Hg, respectively. After pharmacist management, 75% of patients with type 2 diabetes were able to achieve A1C and blood glucose goals, and 71% of patients with hypertension achieved blood pressure <130/80 mm Hg. Conclusions: The Advanced Pharmaceutical Care program allowed pharmacists to identify and overcome patient-specific barriers to care, provide individualized disease state education, and optimize medication management. Medication assistance led to improvements in A1C and blood pressure, but did not affect achievement of disease state goals. Pharmacist involvement in hypertension and diabetes care led to clinically significant reductions in blood pressure and A1C and enabled patients to reach guideline-recommended blood pressure and glycemic goals.

Alterations in Metabolic and Cardiovascular Risk Factors During Critical Training in Wildland Firefighters.

To identify physiologic stressors related to cardiovascular disease via changes in metabolic, inflammatory, and oxidative stress biomarkers during 2 weeks of preseason training in wildland firefighters (WLFFs). Participants were recruited from a local hotshot crew and monitored during preseason training. Fitness was assessed via the Bureau of Land Management fitness challenge. Venipuncture blood was collected on days 1, 4, 8, and 11 and analyzed for changes in a lipid and glucose panel, C-reactive protein, and oxidative stress markers 8-isoprostane (8ISO), 3-nitrotyrosine (3NT), lipid hydroperoxides (LOOH), and protein carbonyls. The high physical demands of training resulted in significant (P < 0.05) reductions in total cholesterol, glucose, and hemoglobin A1c. A main effect for time was observed in 8ISO, 3NT, and LOOH. Alterations in metabolic and oxidative stress markers suggest an acute, high-intensity physical stress during WLFF preseason training.

Treatment of hyperglycemia not associated with NAFLD improvement in children with type 2 diabetes mellitus.

Background and objectivesNonalcoholic fatty liver disease (NAFLD) and type 2 diabetes mellitus (T2DM) have become public health problems in the pediatric population. However, the relationship between these two conditions is not well understood. The primary objective of this study was to assess whether treatment of hyperglycemia in obese, treatment-naive children with type 2 diabetes (T2DM) was associated with an improvement of surrogate markers of NAFLD.Materials and methodsThis retrospective, longitudinal study included 151 obese children with a diagnosis of T2DM (Age: 14 ± 1 years, 72% female children, BMI: 98.6th percentile, and A1c: 10.3 ± 0.2%). Clinical/demographic information was collected before patients started any diabetes treatment and 1 and 3 years after starting metformin and/or insulin therapy.ResultsForty-eight patients (32%) had abnormal ALT/AST (i.e., >40 U/L), suggestive of NAFLD. After 1 year of therapy, there were no significant differences in plasma ALT among patients started on insulin, metformin, or combination: 5±4 vs. −10 ± 3 vs. −2±2 IU/L, respectively, P = .07. Of note, changes in plasma ALT were small, despite a significant reduction of A1c in patients prescribed insulin (alone or with metformin): -2.8 ± 1.0%, P = .01, and −2.7 ± 0.3%, P < .001, respectively. In line with this, no significant correlations were found between changes in A1c and plasma aminotransferases. In contrast, changes in plasma AST/ALT were more strongly associated with BMI changes (r = 0.32, P < .001, and r = 0.19, P = .04, respectively). Similar results were observed after 3 years of follow-up.ConclusionsNonalcoholic fatty liver disease is highly prevalent in obese children with T2DM. Treatment of hyperglycemia with metformin and/or insulin did not result in any significant improvement in surrogate markers of NAFLD (i.e., plasma aminotransferases). While changes in ALT and/or AST may not perfectly reflect histological changes in NAFLD, our findings suggest that the treatment of hyperglycemia per se may not be associated with NAFLD improvement.

A Digital Health Intervention (SweetGoals) for Young Adults With Type 1 Diabetes: Protocol for a Factorial Randomized Trial.

BackgroundMany young adults with type 1 diabetes (T1D) struggle with the complex daily demands of adherence to their medical regimen and fail to achieve target range glycemic control. Few interventions, however, have been developed specifically for this age group.ObjectiveIn this randomized trial, we will provide a mobile app (SweetGoals) to all participants as a “core” intervention. The app prompts participants to upload data from their diabetes devices weekly to a device-agnostic uploader (Glooko), automatically retrieves uploaded data, assesses daily and weekly self-management goals, and generates feedback messages about goal attainment. Further, the trial will test two unique intervention components: (1) incentives to promote consistent daily adherence to goals, and (2) web health coaching to teach effective problem solving focused on personalized barriers to self-management. We will use a novel digital direct-to-patient recruitment method and intervention delivery model that transcends the clinic.MethodsA 2x2 factorial randomized trial will be conducted with 300 young adults ages 19-25 with type 1 diabetes and (Hb)A1c ≥ 8.0%. All participants will receive the SweetGoals app that tracks and provides feedback about two adherence targets: (a) daily glucose monitoring; and (b) mealtime behaviors. Participants will be randomized to the factorial combination of incentives and health coaching. The intervention will last 6 months. The primary outcome will be reduction in A1c. Secondary outcomes include self-regulation mechanisms in longitudinal mediation models and engagement metrics as a predictor of outcomes. Participants will complete 6- and 12-month follow-up assessments. We hypothesize greater sustained A1c improvements in participants who receive coaching and who receive incentives compared to those who do not receive those components.ResultsData collection is expected to be complete by February 2025. Analyses of primary and secondary outcomes are expected by December 2025.ConclusionsSuccessful completion of these aims will support dissemination and effectiveness studies of this intervention that seeks to improve glycemic control in this high-risk and understudied population of young adults with T1D.Trial RegistrationClinicalTrials.gov NCT04646473; https://clinicaltrials.gov/ct2/show/NCT04646473International Registered Report Identifier (IRRID)PRR1-10.2196/27109

Effects of GLP-1 receptor agonists and SGLT-2 inhibitors in heart transplant patients with type 2 diabetes: Initial report from a cardiometabolic center of excellence

Type 2 diabetes mellitus (T2D) is a common comorbidity among patients who have undergone heart transplantation. Recently two classes of glucose-lowering medications (sodium-glucose cotransporter type-2 inhibitors [SGLT-2Is] and glucagon-like-peptide-1 receptor agonists [GLP-1RAs]), have been shown to significantly improve cardiovascular outcomes. There is a paucity of data regarding their use in immunosuppressed patients, with many studies specifically excluding this population. We retrospectively evaluated the safety and efficacy of GLP-1RAs and SGLT-2Is in patients who had undergone orthotopic heart transplant at a high-volume center. Among 21 patients, we found significant weight loss, reductions in insulin use, hemoglobin A1c, and low-density lipoprotein-cholesterol. Moreover, both SGLT-2Is and GLP-1RAs were well tolerated with no adverse events leading to discontinuation of either therapy. While larger studies of patients after solid organ transplant are needed, this small hypothesis-generating study demonstrates that SGLT-2Is and GLP-1RAs appear safe and effective therapies among patients with T2D after heart transplant.

Cardiovascular and renal outcomes with canagliflozin according to baseline diuretic use: a post hoc analysis from the CANVAS Program

AimsThe CANVAS Program identified the effect of canagliflozin on major adverse cardiovascular events (MACE) differed according to whether participants were using diuretics at study commencement. We sought to further evaluate this finding related to baseline differences, treatment effects, safety, and risk factor changes.Methods and resultsThe CANVAS Program enrolled 10 142 participants with type 2 diabetes mellitus and high cardiovascular risk. Participants were randomized to canagliflozin or placebo and followed for a mean of 188 weeks. The primary outcome was major cardiovascular events, a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Secondary outcomes included multiple cardiovascular, renal, and safety events. In this post hoc subgroup analysis, participants were categorized according to baseline use of any diuretic. The effect on outcomes was compared using Cox proportional hazards models, while risk factor changes were compared using mixed‐effect models. At baseline, 4490 (44.3%) participants were using a diuretic. Compared with those not using a diuretic, participants using a diuretic were more likely to be older (mean age ± standard deviation, 64.3 ± 8.0 vs. 62.5 ± 8.3), be female (38.9% vs. 33.4%), and have heart failure (19.6% vs. 10.3%) (all P difference < 0.0001). The effect of canagliflozin on major cardiovascular events was greater for those using diuretic at baseline than for those who were not [adjusted hazard ratio 0.65 (95% confidence interval 0.54–0.78) vs. adjusted hazard ratio 1.13 (95% confidence interval 0.93–1.36), P heterogeneity < 0.0001]. Changes in most risk factors, including blood pressure, body weight, and urine albumin‐to‐creatinine ratio, were similar between groups (all P difference > 0.11), although the effect of canagliflozin on haemoglobin A1c reduction was slightly weaker in participants using compared with not using diuretics at baseline (−0.52% vs. −0.64%, P heterogeneity = 0.0007). Overall serious adverse events and key safety outcomes, including adverse renal events, were also similar (all P heterogeneity > 0.07).ConclusionsParticipants on baseline diuretics derived a greater benefit for major cardiovascular events from canagliflozin, which was not fully explained by differences in participant characteristics nor risk factor changes.

Evaluation of Clinical Outcomes With the V-Go Wearable Insulin Delivery Device in Patients With Type 2 Diabetes.

Uncontrolled type 2 diabetes can lead to a multitude of health complications. Insulin therapy is recommended when patients are unable to reach their A1C goal with oral or noninsulin injectable diabetes medications. This study evaluated the clinical benefits of switching from multiple daily insulin injections to a wearable insulin delivery device (V-Go). A retrospective chart review was conducted on 44 patients who received prescriptions for the V-Go at two family medicine offices. Investigators found a significant reduction in A1C and daily insulin requirements with no impact on weight or BMI.

Rationale and design of a type 2 diabetes prevention intervention for at-risk mothers and children at a Federally Qualified Healthcare Center: EPIC El Rio Families Study Protocol

BackgroundExposure to gestational diabetes mellitus (GDM) is associated with increased risk for type 2 diabetes (T2DM) in mothers, and poor cardiovascular health among offspring. Identifying effective methods to mitigate T2DM risk has the potential to improve health outcomes for mothers with a history of GDM and their children. The goal of the EPIC El Rio Families Study is to implement and evaluate the effects of a 13-week behavioral lifestyle intervention on T2DM risk factors in at-risk mothers and their 8- to 12-year-old children. We describe herein the rationale for our specific approach, the adaption of the DPP-based curriculum for delivery to patients of a Federally Qualified Health Center (FQHC), and the study design and methodology.MethodsThe effects of the intervention on reduction in excess body weight (primary outcome), hemoglobin A1c, blood pressure, and changes in lifestyle behaviors associated with weight trajectory and T2DM risk in mother-child dyads will be evaluated during a 13-week, group randomized trial wherein 60 mothers and their children will be recruited to the intervention or wait-listed control conditions at one of two FQHC locations. Intervention participants (n = 30) will begin the group program immediately, whereas the wait-listed controls (n = 30) will receive a booklet describing self-guided strategies for behavior change. Associated program delivery costs, acceptability of the program to participants and FQHC staff, and potential for long-term sustainability will also be evaluated.DiscussionSuccessful completion in our aims will produce a scalable program with high potential for replication and dissemination, and estimated intervention effects to inform T2DM prevention efforts on families who use the FQHC system. The results from this study will be critical in developing a T2DM prevention model that can be implemented and scaled across FQHCs serving populations disproportionately burdened by T2DM.Trial registrationClinicalTrials.gov NCT03781102; Date of registration: 19 December 2018.

A1C Reduction in Patients Who Declined Pharmacist-Led Diabetes Management Services

Introduction: The purpose of this research is to assess the mean change in A1C associated with patients who declined a pharmacy-led diabetes management program and to evaluate effects of predictor variables on the odds of achieving improved A1C in these patients. Study design: Retrospective, single-center, single-group, cohort study. Methods: Patients 18 years or older with uncontrolled type 2 diabetes (defined as A1C ≥ 9%) who declined pharmacy-led diabetes management services were included in the study. The primary outcome of the study was to assess the mean change in A1C from time of phone call offering pharmacy management services (initial) to last observed A1C (final recorded A1C). Results: A total of 91 patients were included, 46 males and 45 females. The significant reduction in the mean change from baseline A1C to the final measured A1C was −0.59 (95% CI, −0.9327% to −0.2447%, P-value = 0.0010). This resulted in 8.79% of patients’ final A1C falling into the range of < 7%. Conclusion: Our study found a paradoxical reduction in A1C among patients who declined pharmacy-led diabetes management services, however, our study is limited by having no comparison group. Further research needs to be conducted to identify correlations between characteristics of patients declining diabetes management services in order to assist with identifying patient-specific methods for improving patient outcomes.

Use of Flash Continuous Glucose Monitoring Is Associated With A1C Reduction in People With Type 2 Diabetes Treated With Basal Insulin or Noninsulin Therapy.

BACKGROUNDGlycemic control is suboptimal in many individuals with type 2 diabetes. Although use of flash continuous glucose monitoring (CGM) has demonstrated A1C reductions in patients with type 2 diabetes treated with a multiple daily injection or insulin pump therapy regimen, the glycemic benefit of this technology in patients with type 2 diabetes using nonintensive treatment regimens has not been well studied.METHODSThis retrospective, observational study used the IBM Explorys database to assess changes in A1C after flash CGM prescription in a large population with suboptimally controlled type 2 diabetes treated with nonintensive therapy. Inclusion criteria were diagnosis of type 2 diabetes, age <65 years, treatment with basal insulin or noninsulin therapy, naive to any CGM, baseline A1C ≥8%, and a prescription for the FreeStyle Libre flash CGM system during the period between October 2017 and February 2020. Patients served as their own control subject.RESULTSA total of 1,034 adults with type 2 diabetes (mean age 51.6 ± 9.2 years, 50.9% male, baseline A1C 10.1 ± 1.7%) were assessed. More patients received noninsulin treatments (n = 728) than basal insulin therapy (n = 306). We observed a significant reduction in A1C within the full cohort: from 10.1 ± 1.7 to 8.6 ± 1.8%; Δ −1.5 ± 2.2% (P <0.001). The largest reductions were seen in patients with a baseline A1C ≥12.0% (n = 181, A1C reduction −3.7%, P <0.001). Significant reductions were seen in both treatment groups (basal insulin −1.1%, noninsulin −1.6%, both P <0.001).CONCLUSIONPrescription of the flash CGM system was associated with significant reductions in A1C in patients with type 2 diabetes treated with basal insulin or noninsulin therapy. These findings provide evidence for expanding access to flash CGM within the broader population of people with type 2 diabetes.

Individual and Community Social Determinants of Health Associated With Diabetes Management in a Mexican American Population.

Background: Diabetes is a major health burden in Mexican American populations, especially among those in the Lower Rio Grande Valley (LRGV) in the border region of Texas. Understanding the roles that social determinants of health (SDOH) play in diabetes management programs, both at the individual and community level, may inform future intervention strategies.Methods: This study performed a secondary data analysis on 1,568 individuals who participated in Salud y Vida (SyV), a local diabetes and chronic disease management program, between October 2013 and September 2018 recruited from a local clinic. The primary outcome was the reduction of hemoglobin A1C (HbA1C) at the last follow-up visit compared to the baseline. In addition to age, gender, insurance status, education level and marital status, we also investigated 15 community (census tract) SDOH using the American Community Survey. Because of the high correlation in the community SDOH, we developed the community-level indices representing different domains. Using Bayesian multilevel spatial models that account for the geographic dependency, we were able to simultaneously investigate the individual- and community-level SDOH that may impact HbA1C reduction.Results: After accounting for the diabetes self-management education classes taken by the participants and their length of stay in the program, we found that older age at baseline, being married (compared to being widowed or divorced) and English speaking (compared to Spanish) were significantly associated with greater HbA1C reduction. Moreover, we found that the community level SDOH were also highly associated with HbA1C reduction. With every percentile rank decrease in the socioeconomic advantage index, we estimated an additional 0.018% reduction in HbA1C [95% CI (−0.028, −0.007)]. Besides the socioeconomic advantage index, urban core opportunity and immigrant's cohesion and accessibility indices were also statistically associated with HbA1C reduction.Conclusion: To our knowledge, our study is the first to utilize Bayesian multilevel spatial models and simultaneously investigate both individual- and community-level SDOH in the context of diabetes management. Our findings suggest that community SDOH play an important role in diabetes control and management, and the need to consider community and neighborhood context in future interventions programs to maximize their overall effectiveness.

Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial

ObjectiveTo examine whether diabetes shared medical appointments (SMAs) implemented as part of usual clinical practice in diverse health systems are more effective than usual care in improving and sustaining A1c improvements.Research Design and MethodsA multi-site cluster randomized pragmatic trial examining implementation in clinical practice of diabetes SMAs in five Veterans Affairs (VA) health systems was conducted from 2016 to 2020 among 1537 adults with type 2 diabetes and elevated A1cs. Eligible patients were randomly assigned to either: (1) invitation to participate in a series of SMAs totaling 8–9 h; or (2) continuation of usual care. Relative change in A1c (primary outcome) and in systolic blood pressure, insulin starts, statin starts, and anti-hypertensive medication classes (secondary outcomes) were measured as part of usual clinical care at baseline, at 6 months and at 12 months (~7 months after conclusion of the final SMA in four of five sites). We examined outcomes in three samples of SMA participants: all those scheduled for a SMA, those attending at least one SMA, and those attending at least half of SMAs.ResultsBaseline mean A1c was 9.0%. Participants scheduled for an SMA achieved A1c reductions 0.35% points greater than the control group between baseline and 6-months follow up (p = .001). Those who attended at least one SMA achieved reductions 0.42 % points greater (p < .001), and those who attended at least half of scheduled SMAs achieved reductions 0.53 % points greater (p < .001) than the control group. At 12-month follow-up, the three SMA analysis samples achieved reductions from baseline ranging from 0.16 % points (p = 0.12) to 0.29 % points (p = .06) greater than the control group.ConclusionsDiabetes SMAs as implemented in real-life diverse clinical practices improve glycemic control more than usual care immediately after the SMAs, but relative gains are not maintained. Our findings suggest the need for further study of whether a longer term SMA model or other follow-up strategies would sustain relative clinical improvements associated with this intervention.Trial RegistrationClinicalTrials.gov ID NCT02132676

The Effect of Prestudy Insulin Therapy on Safety and Efficacy of Human Regular U-500 Insulin by Pump or Injection: A Posthoc Analysis

ObjectiveWe conducted a posthoc analysis of the VIVID study (Safety and Efficacy of Human Regular U-500 Insulin Administered by Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections in Subjects With Type 2 Diabetes Mellitus: A Randomized, Open-Label, Parallel Clinical Trial), comparing 2 delivery methods of human regular U-500 insulin (U-500R), continuous subcutaneous insulin infusion (CSII) versus multiple daily injection (MDI), in type 2 diabetes requiring high insulin, to determine influence of prestudy insulin on glycemic outcomes. MethodsWe compared A1C, total daily insulin dose (TDD), weight, and hypoglycemia by subgroups of prestudy insulin (prestudy U-500R vs non-U-500R) and treatment (CSII vs MDI). ResultsAt baseline, prestudy U-500R had higher TDD, higher body mass index, lower A1C and fasting plasma glucose, and higher rate of hypoglycemia compared to non-U-500R. Active titration of U-500R reduced A1C in both subgroups, with maximum benefit at 8 weeks. At 26 weeks, CSII provided the greatest reduction in A1C in both subgroups, with a greater reduction in non-U-500R. MDI provided an A1C reduction in both subgroups, with the greater reduction in non-U-500R. At 8 weeks, prestudy U-500R reached its lowest A1C; thereafter, A1C rebounded with MDI and remained stable with CSII. In non-U-500R, A1C continued to decrease to study end. In non-U-500R, hypoglycemia increased during active titration, but then decreased in the posttitration maintenance period. In both subgroups, TDD increased from baseline with MDI but not with CSII. Body weight increased in both subgroups but was greater in prestudy U-500R with CSII compared to MDI. ConclusionRegardless of previous insulin, people on high-dose insulin could lower A1C with U-500R, with additional benefit from CSII. These results may provide guidance for use of U-500R in clinical practice.

Financial incentives to improve glycemic control in African American adults with type 2 diabetes: a pilot randomized controlled trial

BackgroundFinancial incentives is emerging as a viable strategy for improving clinical outcomes for adults with type 2 diabetes. However, there is limited data on optimal structure for financial incentives and whether financial incentives are effective in African Americans with type 2 diabetes. This pilot study evaluated impact of three financial incentive structures on glycemic control in this population.MethodsSixty adults with type 2 diabetes were randomized to one of three financial incentive structures: 1) single incentive (Group 1) at 3 months for Hemoglobin A1c (HbA1c) reduction, 2) two-part equal incentive (Group 2) for home testing of glucose and HbA1c reduction at 3 months, and 3) three-part equal incentive (Group 3) for home testing, attendance of weekly telephone education classes and HbA1c reduction at 3 months. The primary outcome was HbA1c reduction within each group at 3 months post-randomization. Paired t-tests were used to test differences between baseline and 3-month HbA1c within each group.ResultsThe mean age for the sample was 57.9 years and 71.9% were women. Each incentive structure led to significant reductions in HbA1c at 3 months with the greatest reduction from baseline in the group with incentives for multiple components: Group 1 mean reduction = 1.25, Group 2 mean reduction = 1.73, Group 3 mean reduction = 1.74.ConclusionFinancial incentives led to significant reductions in HbA1c from baseline within each group. Incentives for multiple components led to the greatest reductions from baseline. Structured financial incentives that reward home monitoring, attendance of telephone education sessions, and lifestyle modification to lower HbA1c are viable options for glycemic control in African Americans with type 2 diabetes.Trial registrationTrial registration: NCT02722499. Registered 23 March 2016, url.

Association between dental visits at primary care and glycated hemoglobin level in patients with type 2 diabetes: a cohort study.

To evaluate the association between dental visits and variation in the glycated hemoglobin index (A1C) of patients with type 2 diabetes (T2DM) with well or not well glycemic control over time. Patients with T2DM, A1C ≥ 7% (not well-controlled) and < 7% (well-controlled), who attended a primary care service and were followed up from January 2010 to May 2018. The outcome was the variation of A1C obtained from reference laboratories. At the beginning of the study, a questionnaire with behavioral, clinical, and socioeconomic information was carried out. Multiple linear regression analyses tested interaction terms of all variables with the initial glycemic level (not well-controlled or well-controlled). The sample consisted of 507 people, 65% women, and 66% individuals 55 to 74 years old, followed on average for 5.4 years. There was an interaction (p = 0.01) between dental visits and initial A1C. Patients not well-controlled with at least one dental visit had an average reduction in A1C of -0.56 percentage point (95%CI -1.06 - -0.56), whereas the well-controlled group who also had at least one dental visit had an increase of 0.34 percentage point (95%CI -0.18 - 0.87). Dental visits were associated with an improvement in A1C of approximately a half-percentage point in patients who had the initial A1C considered as not well-controlled.

Impact of pharmacist-led care on glycaemic control of patients with uncontrolled type 2 diabetes: a randomised controlled trial in Nigeria.

Background:Diabetes mellitus is a chronic, degenerative disease, requiring a multi-dimensional, multi-professional care by healthcare providers and substantial self-care by the patients, to achieve treatment goals.Objective:To evaluate the impact of pharmacist-led care on glycaemic control in patients with uncontrolled Type 2 DiabetesMethods:In a parallel group, single-blind randomised controlled study; type 2 diabetic patients, with greater than 7% glycated haemoglobin (A1C) were randomised into intervention and usual care groups and followed for six months. Glycated haemoglobin analyzer, lipid analyzer and blood pressure monitor/apparatus were used to measure patients’ laboratory parameters at baseline and six months. Intervention group patients received pharmacist-structured care, made up of patient education and phone calls, in addition to usual care. In an intention to treat analysis, Mann-Whitney U test was used to compare median change at six months in the primary (A1C) and secondary outcome measures. Effect size was computed and proportion of patients that reached target laboratory parameters were compared in both arms.Results:All enrolled participants (108) completed the study, 54 in each arm. Mean age was 51 (SD 11.75) and majority were females (68.5%). Participants in the intervention group had significant reduction in A1C of -0.75%, compared with an increase of 0.15% in the usual care group (p<0.001; eta-square= 0.144). The proportion of those that achieved target A1C of <7% at 6 months in the intervention and usual care group was 42.6% vs 20.8% (p=0.02). Furthermore, intervention patients were about 3 times more likely to have better glucose control; A1C<7% (aOR 2.72, 95% CI: 1.14-6.46) compared to usual care group, adjusted for sex, age, and duration of diabetes.Conclusions:Pharmacist-led care significantly improved glycaemic control in patients with uncontrolled T2DM.

OUTCOME INDICATORS OF MULTI-PROFESSIONAL DIABETES CARE IN A REFERENCE SERVICE

ABSTRACT Objective to identify outcome indicators of the multi-professional Diabetes Mellitus care of a reference outpatient service. Method a descriptive study of evaluative nature, according to the health evaluation framework, carried out by documentary analysis of 173 medical charts, from August to October 2018. The variables were analyzed in the Statistical Package for the Social Science (SPSS), version 22.0, by descriptive statistics, as well as the association of variables, with the Chi-square, Mann-Whitney, and Wilcoxon tests being used, considering p-values ≤ 0.05 as statistically significant. Results predominance of older adult women, with a mean diagnosis time of 11.9 years. The tracking of complications due to Diabetes Mellitus occurred in 90.2% of the users, with a prevalence of 68.2%, of which 34.7% were diagnosed in the service. Absenteeism was 21.4%. The systolic and diastolic arterial pressure and total cholesterol parameters were in line with the proposed goals, while glycated hemoglobin (A1c), fasting glycaemia, HDL-c, LDL-c, triglyceride fractions, and BMI did not reach the target range. There was a significant reduction in final A1c, comparing to initial A1c, as well as an increase in the proportions of users who reached the goals in glycemic control. Conclusion a significant improvement in glycemic control, despite the fact that the parameters did not fully meet the goals, ratifying the importance of an effective assistance model for successful care strategies of Diabetes Mellitus.