Change In Hemoglobin A1c Research Articles

Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence (IDEA) in Prediabetes: A Multisite Randomized Controlled Trial.

To evaluate whether knowledge of a personalized Diabetes Risk Score (DRS) improved performance in a 12-week lifestyle change program for prediabetes. Randomized subjects at four clinics provided samples for a DRS at baseline, 12, and 24 weeks. The intervention group received scores at each point, whereas the control group only received this information at 12 and 24 weeks. Outcomes included attendance and changes in weight, abdominal circumference, blood pressure, fasting glucose, hemoglobin A1c, cholesterol, and risk score. Baseline characteristics were similar in the groups (n = 192) and within risk-stratified subgroups. At 12 weeks, there were no differences in outcomes, with mean weight loss of 4.61 kg in the intervention group and 4.43 kg in the control group (p = 0.79). Both groups were given 12-week risk scores, with previously unseen baseline scores for the control group. The control group continued to lose additional weight (1.21 kg) by 24 weeks, whereas the intervention group regained previously lost weight (0.33 kg) (p = 0.04). The knowledge of a single baseline personalized DRS did not affect performance in a lifestyle modification program. However, the knowledge of an improvement in risk score, and the timing of this information, may impact further adherence.

Economic Value of Improved Accuracy for Self-Monitoring of Blood Glucose Devices for Type 1 Diabetes in Canada.

The objective was to simulate and compare clinical and economic outcomes of self-monitoring of blood glucose (SMBG) devices along error ranges and strip price. We programmed a type 1 diabetes natural history and treatment cost-effectiveness model. In phase 1, using past evidence from in silico modeling validated by the Food and Drug Administration, we associated changes in SMBG error to changes in hemoglobin A1c (HbA1c) and separately, changes in severe hypoglycemia requiring an inpatient stay. In phase 2, using Markov cohort simulation modeling, we estimated clinical and economic outcomes from the Canadian payer perspective. The primary comparison was a SMBG device with strip price $0.73 Canadian dollars (CAD) and 10% error (exceeding accuracy requirements by International Organization for Standardization (ISO) 15197:2013) versus a SMBG device with strip price $0.60 CAD and 15% error (accuracy meeting ISO 15197:2013). Outcomes for the average patient, were quality-adjusted life years (QALYs), incremental cost-effectiveness ratios (ICERs), and budget impact. Assuming benefits translate into HbA1c improvements only, the ICER with 10% error versus 15% was $11 500 CAD per QALY. Assuming the benefits translate into reduced severe hypoglycemia requiring an inpatient stay only, an SMBG device with 10% error dominated (ie, less costly, more effective) an SMBG device with 15% error. The 3-year budget impact findings ranged from $0.004 CAD per member per month for HbA1c improvements to cost-savings for severe hypoglycemia reductions. From efficiency (cost-effectiveness) and affordability (budget impact) payer perspectives, investing in devices with improved accuracy (less error) appears to be an efficient and affordable strategy.

Efficacy and safety of sitagliptin for the treatment of diabetes mellitus complicated by chronic liver injury.

AimTo investigate the efficacy and safety of a dipeptidyl peptidase-4 inhibitor, sitagliptin, for treating diabetes mellitus complicated by chronic liver injury.MethodsSitagliptin was administered for 13.7 ± 10.1 months to 122 patients with DM complicated by chronic liver injury (including 19 patients with liver cirrhosis), and changes in hemoglobin A1c (HbA1c) and liver enzymes (transaminases, etc.) were evaluated.ResultsHbA1c was reduced from 8.48 ± 1.43% to 7.87 ± 1.35% (P < 0.001). Among liver enzymes, alanine aminotransferase (ALT) levels improved from 75.1 ± 45.2 to 65.8 ± 35.8 IU/L (P = 0.012) and gamma-glut amyl-trans peptidase from 155.2 ± 161.1 to 133.2 ± 127.4 IU/L (P = 0.044). Among the causes of liver injury, non-alcoholic fatty liver disease and alcoholic liver disease both showed the reductions in HbA1c with no deterioration of liver enzymes. An analysis of 19 patients with liver cirrhosis also showed reductions in HbA1c with no deterioration of liver enzymes.ConclusionIt is suggested that sitagliptin can be administered effectively and safely to patients with diabetes mellitus complicated by chronic liver injury, including liver cirrhosis.

Alterations in HbA1c resulting from the donation of autologous blood for elective surgery in patients with diabetes mellitus.

The aim of this study was to confirm the change in haemoglobin A1c consequent to pre-operative donation of autologous blood for elective surgery in patients with diabetes mellitus. For enrolment in this prospective study, patients had to be scheduled for multiple autologous blood donations at different times and have a haemoglobin A1c level more than 5.8% at the first donation. The values of four factors, haemoglobin, haemoglobin A1c, glycated albumin, and glycated albumin/haemoglobin A1c ratio were determined. Changes in the values of these four factors between before and after the blood donations were calculated. In all 24 patients studied, haemoglobin and haemoglobin A1c decreased as a result of the autologous blood donations. The group with a reduced glycated albumin/haemoglobin A1c ratio had short intervals between blood donations. Correlations were observed between donation interval and change in haemoglobin A1c (r=-0.63, P=0.003), and between donation interval and change in the glycated albumin/haemoglobin A1c ratio (r=0.489, P=0.045). Haemoglobin A1c levels are likely to be underestimated after autologous blood donation by patients with diabetes mellitus, so glycated albumin may be a better indicator of these patients' glycaemic control.

Hemoglobin A1c (HbA1c) changes over time among adolescent and young adult participants in the T1D exchange clinic registry.

Hemoglobin A1c (HbA1c) levels among individuals with type 1 diabetes (T1D) influence the longitudinal risk for diabetes-related complications. Few studies have examined HbA1c trends across time in children, adolescents, and young adults with T1D. This study examines changes in glycemic control across the specific transition periods of pre-adolescence-to-adolescence and adolescence-to-young adulthood, and the demographic and clinical factors associated with these changes. Available HbA1c lab results for up to 10 yr were collected from medical records at 67 T1D Exchange clinics. Two retrospective cohorts were evaluated: the pre-adolescent-to-adolescent cohort consisting of 85 016 HbA1c measurements from 6574 participants collected when the participants were 8-18 yr old and the adolescent-to-young adult cohort, 2200 participants who were 16-26 yr old at the time of 17 279 HbA1c measurements. HbA1c in the 8-18 cohort increased over time after age 10 yr until ages 16-17; followed by a plateau. HbA1c levels in the 16-26 cohort remained steady from 16-18, and then gradually declined. For both cohorts, race/ethnicity, income, health insurance, and pump use were all significant in explaining individual variations in age-centered HbA1c (p < 0.001). For the 8-18 cohort, insulin pump use, age of onset, and health insurance were significant in predicting individual HbA1c trajectory. Glycemic control among patients 8-18 yr old worsens over time, through age 16. Elevated HbA1c levels observed in 18 yr-olds begin a steady improvement into early adulthood. Focused interventions to prevent deterioration in glucose control in pre-adolescence, adolescence, and early adulthood are needed.

Safety and efficacy of canagliflozin in Japanese patients with type 2 diabetes mellitus: post hoc subgroup analyses according to body mass index in a 52-week open-label study

Background: The safety and efficacy of sodium glucose co-transporter 2 inhibitors in non-obese compared with obese patients with type 2 diabetes mellitus is unknown.Methods: We conducted post hoc analyses of the results of a 52-week open-label study of Japanese type 2 diabetes mellitus patients treated with 100 or 200 mg canagliflozin. Patients were divided into four subgroups according to their baseline body mass index (BMI): group I, BMI < 22 kg/m2; group II, BMI ≥ 22 to < 25 kg/m2; group III, BMI ≥ 25 to < 30 kg/m2 and group IV, BMI ≥ 30 kg/m2.Results: The overall safety was similar among the four BMI subgroups, although there were slight differences in terms of the incidences of hypoglycemia, asymptomatic hypoglycemia, female genital infections and proportions of patients with total ketone body levels exceeding 1000 μmol/l at any time for both canagliflozin doses. Hemoglobin A1c, fasting plasma glucose and body weight decreased significantly from baseline to week 52 at both canagliflozin doses. The changes in hemoglobin A1c, and fasting plasma glucose were not significantly different among the four BMI subgroups for either dose.Conclusion: Canagliflozin was tolerated in patients irrespective of their BMI at the start of treatment, although some caution may be needed.

Hypoglycemia Reduction and Changes in Hemoglobin A1c in the ASPIRE In-Home Study.

Background: ASPIRE In-Home randomized 247 subjects with type 1 diabetes to sensor-augmented pump therapy with or without the Threshold Suspend (TS) feature, which interrupts insulin delivery at a preset sensor glucose value. We studied the effects of TS on nocturnal hypoglycemia (NH) in relation to baseline hemoglobin A1c (A1C) and change in A1C during the study.Materials and Methods: NH event rates and mean area under curve (AUC) of NH events were evaluated at different levels of baseline A1C (<7%, 7–8%, and >8%) and at different levels of changes in A1C (less than −0.3% [decreased], −0.3% to 0.3% [stable], and >0.3% [increased]), in the TS Group compared with the Control Group (sensor-augmented pump only).Results: In the TS Group, 27.9% of the NH events were accompanied by a confirmatory blood glucose value, compared with 39.3% in the Control Group. Among subjects with baseline A1C levels of <7% or 7–8%, those in the TS Group had significantly lower NH event rates than those in the Control Group (P=0.001 and P=0.004, respectively). Among subjects with decreased or stable A1C levels, those in the TS Group had significantly lower NH event rates, and the events had lower AUCs (P≤0.001 for each). Among subjects with increased A1C levels, those in the TS Group had NH events with significantly lower AUCs (P<0.001).Conclusions: Use of the TS feature was associated with decreases in the rate and severity (as measured by AUC) of NH events in many subjects, including those with low baseline A1C levels and those whose A1C values decreased during the study period. Use of the TS feature can help protect against hypoglycemia in those wishing to intensify diabetes management to achieve target glucose levels.

The efficacy and safety of DPP4 inhibitors compared to sulfonylureas as add-on therapy to metformin in patients with Type 2 diabetes: A systematic review and meta-analysis

There is no consensus on the selection of specific drug therapies when metformin fails in Type 2 diabetes (T2D). This meta-analysis was performed to determine the efficacy and safety of Dipeptidyl peptidase-4 inhibitors (DPP4-I) compared to sulfonylurea (SU) as add-on therapy to metformin in inadequately controlled T2D patients. We searched MEDLINE, CENTRAL, EMBASE, and CINAHL for randomized trials comparing DPP4-I to SU as add-on therapy to metformin and reported a change in hemoglobin A1c (HbA1c). Sixteen articles were included. There was a significantly greater reduction in HbA1c from baseline to 12 weeks with SU versus DPP4-I (MD[95% CI]=0.21%(2mmol/mol) [0.06, 0.35]) but no significant difference at 52 and 104 weeks (MD[95% CI]=0.06%(−1mmol/mol) [−0.03, 0.15] and 0.02%(−1mmol/mol) [−0.13,0.18] respectively). SU was associated with weight gain and DPP4-I with weight loss at all time-points. The incidence of hypoglycemia at 12, 52, and 104 weeks was significantly greater with SU (20%, 24%, and 27% respectively) compared to DPP4-I (6%, 3%, and 4% respectively). The proportion of patients with HbA1c<7%(53mmol/mol) without hypoglycemia was significantly higher at 52 and 104 weeks among patients on DPP4-I (RR[95% CI]=1.20 [1.05, 1.37] and 1.53 [1.16, 2.02] respectively). There was no significant difference between the two groups in the incidence of other side effects. While both SU and DPP4-I can be considered as options for add-on therapy to metformin in inadequately controlled T2D, SU results in a significantly increased risk of hypoglycemia and weight gain. By contrast, DPP4-I produce 0.4–0.6% (4–7mmol/mol) reduction in HbA1c, lower risk of hypoglycemia, and weight loss.

Effectiveness of a self-management support program for Thais with type 2 diabetes: Evaluation according to the RE-AIM framework.

Delivering diabetes self-management support is an enormous challenge for healthcare providers with limited human resources. We conducted a cluster randomized controlled trial to assess the effectiveness of a DSMS program incorporating the computer-assisted instruction. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework was applied to evaluate the DSMS program. Ten Public Health Centers in Bangkok, Thailand were randomized into either DSMS program or usual care. Forty eligible patients with type 2 diabetes in each Public Health Center were randomly selected. Totally, 403 patients (200 controls and 203 interventions) participated. About 93.8% participants completed the six-month follow-up. Over six months, adjusted mean changes of hemoglobin A1c (-0.14%, 95% confidence interval = -0.02 to -0.26, fasting plasma glucose (-6.37 mg/dL, -1.95 to -10.78), health behaviors (3.31 score, 2.27 to 4.34), and quality of life (1.41 score, 0.69 to 2.12) were significantly improved in intervention compared to control group. In conclusion, the DSMS program facilitates Public Health Centers to accomplish their support for people with diabetes.

Abstract MP76: The Effect of Exercise Training Modality on 30-Year Cardiovascular Mortality Risk in Individuals with Type 2 Diabetes

Introduction: Current calculators to estimate risk of cardiovascular (CV) disease mortality do not include cardiorespiratory fitness (CRF) or physical activity (PA) measures. This is problematic as CRF is an independent risk factor for CV mortality. To address this issue, Wickramasinghe et al. developed a calculator which includes CRF along with other traditional CV risk factors. The purpose of the present study is to determine the effect of aerobic (AER), resistance (RES) or combination (COMB) exercise training on 30-year CV mortality risk in individuals with type 2 diabetes (T2D). Methods: The present study is an ancillary analysis of the Health Benefits of Aerobic and Resistance Training Study (HART-D). Adults with type 2 diabetes (T2D) (n=196) were randomized to 9 months of AER, RES, COMB exercise training or a control group (CON). Thirty-year CV mortality risk was evaluated by entering each participant’s sex, age, blood pressure, smoking status, T2D status, cholesterol, and BMI into a risk calculator developed by Wickramasinghe et al. at baseline and follow-up. CRF was quantified as the highest metabolic equivalent level (estimated from the final speed and grade using American College of Sports Medicine equations) achieved during a maximal treadmill test at baseline and follow-up. Analysis of covariance was used to evaluate change in CV risk with adjustments for age, sex and baseline CV risk. Results: Participants in the present analysis had a mean (SD) 30-year CV risk of 30.4% (17.8). A significant reduction in 30-year CV risk was observed in the AERO (-2.9%, CI: -4.7 to -1.0) and COMB groups (-2.8%, CI: -4.5 to -1.0), but not in the RES group (0.0%, CI: -1.8 to 1.7) compared to CON (2.1%, CI: -0.1 to 4.3). In the AERO and COMB groups, change in CV risk was associated with change in fat mass (r= -0.19, p=0.04), but not change in lean mass or hemoglobin A1c (all ps&gt;0.05). Conclusions: The present study suggests that 9 months of aerobic exercise training or combination of resistance with aerobic exercise training resulted in a ~3% reduction in absolute 30-year CV risk (~11% relative risk), and further validates the importance of aerobic exercise in the treatment of individuals with T2D.

Glycemic Control After Hospital Discharge in Insulin-Treated Type 2 Diabetes: A Randomized Pilot Study of Daily Remote Glucose Monitoring

Little is known about glycemic control in type 2 diabetes patients treated with insulin in the high-risk period between hospital discharge and follow-up. We sought to assess the impact of remote glucose monitoring on postdischarge glycemic control and insulin titration. We randomly assigned 28 hospitalized type 2 diabetes patients who were discharged home on insulin therapy to routine specialty care (RSC) or RSC with daily remote glucose monitoring (RGM). We compared the primary outcome of mean blood glucose and exploratory outcomes of hypoglycemia/hyperglycemia rates, change in hemoglobin A1c and glycated albumin, and insulin titration frequency between groups. Mean blood glucose was not significantly different between the treatment arms (144 ± 34 mg/dL in the RSC group and 172 ± 41 mg/dL in the RGM group; not significant), nor were there significant differences in any of the other measures of glycemia during the month after discharge. Hypoglycemia (glucometer reading <60 mg/dL) was common, occurring in 46% of subjects, with no difference between groups. In as-treated analysis, insulin dose adjustments (29% with an increase and 43% with decrease in insulin dose) occurred more frequently in the patients who used RGM (average of 2.8 vs. 1.2 dose adjustments; P = .03). In this pilot trial in insulin-treated type 2 diabetes, RGM did not affect glycemic control after hospital discharge; however, the high rate of hypoglycemia in the postdischarge transition period and the higher frequency of insulin titration in patients who used RGM suggest a safety role for such monitoring in the transition from hospital to home.

Comparative effectiveness of early versus delayed metformin in the treatment of type 2 diabetes

AimThe purpose of this study was to evaluate the effectiveness of early versus delayed initiation of metformin in type 2 diabetes. MethodsWe identified 2925 new users of metformin with type 2 diabetes between 2005 and 2012 in the electronic health records of an integrated health system in Northern California. Patients were matched 1:1 on the propensity for receiving early treatment (defined as ≤6 months from first evidence of diabetes). We evaluated the effectiveness of early versus delayed metformin treatment on intermediate clinical outcomes indicated by changes in hemoglobin A1c (HbA1c) and body mass index (BMI), as well as the incidence of therapy intensification (addition or substitution of a second antihyperglycemic agent). ResultsA total of 2144 propensity-score matched patients were included in the early or delayed treatment group (n=1072, in each). Early treatment was associated with significantly larger decreases in HbA1c (−0.36%; 95% confidence intervals [CI]: −0.44 to −0.27%; P<0.001) and BMI (−0.46kg/m2; 95% CI: −0.64 to −0.29kg/m2; P<0.001) relative to delayed treatment. Patients receiving early treatment also had a greater likelihood of attaining an HbA1c<7% (<53mmol/mol) (odds ratio: 2.00; 95% CI: 1.63–2.45; P<0.001) and a reduced risk of therapy intensification (hazard ratio: 0.72; 95% CI: 0.61–0.85; P<0.001). ConclusionsTreatment with metformin earlier in the course of type 2 diabetes is associated with better glycemic control, more pronounced weight reduction, and a lower risk for therapy intensification than delayed treatment. Antihyperglycemic therapy should be initiated early after diagnosis to achieve optimal outcomes.

Efficacy and safety of canagliflozin among patients with type 2 diabetes mellitus: A systematic review and meta-analysis.

Objective:To evaluate the efficacy and safety of canagliflozin in combination therapy among patients with type 2 diabetes mellitus with inadequate glycemic control.Methods:Two review authors independently searched for the relevant randomized controlled clinical trials from the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, IndMed, LILACS, and clinical trials registry www.clinicaltrials.gov. Primary outcomes for this review included: change in hemoglobin A1c (HbA1c) levels, fasting plasma glucose (FPG) levels and risk of occurrence of genital mycotic infections at 26 weeks. We combined results using mean difference (MD) for continuous data, and risk ratio (RR) for dichotomous data.Results:Of the 124 identified reports, five RCTs with 3565 participants were eligible for the meta-analysis. All included studies had compared canagliflozin 100 mg and 300 mg once daily with placebo or sitagliptin 100 mg once daily. We judged that most of the studies had low risk of bias or unclear risk of bias in five major domains. Canagliflozin 300 mg once daily led to a significant decrease in HbA1c levels (IV Fixed -0.77, 95% CI [-0.90, -0.64] P < 0.00001) and FPG levels (IV Fixed -2.08; 95% CI [-2.32, -1.84], P <0.00001), body weight, systolic blood pressure and triglyceride levels after 26 weeks as compared to placebo. There was a also a significant difference in the efficacy of canagliflozin 300 mg and sitagliptin 100 mg once daily in favour of canagliflozin. Both doses of canagliflozin led to genital mycotic infections among males and females, urinary tract infections, pollakiuria, polyuria and postural dizziness.Conclusions:Canagliflozin significantly decreases HbA1c and FPG levels and body weight as compared to placebo among patients with inadequate glycemic control with an earlier regime of glucose lowering agents. Long term safety studies are required to evaluate the incidence of adverse events.

1,5-anhydroglucitol as a useful marker for assessing short-term glycemic excursions in type 1 diabetes.

BackgroundType 1 diabetes is associated with more severe glycemic variability and more frequent hypoglycemia than type 2 diabetes. Glycemic variability is associated with poor glycemic control and diabetic complications. In this study, we demonstrate the clinical usefulness of serum 1,5-anhydroglucitol (1,5-AG) for assessing changes in glycemic excursion in type 1 diabetes.MethodsSeventeen patients with type 1 diabetes were enrolled in this study. A continuous glucose monitoring system (CGMS) was applied twice at a 2-week interval to evaluate changes in glycemic variability. The changes in serum glycemic assays, including 1,5-AG, glycated albumin and hemoglobin A1c (HbA1c), were also evaluated.ResultsMost subjects showed severe glycemic excursions, including hypoglycemia and hyperglycemia. The change in 1,5-AG level was significantly correlated with changes in the glycemic excursion indices of the standard deviation (SD), mean amplitude of glucose excursion (MAGE), lability index, mean postmeal maximum glucose, and area under the curve for glucose above 180 mg/dL (r=-0.576, -0.613, -0.600, -0.630, and -0.500, respectively; all P<0.05). Changes in glycated albumin were correlated with changes in SD and MAGE (r=0.495 and 0.517, respectively; all P<0.05). However, changes in HbA1c were not correlated with any changes in the CGMS variables.Conclusion1,5-AG may be a useful marker for the assessment of short-term changes in glycemic variability. Furthermore, 1,5-AG may have clinical implications for the evaluation and treatment of glycemic excursions in type 1 diabetes.

Observational and clinical trial findings on the comparative effectiveness of diabetes drugs showed agreement

ObjectivesThis study compares an observational study of diabetes treatment effectiveness to randomized controlled trials to assess their convergent validity. Study Design and SettingMultivariate models were developed using observational data to describe change in hemoglobin A1c (HbA1c; % unit) and weight (kilograms) after addition of a second-line oral diabetes drug to metformin monotherapy. Randomized trials of these scenarios were systematically identified. The models were used to simulate each trial, and simulated and actual results were compared by linear regression and meta-analysis. ResultsThirty-two randomized trials of second-line diabetes oral therapy were identified. For all outcomes and drugs studied, simulation and actual results correlated (P < 0.001). There were no statistically significant differences between meta-analyzed randomized and simulated results for effect on HbA1c. For effect on weight, results were qualitatively comparable, but for sulfonylureas, the simulated weight gain was nominally greater than seen in the randomized controlled trials. ConclusionAn observational study of diabetes drug effectiveness showed convergent validity with randomized data. This supports cautious use of the observational research to draw conclusions about drug effectiveness in populations not studied in clinical trials. This approach may be useful in other situations where observational and randomized data need integration.

The Community Diabetes Education (CoDE) program: cost-effectiveness and health outcomes.

Limited evidence exists regarding the long-term effects of community health worker-led diabetes management programs on health outcomes and cost-effectiveness, particularly in low-income, ethnic minority populations. To examine the long-term cost-effectiveness and improvements in diabetes-related complications of a diabetes education and management intervention led by community health workers among uninsured Mexican Americans. Clinical data, changes in hemoglobin A1c over 12 months, and costs from an RCT of 180 uninsured Mexican Americans with type 2 diabetes conducted in 2006 were utilized for secondary analyses in 2012. Simulation modeling was used to estimate long-term cost and health outcomes using the validated Archimedes Model. The absolute differences for the incremental cost-effectiveness ratios and cumulative incidence of diabetes-related complications were derived by comparing intervention and control groups. During a 20-year time horizon, participants who received the intervention would be expected to have significantly lower hemoglobin A1c levels (p<0.001), fewer foot ulcers (p<0.001), and a reduced number of foot amputations (p=0.005) in comparison with a control group receiving usual medical care. An incremental cost-effectiveness ratio of $355 per quality-adjusted life year gained was estimated for intervention participants during the same time period. A simulated clinical trial suggests that a community health worker-led diabetes intervention is a cost-effective way to reduce diabetes-related complications for uninsured Mexican Americans during a 20-year horizon in comparison to usual medical care.

Frequency of Continuous Glucose Monitoring use and Change in Hemoglobin A1C for Adults With Type 1 Diabetes in a Clinical Practice Setting

ObjectiveTo estimate the frequency of continuous glucose monitoring (CGM) use and change in hemoglobin A1c (HbA1c) compared to self-monitoring of blood glucose (SMBG) alone in adults with type 1 diabetes in a clinical practice setting. MethodsWe retrospectively identified 66 adult type 1 diabetes patients at the Barbara Davis Center for Diabetes (BDC) who first initiated CGM between 2006 and 2011 and 67 controls using SMBG. The frequency of CGM use was estimated from survey recall and defined as the mean number of days/month of CGM use during a maximum follow-up of 10 months. Change in HbA1c was calculated as the difference between the baseline value and the lowest follow-up value. ResultsThe mean change in HbA1c for CGM users was −0.48% (95% confidence interval [CI]: −0.67, −0.28) and for SMBG users was −0.37% (95% CI: −0.56, −0.18). The between-group mean difference in change in HbA1c, adjusted for patient characteristics, was −0.11% (95% CI: −0.38, 0.16), whereas the subgroup with a baseline HbA1c ≥7.0% and users of CGM ≥21 days/month was −0.36% (95% CI, −0.78, 0.05). Nearly half (n = 32, 48%) used CGM <21 days/month. The reasons for low frequency of CGM use or discontinuation included sensor costs, frequency of alarms, inaccuracy, and discomfort. ConclusionsThese CGM data from clinical practice suggest a trend toward decreasing HbA1c for adults with type 1 diabetes, especially in patients with higher baseline HbA1c and higher frequency of CGM use. Future studies are needed to assess the use of CGM in larger populations of clinical practice adult type 1 diabetes patients. (Endocr Pract. 2014;20:1007-1015)

Safety test of a supplement, 5-aminolevulinic acid phosphate with sodium ferrous citrate, in diabetic patients treated with oral hypoglycemic agents

Objective: This study aimed to examine the safety of 5-aminolevulinic acid phosphate (5-ALA) with sodium ferrous citrate (SFC) in diabetic patients treated with one or more oral hypoglycemic agents (OHAs).Background: Recent intervention studies performed in the USA and Japan have shown that a nutritional supplement of 5-ALA with SFC efficiently reduced blood glucose levels in pre-diabetic population without any adverse events. Thus, it was anticipated that 5-ALA with SFC may potentially be taken as a beneficial supplement by diabetic patients who were being treated with OHA therapy. Nevertheless, it is important to examine its safety and efficacy in diabetic population.Methods: This study was a prospective single-blinded, randomized, placebo-controlled and parallel-group comparison study. Medically treated diabetic patients between the ages of 30 and 75 were recruited from the Tokyo metropolitan area of Japan and 45 subjects were selected after screening. These subjects were randomly assigned to three groups: daily intake of 15mg 5-ALA, 50mg 5-ALA, and a placebo (n=15, respectively). The supplement or placebo was administered for 12 weeks followed by a four week washout period. The primary endpoint was safety and occurrence of hypoglycemic attack, while the secondary endpoint was changes of fasting blood glucose (FBG) and hemoglobin A1c (HbA1c). Results: Adverse events related to 5-ALA with SFC were not observed in all the groups. Abnormalities in blood and urine tests were not observed either. Significant decrease in FBG was not detected in all the groups. However, there was a small but significant decrease in HbA1c at 4 and 8 week in the 15 mg 5-ALA group. Significant decrease in HbA1c was not observed in the 50 mg 5-ALA group, although a tendency to decrease after 4 weeks was apparent.Conclusion: 5-ALA with SFC is a safe and potentially beneficial supplement if taken by diabetic patients treated with OHAs.Trial registration: UMIN 000008038Key words: type 2 diabetes, 5-aminolevulinic acid (5-ALA), sodium ferrous citrate (SFC), oral hypoglycemic agent (OHA), hemoglobin A1c (HbA1c), fasting blood glucose (FBG)

Impact of a clinical pharmacy program on changes in hemoglobin A1c, diabetes-related hospitalizations, and diabetes-related emergency department visits for patients with diabetes in an underserved population.

Diabetes mellitus is associated with substantial morbidity and mortality. With the rise in prevalence of diabetes, there has been an increased need for clinical pharmacy services focused on diabetes management in ambulatory clinics. However, more data IS needed to determine the overall impact that clinical pharmacists have on preventing diabetes-related inpatient admissions and emergency department (ED) visits for patients with diabetes, especially in an underserved population. To assess the impact of clinical pharmacy services on the change in hemoglobin A1c measurements, the number of diabetes-related hospitalizations, and the number of diabetes-related ED visits for patients with uncontrolled diabetes. This was a retrospective study that evaluated outcomes for patients referred to a clinical pharmacist for management of diabetes, compared with patients who were not seen by a clinical pharmacist. Adult patients aged between 18 and 89 years with a diagnosis of type 1 or type 2 diabetes mellitus were identified, using the electronic medical records from CommUnityCare outpatient clinics in central Texas during the period July 1, 2007, through July 1, 2011. Patients enrolled had poor glycemic control, defined as an A1c ≥9% at baseline (index), with at least 3 visits with a clinical pharmacist or 3 visits to usual care. Patients with at least 1 year of pre-index data, 1 year of post-index follow-up, and a post-index A1c measure were included in the study. Propensity score (PS) matching was used to create a 1:1 cohort. T-tests were used to calculate results for the main outcome variables (change in A1c, change in number of diabetes-related hospitalizations, and change in number of diabetes-related ED visits). In addition, general linear models (GLM) were used to control for baseline demographic and clinical characteristics. A total of 782 patients met inclusion criteria, 557 in the usual care (control) group and 225 in the clinical pharmacy (intervention) group. PS matching provided a 1:1 matched sample of 220 patients per cohort. When assessing the change in the number of diabetes-related hospitalizations from the pre-index year to the post-index year, patients in the control group had an increase of 8 hospitalizations (8 visits per 220 patients, mean = 0.036, SD = 0.284), while the intervention group had a decrease of 1 hospitalization (-1 visit per 220 patients, mean = -0.005, SD=0.278). Both the t-test (P = 0.06) and GLM model (P = 0.06) indicated that the difference was statistically significant. When assessing the change in the number of diabetes-related ED visits from the pre-index year to the post-index year, we found patients in the control group had an increase of 16 ED visits (16 visits per 220 patients, mean = 0.073, SD = 0.584), while the intervention group had an increase of 4 ED visits (4 visits per 220 patients, mean = -0.018, SD=0.641). Both the t-test (P = 0.18) and GLM model (P = 0.28) indicated that the difference was not statistically significant. A1c levels were reduced in the post-index period for both groups. For the control group, A1c reduction was 1.50 (from 11.17 to 9.67, SD = 2.49). For the intervention group, A1c reduction was 1.90 (from 11.09 to 9.19, SD = 2.44). Both the t-test (P = 0.04) and GLM model (P = 0.05) indicated that the A1c difference was statistically significant. Underserved patients with baseline uncontrolled diabetes who were managed by a clinical pharmacist in the outpatient setting had a higher decrease in A1c compared with usual care. The changes in diabetes-related hospitalizations and diabetes-related ED visits were in the hypothesized direction, but the comparison for ED visits was not statistically significant.

Design and methods of a randomised double-blind trial of adding liraglutide to control HbA1c in patients with type 2 diabetes with impaired glycaemic control treated with multiple daily insulin injections (MDI-Liraglutide trial)

AimsPatients with type 2 diabetes are generally treated in primary care setting and as a final treatment step to obtain good glycaemic control, multiple daily insulin injections (MDI) are generally used. The aim of this study is to evaluate the effect of GLP-1 analogue liraglutide on glycaemic control in patients with type 2 diabetes treated with MDI with inadequate glycaemic control. MethodsOverweight and obese patients with type 2 diabetes and impaired glycaemic control treated with MDI were randomised to liraglutide or placebo over 24 weeks. Masked continuous glucose monitoring was performed at baseline and during the trial. The primary endpoint was the change in haemoglobin A1c from baseline to week 24. Additional endpoints include changes in weight, fasting glucose, glycaemic variability, treatment satisfaction, insulin dose, hypoglycaemias, blood pressure and blood lipid levels. ResultsRecruitment occurred between February 2013 and February 2014. A total of 124 patients were randomised. Study completion is anticipated in August 2014. ConclusionsIt is expected that the results of this study will establish whether adding liraglutide to patients with type 2 diabetes treated with MDI will improve glycaemic control, lower body weight, and influence glycaemic variability.