METHODS: This open-label, parallel-group, 26-week, multicentre, treat-to-target trial, randomly allocated participants (1:1) to two titration arms. The Simple algorithm titrated IDegAsp twice weekly based on a single pre-breakfast self-monitored plasma glucose (SMPG) measurement. The Stepwise algorithm titrated IDegAsp once weekly based on the lowest of three consecutive pre-breakfast SMPG measurements. In both groups, IDegAsp once daily was titrated to pre-breakfast plasma glucose values of 4.0-5.0 mmol/l. Primary endpoint was change from baseline in HbA1c (%) after 26 weeks.
RESULTS: Change in HbA1c at Week 26 was IDegAspSimple -14.6 mmol/mol (-1.3%) (to 52.4 mmol/mol; 6.9%) and IDegAspStepwise -11.9 mmol/mol (-1.1%) (to 54.7 mmol/mol; 7.2%). The estimated between-group treatment difference was -1.97 mmol/mol [95% confidence interval (CI) -4.1, 0.2] (-0.2%, 95% CI -0.4, 0.02), confirming the non-inferiority of IDegAspSimple to IDegAspStepwise (non-inferiority limit of ≤ 0.4%). Mean reduction in fasting plasma glucose and 8-point SMPG profiles were similar between groups. Rates of confirmed hypoglycaemia were lower for IDegAspStepwise [2.1 per patient years of exposure (PYE)] vs. IDegAspSimple (3.3 PYE) (estimated rate ratio IDegAspSimple /IDegAspStepwise 1.8; 95% CI 1.1, 2.9). Nocturnal hypoglycaemia rates were similar between groups. No severe hypoglycaemic events were reported.
CONCLUSIONS: In participants with insulin-naïve Type 2 diabetes mellitus, the IDegAspSimple titration algorithm improved HbA1c levels as effectively as a Stepwise titration algorithm. Hypoglycaemia rates were lower in the Stepwise arm.
METHODS: A cross-sectional study was conducted in Hospital Universiti Sains Malaysia, Kelantan from November 2013 till May 2016 among Type 2 DM patients (DM with no DR and DM with NPDR). The patients were evaluated for anterior ocular segment biometry [central corneal thickness (CCT), anterior chamber width (ACW), angle opening distance (AOD) and anterior chamber angle (ACA)] by using Anterior Segment Optical Coherence Tomography (AS-OCT). Three ml venous blood was taken for the measurement of HbA1c.
RESULTS: A total of 150 patients were included in this study (DM with no DR: 50 patients, DM with NPDR: 50 patients, non DM: 50 patients as a control group). The mean CCT and ACW showed significant difference among the three groups (p < 0.001 and p = 0.015 respectively). Based on post hoc result, there were significant mean difference of CCT between non DM and DM with NPDR (mean difference 36.14 μm, p < 0.001) and also between non DM and DM with no DR (mean difference 31.48 μm, p = 0.003). The ACW was significantly narrower in DM with NPDR (11.39 mm SD 0.62) compared to DM with no DR (11.76 mm SD 0.53) (p = 0.012). There were no significant correlation between HbA1c and all the anterior ocular segment biometry.
CONCLUSION: Diabetic patients have significantly thicker CCT regardless of retinopathy status whereas ACW was significantly narrower in DM with NPDR group compared to DM with no DR. There was no significant correlations between HbA1c and all anterior ocular segment biometry in diabetic patients regardless of DR status.
METHODOLOGY: Five electronic databases were searched for studies that compared implant outcomes in patients with differing HbA1c values. Research quality was evaluated using Risk of Bias in Nonrandomized Studies of Interventions (ROBINS-I) tool. Narrative synthesis and meta-analysis were performed for survival rate, plaque index (PI), bleeding on probing (BOP), probing pocket depth, and marginal bone loss (MBL). Categorical dose-response meta-analysis (DRMA) was conducted according to length of follow-up.
RESULTS: Twenty-two studies met the inclusion criteria. Prospective studies were mostly of moderate quality, but non-prospective papers had serious to critical risk of bias. Survival rate was high for the first 3 years (92.6%-100%) for patients with HbA1c less than 8%. Meta-analysis revealed worsening clinical parameters with increasing HbA1c. DRMA further established a significant dose-response relationship between glycemic control with BOP (10% more bleeding, 95% CI 0.05-0.16, P = .008) and MBL (0.05 mm more bone loss, 95% CI 0.01-0.09, P = .002) per HbA1c category, but no association with probing pocket depth. Osseointegration progressed at a slower rate, and inflammatory cytokines and bone biomarkers were adversely affected in patients with HbA1c above 8%.
CONCLUSION: Moderate evidence suggests a high short-term survival but possible dose-response trend of worsening BOP and MBL in association with glycemic control. Clinically, HbA1c values must be considered for risk assessment before placement and throughout the lifespan of the implant placed in a patient with diabetes.
METHODS: Online literature search databases including Scopus, Web of Science, PubMed/Medline, Embase and Google Scholar were searched to discover relevant articles available up to 17 March 2020. We used mean changes and SD of the outcomes to assess treatment response from baseline and mean difference, and 95 % CI were calculated to combined data and assessment effect sizes in astaxanthin and control groups.
RESULTS: 14 eligible articles were included in the final quantitative analysis. Current study revealed that astaxanthin consumption was not associated with FBS, HbA1c, TC, LDL-C, TG, BMI, BW, DBP, and SBP. We did observe an overall increase in HDL-C (WMD: 1.473 mg/dl, 95 % CI: 0.319-2.627, p = 0.012). As for the levels of CRP, only when astaxanthin was administered (i) for relatively long periods (≥ 12 weeks) (WMD: -0.528 mg/l, 95 % CI: -0.990 to -0.066), and (ii) at high dose (> 12 mg/day) (WMD: -0.389 mg/dl, 95 % CI: -0.596 to -0.183), the levels of CRP would decrease.
CONCLUSION: In summary, our systematic review and meta-analysis revealed that astaxanthin consumption was associated with increase in HDL-C and decrease in CRP. Significant associations were not observed for other outcomes.