Effect of Digital-Tool-Supported Basal Insulin Titration Algorithm in Reaching Glycemic Control in Patients with Type 2 Diabetes in Mexico.

BACKGROUND: My Dose Coach (MDC) is a mobile application combined with a web portal that can suggest optimized basal insulin (BI) injection doses using Self-Measured Plasma Glucose (SMPG) and hypoglycemia data. This study aimed to evaluate its efficacy on patients reaching SMPG and Fasting blood glucose (FBG) target range 90-130 mg/dl (5-7.2 mmol/L) goals without severe hypoglycemic episodes. We also addressed the mean reduction in glycated hemoglobin (A1C), FBG, and SMPG and the improvement in the WHO's Five Well Being Index (WBI). METHODS: This prospective pilot study involved the use of MDC in outpatients with type 2 diabetes (T2DM) from a Hospital in Northern Mexico. Patients on treatment with any BI were included in the study. The follow-up was of 16 weeks. Student t-tests or McNemar test were used for effect comparisons. RESULTS: We included 158 patients (46.8% women), mean (SD) age 51 (10.3) years. We achieved SMPG target range in 58.9% [mean (95CI) reduction of 30.9 mg/dl (22.5-37.7; P < .001)] of the patients [66(28) days], with no severe hypoglycemia events. FBG goal was reached in 55.7% [mean (95CI) reduction of 63.4 mg/dl (49.6-77.2; P < .001)]. The mean (95CI) reduction of A1C was 1.78% (1.47-2, P < .01) with the last observation carried forward. There was a mean (95CI) increase of 2.23 (-3, -1.4, P < .01) points in WBI scale. CONCLUSIONS: MDC successfully helped to achieve FBG and SMPG goals, reduced A1C, and increased WBI with no severe hypoglycemia events.

Analysis of Immunization, Adverse Events, and Efficacy of a Fourth Dose of BNT162b2 Vaccine in Health Workers in Mexico, a Pilot Study.

There is scarce information on seroconversion and adverse events after immunization (AEFI) with the fourth dose of BNT162b2. Our aim was to correlate the magnitude of the antibody response to this vaccination regimen in terms of clinical conditions and AEFI. This was an observational pilot study in which SARS-CoV-2 S1−S2 IgG antibodies titers were measured 21−28 days after the first and second dose, three months after the second dose, 1−7 and 21−28 days after the third dose, before the fourth dose, and 21−28 days after the fourth dose. We recruited 112 subjects in a hospital in Mexico, 74% women, with an average age of 43 (SD 9) years. After the first dose, subjects had a median IgG AU/mL (IQR) of 122 (1904) that increased to 1875 (2095), 3020 (2330), and 4230 (3393) 21−28 days after the second, third, and fourth doses, respectively (p < 0.01). The number (%) who experienced any AEFI between the first and fourth doses was 90 (80.4), 89 (79), 65 (58), and 69 (61.5), respectively (p < 0.001). After the fourth dose, the most frequent of AEFI was pain at the injection site (87%). There was a correlation between AEFI and gender after the fourth dose, as well as with antibody levels (p < 0.05). During the Omicron outbreak, six (5.3%) had mild COVID-19 for 8−28 days after the fourth dose. The median increase in S1/S2 IgG was 30.8-fold after the fourth BNT162b2 dose when compared with the first dose and caused mild AEFI.

Effect of Heterologous Vaccination Regimen with Ad5-nCoV CanSinoBio and BNT162b2 Pfizer in SARS-CoV-2 IgG Antibodies Titers.

The efficacy of one dose Ad5-nCoV has been concerning. This study aimed to evaluate the effect of a single dose BNT162b2 in individuals after a completed Ad5-nCoV vaccination regiment compared to a group without this boost measuring SARS-CoV-2 Spike 1−2 IgG antibodies in plasma. This observational study included a subgroup analysis of patients who were immunized with Ad5-nCoV in a northern city of Mexico. During follow-up, some patients self-reported having received a BNT162b2 booster. We report baseline IgG levels, 21−28 days after the Ad5-nCoV dose, three months, and an additional 21−28 days after BNT162b2 (four months after Ad5-nCoV). Seventeen patients, age 40 (16), 52.9% men, were analyzed. We created four groups: G1 and G2 refer to patients without a history of SARS-CoV-2 infection, vaccinated with Ad5-nCoV and Ad5-nCoV/BNT162b2 (n = 4 and n = 6), respectively; G3 and G4 included patients with a history of SARS-CoV-2 infection and immunized with Ad5-nCoV and Ad5-nCoV/BNT162b2 (n = 5 and n = 2), respectively. The Ad5-nCoV/BNT162b2 protocol reported higher antibody titers after 21−28 days. Median (IQR) values were: G1 46.7 (-), G2 1077.5 (1901), G3 1158.5 (2673.5), and G4 2090 (-) (p < 0.05). Headache and pain at injection site were the most frequent adverse reactions associated with Ad5-nCoV (n = 10, 83%) and BNT162b2 (n = 5, 83.3%), respectively. Patients receiving BNT162b2 after Ad5-nCoV had higher SARS-CoV-2 spike 1−2 IgG antibody titers and had no severe adverse reactions.

Effect of the third dose of BNT162b2 vaccine on quantitative SARS-CoV-2 spike 1-2 IgG antibody titers in healthcare personnel.

BACKGROUND: Vaccination is our main strategy to control SARS-CoV-2 infection. Given the decrease in quantitative SARS-CoV-2 spike 1-2 IgG antibody titers three months after the second BNT162b2 dose, healthcare workers received a third booster six months after completing the original protocol. This study aimed to analyze the quantitative SARS-CoV-2 spike 1-2 IgG antibody titers and the safety of the third dose. MATERIAL AND METHODS: A prospective longitudinal cohort study included healthcare workers who received a third booster six months after completing the BNT162b2 regimen. We assessed the quantitative SARS-CoV-2 spike 1-2 IgG antibody titers 21-28 days after the first and second dose, three months after the completed protocol, 1-7 days following the third dose, and 21-28 days after booster administration. RESULTS: The cohort comprised 168 participants aged 41(10) years old, 67% of whom were female. The third dose was associated with an increase in quantitative antibody titers, regardless of previous SARS-CoV-2 history. In cases with a negative SARS-CoV-2 history, the median (IQR) antibody titer values increased from 379 (645.4) to 2960 (2010) AU/ml, whereas in cases with a positive SARS-CoV-2 history, from 590 (1262) to 3090 (2080) AU/ml (p<0.001). The third dose caused a lower number of total (local and systemic) adverse events following immunization (AEFI) compared with the first two vaccines. However, in terms of specific symptoms such as fatigue, myalgia, arthralgia, fever, and adenopathy, the proportion was higher in comparison with the first and second doses (p<0.05). The most common AEFI after the third BNT162b2 vaccine was pain at the injection site (n = 82, 84.5%), followed by fatigue (n = 45, 46.4%) of mild severity (n = 36, 37.1%). CONCLUSION: The third dose applied six months after the original BNT162b2 regimen increased the quantitative SARS-CoV-2 spike 1-2 IgG antibody titers. The booster dose was well tolerated and caused no severe AEFI.

Analysis of immunization time, amplitude, and adverse events of seven different vaccines against SARS-CoV-2 across four different countries.

Background: Scarce information exists in relation to the comparison of seroconversion and adverse events following immunization (AEFI) with different SARS-CoV-2 vaccines. Our aim was to correlate the magnitude of the antibody response to vaccination with previous clinical conditions and AEFI. Methods: A multicentric comparative study where SARS-CoV-2 spike 1-2 IgG antibodies IgG titers were measured at baseline, 21-28 days after the first and second dose (when applicable) of the following vaccines: BNT162b2 mRNA, mRNA-1273, Gam-COVID-Vac, Coronavac, ChAdOx1-S, Ad5-nCoV and Ad26.COV2. Mixed model and Poisson generalized linear models were performed. Results: We recruited 1867 individuals [52 (SD 16.8) years old, 52% men]. All vaccines enhanced anti-S1 and anti-S2 IgG antibodies over time (p<0.01). The highest increase after the first and second dose was observed in mRNA-1273 (p<0.001). There was an effect of previous SARS-CoV-2 infection; and an interaction of age with previous SARS-CoV-2 infection, Gam-COVID-Vac and ChAdOx1-S (p<0.01). There was a negative correlation of Severe or Systemic AEFI (AEs) of naïve SARS-CoV-2 subjects with age and sex (p<0.001); a positive interaction between the delta of antibodies with Gam-COVID-Vac (p=0.002). Coronavac, Gam-COVID-Vac and ChAdOx1-S had less AEs compared to BNT162b (p<0.01). mRNA-1273 had the highest number of AEFIs. The delta of the antibodies showed an association with AEFIs in previously infected individuals (p<0.001). Conclusions: The magnitude of seroconversion is predicted by age, vaccine type and SARS-CoV-2 exposure. AEs are correlated with age, sex, and vaccine type. The delta of the antibody response only correlates with AEs in patients previously exposed to SARS-CoV-2. Registration number: ClinicalTrials.gov, identifier NCT05228912.