Real world effectiveness of subcutaneous semaglutide in type 2 diabetes: A retrospective, cohort study (Sema-MiDiab01).

Introduction: Aim of the present study was to evaluate the real-world impact of once-weekly (OW) subcutaneous semaglutide on different end-points indicative of metabolic control, cardiovascular risk factors, and beta-cell function in type 2 diabetes (T2D). Methods: This was a retrospective, observational study conducted in 5 diabetes clinics in Italy. Changes in HbA1c, fasting blood glucose (FBG), body weight, blood pressure, lipid profile, renal function, and beta-cell function (HOMA-B) during 12 months were evaluated. Results: Overall, 594 patients (97% GLP-1RA naïve) were identified (mean age 63.9 ± 9.5 years, 58.7% men, diabetes duration 11.4 ± 8.0 years). After 6 months of treatment with OW semaglutide, HbA1c levels were reduced by 0.90%, FBG by 26 mg/dl, and body weight by 3.43 kg. Systolic blood pressure, total and LDL-cholesterol significantly improved. Benefits were sustained at 12 months. Renal safety was documented. HOMA-B increased from 40.2% to 57.8% after 6 months (p<0.0001). Discussion: The study highlighted benefits of semaglutide on metabolic control, multiple CV risk factors, and renal safety in the real-world. Semaglutide seems to be an advisable option for preservation of ß-cell function and early evidence suggests it might have a role in modifying insulin resistance (HOMA-IR), the pathogenetic basis of prediabetes and T2D.

Long-term evaluation of treatment protocols for isolated midfacial fractures in a German nation-wide craniomaxillofacial trauma center 2007-2017.

An update on the trends in maxillofacial traumatology provides additional information on the actual and changing needs. This retrospective study aimed to review all patient records of patients treated for isolated midface fractures in the Department of Cranial- and Maxillofacial Surgery at the Dortmund General Hospital between 2007 and 2017. The patient radiographs and patient files were reviewed. The safety and efficacy of the applied methods were controlled by assessing complications based on the Clavien-Dindo classification system. The statistical analysis included descriptive methods including regression analysis and χ2-test. In eleven years, 3474 isolated midface fracture sites have been identified in 2868 patients. The yearly trend is slightly increasing, in elderly clearly worsening, in children and youth decreasing. The male-to-female ratio was 2.16:1 for the whole study population, in the age group 18-25 y.o. 6.95:1 while in elderly above 80 y.o. 1:2.51, the age group specific incidence reflects this result, too. The most common fractures were nasal bone fractures (1405), zygomatic fractures (832) and orbital floor fractures (700). The average hospital stay was 2.7 days, the most fractures were operated within 24 h. The complication rate was 2.02% (Clavien-Dindo class II-V). The incidence of midfacial fractures is increasing in the total population and especially in elderly, but decreasing in children. Development of injury prevention measures is needed in this population. The diagnostic and therapeutic procedures are appropriate, as there is a low complication rate and short inpatient stay observed.

Effects of carbohydrate counting on glucose control and quality of life over 24 weeks in adult patients with type 1 diabetes on continuous subcutaneous insulin infusion: a randomized, prospective clinical trial (GIOCAR).

OBJECTIVE: Few studies have assessed the efficacy of carbohydrate counting in type 1 diabetes, and none have validated its efficacy in patients who are treated with continuous subcutaneous insulin infusion (CSII). The aim of our study was to test the effect of carbohydrate counting on glycemic control and quality of life in adult patients with type 1 diabetes who are receiving CSII. RESEARCH DESIGN AND METHODS: Sixty-one adult patients with type 1 diabetes treated with CSII were randomly assigned to either learning carbohydrate counting (intervention) or estimating pre-meal insulin dose in the usual empirical way (control). At baseline and 12 and 24 weeks, we measured HbA(1c), fasting plasma glucose, BMI, waist circumference, recorded daily insulin dose, and capillary glucose data, and administered the Diabetes-Specific Quality-of-Life Scale (DSQOLS) questionnaire. RESULTS: Intention-to-treat analysis showed improvement of the DSQOLS score related to diet restrictions (week 24 - baseline difference, P = 0.008) and reduction of BMI (P = 0.003) and waist circumference (P = 0.002) in the intervention group compared with control subjects. No changes in HbA(1c), fasting plasma glucose, daily insulin dose, and hypoglycemic episodes (<2.8 mmol/L) were observed. Per-protocol analysis, including only patients who continuously used carbohydrate counting and CSII during the study, confirmed improvement of the DSQOLS score and reduction of BMI and waist circumference, and showed a significant reduction of HbA(1c) (-0.35% vs. control subjects, P = 0.05). CONCLUSIONS: Among adult patients with type 1 diabetes treated with CSII, carbohydrate counting is safe and improves quality of life, reduces BMI and waist circumference, and, in per-protocol analysis, reduces HbA(1c).

Frequency-modulated electromagnetic neural stimulation enhances cutaneous microvascular flow in patients with diabetic neuropathy.

AIM: The aim of this study was to investigate the effects of frequency modulated electromagnetic neural stimulation (FREMS), a recently developed safe and effective treatment of painful diabetic neuropathy, on cutaneous microvascular function. METHODS: Thirty-one patients with painful neuropathy were enrolled in a randomised, double-blind, crossover FREMS vs. placebo study; each received two series of 10 treatments of either FREMS or placebo in random sequence within no more than 3 weeks. Patients were studied at baseline, end of FREMS and placebo series, and after 4 months of follow-up. Cutaneous blood flow was measured by laser doppler flowmetry and partial tissue tension of oxygen (TcPO2) and carbonic anhydride (TcPCO2) by oxymetry at the lower extremities in basal resting conditions and as incremental response after thermal stimulation. RESULTS: Crossover analysis showed no consistent differences between FREMS and placebo. After 4-month follow-up, a 52% increase of cutaneous blood flow was observed in resting conditions (P=.0086 vs. baseline), while no differences were observed as incremental flow after warming; compared with baseline, no significant differences were observed for TcPO2 and TcPCO2, both in resting conditions and as incremental response to warm. CONCLUSION: These results indicate that 10 treatments with FREMS may induce an enhancement of microvascular blood flow measurable at 4 months of follow-up. The findings of this study will need to be confirmed in a larger, adequately powered study (ClinicalTrial.gov Id: NCT00337324).