Significant Increase In HbA1c Research Articles

The Impact of a Nutritional Intervention on Glycemic Control and Cardiovascular Risk Markers in Type 2 Diabetes.

Nutritional management plays a crucial role in treating patients with type 2 diabetes (T2D), working to prevent and control the progression of chronic non-communicable diseases. To evaluate the effects of individualized nutritional interventions on weight, body mass index (BMI), waist circumference (WC), waist-to-hip ratio (WHR), fasting blood glucose (FBG), hemoglobin A1c (HbA1c), total cholesterol (TC), LDL cholesterol (LDL-C), HDL cholesterol (HDL-C), triglycerides (TGs), systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR)} over 12 months and subsequently at follow-up (15 months). This longitudinal experimental study (without randomization and blinding) enrolled 84 sedentary participants with T2D (both sexes, aged 18-80 years). They were divided into a control group of 40 participants who received only medical consultations, and an intervention group of 44 participants who received the same medical care along with a nutritional assessment. Consultations occurred quarterly from August 2020 to November 2022 (first-twelfth month), with six to nine patients per session. Subsequently, a follow-up was conducted from December 2022 to November 2023, during which the intervention group had only medical care (during the 12th-15th months). Personalized dietary planning was inspired by the Mediterranean/DASH diets adapted to Brazilian foods and socioeconomic cultures. Normal variables were compared between groups for each time point and also within each group across different time points using a two-way ANOVA (repeated measures for intragroup) followed by the Šídák post hoc test. Non-normal variables were compared between groups for each time point using Kruskal-Wallis followed by the Dunn post hoc test, and within each group across different time points using Friedman followed by the Dunn post hoc test. Data with a Gaussian distribution were presented as mean ± standard deviation (SD), and data with a non-Gaussian distribution were presented as median ± interquartile range (IQR). For all cases, α < 0.05 and p < 0.05 were adopted. In the intervention group, significant reductions were observed between the first and twelfth month for all parameters (p < 0.05), (except for TC), along with an increase in HDL-C (p = 0.0105). Conversely, in the control group, there was a significant increase in HbA1c, weight, BMI, FBG, and WHR (p < 0.05) between the first and twelfth months. Regarding the comparison between groups, there was a significant difference for all analyzed parameters (p < 0.05) from the first to the twelfth month. In the follow-up, differences were also observed (p < 0.05), except for BMI (p > 0.05). The individualized nutritional intervention improved eating habits, anthropometric, biochemical, and cardiovascular markers in T2D over 12 months, with sustained results during follow-up. The dietary plan inspired by the Mediterranean and DASH diets demonstrated good adaptation to the Brazilian food culture and the patients' socioeconomic contexts. Consistent monitoring and personalized nutritional management are essential for optimizing long-term outcomes. However, more clinical trials are necessary in order to optimize the level of evidence for longitudinal interventions.

Vitamin D, anti-Mullerian hormone and glycemic status in infertile polycystic ovarian syndrome (PCOS), infertile non PCOS and fertile non PCOS at Mediheal Fertility Center - Western Kenya

Background: Diabetes of the bearded women was first described by Achard and Theirs in 1921 and since then insulin resistance and hyperinsulinemia in women with polycystic ovary syndrome (PCOS) remains one of the commonest metabolic problems. Insulin resistance and type II diabetes mellitus occurs in 70% of women with PCOS. The mechanism of insulin resistance has not been well established and inconsistent study results have complicated treatment modalities and management of insulin resistance and PCOS in general. There is evidence that 80% of women with PCOS are deficient in Vitamin D and this could be the missing link between Vitamin D and insulin resistance.&#x0D; Objective: To determine the correlation of Vitamin D, AMH and glycemic status in infertile PCOS, infertile non PCOS patients and fertile non PCOS attending Mediheal Fertility Center in Western Kenya as there is dearth of such studies within Kenyan population.&#x0D; Methods: A case control design with 20 patients per group for infertile PCOS, infertile non PCOS and fertile non PCOS which served as normal controls. Quantification of HbA1c was done at AMPATH reference laboratories using fluorescence immunoassay while Vitamin D and AMH was done at MTRH laboratories using ECLIA Roche. Data was analyzed using Statistical Package for Social Sciences (SPSS) version 25.&#x0D; Results: The mean HbA1c and median serum AMH in infertile PCOS, infertile non PCOS and infertile non PCOS were 6.1±0.4 and 7.5(6.2, 11.1), 5.5±0.3, and (1.2, 4.4), 5.6±0.3 and 2.0(1.7, 2.3) respectively. The study revealed statistically significant increase in HbA1c and serum AMH in infertile PCOS as compared to infertile non PCOS and fertile non PCOS (F=15.7, p&lt;0.001 and F=46.7, p&lt;0.001) respectively. In addition, Vitamin D was significantly deficient among infertile PCOS versus infertile non PCOS and fertile non PCOS (F=41.8, p&lt;0.001).&#x0D; Conclusion: Infertile patients with PCOS have deficiency in Vitamin D and increase in HbA1c and AMH hence there might be a link of Vit D and AMH in pathophysiology of insulin resistance among PCOS patient

Recent Patterns and Assessment of Long-term Complications following SARS-CoV-2 Infection and Vaccination in the Context of Diabetes Prevalence among Blood Donors.

Much increasing evidence has suggested that long-term complications post vaccination of SARS-CoV-2 experience a wide range of complication including diabetes. The risk and burden of type 1 diabetes is extensively reported, but type 2 diabetes mellitus (T2D) has yet to be characterized. To address this gap, we aimed to examine trends of long-term complications post SARS-CoV-2 infection and vaccination in diabetes incidence among the Saudi population. In this cross-sectional hospital-based study, we analyzed the blood profile of first-time blood donors from the University Hospital of King Abdulaziz University, Jeddah. Saudi Arabia. Various blood parameters, HbA1c was measured in the month of May 2023. All the donors were non-diabetic and were never diagnosed with T2D before the current blood donation. 203 healthy subjects donated their blood, out of which 104 had abnormally high HbA1c tending towards diagnosis of T2D and 99 had with blood profiles. The study followed the STROBE reporting guidelines. Out of 203 donors 104 (male 50(48.1%), female 54(51.9%)) were diagnosed with increased HbA1c (8.24 in males) compared to 7.61 of HbA1c in females. 35.6% were above ˃65 years, with 52.9% with O+ from the ABO blood group. Liver functions indicated significant p˂0.05, 0.04, increased amount of GGT (46.47 U/L), Alkaline phosphatase (99.93 ±64.26 uL) respectively in HbA1c elevated donors KFT represented significant p˂0.05, 0.02 elevated levels of urea (6.73 ±5.51 mmol/L), creatinine (129.97 ±195.17 umol/L) respectively along with elevated values of Lactate dehydrogenase (LDH) (263.72± 196.70 uL) and triglycerides (1.66 ±0.74mmol/L) when compared to normal value of HbA1c donors. In the present cross-sectional study, significant increase in HbA1c, trending towards increased cases of T2D post SARS-CoV-2 infection and vaccination. Males are much affected compared to females. Further maximum number of cases were from donors above the age of 65 years with altered partial LFT (GGT, Alkaline phosphatase), KFT (urea, creatinine), lipid profile (TG) and LDH in post SARS-CoV-2 and vaccination blood donors. Increase in HbA1c in 50% of donors, irrespective of gender, is an alarming figure for health authorities, with altered LFT, KFT and LDH tests and, in the near future, may increase the incidence of T2D. Large-scale population-based studies are required to prevent future incidences of T2D in young children who will be vaccinated.

Low to High Intensity Exercise dalam Menurunkan Kadar Gula Darah pada Pasien DM Tipe 2

This study aims to map and synthesize evidence regarding the effectiveness of low to high-intensity exercise in reducing blood sugar levels in type 2 DM patients according to patient characteristics. The method used is a scoping review with a search strategy using the PICO(s) format. Pubmed, Science Direct, CINAHL, and the Google Scholar search engine are the databases used. The research results showed that eight articles were in English, five studies showed a significant reduction in blood sugar, and three others showed no significant decrease. Apart from that, it was also found that there was an increase in insulin, which showed a significant increase in HbA1c, and there was no increase in the dose of anti-diabetic therapy. Several types of exercise are used at all intensities depending on the patient's ability, including walking, jogging, power cycling, and walking on a treadmill. In conclusion, exercise can reduce weight for obese patients and increase muscle strength, followed by improved physical function for patients with weight loss.&#x0D; &#x0D; Keywords: Diabetes Mellitus Type 2, Exercise Therapy, Blood Glucose

1163-P: The Arrival of a New Sibling May Be Associated with a Deterioration in Glycemic Control for Children with Type 1 Diabetes

Introduction: Caring for young children with Type 1 diabetes comes with significant burden for parents. We hypothesised that pregnancy and the arrival of a new sibling may be associated with a deterioration in control of type 1 diabetes for older siblings with type 1 diabetes. Research Design and Methods: We identified young children currently under the care of the John Hunter Children's Hospital Paediatric Diabetes team who had welcomed a younger sibling since their diagnosis using our prospective Paediatric Diabetes database. We reviewed the HbA1c pre and post the arrival of a new sibling. Results: 38 children (20 male) had become older siblings since diagnosis of type 1 diabetes. 5 children were excluded as no data were available prior to pregnancy. Mean age of children at diagnosis was 3.5 years. Mean age at arrival of sibling was 6years with mean duration of diabetes at that time of 3.4 years. 15 of eligible participants were using insulin pump therapy. Mean HbA1c during pregnancy was 51mmol/mol (6.8%) compared to 54mmol/mol (7.1%) following delivery (p&amp;lt;0.05). 67% of children had HbA1c &amp;lt;53mmol/mol (7%) during pregnancy compared to 53% following delivery. Conclusion: The arrival of a new sibling was associated with a significant increase in HbA1c. This may be due to the high care burden of type 1 diabetes on parents which cannot be met when also attempting to attend to the needs of a newborn. Programs to assist new parents may help children with young siblings to continue to meet glycaemic targets. Despite the young age of the cohort of children prior to delivery of a new sibling, 67% were able to meet the ADA glycaemic target of &amp;lt;7%. This indicates that the goals of intensive management of diabetes are achievable even in the toddler, preschool and early primary school years. Disclosure P.E.Lopez: None. B.R.King: None. C.E.Smart: None. A.Sinclair: None. M.Neylan: None. R.Seckold: None. M.A.Paterson: None.

Comparison of Glucose Control Profile in Patients With Depression and Type 2 Diabetes Receiving Bupropion or Venlafaxine: A Randomized Controlled Clinical Trial

Background and Objective This study aims to compare the effects of bupropion and venlafaxine on glucose control of patients with depression and type 2 diabetes (T2D). Materials &amp; Methods TThis randomized controlled trial was carried out in endocrinology clinic affiliated to Babol University of Medical Sciences on adult patients with comorbid T2D and depression in two groups. The first group (n=19) received venlafaxine 37.5-150 mg daily, while the second group (n=16) was treated with bupropion 75-300 mg per day. The primary outcomes were the severity of depressive symptoms and the glucose control profile. Depressive symptoms were assessed with the Beck depression inventory (BDI). Data was analyzed in SPSS software, version 17 package. P&lt;0.05 was considered as statically significant. Results A significant decrease in depressive symptoms for both groups was reported, but the difference between the two groups was not statistically significant (P=0.342). Venlafaxine caused a significant increase in HbA1c from 7.64 to 8.03 (P=0.04), while bupropion caused a decrease in HbA1c from 7.35 to 7.23 (P=0.06). These changes were significantly different between the two groups (P=0.028). Conclusion Venlafaxine can reduce depression, but it is not suggested as a proper drug for treating depression in people with T2D. However, bupropion seems to be a good choice due to its positive effect on depressive symptoms and glycemic control in patients with comorbid T2D and depression.

Physical activity during COVID-19 pandemic and its impact on glycemic control in children with type 1 diabetes mellitus

Background: Physical activity is one of the important factors affecting glycemic control in type 1 diabetes mellitus (T1DM). During COVID-19 pandemic the government imposed restrictions to prevent the spread of COVID and physical activity of children was curtailed. We assessed the physical activity during COVID-19 pandemic restrictions (from September 2020 to September 2021) and its association with their glycemic control. Methods: 48 children with T1DM receiving treatment in paediatric endocrinology outpatient department (OPD), AIIMS, New Delhi were enrolled. Socio-clinical data were collected using pre-validated and tested self-structured tool, physical activity was assessed using global physical activity questionnaire and glycemic control was assessed by glycated haemoglobin (HbA1C) and compared to baseline level before the onset of pandemic. Results: Among 48 children (11.2±3.7 years, 25 M: 23 F), 79.2% fulfilled the 60 minutes’ requirement of physical activity/day. Moderate negative correlation was found in recommended physical activity duration and HbA1c during COVID-19 pandemic. However, there was a significant increase in the HbA1C level from 7.6±1.5 to 8.5±1.8 during COVID-19 pandemic. Conclusions: There was a moderate negative correlation between duration of physical activity and HbA1c of children. In spite of restrictions imposed by the government, children who were physically active were able to maintain good glycemic control. Although there was significant increase in the mean HbA1c of children during COVID-19 pandemic but the percentage of hyperglycemic events was significantly lower among the children who had walked/rode bicycle for going from one place to another and who had more rooms to play at home had good glycemic control.

Laboratory Characteristics on SARS-CoV-2 Infection among Patients with Diabetes Mellitus: A Single-Center Retrospective Study.

Diabetic patients have been severely affected by COVID-19 infection. It has been reported that the disease is more progressive leading to venous and arterial thromboembolism, due to multiple factors. This study was conducted to determine the hematologic parameters including D-dimer in diabetic patients with COVID-19 infection in association with disease severity and treatment. This retrospective cohort study was conducted at King Fahad Medical City, Saudi Arabia, after obtaining IRB approval, by collecting data regarding all laboratory parameters, disease severity, and anticoagulant treatment of COVID-19 diabetic patients (n = 159) from medical records from March to December 2020. Mean value of white blood cells, neutrophils, monocytes, eosinophils, lymphocyte monocyte ratio, C-reactive protein, serum ferritin, and LDH levels was elevated in severe cases than in mild cases with statistical significant increase in HbA1c (0.047), serum fibrinogen (0.007), C-reactive protein (0.005), serum ferritin (0.034), and serum LDH (0.015). Mortality was observed in 14 (8.8%) patients mostly with severe COVID-19 with diabetes. In our study, treatment with low molecular weight heparin was not significantly related to severity. A logistic regression analysis indicated an association of some laboratory parameters with severity and mortality of the disease. The routine blood parameters if detected early will enable physicians to identify severe cases of COVID-19 patients with Diabetes for prompt treatment and save considerable time and resources.

The Impact of COVID-19 Lockdown on the Incidence of Type 1 DM and the Glycemic Control of Diabetic Children: Findings from a Teaching Hospital, Saudi Arabia.

OBJECTIVE: We evaluated glycemic control among T1DM pediatric patients attending the endocrinology pediatrics clinics at King Fahd Hospital of the University (KFHU) prior to and during COVID-19 restraining regulations. In addition, we assessed the trends and variations in the incidence of T1DM during 2017-2021, including the COVID-19 years by identifying newly diagnosed patients presenting to pediatrics emergency department (ED) in KFHU. METHODS: To estimate the effect of COVID-19 on the incidence of T1DM, we identified newly diagnosed cases of T1DM among pediatric patients attending the ED during the years 2017- 2021. The participants' data were collected through electronic medical records. Information collected included patient age, sex, and HbA1c readings. Three HbA1c readings of interest that were defined and collected are pre-COVID reading, in-COVID reading, and post-COVID reading. RESULTS: The difference of female participants' readings was statistically non-significant (Z= -0.416, p = 0.678), with a pre- and post-COVID median of 10.70 (Q1= 9.00, Q3= 12.15), and 10.50 (Q1= 8.80, Q3= 12.35), respectively. In contrast, the difference was statistically significant among male participants (Z= -2.334, p = 0.02), with a pre- and post-COVID median of 10.20 (Q1= 8.70, Q3= 11.80), and 10.65 (Q1= 9.00, Q3= 12.70), respectively. There was a statistically significant increase in HbA1c of persons > 11 years old (Z= -2.471, p= 0.013), with a pre- and post-COVID median of 10.40 (Q1= 9.00, Q3= 12.10), and 10.90 (Q1= 9.00, Q3= 12.60), respectively. Conversely, persons ≤ 11 years old showed no statistically significant change in HbA1c (Z= -.457, p= 0.648), with a pre- and post-COVID median of 10.45 (Q1= 8.70, Q3= 11.85), and 10.20 (Q1= 8.40, Q3= 12.075), respectively. Disregarding any influence of time, the effect of sex showed no statistically significant difference in HbA1c between males and females [F (1,125) = 0.008, p = 0.930]. Meanwhile, the age effect on HbA1c, regardless of time influence, was statistically significant [F (1,125) = 4.993, p = 0.027]. There was no statistically significant interaction between time and sex on HbA1c levels [F (1.74, 217) = 0.096, p = 0.883] and between age and time [F (3.92,289.57) = 1.693, p = 0.190]. CONCLUSIONS: The number of visits to healthcare facilities dropped significantly during the COVID-19 pandemic, but the rate of newly diagnosed T1DM increased. There was a variable effect on HbA1c levels of those patients, which suggests that each demographic group in the population might have been affected differently by the pandemic. Future research should determine factors associated with better glycemic control and measures to sustain these changes the pandemic might have created.

Ramazan Orucu Tutan Diabetes Mellitus Hastalarında Kendi Kendine Glikoz Takibinin Glisemik Kontrole Etkisi

Aim: It is known that a significant number of patients with diabetes insist on fasting in the month of Ramadan, despite the advice of their physicians and reliable authorities. In order to provide the best possible care and support to these patients, the International Diabetes Federation (IDF) and the Diabetes and Ramadan (DAR) International Alliance practical guidelines have been created by the International Alliance. The aim of this study was to investigate the effect of consulting a physician and self glucose monitoring on diabetes management during Ramadan in patients with fasting diabetes.Methods: With this retrospective observational study, patients over 18 years of age who were diagnosed with diabetes, who came to the diabetes outpatient clinic for control after Ramadan and who made their follow-up from our outpatient clinic before Ramadan, were included. Everyone who intends to fast (previous or not) has been asked about previous fasting experiences, questions about whether they consulted the doctor before Ramadan, and those who fasted, how they spent this Ramadan, the questionnaire was filled. The biochemical data of fasting patients before and after Ramadan were analyzed.Results: A total of 394 patients with diabetes participated in the questionnaire and 98 of them (24.9 %) who were fasted were included in the study. The mean age of the fasting patients with diabetes was 59.7 ± 12.3 years and39.2 %werefemale. It was detected that 86.7% of the fasting people were fasting for more than 15 days. Fasting rates were higher in males than females (32.4% to 20.8%) It was found that 25.9% of patients with type 2 DM and 10.3% of patients with type 1 DM were fasting. It was determined that 62.8% of the patients intending to fast were consulted to the physician about this subject, 55.3% of them were determined risk by physician and 70% of them followed up with selfmonitoring blood glucose (SMBG). It was determined that 23.4% (23/98) of fasting patients had a reduction in the number or dose of diabetes medications used; 5.1% (5/98) experienced a complication that would disrupt fasting; 16.3% gained weight (2.8 ± 2.4 kg) and 23.5% lost weight (2.7 ± 1.9 kg). A significant increase in HbA1c and a significant decrease in UACR were detected. It has been determined that A1c control of those who follow with SMBG is better protected than those who do not.Conclusion: In our study, it was seen that a quarter of patients with diabetes fasted. The most valuable result of this study is that the diabetic patients have achieved a more successful diabetes control by providing self-auto control mechanism with SMBG, regardless of whether or not they have received medical advice by physician consultationin Ramadan.

Biochemical and Molecular Studies of Different Parameters as Markers for Nephropathy in Type 1 Diabetic Patients

Albuminuria is the most characteristic marker of diabetic nephropathy (DN), which is a diabetic complication associated with DN progression. However, renal functions decreased by about one-third of diabetic patients before the occurrence of albuminuria. We study the role of telomere length (TL) of blood leukocytes, some inflammatory markers in the progression of DN in patients with type 1 diabetes (T1D). Volunteers were selected and distributed into four groups: group 1 included 20 healthy subjects as control, group 2: 20 T1D patients with albumin excretion rate (AER) &lt; 30 mg/gm creatinine, group 3: 15 T1D patients with (300 &gt; AER &gt; 30 mg/gm creatinine), group 4: 15 T1D patients with (AER &gt; 300 mg/gm creatinine) and group 5 (DN group), which is a collective group between group 3 and group 4. Glycated haemoglobin (HbA1c), serum urea, creatinine, malondialdehyde (MDA), 8-OHdG, and TL in leukocytes were measured. Results showed a significant increase in HbA1c, creatinine, urea, 8-OHdG, transforming growth factor β1 (TGF-β1), MDA and decrease in TL in G2, G3, G4, and G5 compared with control with a p-value &lt; 0.05.

Decreased Cardiac NOX4 and SIRT-1 Protein Levels Contribute to Decreased Angiogenesis in the Heart of Diabetic Rats: Rescue Effects of IGF-1 and Exercise.

Purpose: Reduced angiogenesis in the heart tissue is a primary risk factor for heart disease in the diabetes condition. This study was aimed to evaluate the changes of two main angiogenesis mediators, NADPH oxidase 4 (NOX4) and sirtuin 1 (SIRT-1) protein levels in the heart of diabetic rats and the impact of Insulin-like growth factor 1 (IGF-1) and exercise on these proteins. Methods: Injection of 60 mg/kg of streptozotocin in 40 male Wistar rats led to the induction of type 1 diabetes. Angiogenesis was detected in the hearts by immunostaining for PECAM-1/ CD31 after 30 days of treatment with IGF-1 (2 mg/kg/day) and exercise. ELISA technique was utilized to establish the expression levels of NOX4 and SIRT-1 within the heart. Results: The results revealed a significant increase in HbA1c and a significant decrease in SIRT1, NOX4 levels and angiogenesis grade in the heart of diabetes group compared to control group. Meanwhile, IGF-1 and exercise alone or in combination completely masked these effects. Additionally, synergistic effect on SIRT-1, HbA1c levels and angiogenesis grade is evident when IGF-1 and exercise are applied simultaneously. Conclusion: Our findings suggest that reduction in angiogenesis in the heart of diabetic rats may be mediated by down expression of NOX4 and SIRT-1 protein levels. It was also displayed that IGF-1 and exercise as novel therapies increase NOX4 and SIRT-1 protein levels within the hearts of diabetic rats.

Metabolic and clinical effect of alpha-lipoic acid administration in schizophrenic subjects stabilized with atypical antipsychotics: A 12-week, open-label, uncontrolled study

BackgroundMany of the atypical antipsychotics induce metabolic side effects, limiting their use in clinical practice. Alpha-lipoic acid (ALA) was proposed as a new approach in schizophrenia to improve metabolic effects of atypical antipsychotics. The aim of the study is to evaluate the effect of ALA on metabolic and clinical parameters among schizophrenic subjects. Methods15 schizophrenic subjects, in stable atypical antipsychotic monotherapy were included in the study. ALA was administrated at the oral daily dose of 600 ​mg/d in addition to antipsychotic therapy. Metabolic, clinical, and psychopathological parameters were measured at typical antipsychotics. e initial screening, and after 12 weeks. ResultsALA produced a statistically significant reduction in QTc (p ​= ​0.012), blood glucose (p ​= 0.005), AST (p ​= ​0.021), γGT (p ​= ​0.035), CPK (p ​= ​0.005) and prolactinaemia (p ​= ​0.026). In contrast, there was a significant increase in HbA1c (p ​= ​0.026). No effects on body weight and blood lipid levels (triglycerides, total cholesterol, HDL, LDL) emerged. ConclusionsALA treatment appeared to be effective for reducing diabetes risk, liver functionality parameters, hyperprolactinaemia and QTC interval. ALA appears to be safe as adjunctive components in schizophrenia.

Structured self-monitoring of blood glucose is associated with more appropriate therapeutic interventions than unstructured self-monitoring: A novel analysis of data from the PRISMA trial

AimsTo investigate the relationship between single therapeutic interventions and indicatorsofglycemic control in the PRISMA trial, a large study comparing the effects of intensive structured SMBG (ISM) vs. active control (AC) in non-insulin-treated type 2 diabetes (T2D). MethodsInformation was collected at four time points, corresponding to months 3, 6, 9, and 12 and visits 2, 3, 4, and 5, respectively. Data on therapeutic interventions, HbA1c levels and the number of hypoglycemic episodes at each visit were analyzed. ResultsIntensification of drug therapy occurred in 20.3% vs. 15.6%, and no change in 71.8% vs. 78.7% of visits for the ISM and AC groups, respectively. On the other hand, de-intensification and redistribution of drugs and/or drug dose occurred in a similar proportion of visits. Intensification of drug therapy in both groups was associated with significant reductions in HbA1c vs. the previous visit, while de-intensification of therapy led to a significant increase in HbA1c in the AC group only. Conclusions. Our data strongly support that structured SMBG has clinical value in reducing HbA1c in non-insulin-treated T2D and suggest that this clinical benefit may be mediated by more appropriate and timely changes in drug therapy.

Use of Personal Continuous Glucose Monitoring Device Is Associated With Reduced Risk of Hypoglycemia in a 16-Week Clinical Trial of People With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion.

Continuous glucose monitoring (CGM) has the potential to promote diabetes self-management at home with a better glycemic control as outcome. Investigation of the effect of CGM has typically been carried out based on randomized controlled trials with prespecified CGM devices on CGM-naïve participants. The aim of this study was to investigate the effect on glycemic control in people using their personal CGM before and during the trial. Data from the Onset 5 trial of 472 people with type 1 diabetes using either their personal CGM (n = 117) or no CGM (n = 355) and continuous subcutaneous insulin infusion in a 16-week treatment period were extracted. Change from baseline in glycated hemoglobin A1c (HbA1c), number of hypoglycemic episodes, and CGM metrics at the end of treatment were analyzed with analysis of variance repeated-measures models. Use of personal CGM compared with no CGM was associated with a reduction in risk of documented symptomatic hypoglycemia (event rate ratio: 0.82; 95% CI: 0.69-0.97) and asymptomatic hypoglycemia (event rate ratio: 0.72; 95% CI: 0.53-0.97), reduced time spent in hypoglycemia (P = .0070), and less glycemic variability (P = .0043) without a statistically significant increase in HbA1c (P = .2028). Results indicate that use of personal CGM compared with no CGM in a population of type 1 diabetes is associated with a safer glycemic control without a statistically significantly deteriorated effect on HbA1c, which adds to the evidence about the real-world use of CGM, where device type is not prespecified, and users are not CGM naïve.

The Influence of Gender and Menopausal Status on Hba1c Variation in a Big Data Study of a Saudi Population.

Glycated haemoglobin (HbA1c) is the gold standard measurement in the screening, diagnosis and monitoring of diabetes mellitus. Saudi Arabia has a high prevalence of diabetes mellitus that is expected to rise, and the HbA1c test is commonly used in the screening, diagnosis and monitoring of diabetes. This study aims to assess the impact of age and gender on HbA1c levels, and the influence of menopausal status on HbA1c variation in a large group of Saudis. Age, gender, and HbA1c results of 168,614 Saudi adult individuals were obtained from their medical records. Patients' records were extracted irrespective of their status regarding the presence of diabetes and the status of glycaemic control. Linear regression models were used for predicting HbA1c from age and gender, and their interaction term. HbA1c levels were compared between genders in different age groups and different HbA1c categories. There was a statistically significant positive correlation between age and HbA1c levels, where for each ten years increase in age, HbA1c increased by 0.35%. Although the overall mean HbA1c in women was significantly lower than in men (P < 0.001), women showed a significant increase in HbA1c with older age compared to men (B = 0.014, P < 0.001). Furthermore, the mean HbA1c levels in the age group > 50 years was significantly higher than before that age (P < 0.001). Thus, HbA1c increased by 1.118% in age > 50 years group compared to age ≤ 50 years, and this increase in HbA1c was significantly higher in women compared to men (B = 0.495, P < 0.001). HbA1c levels are lower in women before the estimated menopausal age, which should be taken into consideration when using HbA1c for screening, diagnosis, and monitoring of diabetes in Saudi adult women. The short lifespan of red blood cells, due to loss of blood through menstruation, in women before menopause age, is a possible reason for these variations.

583-P: Effects and Safety of Pemafibrate, a Novel Hypolipidemic Agent in Japanese Type 2 Diabetes Patients Receiving Statins

The combination therapy of statins and fibrates may increase the risk of hepatic dysfunction and myopathy, so this combination was contraindicated in patients with renal impairment and required careful administration even for patients with normal renal function. However, in Japan, patients with renal impairment were excluded from the relative contraindication category in 2018. In the present study, we additionally administered 0.2 mg/day pemafibrate (PFB), a novel fibrate, for 6 months to 27 type 2 diabetes patients with dyslipidemia already receiving statins for 6 months (combination group), and examined the efficacy and safety of the combination therapy in comparison with a PFB monotherapy group. In the combination group, a significant decrease in serum total cholesterol level was observed after 6 months of PFB treatment compared to baseline, along with increase in HDL-cholesterol. A significant decrease in serum triglyceride and a significant increase in HbA1c were observed in both groups. Significant decreases in serum creatinine kinase, which is an indicator of myopathy, and serum γ-GTP, a parameter of hepatic dysfunction, were observed in the combination group. These results demonstrated that the statin-PFB combination therapy in type 2 diabetes patients with dyslipidemia improved lipid metabolism safely without increasing the risk of hepatic dysfunction and myopathy. Disclosure M. Kusunoki: Other Relationship; Self; Kaken Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd. D. Sato: None. T. Sakazaki: None. Y. Natsume: None. T. Miyata: None.

Glucose Metabolism Evaluated by Glycated Hemoglobin and Insulin Sensitivity Indices in Children Treated with Recombinant Human Growth Hormone

Objective:To evaluate glucose metabolism and insulin sensitivity in children with idiopathic growth hormone (GH) deficiency, treated with recombinant human GH (rhGH), and to identify possible risk factors for the development of glucose abnormalities in this population.Methods:We retrospectively collected data from 101 patients (60 males, median age 10.4 years, 77 prepubertal), with confirmed GH deficiency, enrolled before starting rhGH and followed up during the first three years of treatment. Glucose metabolism was evaluated annually by oral glucose tolerance test (OGTT) and glycated hemoglobin A1c (HbA1c). OGTT was used to calculate insulin sensitivity (HOMA-S) and insulin resistance (HOMA-IR), defined as HOMA-IR >3.Results:RhGH was effective in improving growth and dosages significantly reduced after the first year of therapy. No patient developed diabetes mellitus. After one year of therapy, a significant increase in HbA1c (p=0.0042) and insulin levels (fasting p<0.0001, 60 min p=0.0018, 120 min p=0.0003) was observed, with a higher prevalence of IR (p<0.05). These indices did not alter further during the follow-up and were not related to GH dose or to family history of diabetes. A significant correlation was found only for IR indices and pubertal status, weight and age (p<0.05).Conclusion:In this retrospective study on a large GH deficient pediatric population, conventional use of replacement therapy resulted in an increase in HbA1c and IR after one year of therapy, regardless of rhGH dosage. These alterations did not worsen significantly in the following two years and were not associated with overt diabetes.

Assessment of glucose variability in subjects with prediabetes

The aim of the study was to assess glucose variability in subjects with prediabetes by means of CGM. Material and methods: 32 subjects with prediabetes – mean age 56.6 ± 9.6 years, mean BMI 30.3 ± 5.3 kg/m2 and 18 subjects with normal glucose tolerance (NGT) – mean age 54.4 ± 9.9 years, mean BMI 24.8 ± 6.9 kg/m2, were enrolled. Glucose tolerance was studied during OGTT. HbA1c was measured by NGSP certified method. CGM was performed with FreeStyle Libre Pro sensor. Results: The following indices of glucose variability were significantly higher in the prediabetes group – CV (p < 0.041), J-index (p < 0.014), CONGA (p < 0.047) and GRADE (p < 0.036). A significant increase in HbA1c (p < 0.036), mean interstitial glucose (p < 0.025), time above range (p < 0.018) and a significant decrease in time in range (p < 0.014) was found in prediabetes compared to NGT. Significant correlations between HbA1c and LBGI (r = −0.33, p = 0.02), HBGI (r = 0.31, p = 0.03), CONGA (r = 0.36, p = 0.01), J-index (r = 0.37, p = 0.01) and M−value (r = −0.34, p = 0.02) were established. Conclusion: Glucose variability is significantly increased in prediabetes and is an additional parameter in the assessment of glucose homeostasis even at these early stages of glucose dysregulation.

Effects of pasireotide treatment on coagulative profile: a prospective study in patients with Cushing's disease.

Cushing's disease (CD) is characterized by procoagulative profile. Treatment with cortisol-reducing medications might normalize the coagulation impairment potentially eliminating the risk of thromboembolic complications. The aim of this prospective study is to evaluate the effectiveness of 6-12 months of treatment with pasireotide (Signifor®, Novartis) 600 µg twice daily on coagulative factors in 21 patients (16 females, mean age 46 ± 12.2 years) with CD. Biochemical, hormonal (urinary free cortisol, UFC; late night salivary cortisol, LNSC; ACTH) and coagulative parameters as Protrombin time (PT), aPTT, factors VIII, IX and XI, antithrombin III, protein C, protein S, fibrinogen, were evaluated at baseline and during therapy. UFC showed a significant reduction from baseline (3.2 ± 1.8 vs. 1.0 ± 0.8, p < 0.0001) with normalization in 13/21 (61.9%) and in 7/16 (43.8%) at 6 and 12 months, respectively. On the same way LNSC returned to normal in 5/11 at 6 months, showing a trend to reduction (8.6 ± 5 vs. 4.1 ± 2.9), even though without statistical significance (p = 0.07). Throughout the treatment period there was an increase in serum glycaemia (5.5 ± 2.3 vs. 6.8 ± 2.3 mmol/L, p = 0.09), with a concomitant significant increase in HbA1c after 6 months (40.7 ± 8.4 vs. 50.7 ± 12.3 mmol/mol, p = 0.006). Regarding coagulative parameters, no differences were found neither in clotting nor in anticoagulant factors during therapy. No patients developed thrombotic complication during treatment. Pasireotide resulted an effective treatment in controlling hypercortisolism in more than half of CD patients with partial restoration also of circadian cortisol secretion. No significant improvements were observed on clotting factors; this fact might depend on persistence of typical alteration of CD, such as obesity and hypertension, and reflects also on the worsening in glucide metabolism induced by the drug. Clinical implications of persistent procoagulative impairment while on medical therapy should be considered.