Effects of Dapagliflozin Adjunct to Insulin on Glycemic Variations in Patients with Newly Diagnosed Type 2 Diabetes: A Randomized, Controlled, Open-Labeled Trial

Background. This study is aimed at investigating whether dapagliflozin adjunct to insulin therapy further improves glycemic control compared to insulin therapy alone in patients with newly diagnosed type 2 diabetes (T2D). Methods. This single-centre, randomized, controlled, open-labeled trial recruited newly diagnosed T2D patients. Subjects were randomized 1 : 1 to the dapagliflozin add-on to continuous subcutaneous insulin infusion (CSII) group (DAPA) or the CSII therapy group for 5 weeks. Standard meal tests were performed 3 times at days -3, 7, and 35 for glucose, C-peptide, and insulin level determination. Two-time continuous glucose monitoring (CGM) was performed at baseline and at the end of the study. The primary endpoint was the difference in the mean amplitude of glycemic excursions (MAGEs) between the groups. Results. A total of 66 subjects completed the study, with 34 and 32 patients in the DAPA and CSII groups, respectively. Patients in the DAPA group exhibited significant decreases in MAGE levels at the endpoint. We also observed that patients in the DAPA group had a lower homoeostasis model assessment insulin resistance (HOMA-IR) and a higher homoeostasis model assessment B (HOMA-B) value at 1 week and 5 weeks compared to those with insulin therapy, respectively. In addition, our data showed that patients in the DAPA group showed a significantly lower insulin dose (0.07 U/kg) and weighed less than those in the CSII group. Conclusion. Our data indicate that dapagliflozin adjunct to insulin is a safe and effective therapy for improving glycemic variations, insulin sensitivity, and weight loss in newly diagnosed T2D patients.

The Magnitude of Dexamethasone-Induced Hyperglycemia in Cataract Surgical Patients with Normal Glucose Metabolism- A Continuous Glucose Monitoring Based Study

Background: To determined 24-hrs glycemic variations using continuous glucose monitoring (CGM) in cataract surgical patients with normal glucose metabolism receiving dexamethasone therapy.Methods: This was a single-center, randomized, observational and prospective trial. Between June 2017 and December 2018, cataract surgical patients with normal glucose toleration were recruited, and were randomized assigned at a ratio of 1:2 to either receiving 10 mg dexamethasone daily for 3 days after cataract surgical (dexamethasone group) or without dexamethasone therapy (control group). A retrospective CGM was performed at afternoon on -1 day before cataract operation performed for at least 3 days. The primary endpoint was the difference in mean amplitude of glycemic excursions (MAGE) between the two groups.Results: We observed that patients receiving 10 mg dexamethasone daily showing mild increase in mean glucose and hourly mean glucose throughout 24-hrs compared to control group. We also detected that dexamethasone leading to a significant increase in glycemic variation, in term of standard deviation, and a number increase in MAGE and CV%.Conclusion: Our data reveal that short period administration of dexamethasone leading a mild increase in glycemic variations (GV). However, the increased GV may have not clinically relevant. Our data indicates that short duration of 10 mg dexamethasone once daily may be a safe therapy regarding glycemic metabolism in subjects without diabetes.

Diabetic acute ischaemic stroke patients have an increase in glycemic variations assessed by continuous glucose monitoring: a multi-center, observational study

Background One-third of acute ischaemic stroke (AIS) occurs in patients with an abnormal glucose metabolism, but little is known the differences in glycemic variations (GV) between stroke patients with and without abnormal glucose metabolism. The objective of this study was to observe the differences in GV between AIS patients with T2D and without T2D using continuous glucose monitoring (CGM). Methods This was a multi-center, prospective, observational study performed between March 2018 and September 2018 in 5 hospitals in China. After admission, all recruited patients were subjected to a consecutive 4-day CGM. At the endpoint, patients were divided into two groups according to the T2D status. The primary outcome was the differences in GV between AIS patients with and without T2D. Results A total of 149 patients (63 patients with T2D and 86 patients without T2D) were recruited into this study. AIS patients with T2D had a significant increase in the standard deviation of mean glucose, the mean amplitude glycemic excursions, the mean lowest glucose, the incremental area over the curve of hypoglycemia, the percentage of time spent in hypoglycemia, and the time in target range compared to those AIS patients without T2D (p<0.05 for all). Conclusions Our data demonstrates that AIS patients with T2D had a significant increase in GV compared to those without T2D. Our results indicated that therapies aimed to improvement in GV may be important to a better clinical outcome in patients with AIS after the onset of a stroke.

Serum ErbB2 concentration positively correlated to the glycemic variations in newly diagnosed Type 2 diabetic patients

Background Accumulated evidences indicate that elevated levels of circulating ErbB2 are closely associated with increased incidence of diabetes. However, the relationship between ErbB2 concentration and glycemic variations (GV) in type 2 diabetic (T2D) patients remains elucidated. The aim of this study was to assess whether there is an association between serum ErbB2 concentration and GV in newly diagnosed T2D patients. Methods This was a three-center, and observational study. Between April 2019 and July 2019, a total of 106 newly diagnosed T2D patients were recruited. All recruited subjects were admitted as inpatients and received anti-diabetes agents free during the study period. At baseline, fasting serum was collected for ErbB2 measurement and all recruited patients were subjected a prospective CGM for at least 3 days. The primary endpoint was the relationships between ErbB2 concentrations and GV in T2D patients. Results Data of a total of 95 subjects who met the inclusion criteria were analyzed at the endpoint. Subjects were divided into quartiles according to their serum ErbB2 concentrations. We observed that subjects with an elevated level of ErbB2 had a higher value of GV in terms of mean amplitude of glucose excursion (MAGE), standard deviation of mean glucose (SDMG), and the coefficient of variation (CV%) than those with lower levels (all P<0.05). Multiple linear regression analyzes after adjusting for confounder factors indicate that serum ErbB2 levels were significantly positively correlated with the MAGE (β=0.664, t=7.218, P<0.01), SD (β=0.469, t=5.125, P<0.01) and CV% (β=0.337, t=4.442, P<0.01), respectively. Conclusion Serum ErbB2 concentration was positively correlated to the glycemic variations in newly diagnosed T2D patients. Our data indicating that ErbB2 may be a potential treatment target for diabetic patients for improvement in glycemic control. Keywords Type 2 Diabetes, glycemic control, ErbB2

The magnitude of dexamethasone-induced hyperglycemia in cataract surgical patients with normal glucose metabolism: a continuous glucose monitoring based study

Background To determined 24-hrs glycemic variations using continuous glucose monitoring (CGM) in cataract surgical patients with normal glucose metabolism receiving dexamethasone therapy. Methods This was a single-center, randomized, observational and prospective trial. Between June 2017 and December 2018, cataract surgical patients with normal glucose toleration were recruited, and were randomized assigned at a ratio of 1:2 to either receiving 10 mg dexamethasone daily for 3 days after cataract surgical (dexamethasone group) or without dexamethasone therapy (control group). A retrospective CGM was performed at afternoon on -1 day before cataract operation performed for at least 3 days. The primary endpoint was the difference in mean amplitude of glycemic excursions (MAGE) between the two groups. Results We observed that patients receiving 10 mg dexamethasone daily showing mild increase in mean glucose and hourly mean glucose throughout 24-hrs compared to control group. We also detected that dexamethasone leading to a significant increase in glycemic variation, in term of standard deviation, and a number increase in MAGE and CV%.Conclusion Our data reveal that short period administration of dexamethasone leading a mild increase in glycemic variations (GV). However, the increased GV may have not clinically relevant. Our data indicates that short duration of 10 mg dexamethasone once daily may be a safe therapy regarding glycemic metabolism in subjects without diabetes.

Comparison of Efficacy and Safety of Lispro and Aspart Evaluated by Continuous Glucose Monitoring System in Patients with Newly Diagnosed Type 2 Diabetes

Objective. To compare the effect of the rapid-acting insulin analogues (RAIAs) aspart (NovoRapid) and lispro (Prandilin) on glycemic variations by continuous glucose monitoring system (CGMS) in patients within newly diagnosed type 2 diabetes mellitus (T2DM) receiving continuous subcutaneous insulin infusion (CSII) and metformin intensive therapy. Methods. This is a single-blind randomized controlled trial. A total of 110 patients with newly diagnosed T2DM and with hemoglobin A1c (HbA1c%) above 9% was hospitalized and randomly divided into two groups: group Asp (NovoRapid group) and group Lis (Prandilin group). They all received CSII and metformin therapy. Treatments were maintained for 2-3 weeks after the glycaemic target was reached. C-peptide and insulin and fructosamine were determined. CGMS was continuously applied for 4 days after reaching the glycemic target. Results. There were no significant differences in daily dosages of insulin, fasting plasma C-P and 2 h postprandial C-P and insulin, and fructosamine at the baseline and endpoint between the groups Asp and Lis. No significant differences were seen in the 24 h mean amplitude of glycemic excursions (MAGE), 24 h mean blood glucose (MBG), the standard deviation of the MBG (SDBG), fasting blood glucose, number of glycemic excursion (NGE), and the incidence of hypoglycemia between the two groups. Similarly, no significant differences were found in areas under the curve (AUC) of glucose above 10.0 mmol/L or the decremental area over the curve (AOC) of glucose below 3.9 mmol/L between the two groups. Conclusions. Lispro and aspart had the similar ability to control the glycemic variations in patients with newly diagnosed T2DM. This study was registered with ClinicalTrials.gov, number ChiCTR-IPR-17010338.