As a new class of antidiabetic drug, incretin-based therapies, which include dipeptidyl peptidase-4 inhibitors (DPP-4Is) and glucagon-like peptide-1 receptor agonists (GLP-1 RAs), have raised ...concerns about symptoms of withdrawal in patients with type 2 diabetes mellitus (T2DM), such as dizziness and headache. To systematically evaluate whether incretin-based therapies may lead to dizziness and headache in patients with T2DM compared to other traditional antidiabetic drugs or placebo. We searched Medline, Embase, the Cochrane library, and clinicaltrials.gov from inception through June 23, 2017, to identify randomized controlled trials of the safety of DPP-4Is or GLP-1 RAs versus placebo or other antidiabetic drugs in T2DM patients. We used the network meta-analysis under the frequentist framework to compare the association between multiple antidiabetic drugs and dizziness and headache. A total of 233 clinical trials with nine treatments and 147,710 patients were included: two incretin-based therapies, one placebo, and six traditional antidiabetic drugs (metformin, insulin, sulfonylurea, thiazolidinediones, alpha-glucosidase inhibitor, and sodium-glucose co-transporter 2). Compared to insulin, thiazolidinediones, or placebo, GLP-1 RAs statistically significantly increased the risk of dizziness (odds ratios ORs: 1.92, 1.57, and 1.40, respectively) and headache (ORs: 1.34, 1.41, and 1.18, respectively). DPP-4Is increased the risk of headache (OR: 1.22, 95% confidence interval CI: 1.02 to 1.46; moderate quality) and dizziness (OR: 1.46, 95% CI: 1.05 to 2.03; moderate quality) compared to insulin. Of the incretin-based therapies, DPP-4Is had a lower risk of dizziness than GLP-1 RAs (OR: 0.76, 95% CI: 0.67 to 0.87; high quality). Ranking probability analysis indicated that GLP-1 RAs may have the greatest risk of both dizziness and headache among the nine treatments (22.5% and 23.4%, respectively), whereas DPP-4Is were in the middle (46.2% and 45.0%, respectively). Incretin-based therapies increase the risk of dizziness and headache compared to insulin, thiazolidinediones, and placebo.
To evaluate the effectiveness of the mobile health application (APP) education in basal insulin optimal management program for insulin-naive type 2 diabetes (T2D) patients in China.
The basal ...insulin optimal management program was launched in 297 hospitals in China, throughout the six main regions of China. A total of 17,208 insulin-naive patients with T2D who started to use basal insulin were screened. The mobile health APP was downloaded in each recruited patient's mobile phone and the doctor's mobile phone. Then, according to the instructions and education materials in the APP, these patients began their self-management of insulin dosage titrations and contacted their doctors by APP if they need help.
Overall, 12,530 patients with T2D were finally included in the analysis. The average age was 51.97±12.76 years, and 58% of them were males. The average body mass index is 24.46±3.83 kg/m
, and the average HbA1c at baseline was 8.33±2.11% with 24% of the subjects reaching the target of HbA1c<7.0% at baseline. After 3 months of treatment and educations through the APP, HbA1c decreased significantly from baseline (-1.02±1.72%), with 59% of the patients reaching HbA1c<7.0%. After 6 months, the glycemic control of HbA1c also decreased from baseline significantly (-1.01±1.67%). Dosage of insulin daily was 0.23±0.09 IU/kg at baseline, and 0.23±0.23 IU/kg after 6 months of treatment. Regarding the profiles of hypoglycemia treatment, 3145 patients received basal insulin in combination with mono oral anti-diabetic drug (OAD), 1204 patients with dual OADs, 208 patients with triple OADs, and 17 patients with quarter OADs.
Patients could benefit from the basal insulin optimal management program in self-management by using mobile health APP educations. For T2D patients who are going to start insulin treatment, mobile health APP can help them to reach the target of glycemic control with appropriate dosage of insulin.
Highlights • This is the largest scale multicenter study. • This study developed an alternative, simple and rapid test for DSPN screening. • AR + V + T can effectively screen for DSPN.
The 9th Cardiovascular Outcome Trial (CVOT) Summit: Congress on Cardiovascular, Kidney, and Metabolic Outcomes was held virtually on November 30-December 1, 2023. This reference congress served as a ...platform for in-depth discussions and exchange on recently completed outcomes trials including dapagliflozin (DAPA-MI), semaglutide (SELECT and STEP-HFpEF) and bempedoic acid (CLEAR Outcomes), and the advances they represent in reducing the risk of major adverse cardiovascular events (MACE), improving metabolic outcomes, and treating obesity-related heart failure with preserved ejection fraction (HFpEF). A broad audience of endocrinologists, diabetologists, cardiologists, nephrologists and primary care physicians participated in online discussions on guideline updates for the management of cardiovascular disease (CVD) in diabetes, heart failure (HF) and chronic kidney disease (CKD); advances in the management of type 1 diabetes (T1D) and its comorbidities; advances in the management of CKD with SGLT2 inhibitors and non-steroidal mineralocorticoid receptor antagonists (nsMRAs); and advances in the treatment of obesity with GLP-1 and dual GIP/GLP-1 receptor agonists. The association of diabetes and obesity with nonalcoholic steatohepatitis (NASH; metabolic dysfunction-associated steatohepatitis, MASH) and cancer and possible treatments for these complications were also explored. It is generally assumed that treatment of chronic diseases is equally effective for all patients. However, as discussed at the Summit, this assumption may not be true. Therefore, it is important to enroll patients from diverse racial and ethnic groups in clinical trials and to analyze patient-reported outcomes to assess treatment efficacy, and to develop innovative approaches to tailor medications to those who benefit most with minimal side effects. Other keys to a successful management of diabetes and comorbidities, including dementia, entail the use of continuous glucose monitoring (CGM) technology and the implementation of appropriate patient-physician communication strategies. The 10th Cardiovascular Outcome Trial Summit will be held virtually on December 5-6, 2024 ( http://www.cvot.org ).
Abstract
Background
The aim of the present study was to investigate the prevalence of diabetic ketosis (
DK
) and its risk factors in Chinese diabetes patients with severe hyperglycemia.
Methods
The ...present multicenter cross‐sectional study was performed on patients aged >16 years with diabetes mellitus (
DM
) and random blood glucose levels >13.9 mmol/L (>250 mg/dL). Blood ketones (β‐hydroxybutyric acid) and urinary ketones (acetoacetic acid) were measured and information on patient demographic and clinical characteristics was collected.
Results
Of 1235 patients enrolled in the study (93 with type 1
DM
T1
DM
), 1142 with type 2
DM
T2
DM
), 242 (19.6%) had
DK
(blood ketone levels ≥0.6 mmol/L). Proportionately,
DK
was more frequent and more severe in patients with T1
DM
than T2
DM
(55.9% vs 16.6%, respectively), but in absolute terms occurred in more patients with T2
DM
(52 vs 190). In patients with blood ketone levels ≥3 mmol/L, the cut‐off point of blood glucose levels was 19.05 mmol/L. Risk factors significantly associated with higher blood ketone levels in T2
DM
included younger age, a shorter duration of diabetes, and not using antidiabetic medication within 12 months prior to the hyperglycemic episode.
Conclusions
The prevalence of
DK
is lower in patients with T2
DM
than T1
DM
, but the number of patients with
DK
is higher for those with T2
DM
because of more T2
DM
patients in China. Patients with T2
DM
who have a younger age, shorter duration of diabetes, and a lack of antidiabetic treatment will suffer from
DK
more often than older patients with longer T2
DM
duration and receiving antidiabetic treatment.
摘要
背景
本研究旨在调查有严重高血糖症状的中国糖尿病患者中糖尿病酮症患病率及危险因素。
方法
本研究为多中心、横断面调查。年龄16岁以上、随机血糖> 13.9 mmol/L(> 250 mg/dL)的糖尿病患者入选本研究。测定患者的血酮(β‐羟丁酸)和尿酮(乙酰乙酸)。收集患者的人口学信息和相关临床资料。
结果
1235例患者入选本研究(93例1型糖尿病和1142例2型糖尿病), 242例(19.6%)被诊断为糖尿病酮症(快速血酮 ≥ 0.6 mmol/L)。相对应地, 1型糖尿病患者的酮症患病率更高(1型糖尿病酮症患病率55.9% , 2型糖尿病酮症患病率16.6%)并且程度更严重, 但2型糖尿病患者酮症的绝对数量更多(1型糖尿病52例酮症, 2型糖尿病190例酮症)。快速血糖≥ 19.05 mmol/L是快速血酮水平≥ 3 mmol/L的血糖诊断切点。与2型糖尿病患者血酮升高显著相关的危险因素包括:年龄小、糖尿病病程短、在高血糖发生前12个月未采取降糖药物治疗。
结论
在中国严重高血糖的患者中, 2型糖尿病患者的酮症患病率低于1型糖尿病, 但其酮症患者的绝对数量更高, 因为2型糖尿病患者数目更多。2型糖尿病患者发生酮症的危险因素包括年轻、糖尿病病程短、未及时采取降糖药物治疗。
Abstract
Purpose/Aim of the study: Exostosin 2 (EXT2) is involved in early pancreatic development and the regulation of insulin synthesis. In this study, we aim to evaluate the contribution of EXT2 ...to the genetic pathogenesis of type 2 diabetes and its related traits in the Chinese population. Materials and methods: A case-control study in a Chinese Han population was conducted that included 4766 patients with type 2 diabetes and 4596 control subjects from 14 different regions of China. Three single nucleotide polymorphism (SNP), rs3740878, rs11037909 and rs1113132, in the EXT2 gene were genotyped using the Illumina GoldenGate Genotyping assay. Results: After adjusting for sex, age and body mass index, logistic regression analysis revealed that the EXT2 gene had no association with type 2 diabetes using an additive genetic model rs3740878 (Odds Ratio (OR) = 0.996, 95% confidence interval (CI) 0.928-1.069, p = 0.910), rs11037909 (OR = 1.003, 95%CI 0.933-1.078, p = 0.931), and rs1113132 (OR = 0.993, 95% CI 0.925-1.065, p = 0.842). None of these SNPs were associated with beta cell function as determined using the baseline disposition index, early phase insulin secretion and Oral Glucose Tolerance Test (OGTT) total disposition index. Conclusions: Our study suggests that the EXT2 gene might not have a major role in the development of type 2 diabetes in the Chinese population.
Objective. To investigate the associations of 25-(OH)D and β-cell function or insulin resistance or albuminuria in Chinese type 2 diabetic patients. Methods. In total, 1408 type 2 diabetic patients ...without vitamin D supplement were included in this retrospective study. Results. Comparison between patients with and without 25-(OH)D deficiency indicated that, compared with patients with 25-(OH)D ...5; 50 nmol/L, patients with 25-(OH)D < 50 nmol/L showed a higher level of urine albumin-creatinine ratio (ACR) (90.15±10.30 mg/g versus 52.79±14.97 mg/g). Multiple regression analysis indicated that 25-(OH)D was independently and negatively correlated with urine ACR (OR=0.985 , 95%CI 0.972-0.999, P=0.03 ), adjusted by age, diabetic duration, HBP duration, SBP, HbA1c, creatinine, LDL-C, triglyceride, total cholesterol, and HDL-C. Compared with patients with normal level of urine ACR, patients with higher level of urine ACR showed a significant lower level of 25-(OH)D (34.49±13.52 nmol/L versus 37.46±13.6 nmol/L, P=0.00 ). Analysis of the associations of 25-(OH)D and β-cell function or insulin resistance showed that 25-(OH)D may not correlate with β-cell function or insulin resistance. Conclusion. 25-(OH)D was independently associated with albuminuria in Chinese type 2 diabetic patients but was not associated with β-cell function or insulin resistance.
Abstract
Background
The aim of the present study was to investigate the value of clinical characteristics in predicting sulfonylurea (
SU
) treatment responses.
Methods
All 747 subjects in the ...present study were from the
X
iaoke
P
ill
C
linical
T
rial evaluating the safety and efficacy of
SU
. Subjects had the same initial dose of glibenclamide and drug doses were adjusted every 4 weeks during the 48‐week follow‐up period. Primary
SU
failure was defined as a <10% reduction in fasting plasma glucose (
FPG
) at the end of
W
eek 4 from randomization, whereas secondary
SU
failure was defined as a consecutive confirmed level of
FPG
>7 mmol/L.
Results
Kaplan–
M
eier survival analysis revealed that lower baseline basal disposition index (
DI
b
) and higher
FPG
predict secondary
SU
failure. Inversely, higher baseline
DI
b
and lower
FPG
predict primary
SU
failure. Primary
SU
failure can predict secondary
SU
failure. The combination of lower baseline
DI
b
with primary
SU
failure is a better predictor of secondary
SU
failure than lower baseline
DI
b
or primary
SU
failure alone.
Conclusions
Patients with good glycemic control and higher β‐cell reserve at entry are more likely to experience primary
SU
failure but are less likely to experience secondary
SU
failure. By combining baseline
DI
b
with initial response at the first month of treatment, we can get quick information about the long‐term efficacy of
SU
treatment.
摘要
背景
本研究的目的是调查预测磺脲类药物治疗反应的临床特征的价值。
方法
本研究纳入的747名患者来自消渴丸临床试验(Xiaoke Pill Clinical Trial), 评估了磺脲类药物的安全性和疗效。患者使用的格列本脲起始剂量相同, 在为期48周的随访期间每4周调整一次药物剂量。原发性失效定义为随机分组后的第4周末空腹血糖的降低小于10%, 继发性失效定义为重复确认的空腹血糖 > 7 mmol/L。
结果
Kaplan–Meier生存分析显示基线时较低的基础处置指数(basal disposition index, DI
b
)和较高的空腹血糖可预测继发性失效。与此相反, 基线时较高的DI
b
和较低的空腹血糖可预测原发性失效。原发性失效可预测继发性失效。基线时较低的DI
b
联合原发性失效与单独的两者相比可以更好地预测继发性失效。
结论
在研究开始时患者的血糖控制较好以及β细胞储备较高则发生原发性磺脲类药物失效的可能性较高, 但发生继发性失效的可能性较低。将基线DI
b
与磺脲类药物治疗一个月后的初始反应相结合, 可以快速得知磺脲类药物长期疗效的信息。
ObjectivesTo evaluate the risk of cancers of digestive system with incretin-based therapies among patients with type 2 diabetes mellitus.Research design and methodsMedline, Embase, Cochrane Library ...and ClinicalTrials.gov databases were searched for randomized controlled clinical trials that compared incretin-based drugs with placebo or other antidiabetic drugs. Paired reviewers independently screened citations, extracted data and assessed risk of bias of included studies. Network meta-analysis was performed, followed by subgroup analysis. The Grading of Recommendations Assessment, Development and Evaluation system was used to assess the quality of evidence.ResultsA total of 84 studies (n=101 595) involving cancers of digestive system were identified (a median follow-up of 30 weeks). The risk of cancers of digestive system with incretin-based therapies was comparable with insulin (OR: 0.86, 95% CI 0.27 to 2.69), metformin (OR: 0.32, 95% CI 0.07 to 1.38), sodium-glucose co-transporter 2 (OR: 5.26, 95% CI 0.58 to 47.41), sulfonylureas (OR: 1.27, 95% CI 0.68 to 2.39), thiazolidinediones (OR: 0.42, 95% CI 0.13 to 1.42), alpha-glucosidase inhibitors (OR: 2.98, 95% CI 0.12 to 73.80), and placebo (OR: 0.87, 95% CI 0.71 to 1.05). The results of subgroup analysis based on the type of digestive system cancers indicated that incretin-based therapies did not increase the risk of gastrointestinal cancers, respectively. The results of subgroup analysis based on age, duration, mean HbA1c, trial duration, and sample size did not indicate the risk of digestive system cancers.ConclusionsModerate to high Grading of Recommendations Assessment, Development and Evaluation evidence suggests that incretin-based therapies were not associated with an increased risk of cancer of digestive system in patients with type 2 diabetes mellitus.
Background: The COVID-19 pandemic has forced rapid reconsideration of the way in which health care is delivered in patients with T1DM. We explored the effect of an online structured DSMES program on ...glycemic control and self-management behavior in patients with T1DM.
Methods: The intervention included 2 modules: (1) series of online DSMES sessions based video courses and personalized discussion on diabetes management; (2) continuous interactions and support based Wechat platform through text, audio or video.
Results: A total of 36 subjects were enrolled into the final analysis, of them, 26 (72.2%) were young adults above 18 years and 10 (27.8%) were children and adolescence below 18. There were significant changes in HbA1c, TIR and hypoglycemic event in young adults; however, no significant difference were found in children and adolescence. There were significant behavior change measured using self-management scale of T1DM for Chinese adults (SMOD-CA) in participants aged ≥18, mainly in the domains of daily performance, coping with disease-related problems and goals of disease management; however, no significant behavior change were found in adolescence with T1DM (DBRS). (Table 1)
Conclusions: The online structured DSMES program improved glycemic control, self-management behavior and reduced hypoglycemic event in young adults but not in children and adolescence with T1DM.
Disclosure
L. An: None. L. Ji: Other Relationship; Eli Lilly and Company, Novo Nordisk, Merck & Co., Inc., Bayer Inc., Sanofi-Aventis U. S., Roche Pharmaceuticals, MSD Life Science Foundation, AstraZeneca, Boehringer Ingelheim Inc., Abbott, Metronics.