Chinese mainland of the Type 2 Diabetes Randomized Controlled Clinical Trial (RCT) study -- Lancet Diabetes Endocrinol

China has the largest number of people with diabetes in the world, and according to published national surveys, the prevalence of diabetes in China has increased dramatically over the past 30 years.
chinese adult diabetes is significantly different from that of the white European population in genetic and pathophysiological processes.
because there is little evidence of high-quality randomized controlled clinical trials (RPTs) in Chinese patients, the clinical practice guidelines for adult diabetes management in China are very similar to 1000 guidelines in Europe and North America.
face of the growing burden of diabetes, China needs to strictly design and effectively implement the RCT to develop specific treatment and prevention strategies.
to understand the overview of type 2 diabetes RCT research in China and to identify the limitations of the trial to improve the level of diabetes research.
the RCT carried out by type Chinese mainland 2 diabetes in the past 30 years was summarized and summarized by the team of Ning Guang academicians of Ruijin Hospital affiliated with Shanghai Jiaoba University School of Medicine, and the improvement of clinical research was put forward.
the findings were published in The Lancet Diabetes and Endocrinology.
In the study, researchers searched English-language journals and clinical trial registration sites and eventually included 1,044 clinical trials, 92 percent of which were conducted in Chinese mainland and 8 percent in patients with type Chinese mainland 2 diabetes who participated in international multi-center clinical trials.
addition, more than 60 per cent of the experimental interventions were drug therapy, the other 10.3 per cent behavioural interventions, 6.4 per cent non-drug interventions such as surgery, and 5.2 per cent dietary supplements.
note that only 3.5 per cent of outcomes are mainly due to complications of diabetes, including cardiovascular disease, diabetic retinal lesions and end-stage kidney disease.
the number of RCT interventions for type 2 diabetes, prior to 2000, RCT studies for type 2 diabetes were limited and not reported.
between 2000 and 2010, Chinese mainland RCTs for people with type 2 diabetes increased dramatically.
levelled off after 2010, with 60 additional clinical trials of type 2 diabetes started each year.
number of clinical trials started in 2019 continues to rise and has almost doubled.
From 1995 to 2020, the number of RCT studies on type 2 diabetes profiled the geographical distribution of type 2 diabetes RCT, however, from a national perspective, clinical trials of type 2 diabetes were unevenly conducted, with 73.7% concentrated in east China, 13.3%, 9.2% and 3.8% in the west, central and northeast regions, respectively.
in terms of inclusion of subjects, no more than 10 per cent of the subjects were included in clinical trials, and 37.9 per cent of the trials included fewer than 100 subjects.
, 26.3% of the trials used an open design, with single-blind and double-blind trials accounting for 5.4% and 22.2%, respectively.
, 37.7 per cent of the trials did not mention the type of blindness.
In addition, of the 466 trials for which data are available (excluding multi-country trials), the follow-up rate for 211 trials was less than 5.0%, the follow-up rate for 88 trials was 5.0%-9.9%, the follow-up rate for 127 trials was 10.0% or higher, and the rate of missed visits was not mentioned in 40 trials.
, the rate of missed visits was usually higher in behavioral intervention trials and longer follow-up trials.
, while clinical trial registrations and results reporting are improving globally, the failure to upload trial results as required still needs to be strengthened, and many clinical trials are not tracking their progress and status.
According to the data, only 48.1 percent of clinical trials for type 2 diabetes published in 2018 reported clinical trial registration numbers, and data on the progress of other registered clinical trials remained missing, such as important clinical trial information such as inclusion and exclusion criteria, blinding methods, randomized processes, and participating units.
, China has the largest number of diabetics in the world, and its huge medical needs are not being met.
Therefore, there is a need to strengthen regulation, improve clinical trial registration and compliance with reporting results, increase the transparency of clinical trials, and thus improve the quality of clinical trials, ultimately providing a high level of clinical practice.