Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05531838 |
Other study ID # |
CTCCR-2021C20 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 17, 2022 |
Est. completion date |
December 31, 2023 |
Study information
Verified date |
September 2022 |
Source |
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Systematically screen the high-risk population of diabetes in Xinqiao district to understand
the characteristics of early glucose metabolism changes and pancreatic islet function changes
in patients with pre diabetes. Relying on MMC platform and combined with CGM therapeutic
monitoring technology to standardize the management of patients with prediabetes, it is
expected that the annual conversion rate of diabetes in patients with prediabetes will be 8%
(according to the literature, if the pre diabetes population is not intervened, the annual
conversion rate of diabetes will be about 14%), which will move forward the management of
diabetes and create a new mode of pre diabetes management.
Description:
Part I: Establish the first standardized study cohort of prediabetes patients in Songjiang
On the basis of previous studies, we will continue to carry out early screening of diabetes
high-risk groups. It is planned to complete 500 high-risk screening cases in Xinqiao area,
and all screened patients will have their medical history and relevant laboratory
examinations, and will be followed up regularly. The standard OGTT method was used for
screening. The screening contents included: fasting blood glucose and insulin, blood glucose
and insulin levels 2 hours after 75g glucose load, and glycosylated hemoglobin levels. In
addition to glucose metabolism, other metabolic related diseases such as hematuria routine,
liver and kidney function, uric acid, blood lipids, thyroid function, and urine protein /
creatinine were also screened. The establishment of the high-quality high-risk screening
project in Xinqiao community will establish the first standardized research cohort of
diabetes high-risk and pre diabetes patients in Songjiang area, which has very important
strategic significance.
Part II: Standardized management and follow-up based on MMC mode combined with CGM
therapeutic monitoring technology
For patients with pre diabetes diagnosed by screening, we will rely on MMC mode and CGM
technology for standardized management and follow-up. The management mode is mainly embodied
in the following forms: ① using CGM Technology (dynamic glucose monitoring system for
auxiliary Lishan instant sense hospital), on the basis of the original eating habits of
patients, according to the guidelines and the training of MMC center, patients are guided to
adjust their eating mode according to the glucose map monitored by the dynamic glucose
monitoring system and the log recorded, so as to implement therapeutic monitoring, so as to
control the blood glucose level within the target range as far as possible, And record the
amount of various foods accordingly, and then maintain the eating mode and amount basically
unchanged. ② Offline management. Patient education at least twice a year and hospital
follow-up once a year; ③ Issue health instruction manuals, blood glucose monitoring diaries,
etc; ④ A full-time wechat management group is established, and full-time intelligent
assistants push diet, sports and other guidance every day. Taking the cases of diabetes
patients screened in the previous study of the research group as the control, the annual
conversion rate of diabetes was observed one year later.