The goal of this clinical trial is to learn if continuous glucose monitoring system works to improve glucose control in non-insulin-treated older adults with type 2 diabetes. The main questions it aims to answer are:
* Dose the use of continuous glucose monitoring system improve glucose control in older adults with type 2 diabetes treated with oral antidiabetic drugs only? * Dose the use of continuous glucose monitoring system affect psychological outcomes in older adults with type 2 diabetes treated with oral antidiabetic drugs only? Researchers will compare continuous glucose monitoring to standard blood glucose monitoring to see if continuous glucose monitoring works better in glucose management.
Participants will:
* Wear continuous glucose monitoring every 2 months or standard blood glucose monitoring for 6 months * Visit the clinic once every 2 months for follow-up * Keep a diary of their blood glucose when continuous glucose monitoring was not used
Age ≥ 60 years at the time of screening;
Diagnosed with type 2 diabetes mellitus;
Treated with two or more oral antidiabetic drugs with a stable medication regimen (medication classes) during the 3 months prior to entry;
Suboptimal glycemic control, defined as HbA1c ≥ 7.5% and ≤ 10% at screening or within 30 days prior to screening visit;
Use of insulin or Glucagon-Like Peptide-1 （GLP-1） receptor agonists within 3 months prior to screening;
Use of any CGM device within 3 months prior to screening;
Participants were unable to tolerate tape adhesive around sensor placement area, or with medically documented allergy towards the adhesive (glue) of plasters, or with serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) around sensor placement area;
Considered unsuitable for participation by the investigators, including but not limited to individuals with dementia, psychiatric disorders, extreme visual or hearing impairment that would impair ability to use real-time CGM assessed;
Parallel
real-time CGM
Devicereal-time CGM can provide real-time tracking of glucose levels, and offer glucose trend graphs and user-configurable low and high glucose alerts.
Change in HbA1c
Change in HbA1c from baseline to 24 weeks
Time in range of 70-180 mg/dL
A treatment group comparison of percentage of time spent in glucose range between 70 and 180 mg/dL measured by CGM
Time below range of 70 mg/dL
A treatment group comparison of percentage of time spent in glucose range below 70 mg/dL measured by CGM
Time above range of 180 mg/dL
A treatment group comparison of percentage of time spent in glucose range above 180 mg/dL measured by CGM
Glucose coefficient of variability
A treatment group comparison of glucose coefficient of variability measured by CGM
HbA1c <7.0%
Percentage of subjects with A1C less than 7%
Reduction in HbA1c ≥0.5%
Percentage of subjects with a reduction in A1C greater than or equal to 0.5%
Rate of hypoglycemia events per week
Hypoglycemia event was defined as 15 consecutive minutes with a sensor glucose value \<70 mg/dL
Time in tight range of 70-140 mg/dL
A treatment group comparison of the percentage of time spent in glucose range between 70 and 140 mg/dL measured by CGM
Click on the lead sponsor to view all of their trials.
Shanghai 6th People's Hospital
Lead sponsor
Shenzhen Center for Chronic Disease Control
Collaborator
Shenzhen Baoan District People's Hospital
Collaborator
Shenzhen Haile Community Health Service Station
Collaborator
Shenzhen Buxin Community Health Service Center
Collaborator
Shenzhen Dalang Community Health Service Center
Collaborator
Shenzhen Haihua Community Health Service Center
Collaborator
Shenzhen Pingzhou Community Health Service Center
Collaborator
Shenzhen Fifth Avenue Health Service Station
Collaborator
Shenzhen Haifu Health Service Station
Collaborator
Shenzhen Haile Huafu Health Service Station
Collaborator
Shenzhen Haiyu Health Service Station
Collaborator
Shenzhen Jiaan Health Service Station
Collaborator
Shenzhen Jiari Mingju Health Service Station
Collaborator
Shenzhen Jiangangshan Health Service Center
Collaborator
Shenzhen Xinan Lake Health Service Station
Collaborator
Shenzhen Xingdong Health Service Station
Collaborator
Shenzhen Zhongliang Chuangxin Health Service Station
Collaborator
Shenzhen Guantian Community Health Service Station
Collaborator
Shenzhen Huiyu Mingdu Community Health Service Station
Collaborator
Shenzhen Langxin Community Health Service Station
Collaborator
Shenzhen Luozu Community Health Service Center
Collaborator
Shenzhen Tianbao Community Health Service Center
Collaborator
Shenzhen Shuitian Health Service Center
Collaborator
