Effect of Continuous Glucose Monitoring System on Glycemic Control in Non-insulin-Treated Elderly People With Type 2 Diabetes
Recruiting · NCT07007676 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai 6th People's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Inclusion criteria
- 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;
- Has a smart phone compatible with CGM and BGM systems;
- Willing and able to provide written informed consent;
- At least 240 hours (10 out of 14 days) of sensor glucose data from the blinded CGM pre-randomization phase.
Exclusion criteria
- 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;
- Planned surgery or other procedures within the next 6 months that may interfere with scheduled follow-up visits;
- Current or anticipated acute uses of glucocorticoids (oral, injectable, or IV), that will affect glycemic control;
- Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2;
- Participation in any other clinical trial within 3 month prior to screening, or concurrently enrolled, or planning to participate in another trial during the study period.
Where it is running
21 locations listed.
- Shenzhen Jiangangshan Health Service Center - Shenzhen, Guandong, China
- Shenzhen Fifth Avenue Health Service Station - Shenzhen, Guangdong, China
- Shenzhen Haifu Health Service Station - Shenzhen, Guangdong, China
- Shenzhen Haile Huafu Health Service Station - Shenzhen, Guangdong, China
- Shenzhen Haiyu Health Service Station - Shenzhen, Guangdong, China
- Shenzhen Jiaan Health Service Station - Shenzhen, Guangdong, China
- Shenzhen Jiari Mingju Health Service Station - Shenzhen, Guangdong, China
- Shenzhen Xinan Lake Health Service Station - Shenzhen, Guangdong, China
- Shenzhen Xingdong Health Service Station - Shenzhen, Guangdong, China
- Shenzhen Zhongliang Chuangxin Health Service Station - Shenzhen, Guangdong, China
- Guantian Community Health Service Station - Shenzhen, Guangdong, China
- Huiyu Mingdu Community Health Service Station - Shenzhen, Guangdong, China
- Langxin Community Health Service Station - Shenzhen, Guangdong, China
- Luozu Community Health Service Center - Shenzhen, Guangdong, China
- Shuitian Health Service Center - Shenzhen, Guangdong, China
- Tianbao Community Health Service Center - Shenzhen, Guangdong, China
- Shenzhen Buxin Community Health Service Center - Shenzhen, Guangdong, China
- Shenzhen Dalang Community Health Service Center - Shenzhen, Guangdong, China
- Shenzhen Haihua Community Health Service Center - Shenzhen, Guangdong, China
- Shenzhen Haile Community Health Service Station - Shenzhen, Guangdong, China
- Shenzhen Pingzhou Community Health Service Center - Shenzhen, Guangdong, China