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Effect of Continuous Glucose Monitoring System on Glycemic Control in Non-insulin-Treated Elderly People With Type 2 Diabetes

RecruitingNAAges 60 Years - anyAllShanghai 6th People's Hospital
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • real-time CGM
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Where

21 sites
Shenzhen Jiangangshan Health Service Center
Shenzhen, China
Shenzhen Fifth Avenue Health Service Station
Shenzhen, China
Shenzhen Haifu Health Service Station
Shenzhen, China
Shenzhen Haile Huafu Health Service Station
Shenzhen, China
Shenzhen Haiyu Health Service Station
Shenzhen, China
Shenzhen Jiaan Health Service Station
Shenzhen, China
Shenzhen Jiari Mingju Health Service Station
Shenzhen, China
Shenzhen Xinan Lake Health Service Station
Shenzhen, China

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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