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

Launched by SHANGHAI 6TH PEOPLE'S HOSPITAL · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a continuous glucose monitoring system can help older adults with type 2 diabetes who are not using insulin better manage their blood sugar levels. The researchers want to find out if this system works better than standard blood glucose monitoring methods and if it has any effect on the participants’ mental well-being. To participate, individuals should be at least 60 years old, have been diagnosed with type 2 diabetes, and have been using two or more oral medications for their diabetes for at least three months without changes. They should also have blood sugar levels that are not well controlled.

Participants in the trial will wear the continuous glucose monitoring system for two months or use standard blood glucose monitoring for six months. They will visit the clinic every two months for follow-up appointments and keep a diary of their blood sugar levels when not using the continuous monitoring system. This study is not yet recruiting participants, but if you're interested and meet the criteria, it could be a valuable opportunity to contribute to diabetes research and potentially improve your diabetes management.

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Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 60 years at the time of screening;
• • Diagnosed with type 2 diabetes mellitus;
• • Treated with two or more oral antidiabetic drugs for at least 3 months prior to screening, with a stable regimen (i.e., no change in drug classes);
• • Suboptimal glycemic control, defined as HbA1c ≥ 7.5% and ≤ 10% at screening or within 30 days prior to screening visit;
• • Willing and able to use the real time-continuous glucose monitoring system;
• • Willing and able to provide written informed consent;
• • At least 240 hours (10 out of 14 days) of sensor glucose data and self-monitoring of blood glucose frequency ≥2 times per week from the blinded CGM pre- randomization phase.
• Exclusion Criteria:
• • Use of insulin or Glucagon-Like Peptide-1 （GLP-1） receptor agonists either at screening or within the past 3 months;
• • Use of any CGM device either at screening or within the past 3 months;
• • 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.
• • Expectation that participant will be moving out of the area of the clinical center or have planned surgery during the next 6 months;
• • Current or anticipated acute uses of glucocorticoids (oral, injectable, or IV), that will affect glycemic control (Long-term stable glucocorticoid doses are allowed, such as when used for the treatment of rheumatoid arthritis or Addison's disease);
• • Stage 4 or 5 renal disease or most recent glomerular filtration rate （GFR） \< 30 ml/min/m2 from local lab within the past 3 months;
• • Participation in any other clinical trial within 1 month prior to screening, or concurrently enrolled, or planning to participate in another trial during the study period.