What is continuous glucose monitoring studying for type 2 diabetes?

Continuous glucose monitoring is being studied to see if it improves blood sugar control and psychological outcomes in older adults with type 2 diabetes who use only oral medications. The trial compares continuous glucose monitoring to standard blood glucose testing to understand which method manages glucose better. This research is sponsored by Shanghai 6th People's Hospital.

Who may be eligible for this type 2 diabetes clinical trial?

Adults aged 60 or older with type 2 diabetes treated with oral antidiabetic drugs may be eligible. Participants should not have used insulin or CGM devices recently and must have a compatible smartphone. Please review eligibility criteria for more details.

Is there any cost to participate in this type 2 diabetes clinical trial?

Study-related care, including the study devices and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 60Years +

All Genders

ID07007676

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

Led by Shanghai 6th People's Hospital · Updated on 2026-04-13

148

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating if using a continuous glucose monitoring (CGM) system helps improve blood sugar control in older adults with type 2 diabetes who manage their condition with oral medications only. This study compares continuous glucose monitoring to the standard fingerstick blood glucose monitoring to see which method better manages glucose levels and affects psychological well-being in this population. Participants will be assigned to one of two groups: the CGM group will use a CGM sensor every two months and be instructed on its use, including checking blood glucose when symptoms do not match CGM readings. The blood glucose meter (BGM) group will use a fingerstick glucose meter about twice a week but can check more often if desired. The study lasts six months with follow-up visits every two months. During the study, participants will visit the clinic every two months for check-ups and keep a glucose diary when not using CGM. Researchers will measure changes in HbA1c after 24 weeks, along with time spent in blood glucose target ranges, glucose variability, and average glucose levels. This trial is sponsored by Shanghai 6th People's Hospital and runs until mid-2027.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 60Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 60 years or older at the time of screening
Diagnosed with type 2 diabetes mellitus
Treated with two or more oral antidiabetic drugs with a stable medication regimen for at least 3 months prior to entry
Suboptimal glycemic control with HbA1c between 7.5% and 10% at screening or within 30 days prior
Has a smartphone 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

You will not qualify if you...

Use of insulin or GLP-1 receptor agonists within 3 months prior to screening
Use of any CGM device within 3 months prior to screening
Unable to tolerate tape adhesive or with allergy or serious skin diseases around sensor placement area
Considered unsuitable by investigators due to conditions like dementia, psychiatric disorders, or severe visual or hearing impairment
Planned surgery or procedures within 6 months that may interfere with follow-up visits
Current or expected acute use of glucocorticoids affecting glycemic control
Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2
Participation in another clinical trial within 3 months prior to screening or planning concurrent trial participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 24 weeks

Participants use either a continuous glucose monitoring (CGM) device or a blood glucose meter (BGM) to monitor glucose levels and manage glycemic control.

Visits every 2 months for CGM sensor use; fingerstick glucose checks with BGM group recommended twice weekly

Trial Site Locations

Total: 15 locations

Shenzhen Jiangangshan Health Service Center

Shenzhen, Guandong, China, 518000

Actively Recruiting

Shenzhen Fifth Avenue Health Service Station