Effect of Continuous Glucose Monitoring System on Glycemic Control in Non-insulin-Treated Elderly People With Type 2 Diabetes
NCT ID: NCT07007676
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
148 participants
INTERVENTIONAL
2025-07-14
2026-12-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Real-time Continuous Glucose Monitoring （CGM） group
CGM group participants will be asked to use a CGM sensor every 2 months. Participants will be instructed to use the sensor. In addition, participants will be advised to check the blood glucose when symptoms or expectations do not match the CGM reading.
real-time CGM
real-time CGM can provide real-time tracking of glucose levels, and offer glucose trend graphs and user-configurable low and high glucose alerts.
Blood Glucose Meter （BGM） group
BGM group participants will be asked to use a study blood glucose meter with test strips for a fingerstick blood glucose check with a recommendation of 2 times a week. Participants will be permitted to check a fingerstick glucose as many times a week as they choose.
No interventions assigned to this group
Interventions
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real-time CGM
real-time CGM can provide real-time tracking of glucose levels, and offer glucose trend graphs and user-configurable low and high glucose alerts.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
60 Years
ALL
No
Sponsors
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Shenzhen Center for Chronic Disease Control
OTHER
Shenzhen Baoan District People 's Hospital
UNKNOWN
Shenzhen Haile Community Health Service Station
UNKNOWN
Shenzhen Buxin Community Health Service Center
UNKNOWN
Shenzhen Dalang Community Health Service Center
UNKNOWN
Shenzhen Haihua Community Health Service Center
UNKNOWN
Shenzhen Pingzhou Community Health Service Center
UNKNOWN
Shanghai 6th People's Hospital
OTHER
Responsible Party
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Jian Zhou
Professor, Chief Physician, Deputy Director
Principal Investigators
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Jian Zhou, Prof., Dr., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai 6th People's Hospital
Xiaobing Wu, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Center for Chronic Disease Control
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20250522001
Identifier Type: -
Identifier Source: org_study_id
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