NCT07007676 Effect of Continuous Glucose Monitoring System on Glycemic Control in Non-insulin-Treated Elderly People With Type 2 Diabetes
| NCT ID | NCT07007676 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai 6th People's Hospital |
| Condition | Diabetes Mellitus Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2025-07-14 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 148 participants in total. It began in 2025-07-14 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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 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.
Contact & Investigator
Jian Zhou, Prof., Dr., Ph.D
PRINCIPAL INVESTIGATOR
Shanghai 6th People's Hospital
Frequently Asked Questions
Who can join the NCT07007676 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Diabetes Mellitus Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07007676 currently recruiting?
Yes, NCT07007676 is actively recruiting participants. Contact the research team at zhoujian@sjtu.edu.cn for enrollment information.
Where is the NCT07007676 trial being conducted?
This trial is being conducted at Shenzhen, China, Shenzhen, China, Shenzhen, China, Shenzhen, China and 11 additional locations.
Who is sponsoring the NCT07007676 clinical trial?
NCT07007676 is sponsored by Shanghai 6th People's Hospital. The principal investigator is Jian Zhou, Prof., Dr., Ph.D at Shanghai 6th People's Hospital. The trial plans to enroll 148 participants.
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