Continuous glucose monitoring for older adults with type 2 diabetes on oral medications

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Older adults (age ≥60) with type 2 diabetes who are treated with two or more oral antidiabetic drugs and have suboptimal control (HbA1c 7.5–10%) are enrolled. After a blinded CGM run-in, participants are assigned to use a real-time continuous glucose monitor periodically (every two months) or to continue standard fingerstick blood glucose monitoring over a six-month period. Clinic visits occur every two months and participants keep a glucose diary when not using CGM. The study compares glucose control metrics and psychological outcomes between the CGM and standard monitoring groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shenzhen Jiangangshan Health Service Center
  Shenzhen, Guandong, China Recruiting
• Shenzhen Fifth Avenue Health Service Station
  Shenzhen, Guangdong, China Recruiting
• Shenzhen Haifu Health Service Station
  Shenzhen, Guangdong, China Recruiting
• Shenzhen Haile Huafu Health Service Station
  Shenzhen, Guangdong, China Recruiting
• Shenzhen Haiyu Health Service Station
  Shenzhen, Guangdong, China Recruiting
• Shenzhen Jiaan Health Service Station
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Principal investigator: Jian Zhou, Prof., Dr., Ph.D — Shanghai 6th People's Hospital
• Study coordinator: Jian Zhou, Prof., Dr., Ph.D
• Email: zhoujian@sjtu.edu.cn
• Phone: 86-21-64369181

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.