Continuous glucose monitoring for older adults with type 2 diabetes on oral medications
Effect of contINuous Glucose moniToring System on glycEmic controL in Non-insuLin-Treated Elderly People With Type 2 Diabetes: a Randomized Controlled Trial
NA · Shanghai 6th People's Hospital · NCT07007676
This project will test whether wearing a continuous glucose monitor helps older adults with type 2 diabetes who take only oral medications control their blood sugar and improve psychological outcomes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Shanghai 6th People's Hospital (other) |
| Locations | 15 sites (Shenzhen, Guandong and 14 other locations) |
| Trial ID | NCT07007676 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people aged 60 or older with type 2 diabetes controlled only with oral medications (two or more classes), HbA1c between 7.5% and 10%, and a smartphone compatible with the monitoring systems.
Not a fit: People using insulin or GLP-1 receptor agonists, those with recent CGM use, or those with adhesive allergies/serious skin disease around sensor sites are unlikely to benefit from this specific protocol.
Why it matters
Potential benefit: If successful, CGM use could lead to better day-to-day blood sugar control and fewer high or low glucose episodes for older adults on oral diabetes medications.
How similar studies have performed: Continuous glucose monitoring has improved glucose control in many insulin-treated populations and shown mixed but promising results in non-insulin users, while data specifically in older adults remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shenzhen, Guandong and 14 other locations
- 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)
- Shenzhen Jiari Mingju Health Service Station — Shenzhen, Guangdong, China (RECRUITING)
- Shenzhen Xinan Lake Health Service Station — Shenzhen, Guangdong, China (RECRUITING)
- Shenzhen Xingdong Health Service Station — Shenzhen, Guangdong, China (RECRUITING)
- Shenzhen Zhongliang Chuangxin Health Service Station — Shenzhen, Guangdong, China (RECRUITING)
- Shenzhen Buxin Community Health Service Center — Shenzhen, Guangdong, China (RECRUITING)
- Shenzhen Dalang Community Health Service Center — Shenzhen, Guangdong, China (RECRUITING)
- Shenzhen Haihua Community Health Service Center — Shenzhen, Guangdong, China (RECRUITING)
- Shenzhen Haile Community Health Service Station — Shenzhen, Guangdong, China (RECRUITING)
- Shenzhen Pingzhou Community Health Service Center — 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus Type 2, continuous glucose monitoring, non-insulin-treated, type 2 diabetes in the elderly