Diabetes Mellitus Type 2
Conditions
Keywords
continuous glucose monitoring, non-insulin-treated, type 2 diabetes in the elderly
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
Interventions
DEVICEreal-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.
Sponsors
Shanghai 6th People's Hospital
Shenzhen Center for Chronic Disease Control
Shenzhen Baoan District People's Hospital
Shenzhen Haile Community Health Service Station
Shenzhen Buxin Community Health Service Center
Shenzhen Dalang Community Health Service Center
Shenzhen Haihua Community Health Service Center
Shenzhen Pingzhou Community Health Service Center
Shenzhen Fifth Avenue Health Service Station
Shenzhen Haifu Health Service Station
Shenzhen Haile Huafu Health Service Station
Shenzhen Haiyu Health Service Station
Shenzhen Jiaan Health Service Station
Shenzhen Jiari Mingju Health Service Station
Shenzhen Jiangangshan Health Service Center
Shenzhen Xinan Lake Health Service Station
Shenzhen Xingdong Health Service Station
Shenzhen Zhongliang Chuangxin Health Service Station
Shenzhen Guantian Community Health Service Station
Shenzhen Huiyu Mingdu Community Health Service Station
Shenzhen Langxin Community Health Service Station
Shenzhen Luozu Community Health Service Center
Shenzhen Tianbao Community Health Service Center
Shenzhen Shuitian Health Service Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | 24 weeks from baseline | Change in HbA1c from baseline to 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in range of 70-180 mg/dL | 24 weeks from baseline | A treatment group comparison of percentage of time spent in glucose range between 70 and 180 mg/dL measured by CGM |
| Time below range of 70 mg/dL | 24 weeks from baseline | A treatment group comparison of percentage of time spent in glucose range below 70 mg/dL measured by CGM |
| Time above range of 180 mg/dL | 24 weeks from baseline | A treatment group comparison of percentage of time spent in glucose range above 180 mg/dL measured by CGM |
| Glucose coefficient of variability | 24 weeks from baseline | A treatment group comparison of glucose coefficient of variability measured by CGM |
| Mean glucose | 24 weeks from baseline | A treatment group comparison of the mean glucose measured by CGM |
Countries
China
Contacts
CONTACTJian Zhou, Prof., Dr., Ph.D
CONTACTYaxin Wang, Dr.
PRINCIPAL_INVESTIGATORJian Zhou, Prof., Dr., Ph.D
Shanghai 6th People's Hospital
PRINCIPAL_INVESTIGATORXiaobing Wu, Ph.D
Shenzhen Center for Chronic Disease Control
Outcome results
None listed