Effect of contINuous Glucose moniToring System on glycEmic controL in Non-insuLin-Treated Elderly People With Type 2 Diabetes: a Randomized Controlled Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shenzhen Buxin Community Health Service Center
RECRUITING
Shenzhen
Shenzhen Dalang Community Health Service Center
RECRUITING
Shenzhen
Shenzhen Haihua Community Health Service Center
RECRUITING
Shenzhen
Shenzhen Haile Community Health Service Station
RECRUITING
Shenzhen
Shenzhen Pingzhou Community Health Service Center
RECRUITING
Shenzhen
Contact Information
Primary
Jian Zhou, Prof., Dr., Ph.D
zhoujian@sjtu.edu.cn
86-21-64369181
Backup
Yaxin Wang, Dr.
wangyaxin2019@126.com
Time Frame
Start Date: 2025-07-14
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 148
Treatments
Experimental: 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.
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Shenzhen Pingzhou Community Health Service Center, Shenzhen Center for Chronic Disease Control, Shenzhen Baoan District People 's Hospital, Shenzhen Buxin Community Health Service Center, Shenzhen Haile Community Health Service Station, Shenzhen Haihua Community Health Service Center, Shenzhen Dalang Community Health Service Center
Leads: Shanghai 6th People's Hospital

This content was sourced from clinicaltrials.gov