Effect of Continuous Glucose Monitoring System on Glycemic Control in Non-insulin-Treated Elderly People With Type 2 Diabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorShanghai 6th People's Hospital

About this trial

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

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • real-time CGM

Treatment groups

148 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shanghai 6th People's Hospital

Lead sponsor

Shenzhen Center for Chronic Disease Control

Collaborator

Shenzhen Baoan District People 's Hospital

Collaborator

Shenzhen Haile Community Health Service Station

Collaborator

Shenzhen Buxin Community Health Service Center

Collaborator

Shenzhen Dalang Community Health Service Center

Collaborator

Shenzhen Haihua Community Health Service Center

Collaborator

Shenzhen Pingzhou Community Health Service Center

Collaborator

Shenzhen Fifth Avenue Health Service Station

Collaborator

Shenzhen Haifu Health Service Station

Collaborator

Shenzhen Haile Huafu Health Service Station

Collaborator

Shenzhen Haiyu Health Service Station

Collaborator

Shenzhen Jiaan Health Service Station

Collaborator

Shenzhen Jiari Mingju Health Service Station

Collaborator

Shenzhen Jiangangshan Health Service Center

Collaborator

Shenzhen Xinan Lake Health Service Station

Collaborator

Shenzhen Xingdong Health Service Station

Collaborator

Shenzhen Zhongliang Chuangxin Health Service Station

Collaborator