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

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus Type 2

• Registration Number: NCT07007676
• Lead Sponsor: Shanghai 6th People's Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-23
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Study Start: 2025-06-15
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Age ≥ 60 years at the time of screening;
• Diagnosed with type 2 diabetes mellitus;
• Treated with two or more oral antidiabetic drugs for at least 3 months prior to screening, with a stable regimen (i.e., no change in drug classes);
• Suboptimal glycemic control, defined as HbA1c ≥ 7.5% and ≤ 10% at screening or within 30 days prior to screening visit;
• Willing and able to use the real time-continuous glucose monitoring system;
• Willing and able to provide written informed consent;
• At least 240 hours (10 out of 14 days) of sensor glucose data and self-monitoring of blood glucose frequency ≥2 times per week from the blinded CGM pre- randomization phase.

Exclusion Criteria

• Use of insulin or Glucagon-Like Peptide-1 （GLP-1） receptor agonists either at screening or within the past 3 months;
• Use of any CGM device either at screening or within the past 3 months;
• 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.
• Expectation that participant will be moving out of the area of the clinical center or have planned surgery during the next 6 months;
• Current or anticipated acute uses of glucocorticoids (oral, injectable, or IV), that will affect glycemic control (Long-term stable glucocorticoid doses are allowed, such as when used for the treatment of rheumatoid arthritis or Addison's disease);
• Stage 4 or 5 renal disease or most recent glomerular filtration rate （GFR） < 30 ml/min/m2 from local lab within the past 3 months;
• Participation in any other clinical trial within 1 month prior to screening, or concurrently enrolled, or planning to participate in another trial during the study period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	24 weeks from baseline	Change in HbA1c from baseline to 24 weeks

Secondary Outcome Measures

Name	Time	Method
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
Change in the scores of psychological-related questionnaires	24 weeks from baseline	Psychological-related events were measured by Diabetes Distress Scale and Patient Health Questionnaire-8 items.
HbA1c <7.0%	24 weeks from baseline	Percentage of subjects with A1C less than 7%
Reduction in HbA1c ≥0.5%	24 weeks from baseline	Percentage of subjects with a reduction in A1C greater than or equal to 0.5%
Rate of hypoglycemia events per week	24 weeks from baseline	Hypoglycemia event was defined as 15 consecutive minutes with a sensor glucose value \<70 mg/dL
Time in tight range of 70-140 mg/dL	24 weeks from baseline	A treatment group comparison of the percentage of time spent in glucose range between 70 and 140 mg/dL measured by CGM
Glycemia risk index (GRI)	24 weeks from baseline	A treatment group comparison of the glycemia risk index measured by CGM. Glycemia risk index (GRI) was calculated according to the following equation: GRI = (3.0×VLow) + (2.4×Low) + (1.6×VHigh) + (0.8×High).
Glucose standard deviation	24 weeks from baseline	A treatment group comparison of the glucose standard deviation measured by CGM
Days to initiate inulin treatment	24 weeks from baseline	A treatment group comparison of the days to initiate inulin treatment during study period
Change in the score of blood glucose monitoring satisfaction questionnaire	24 weeks from baseline	Change in the score of blood glucose monitoring satisfaction questionnaire from 24 weeks from baseline