Clinical trial NCT07007676: Effect of Continuous Glucose Monitoring System on Glycemic Control in Non-insulin-Treated Elderly People With Type 2 Diabetes
Official title: Effect of contINuous Glucose moniToring System on glycEmic controL in Non-insuLin-Treated Elderly People With Type 2 Diabetes: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus Type 2
Keywords: continuous glucose monitoring
non-insulin-treated
type 2 diabetes in the elderly
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
Collaborators: name: Shenzhen Center for Chronic Disease Control
name: Shenzhen Baoan District People 's Hospital
name: Shenzhen Haile Community Health Service Station
name: Shenzhen Buxin Community Health Service Center
name: Shenzhen Dalang Community Health Service Center
name: Shenzhen Haihua Community Health Service Center
name: Shenzhen Pingzhou Community Health Service Center
First posted: 2025-06-06
Enrollment: 148
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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 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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: 24 weeks from baseline
Secondary outcomes:
measure: Time in range of 70-180 mg/dL
timeFrame: 24 weeks from baseline
measure: Time below range of 70 mg/dL
timeFrame: 24 weeks from baseline
measure: Time above range of 180 mg/dL
timeFrame: 24 weeks from baseline
measure: Glucose coefficient of variability
timeFrame: 24 weeks from baseline
measure: Mean glucose
timeFrame: 24 weeks from baseline
measure: Change in the scores of psychological-related questionnaires
timeFrame: 24 weeks from baseline
measure: HbA1c <7.0%
timeFrame: 24 weeks from baseline
measure: Reduction in HbA1c ≥0.5%
timeFrame: 24 weeks from baseline
measure: Rate of hypoglycemia events per week
timeFrame: 24 weeks from baseline
measure: Time in tight range of 70-140 mg/dL
timeFrame: 24 weeks from baseline
measure: Glycemia risk index (GRI)
timeFrame: 24 weeks from baseline
measure: Glucose standard deviation
timeFrame: 24 weeks from baseline
measure: Days to initiate inulin treatment
timeFrame: 24 weeks from baseline
measure: Change in the score of blood glucose monitoring satisfaction questionnaire
timeFrame: 24 weeks from baseline
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Jian Prof. Zhou, Dr.
role: PRINCIPAL_INVESTIGATOR
References: