NCT07007676|Recruiting

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

INTELLECT

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

Shanghai 6th People's Hospital ClinicalTrials.gov

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1 other identifier

20250522001

Study Type

interventional

Target

148

Locations

1 country

Sites

Timeline

RegisteredJun 2025

StartedJul 2025

CompletionJun 2027

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

148

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline

14mo left

Started Jul 2025

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach

1 country

15 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

Study Progress42%

Jul 2025Jun 2027

First Submitted

Initial submission to the registry

May 23, 2025

Completed

14 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed

1 month until next milestone

Study Start

First participant enrolled

July 14, 2025

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

May 23, 2025

Last Update Submit

April 8, 2026

Conditions

Diabetes Mellitus Type 2

Keywords

continuous glucose monitoringnon-insulin-treatedtype 2 diabetes in the elderly

Outcome Measures

Primary Outcomes (1)

Change in HbA1c
Change in HbA1c from baseline to 24 weeks
24 weeks from baseline

Secondary Outcomes (5)

Time in range of 70-180 mg/dL
24 weeks from baseline
Time below range of 70 mg/dL
24 weeks from baseline
Time above range of 180 mg/dL
24 weeks from baseline
Glucose coefficient of variability
24 weeks from baseline
Mean glucose
24 weeks from baseline

Other Outcomes (9)

HbA1c <7.0%
24 weeks from baseline
Reduction in HbA1c ≥0.5%
24 weeks from baseline
Rate of hypoglycemia events per week
24 weeks from baseline
+6 more other outcomes

Study Arms (2)

Real-time Continuous Glucose Monitoring （CGM） group

EXPERIMENTAL

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.

Device: real-time CGM

Blood Glucose Meter （BGM） group

NO INTERVENTION

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.

Interventions

real-time CGMDEVICE

real-time CGM can provide real-time tracking of glucose levels, and offer glucose trend graphs and user-configurable low and high glucose alerts.

Also known as: rtCGM, RT-CGM

Real-time Continuous Glucose Monitoring （CGM） group

Eligibility Criteria

Age60 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Shanghai 6th People's Hospitallead
Shenzhen Center for Chronic Disease Controlcollaborator
Shenzhen Baoan District People 's Hospitalcollaborator
Shenzhen Haile Community Health Service Stationcollaborator
Shenzhen Buxin Community Health Service Centercollaborator
Shenzhen Dalang Community Health Service Centercollaborator
Shenzhen Haihua Community Health Service Centercollaborator
Shenzhen Pingzhou Community Health Service Centercollaborator
Shenzhen Haiyu Health Service Stationcollaborator
Shenzhen Haifu Health Service Stationcollaborator
Shenzhen Zhongliang Chuangxin Health Service Stationcollaborator
Shenzhen Fifth Avenue Health Service Stationcollaborator
Shenzhen Haile Huafu Health Service Stationcollaborator
Shenzhen Jiaan Health Service Stationcollaborator
Shenzhen Jiari Mingju Health Service Stationcollaborator
Shenzhen Jiangangshan Health Service Centercollaborator
Shenzhen Xinan Lake Health Service Stationcollaborator
Shenzhen Xingdong Health Service Stationcollaborator

Study Sites (15)

Shenzhen Jiangangshan Health Service Center

Shenzhen, Guandong, 518000, China

RECRUITING

Shenzhen Fifth Avenue Health Service Station