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Diabetes Mellitus Type 2INTELLECTNCT07007676

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

A study testing real-time CGM in people with Diabetes Mellitus Type 2, run by Shanghai 6th People's Hospital at 21 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Diabetes Mellitus Type 2
What is being tested?
real-time CGM
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
21 sitesChina
Study dates
14 Jul 2025to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jian Zhou, Prof., Dr., Ph.D contact

86-21-64369181

zhoujian@sjtu.edu.cn

Yaxin Wang, Dr. contact

wangyaxin2019@126.com

21 sites in 1 country

China21 sites, 21 recruiting

  • Shenzhen Jiangangshan Health Service Center

    Shenzhen, Guandong, 518000

    Yashi Cai, 86-0755-23318527, yashitasi@163.com

    Recruiting

  • Shenzhen Fifth Avenue Health Service Station

    Shenzhen, Guangdong, 518000

    Yiping Tang, 86-0755-29196916, singoprince@126.com

    Recruiting

  • Shenzhen Haifu Health Service Station

    Shenzhen, Guangdong, 518000

    Liuyan Hong, 86-0755-27578485, 1002304709@qq.com

    Recruiting

  • Shenzhen Haile Huafu Health Service Station

    Shenzhen, Guangdong, 518000

    Xiaoyue Mei, 86-0755-27592121, 195755179@qq.com

    Recruiting

  • Shenzhen Haiyu Health Service Station

    Shenzhen, Guangdong, 518000

    Xiaoyan Kong, 86-0755-29657241, bahysk@126.com

    Recruiting

  • Shenzhen Jiaan Health Service Station

    Shenzhen, Guangdong, 518000

    Qiaoyun He, 86-0755-27872784, 1259406011@qq.com

    Recruiting

  • Shenzhen Jiari Mingju Health Service Station

    Shenzhen, Guangdong, 518000

    Yangyao Ou, 86-0755-27780827, jrmjsk@126.com

    Recruiting

  • Shenzhen Xinan Lake Health Service Station

    Shenzhen, Guangdong, 518000

    Junxia Chen, 86-0755-27880092, 446448865@qq.com

    Recruiting

  • Shenzhen Xingdong Health Service Station

    Shenzhen, Guangdong, 518000

    Liang Mao, 86-0755-27661072, 957127613@qq.com

    Recruiting

  • Shenzhen Zhongliang Chuangxin Health Service Station

    Shenzhen, Guangdong, 518000

    Feiyan Yu, 86-0755-27873123, zlcxskz@126.com

    Recruiting

  • Guantian Community Health Service Station

    Shenzhen, Guangdong, 518108

    Ying Feng, 0755-27610155, syyygcp@baoan.gov.cn

    Recruiting

  • Huiyu Mingdu Community Health Service Station

    Shenzhen, Guangdong, 518108

    Wei Luo, 0755-23050120, syyygcp@baoan.gov.cn

    Recruiting

  • Langxin Community Health Service Station

    Shenzhen, Guangdong, 518108

    Wenxiong Zhu, 0755-27767861, syyygcp@baoan.gov.cn

    Recruiting

  • Luozu Community Health Service Center

    Shenzhen, Guangdong, 518108

    Haijian Chen, 0755-27627624, syyygcp@baoan.gov.cn

    Recruiting

  • Shuitian Health Service Center

    Shenzhen, Guangdong, 518108

    Yongsu Huang, 0755-27781357, syyygcp@baoan.gov.cn

    Recruiting

  • Tianbao Community Health Service Center

    Shenzhen, Guangdong, 518108

    Yanling Ou, 0755-27625012, syyygcp@baoan.gov.cn

    Recruiting

  • Shenzhen Buxin Community Health Service Center

    Shenzhen, Guangdong

    Yulan Ye, Dr., +86075527829064, yeyl@126.com

    Recruiting

  • Shenzhen Dalang Community Health Service Center

    Shenzhen, Guangdong

    Jingya Qiu, Dr., +86 755 2788 4372, qiujy@126.com

    Recruiting

  • Shenzhen Haihua Community Health Service Center

    Shenzhen, Guangdong

    Jiechun Huang, Dr., +86 755 2789 5680, hjc0521@126.com

    Recruiting

  • Shenzhen Haile Community Health Service Station

    Shenzhen, Guangdong

    Jing Liu, Dr., +86 755 2784 2711, liuj@126.com

    Recruiting

  • Shenzhen Pingzhou Community Health Service Center

    Shenzhen, Guangdong

    Ruyu Lin, Dr., +86 0755 23056512, linry@126.com

    Recruiting

Other trials in China

About this study

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

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.
Read more

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
Being tested
real-time CGM
Keywords
continuous glucose monitoring, non-insulin-treated, type 2 diabetes in the elderly
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • real-time CGMDevice

    Also called rtCGM, RT-CGM

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

Study groups in NCT07007676
Study groupRoleWhat they receive
Real-time Continuous Glucose Monitoring （CGM） groupExperimentalCGM 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.
Receives: Device: real-time CGM
Blood Glucose Meter （BGM） groupNo interventionBGM 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    Change in HbA1c from baseline to 24 weeks

    Measured: 24 weeks from baseline

Secondary outcomes (5)

  1. Time in range of 70-180 mg/dL

    A treatment group comparison of percentage of time spent in glucose range between 70 and 180 mg/dL measured by CGM

    Measured: 24 weeks from baseline

  2. Time below range of 70 mg/dL

    A treatment group comparison of percentage of time spent in glucose range below 70 mg/dL measured by CGM

    Measured: 24 weeks from baseline

  3. Time above range of 180 mg/dL

    A treatment group comparison of percentage of time spent in glucose range above 180 mg/dL measured by CGM

    Measured: 24 weeks from baseline

  4. Glucose coefficient of variability

    A treatment group comparison of glucose coefficient of variability measured by CGM

    Measured: 24 weeks from baseline

  5. Mean glucose

    A treatment group comparison of the mean glucose measured by CGM

    Measured: 24 weeks from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2025
  2. Study start14 Jul 2025
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07007676
Sponsor's protocol ID
20250522001
Acronym
INTELLECT
Status last verified
Apr 2026
First submitted
23 May 2025
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing real-time CGM in people with Diabetes Mellitus Type 2, run by Shanghai 6th People's Hospital at 21 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jian Zhou, Prof., Dr., Ph.D (86-21-64369181, zhoujian@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: 24 weeks from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07007676.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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