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NCT Number: NCT07007676

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

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

Recruiting

Interested in participating?

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shenzhen Jiangangshan Health Service Center, Shenzhen, Guandong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

real-time CGM

Device

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

Other names: rtCGM, RT-CGM

Primary outcomes

  1. Change in HbA1c

    Time frame: 24 weeks from baseline

    Change in HbA1c from baseline to 24 weeks

Secondary outcomes

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

    Time frame: 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

  2. Time below range of 70 mg/dL

    Time frame: 24 weeks from baseline

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

  3. Time above range of 180 mg/dL

    Time frame: 24 weeks from baseline

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

  4. Glucose coefficient of variability

    Time frame: 24 weeks from baseline

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

  5. Mean glucose

    Time frame: 24 weeks from baseline

    A treatment group comparison of the mean glucose measured by CGM

Other outcomes

  1. HbA1c <7.0%

    Time frame: 24 weeks from baseline

    Percentage of subjects with A1C less than 7%

  2. Reduction in HbA1c ≥0.5%

    Time frame: 24 weeks from baseline

    Percentage of subjects with a reduction in A1C greater than or equal to 0.5%

  3. Rate of hypoglycemia events per week

    Time frame: 24 weeks from baseline

    Hypoglycemia event was defined as 15 consecutive minutes with a sensor glucose value <70 mg/dL

  4. Time in tight range of 70-140 mg/dL

    Time frame: 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

  5. Glycemia risk index (GRI)

    Time frame: 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).

  6. Glucose standard deviation

    Time frame: 24 weeks from baseline

    A treatment group comparison of the glucose standard deviation measured by CGM

  7. Days to initiate inulin treatment

    Time frame: 24 weeks from baseline

    A treatment group comparison of the days to initiate inulin treatment during study period

  8. Change in the scores of psychological-related questionnaires

    Time frame: 24 weeks from baseline

    Psychological-related events were measured by Diabetes Distress Scale and Patient Health Questionnaire-8 items.

  9. Change in the score of blood glucose monitoring satisfaction questionnaire

    Time frame: 24 weeks from baseline

    Change in the score of blood glucose monitoring satisfaction questionnaire from 24 weeks from baseline

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

86-21-64369181

Yaxin Wang, Dr.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Shanghai 6th People's Hospital

Other

Collaborators

  • Shenzhen Baoan District People's Hospital
  • Shenzhen Buxin Community Health Service Center
  • Shenzhen Center for Chronic Disease Control
  • Shenzhen Dalang Community Health Service Center
  • Shenzhen Fifth Avenue Health Service Station
  • Shenzhen Haifu Health Service Station
  • Shenzhen Haihua Community Health Service Center
  • Shenzhen Haile Community Health Service Station
  • Shenzhen Haile Huafu Health Service Station
  • Shenzhen Haiyu Health Service Station
  • Shenzhen Jiaan Health Service Station
  • Shenzhen Jiangangshan Health Service Center
  • Shenzhen Jiari Mingju Health Service Station
  • Shenzhen Pingzhou Community Health Service Center
  • Shenzhen Xinan Lake Health Service Station
  • Shenzhen Xingdong Health Service Station
  • Shenzhen Zhongliang Chuangxin Health Service Station

Registry information

Official study title

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

Acronym: INTELLECT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 6, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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