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Recruiting NCT07007676

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

No phase Interventional Diabetes Mellitus Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: real-time CGM.
Who it may be relevant to
Registry conditions: Diabetes Mellitus Type 2. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Interventions

  • Device real-time 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.

Primary outcome measures

  • Change in HbA1c [Time frame: 24 weeks from baseline]
Secondary outcome measures (5)
  • Time in range of 70-180 mg/dL [Time frame: 24 weeks from baseline]
  • Time below range of 70 mg/dL [Time frame: 24 weeks from baseline]
  • Time above range of 180 mg/dL [Time frame: 24 weeks from baseline]
  • Glucose coefficient of variability [Time frame: 24 weeks from baseline]
  • Mean glucose [Time frame: 24 weeks from baseline]

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 15 centers
  • Shenzhen Jiangangshan Health Service Center — Shenzhen
  • Shenzhen Fifth Avenue Health Service Station — Shenzhen
  • Shenzhen Haifu Health Service Station — Shenzhen
  • Shenzhen Haile Huafu Health Service Station — Shenzhen
  • Shenzhen Haiyu Health Service Station — Shenzhen
  • Shenzhen Jiaan Health Service Station — Shenzhen
  • Shenzhen Jiari Mingju Health Service Station — Shenzhen
  • Shenzhen Xinan Lake Health Service Station — Shenzhen
  • … and 7 more centers

Identifiers

NCT: NCT07007676 · 20250522001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗