BridgeMD
New treatment option for Diabetes Mellitus Type 2
Official title Effect of Continuous Glucose Monitoring System on Glycemic Control in Non-insulin-Treated Elderly People With Type 2 Diabetes
ClinicalTrials.gov ID: NCT07007676
What this study is testing
- What it's testing
- 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?
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join 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;
You likely can't join 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...
- Considered unsuitable for participation by the investigators, including but not limited to individuals with dementia, psychiatric disorders, extreme...
- 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;
See the full eligibility 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guandong, China
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guandong, China; Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.