CONtiNuous glucosE Monitoring (CGM) in People wiTh Type 2 Diabetes Not on Insulin (NCT06601166) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
CONtiNuous glucosE Monitoring (CGM) in People wiTh Type 2 Diabetes Not on Insulin
United States283 participantsStarted 2024-08-15
Plain-language summary
This multi-center study is a 26-week randomized controlled trial (RCT) in which adults (≥18 years) with type 2 diabetes (T2D) not using insulin and managed in a primary-care setting will be randomly assigned 1:1 to either use of real-time continuous glucose monitoring (CGM) or routine care (RC) plus interval blinded CGM wear.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \>18 years old at the time of enrollment (date informed consent form signed is considered date of enrollment).
. Clinical diagnosis of type 2 diabetes based on investigator assessment of at least 6 months duration at time of enrollment that is being managed in a primary care setting by a primary care physician or nurse practitioner or physician assistant.
. Screening HbA1c ≥7.5% (Based on point-of care or local lab within 28 days of enrollment).
. Able to read and understand written English or Spanish.
. No personal real-time or intermittent scanned (Flash) CGM 6 months prior to enrollment.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the benefit on glycemic control and safety from baseline to week 26 using CGM versus RC.
. Stable medication regimen (medication classes) and dose (equivalent dose if medication has been changed within same medication class) for any glucose lowering or weight loss medications for 30 days prior to enrollment.
. Willing to utilize the study devices and download Apps during the course of the study.
. Investigator believes that the participant has the cognitive capacity to provide informed consent, can successfully and safely use CGM, and is capable of adhering to the protocol and completing the study.
. Participants capable of becoming pregnant must meet one of the following criteria:
0. Use of insulin in the 12 months prior to screening or planning to initiate insulin during the next 12 months.
1. Thyroid stimulating hormone (TSH) outside the study central laboratory's reference range (above or below).
2. Concomitant disease or condition that in the opinion of the investigator may compromise patient safety including but not limited to; cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits.
3. Bariatric surgical procedure within the year prior to enrollment or plans for undergoing bariatric surgery during the study.