My Diabetes Study - CGM Initiation Approach & Time In Range (NCT05928572) | Clinical Trial Compass
CompletedNot Applicable
My Diabetes Study - CGM Initiation Approach & Time In Range
United States159 participantsStarted 2023-07-25
Plain-language summary
This study includes two phases. The purpose of Phase 1 of this study is to understand if there is a difference between two ways of introducing a continuous glucose monitor (CGM) to people with type 2 diabetes (T2D). The study will evaluate the effect of using a nutrition-focused approach (NFA) versus a self-directed approach (SDA) during CGM initiation on time in range (TIR) glucose. TIR is the percent of time that someone's glucose is between 70 and 180 mg/dL. It is possible that the approach used to introduce the CGM could impact TIR and other outcomes.
The purpose of Phase 2 of the study is to evaluate the impact of discontinuing CGM for 4 months after the completion of the Phase 1 study intervention on CGM-derived metrics, dietary intake assessment, and patient reported outcomes.
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:
* Adults \>18 years of age
* T2D diagnosis
* HbA1c 7.0%-10.0% based on point-of-care test at screening
* Taking no diabetes medication or taking stable-dose diabetes medication(s) for at least 30 days; willing to maintain stable diabetes medication regimen for the duration of the study
* Has a personal cellular-plan or wifi-connected smartphone that is compatible with required CGM apps and which will be consistently available for duration of the study
* Has not used a personal CGM system within 90 days
* Willing and able to wear CGM and use the associated CGM mobile apps throughout the duration of the study
* Willing and able to make diet/lifestyle modifications in response to CGM data
* Able to read and understand English
* Able to attend study visits and complete the requirements of study
Exclusion Criteria:
* Currently taking or planning to take any form of insulin, sulfonylureas, meglitinides, or other anti-hyperglycemic diabetes medication that carry a known hypoglycemia risk
* Has used a personal CGM in the 90 days prior to consent
* Known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin
* Skin conditions that are not compatible with CGM wear
* Intended use of \> 4g acetaminophen/day or hydroxyurea during the study
* Planning to become pregnant; pregnant; or lactating
* Current participation in another interventional clinical trial
* Unsuitable for participation due to any other cause, including but not limited to sign…
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
Phase 1 Change in CGM-derived Time in Range (TIR)
Timeframe: From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)