Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents W… (NCT04540536) | Clinical Trial Compass
CompletedNot Applicable
Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes
United States20 participantsStarted 2021-11-01
Plain-language summary
Adolescents with Type 1 Diabetes (age 13-18 years, T1D duration \>6 months managed on insulin) and poor glycemic control will wear a blinded CGM to obtain baseline data. After assuring adherence to CGM wear, participants will receive a non-blinded CGM and will share their blood glucose levels with the study team. Clinical personnel will remotely monitor patients in real-time for 3 months and communicate regularly over secure text messaging with participants and their parents. Following active remote monitoring, the participants will wear a non-blinded CGM for 3 months. Primary outcome assessment will be the change in HbA1c after 3 months of real-time remote continuous glucose monitoring.
Who can participate
Age range
13 Years – 18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
* Age between 13-18
* Diagnosis of type 1 diabetes for at least six months.
* Both sexes and all ethnicities included.
* Subject and at least one parent able to communicate in English.
* Poorly controlled T1D as evidenced by a \>30% annual risk of developing DKA in the following year OR Hemoglobin A1c ≥ 12%
* Treated with subcutaneous insulin, either with a basal/bolus insulin regimen or a continuous subcutaneous insulin infusion (CSII) device.
* Willing to wear CGM and utilize the share function to clinician and guardian, with measuring blood glucose checks as required by the CGM.
* Owning a smartphone compatible with Dexcom G6 software to allow the use of share/follow features with internet access capabilities
* Willing to participate in secure text messaging with study personnel.
* Female participants must have a negative pregnancy test.
Exclusion criteria
* Type 2 diabetes, secondary diabetes or CF related diabetes.
* Other severe chronic disease (e.g., cancer) which in the judgment of the investigator is likely to significantly affect glycemic control.
* Patients cannot be taking systemic corticosteroids at enrollment because of adverse effects on glycemic control, but we will not disqualify subjects who require such therapy during the study. Inhaled or topical corticosteroids are permissible.
* Patients with uncontrolled hypothyroidism (TSH \>20) or uncontrolled hyperthyroidism will be excluded from the study. Patients with out of range values may …
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
Change in Hemoglobin A1c From Baseline to 3 Months
Timeframe: 3 months
Trial details
NCT IDNCT04540536
SponsorUniversity of Texas Southwestern Medical Center