NCT04540536Completed
Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 17 Jul 2020
- Start date
- 1 Nov 2021
- Primary completion date
- 1 Dec 2024
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Type 1 diabetes
- NCT number
- NCT04540536
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 1 Nov 2021 to the primary completion date, 1 Dec 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 be retested after medication dose adjustment.
- Red blood cell transfusion within 3 months prior to study enrollment
Other illness
- 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.
- Developmental delay or behavioral disorder in the patient of sufficient severity, in the judgment of the investigator, to interfere with study activities. Severe uncontrolled depression defined as PHQ-9A \>15 at time of enrollment is an exclusion criterion.
- Medical or psychiatric disorder in a parent of sufficient severity, in the judgment of the investigator, to interfere with study activities.
- CGM adhesive allergy
- Skin condition that makes CGM placement contraindicated.
- Sickle cell disease or hemoglobinopathy
Other
- Pregnancy, planned pregnancy or breast feeding
Who the study is looking for
- 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.
Age in the registry: 13 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Childrens Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.