Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Texas Southwestern Medical Center
With
DexCom, Inc.
Age
13–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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 be retested after medication dose adjustment.
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.
Pregnancy, planned pregnancy or breast feeding
CGM adhesive allergy
Skin condition that makes CGM placement contraindicated.
Sickle cell disease or hemoglobinopathy
Red blood cell transfusion within 3 months prior to study enrollment
Clareo Health | Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes
