Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

  • STATUS
    Recruiting
  • End date
    Oct 15, 2023
  • participants needed
    20
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 15 October 2022

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.

Details
Condition Diabetes Mellitus, Type 1, Noncompliance, Patient
Treatment Continuous glucose monitoring, Secure texting
Clinical Study IdentifierNCT04540536
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on15 October 2022

Eligibility

Yes No Not Sure

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 >40% annual risk of developing DKA in the following year
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 hypothyroidism or hyperthyroidism must be clinically euthyroid and have free T4 and TSH within age-appropriate reference ranges at last medically indicated testing. 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 >9 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
Regular CGM for the month preceding study period
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
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