Clinical Trial Design

A prospective, longitudinal, open-label feasibility trial was conducted at a single clinical center from December 2019 to June 2020. Children with type 1 diabetes who were aged 3-12 years were enrolled. To be included in this trial, the child had to live with a caregiver who could upload data and attend remote visits. Moreover, the treatment at the time of the initiation visit had to include the use of an insulin pump for at least 6 months and the use of CGM sensor for at least 1 month. Children were asked for their consent to continue CGM during this study. Caregivers’ ability to use an insulin pump and CGM sensor was verified. This included their ability to insert the infusion set, change the reservoir or patch pump (ie, where applicable), calibrate CGM sensors, and read and interpret related data.

Families could not participate in the trial if the caregivers who operated the study tools were diagnosed with a physical or mental health condition that severely interfered with their ability to complete the study protocol. Families were also excluded if they had no access to a computer or if they were experiencing problems with their at-home cellular/Wi-Fi connection (ie, problems that interfered with their ability to upload data and attend video consultations).