Feasibility and effectiveness of real-time, remote continuous glucose monitoring in adolescents with poorly controlled type 1 diabetes
Study ID: STU-2020-0699
We will conduct a pilot study, which will enroll 20 adolescents age 13-18 years with Type 1 Diabetes duration for at least 6 months managed with insulin who have poor glycemic control. Participants 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. exploratory outcomes include change in depression scale, quality of life, and self-efficacy measured with Peds PHQ-9a, PeD-QoL4a, SeDM, and Collaborative Parent involvement Scale scores, the difference in a1c between clinical remote monitoring Hba1c (end of phase 1) and self-monitoring utilizing CGM (end of phase 2). CGM time in range, percent hyperglycemic, percent hypoglycemic and mean CGM glucose, and percent CGM wear will be compared between baseline and end of each study phase.
The demands on the adolescent for self-care of Type 1 diabetes are arduous: the american Diabetes association (aDa) recommended standards of care for youth (children and adolescents) with type 1 diabetes include frequent blood glucose checks (up to 6-10 times daily) and an intensive insulin regimen. Many adolescents with Type 1 diabetes mellitus have poorly controlled diabetes which increases their risk for acute complications like diabetic ketoacidosis and long-term complications including nephropathy, neuropathy, retinopathy, and macrovascular disease. Previous studies have shown the clinical benefit of having a Continuous Glucose Monitor (CGM) in reducing hemoglobin a1C (Hba1c) with regular use of the device among patients with diabetes requiring insulin. Certain CGM devices allow real-time blood glucose values to be transmitted remotely to other devices and enable primary caregivers to follow blood glucose readings. To our knowledge, there are no published studies [See protocol for complete text]