Trial Outcomes & Findings for Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes (NCT NCT04540536)

Subjects with Type 1 Diabetes were enrolled in the study

11 participants were assigned to the study arm but only 8 completed the study

Change in hemoglobin A1c from baseline to 3 months (three-month follow-up visit after remote continuous glucose monitoring and secure text messaging)

Depression screening will be assessed by Patient Health Questionnaire (PHQ-9A), a depression questionnaire consisting of 9 items answered on a scale from "0" (not at all) to "3" (nearly every day). Total depression severity score ranges of 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.

Quality of life screening assessed by the Pediatric Quality Life Inventory for teens 13-18, PedsQL4.08, a 23-item questionnaire with a 5-point Likert scale from 0 (never) to 4 (almost always). Items are reversed and then added. The higher the score, the better the quality of life. Scale - minimum score:0, Maximum score us 92

Self-efficacy assessed by The Self-Efficacy for Diabetes Self-Management Measure (SEDM), a 10-item self-report scale that covers the major aspects of diabetes self-management including monitoring blood glucose levels, dosing insulin, food choices, and exercise, and performance of diabetes-related tasks when feeling overwhelmed or frustrated. Total score range for the SEDM is 1-10, with a higher score indicating higher self-efficacy.

Parent-child collaboration in diabetes care assessed using the Collaborative Parent Involvement Scale, a 12-item questionnaire with a five-point Likert scale, from almost never to always, and is targeted for adolescents. The scale aims to assess parental use of problem solving, teachable moments, diabetes, help with autonomy, and supervision of diabetes care when the adolescent is not around. Higher scores indicate better parent-adolescent collaboration Minimum score is zero and maximum is 60

Depression screening assessed by Patient Health Questionnaire (PHQ-9A), a depression questionnaire consisting of 9 items answered on a scale from "0" (not at all) to "3" (nearly every day). Total depression severity score ranges of 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Minimum is 0 and maximum is 27

Quality of life screening assessed by the Pediatric Quality Life Inventory for teens 13-18, PedsQL4.08, a 23-item questionnaire with a 5-point Likert scale from 0 (never) to 4 (almost always). Items are reversed and then added. The higher the score, the better the quality of life. Minimum:0, maximum: 115

Self-efficacy assessed by The Self-Efficacy for Diabetes Self-Management Measure (SEDM), a 10-item self-report scale that covers the major aspects of diabetes self-management including monitoring blood glucose levels, dosing insulin, food choices, and exercise, and performance of diabetes-related tasks when feeling overwhelmed or frustrated. Total score range for the SEDM is 1-10, with a higher score indicating higher self-efficacy. Minimum: 0 to maximum: 100

Parent-child collaboration in diabetes care assessed using the Collaborative Parent Involvement Scale, a 12-item questionnaire with a five-point Likert scale, from almost never to always, and is targeted for adolescents. The scale aims to assess parental use of problem solving, teachable moments, diabetes, help with autonomy, and supervision of diabetes care when the adolescent is not around. Higher scores indicate better parent-adolescent collaboration. Min: 0 and max : 60

CGM time in range percentage change will be compared between baseline, and end of clinical remote monitoring of CGM at 3 months. This is obtained from the CGM data

CGM time in range percentage change will be compared between baseline, and end of self-monitoring CGM at 6 months.This is obtained from the CGM data

CGM time in range percentage change will be compared between clinical remote monitoring of CGM at 3 months and self-monitoring of CG, at 6 months. This is obtained from the CGM data.

Percent change is calculated as the relative difference between time in hyperglycemia at clinical remote monitoring of CGM at 3 months and baseline. Time in hyperglycemia is defined as the percentage of glucose readings above the prespecified threshold (e.g., \>180 mg/dL) during continuous glucose monitoring. A negative value indicates a reduction in time spent in hyperglycemia.

Percent change is calculated as the relative difference between time in hyperglycemia at self-monitoring of CGM (6 months) and clinical remote monitoring of CGM (3 months). Time in hyperglycemia is defined as the percentage of glucose readings above the prespecified threshold (e.g., \>180 mg/dL) during continuous glucose monitoring. A negative value indicates a reduction in time spent in hyperglycemia.

Percent change is calculated as the relative difference between time in hyperglycemia at self-monitoring of CGM at 6 months and baseline. Time in hyperglycemia is defined as the percentage of glucose readings above the prespecified threshold (e.g., \>180 mg/dL) during continuous glucose monitoring. A negative value indicates a reduction in time spent in hyperglycemia.

This measure describes the relative change in the percentage of time participants wore the continuous glucose monitor (CGM)between baseline and clinical remote monitoring of CGM at 3 months. Wear time was calculated based on the amount of time the device recorded valid glucose readings compared with the total possible monitoring time. Change in CGM wear time was calculated as \[the difference in wear-time percentage between clinical remote monitoring period- percent valid wear time at baseline\] / percent of valid wear time at baseline x 100. A positive value indicates increased wear time at Timepoint 2 compared with Timepoint 1; a negative value indicates decreased wear time.

This measure describes the relative change in the percentage of time participants wore the continuous glucose monitor (CGM)between baseline and self-monitoring of CGM at 6 months. Wear time was calculated based on the amount of time the device recorded valid glucose readings compared with the total possible monitoring time. Change in CGM wear time was calculated as \[the difference in wear-time percentage between self- monitoring period- percent valid wear time at baseline\] / percent of valid wear time at baseline x 100. A positive value indicates increased wear time at Timepoint 2 compared with Timepoint 1; a negative value indicates decreased wear time.

This measure describes the relative change in the percentage of time participants wore the continuous glucose monitor (CGM) between Clinical Remote Monitoring of CGM at 3 Months to Self-monitoring CGM at 6 Months. Wear time was calculated based on the amount of time the device recorded valid glucose readings compared with the total possible monitoring time. Change in CGM wear time was calculated as \[the difference in wear-time percentage between self- monitoring period- percent valid wear time at Clinical Remote Monitoring of CGM\] / percent of valid wear time at Clinical Remote Monitoring of CGM x 100. A positive value indicates increased wear time at Timepoint 2 compared with Timepoint 1; a negative value indicates decreased wear time.

Mean time (in hours) taken for a text to be read by a participant or a guardian.