| Primary | Change in Hemoglobin A1c From Baseline to 3 Months | Change in hemoglobin A1c from baseline to 3 months (three-month follow-up visit after remote continuous glucose monitoring and secure text messaging) | 1 patient withdrew prior to obtaining this data | Posted | | Mean | Standard Deviation | percent | | 3 months | | | | ID | Title | Description |
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| OG000 | Real Time Monitoring | |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Paired t test | | 0.03 | | Mean Difference (Final Values) | -0.9 | Standard Deviation | 1.1 | 2-Sided | 95 | -1.7 | -0.13 | | | | | Other | | |
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| Secondary | Change in Depression Score After Clinical Remote CGM 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. | 1 patient withdrew prior to obtaining the data | Posted | | Mean | Standard Deviation | score on scale | | 3 months | | | | ID | Title | Description |
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| OG000 | Real Time Monitoring | |
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| Other Pre-specified | Change in Quality of Life Score After Clinical Remote CGM Monitoring and Secure Text Messaging. | 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 | 1 patient withdrew prior to obtaining this data | Posted | | Mean | Standard Deviation | score on scale | | 3 months | | | | ID | Title | Description |
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| OG000 | Realtime Monitoring | |
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| Other Pre-specified | Change in Self Efficacy Score After Clinical Remote CGM Monitoring and Secure Text Messaging. | 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. | 1 participant withdrew prior to obtaining these data | Posted | | Mean | Standard Deviation | score on scale | | 3 months | | | | ID | Title | Description |
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| OG000 | Real Time Monitoring | |
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| Other Pre-specified | Change in Parent-child Collaboration Score After Clinical Remote CGM Monitoring and Secure Text Messaging. | 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 | 1 patient withdrew prior to obtaining this data | Posted | | Mean | Standard Deviation | score on scale | | 3 months | | | | ID | Title | Description |
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| OG000 | Real Time Monitoring | |
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| Other Pre-specified | Change in Depression Score 3 Months After Clinical Remote Continuous Glucose Monitoring Monitoring and Immediately After a Period of Self-monitoring of CGM Data | 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 | Out of 8 subjects who completed phase 3, 2 patients did not complete the survey and therefore only 6 analyzed for this outcome. | Posted | | Mean | Standard Deviation | score on scale | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention Arm | Participants undergoing intervention who undergo clinical remote Continuous Glucose Monitoring in phase 2 and who undergo self monitoring CGM in phase 3 |
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| Other Pre-specified | Change in Quality of Life Score 3 Months After Clinical Remote Continuous Glucose Monitoring Monitoring and Immediately After a Period of Self-monitoring of CGM Data | 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 | Out of 8 subjects who completed phase 3, 2 patients did not complete the survey and therefore only 6 analyzed for this outcome. | Posted | | Mean | Standard Deviation | score on scale | | 6 months | | | | ID | Title | Description |
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| OG000 | Arm 1- Realtime Monitoring | |
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| Other Pre-specified | Change in Self Efficacy Score 3 Months After Clinical Remote Continuous Glucose Monitoring Monitoring and Immediately After a Period of Self-monitoring of CGM Data | 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 | Out of 8 subjects who completed phase 3, 2 patients did not complete the survey and therefore only 6 analyzed for this outcome. | Posted | | Mean | Standard Deviation | score on scale | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention Arm | Participants undergoing intervention who undergo clinical remote Continuous Glucose Monitoring in phase 2 and who undergo self monitoring CGM in phase 3 |
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| Other Pre-specified | Change in Parent-child Collaboration Score 3 Months After Clinical Remote Continuous Glucose Monitoring Monitoring and Immediately After a Period of Self-monitoring of CGM Data | 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 | 2 patients withdrew, 1 died and 2 did not complete the survey | Posted | | Mean | Standard Deviation | score on scale | | 6 months | | | | ID | Title | Description |
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| OG000 | Arm 1 - Realtime Monitoring | |
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| Other Pre-specified | CGM Time in Range Percentage Change Will be Compared Between Baseline and End of Clinical Remote Monitoring of CGM at 3 Months | 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 | | Posted | | Mean | Standard Deviation | percent change | | baseline, end of clinical remote monitoring of CGM (3 months) | | | | ID | Title | Description |
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| OG000 | Intervention Arm | Participants who started from baseline and underwent clinical remote Continuous Glucose Monitoring in phase 2 and who undergo self monitoring CGM in phase 3 |
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| Other Pre-specified | CGM Time in Range Percentage Change Will be Compared Between Baseline and End of Self-monitoring of CGM at 6 Months | 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 | | Posted | | Mean | Standard Deviation | percent change | | baseline, end of self monitoring CGM (6 months) | | | | ID | Title | Description |
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| OG000 | Intervention Arm | Participants who started from baseline and underwent clinical remote Continuous Glucose Monitoring in phase 2 and who undergo self monitoring CGM in phase 3 |
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| Other Pre-specified | CGM Time in Range Percentage Change Will be Compared Between Clinical Remote Monitoring (3 Months) and Self-monitoring of CGM (6 Months) | 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. | | Posted | | Mean | Standard Deviation | percent change | | clinical remote monitoring of CGM (3 months), self monitoring of CGM (6 months) | | | | ID | Title | Description |
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| OG000 | Intervention Arm | Participants who underwent clinical remote Continuous Glucose Monitoring in phase 2 and who undergo self monitoring CGM in phase 3 |
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| Other Pre-specified | Percent Change of Time in Hyperglycemia From Baseline to Clinical Remote Monitoring of CGM at 3 Months | 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. | | Posted | | Mean | Standard Deviation | percent change | | baseline, clinical remote monitoring of CGM (3 months) | | | | ID | Title | Description |
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| OG000 | Intervention Arm | Participants who started from baseline and underwent clinical remote Continuous Glucose Monitoring in phase 2 |
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| Other Pre-specified | Percent Change of Time in Hyperglycemia From Clinical Remote Monitoring of CGM at 3 Months to Self-monitoring CGM at 6 Months | 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. | | Posted | | Mean | Standard Deviation | percent change | | clinical remote monitoring of CGM (3 months), self-monitoring of CGM (6 months) | | | | ID | Title | Description |
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| OG000 | Intervention Arm | Participants who underwent clinical remote Continuous Glucose Monitoring in phase 2 and who undergo self monitoring CGM in phase 3 |
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| Other Pre-specified | Percent Change of Time in Hyperglycemia From Baseline to Self-monitoring of CGM at 6 Months | 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. | | Posted | | Mean | Standard Deviation | percent change | | baseline, self monitoring of CGM (6 months) | | | | ID | Title | Description |
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| OG000 | Intervention Arm | Participants who started from baseline and underwent self-Monitoring of CGM in phase 3 |
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| Other Pre-specified | Percent Change of Time Participants Wore the CGM From Baseline to Clinical Remote Monitoring of CGM at 3 Months | 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. | | Posted | | Mean | Standard Deviation | percent change | | Baseline, clinical remote monitoring of CGM (at 3 months) | | | | ID | Title | Description |
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| OG000 | Intervention Arm | Participants who started from baseline and underwent clinical remote Continuous Glucose Monitoring in phase 2 |
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| Other Pre-specified | Percent Change of Time Participants Wore the CGM From Baseline to Clinical Remote Monitoring of CGM at 6 Months | 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. | | Posted | | Mean | Standard Deviation | percent change | | baseline, self monitoring of CGM (6 months) | | | | ID | Title | Description |
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| OG000 | Intervention Arm | Participants who started from baseline and underwent self-Monitoring of CGM in phase 3 |
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| Other Pre-specified | Percent Change of Time Participants Wore the CGM Clinical Remote Monitoring of CGM at 3 Months to Self-monitoring CGM at 6 Months | 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. | | Posted | | Mean | Standard Deviation | percent change | | clinical remote monitoring of CGM (3 months), self-monitoring of CGM (6 months) | | | | ID | Title | Description |
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| OG000 | Intervention Arm | Participants who underwent clinical remote Continuous Glucose Monitoring in phase 2 and who undergo self monitoring CGM in phase 3 |
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| Other Pre-specified | Mean Time (Hours) Taken for a Text to be Read by a Participant or a Guardian. | Mean time (in hours) taken for a text to be read by a participant or a guardian. | | Posted | | Mean | Standard Deviation | hours | | 3 months | | | | ID | Title | Description |
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| OG000 | Arm 1- Realtime Monitoring | |
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