Trial results for a study on the feasibility and effectiveness of real-time, remote continuous glucose monitoring (CGM) in adolescents with poorly controlled Type 1 Diabetes were posted on ClinicalTrials.gov on 2026-03-03, showing a mean reduction in Hemoglobin A1c of 0.9% (p=0.03) at 3 months.
Background
Type 1 Diabetes (T1D) in adolescents, particularly those with poor glycemic control, presents significant management challenges. Adherence to treatment regimens, including insulin management, is crucial but can be difficult for this age group. Continuous Glucose Monitoring (CGM) offers real-time glucose data, but its effectiveness can be enhanced by active clinical engagement. Strategies that support adolescents in managing their T1D, especially those facing noncompliance issues, are vital for improving glycemic control and overall well-being.
Trial design
This completed study, designated as Phase NA, enrolled 20 participants aged 13-18 years with Type 1 Diabetes of more than 6 months duration, managed on insulin, and experiencing poor glycemic control. The study investigated the feasibility and effectiveness of real-time, remote continuous glucose monitoring (CGM) with clinical personnel monitoring patients remotely for 3 months and communicating regularly via secure text messaging with participants and their parents. Conditions studied included Diabetes Mellitus, Type 1 and Noncompliance, Patient. The primary outcome assessed was the change in Hemoglobin A1c from baseline to 3 months.
Key results
The trial reported several key measurements and analyses:
- Change in Hemoglobin A1c From Baseline to 3 Months (Real Time Monitoring group): A mean reduction of -0.9 percent (Standard Deviation 1.1) was observed. A paired t-test analysis indicated a mean difference of -0.9 (95.0% Confidence Interval: -1.7 to -0.13) with a p-value of 0.03.
- Change in Depression Score After Clinical Remote CGM Monitoring and Secure Text Messaging (Real Time Monitoring group): The mean change was -1 score on scale (Standard Deviation 1.9).
- Change in Quality of Life Score After Clinical Remote CGM Monitoring and Secure Text Messaging (Realtime Monitoring group): The mean change was -4.5 score on scale (Standard Deviation 10.5).
- Change in Self Efficacy Score After Clinical Remote CGM Monitoring and Secure Text Messaging (Real Time Monitoring group): The mean change was -0.007 score on scale (Standard Deviation 1.8).
- Change in Parent-child Collaboration Score After Clinical Remote CGM Monitoring and Secure Text Messaging (Real Time Monitoring group): The mean change was -7.7 score on scale (Standard Deviation 14).
- Change in Depression Score 3 Months After Clinical Remote Continuous Glucose Monitoring Monitoring and Immediately After a Period of Self-monitoring of CGM Data (Intervention Arm): The mean change was -0.2 score on scale (Standard Deviation 0.4).
- 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 (Arm 1- Realtime Monitoring): The mean change was 0 score on scale (Standard Deviation 4.3).
- 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 (Intervention Arm): The mean change was -0.2 score on scale (Standard Deviation 1).
- 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 (Arm 1 - Realtime Monitoring): The mean change was 12.7 score on scale (Standard Deviation 18.3).
- CGM Time in Range Percentage Change Will be Compared Between Baseline and End of Clinical Remote Monitoring of CGM at 3 Months (Intervention Arm): The mean change was -0.05 percent change (Standard Deviation 11.8).
- CGM Time in Range Percentage Change Will be Compared Between Baseline and End of Self-monitoring of CGM at 6 Months (Intervention Arm): The mean change was -4.1 percent change (Standard Deviation 15).
- CGM Time in Range Percentage Change Will be Compared Between Clinical Remote Monitoring (3 Months) and Self-monitoring of CGM (6 Months) (Intervention Arm): The mean change was -4.2 percent change (Standard Deviation 10.8).
What this means
The results suggest that real-time, remote continuous glucose monitoring combined with secure text messaging can lead to a statistically significant reduction in Hemoglobin A1c in adolescents with poorly controlled Type 1 Diabetes over a 3-month period. While other measures like depression, quality of life, and self-efficacy scores also showed changes, the most notable finding is the improvement in glycemic control. This approach could offer a valuable tool for clinicians to support adolescents in managing their condition and potentially improve adherence and health outcomes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04540536, titled "Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes", were posted on 2026-03-03 on clinicaltrials.gov.