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Continuous Glucose Monitoring and Behavioral Change Intervention for People With Type 2 Diabetes and Diabetes Distress

Northwell Health · 2024
ClinicalTrials.gov · Datasets · License: Public Domain · 2024
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behavior-changenatype-2-diabeteswalking
The purpose of this study is to use a Personalized Trial (N-of-1) design to test the effect of an intervention that pairs continuous glucose monitoring (CGM) with text message-delivered behavior change interventions for physical activity and mood on outcomes of glycemic regulation and diabetes distress among adults with type 2 diabetes and diabetes distress. Participants (n=60) will be given CGM sensors and a FitBit watch to wear during the 10-week study. Participants will complete a two-week baseline/run-in period, during which the participants usual blood glucose and physical activity will be monitored. After successful completion of the run-in period, participants will enter an eight-week intervention period, during which the participant will be randomized to either of two arms, which will both receive two interventions in alternating order - 1) CGM paired with behavioral intervention for physical activity and 2) CGM paired with behavioral intervention for mood. Every two weeks, participants will complete self-report measures assessing mood and health-related behavior and a hemoglobin A1C test. At the end of the trial, participants will receive a summary of the data to help the participants learn more about the responses to the two interventions and to inform investigators about the feasibility of an N-of-1 study design for future research and clinical applications.
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