Continuous Glucose Monitoring and Behavioral Change Intervention for People With Type 2 Diabetes and Diabetes Distress
NCT ID: NCT05941000
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3 participants
INTERVENTIONAL
2024-09-10
2025-02-28
Brief Summary
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Detailed Description
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Participants (n=60) will be recruited into a 10-week Personalized Trial consisting of a two-week baseline/run-in period and an eight-week intervention period. Two interventions will be delivered to each participant: 1) CGM paired with behavioral intervention for physical activity and 2) CGM paired with behavioral intervention for mood. Both interventions will include the use of CGM paired with a behavioral intervention delivered via mobile technology using behavior change techniques of self-monitoring and action planning. After completing the two-week baseline/run-in period, participants will be randomly assigned into one of two arms. In one arm, participants will receive CGM plus the physical activity behavior change technique intervention in weeks 1-2 and 7-8 and the mood intervention during weeks 3-6 of the intervention period. In the second arm, participants will receive the opposite interventions to the first arm.
Participants will be provided and asked to use Freestyle Libre CGM sensors that will monitor the participants blood glucose levels and a Fitbit watch that will track the participants physical activity. The participant will complete measures assessing diabetes distress, diabetes self-management behavior frequency, depressive symptom severity, and health-related problem-solving once every two weeks. The participant will be sent and asked to return a self-administered hemoglobin A1C test every two weeks. At the end of the participants participation, participants will receive a summary of the data to help the participant 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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CGM paired with behavior change technique interventions, physical activity intervention first
Participants in this arm will receive a continuous glucose monitor and they will receive two behavior change technique interventions via daily text messages over the course of eight weeks, in a series of four, two-week blocks. In the first two-week block, they will receive the physical activity behavior change technique intervention. In the second and third two-week blocks, they will receive the mood behavior change technique intervention. In the fourth two-week block, they will receive the physical activity behavior change technique intervention.
Self-Monitoring of Behavior for Physical Activity
Self-Monitoring of Behavior for Physical Activity: Individuals will receive daily text messages that include the Self-Monitoring behavior change technique message with the goal of self-monitoring the number of steps taken on the prior day relative to their baseline average number of steps.
Action Planning for Physical Activity
Action Planning for Physical Activity: Individuals will receive daily text messages that include the Action Planning behavior change technique with the goal of planning to take action to walk an extra 1,000 steps relative to their baseline average step count.
Self-Monitoring of Behavior for Mood
Self-Monitoring of Behavior for Mood: Individuals will receive daily text messages that include the Self-Monitoring behavior change technique message with the goal of self-monitoring their mood on the prior day.
Action Planning for Mood
Action Planning for Mood: Individuals will receive daily text messages that include the Action Planning behavior change technique with the goal of planning to take action to improve their mood.
CGM paired with behavior change technique interventions, mood intervention first
Participants in this arm will receive a continuous glucose monitor and they will receive two behavior change technique interventions via daily text messages over the course of eight weeks, in a series of four, two-week blocks. In the first two-week block, they will receive the mood behavior change technique intervention. In the second and third two-week blocks, they will receive the physical activity behavior change technique intervention. In the fourth two-week block, they will receive the mood behavior change technique intervention.
Self-Monitoring of Behavior for Physical Activity
Self-Monitoring of Behavior for Physical Activity: Individuals will receive daily text messages that include the Self-Monitoring behavior change technique message with the goal of self-monitoring the number of steps taken on the prior day relative to their baseline average number of steps.
Action Planning for Physical Activity
Action Planning for Physical Activity: Individuals will receive daily text messages that include the Action Planning behavior change technique with the goal of planning to take action to walk an extra 1,000 steps relative to their baseline average step count.
Self-Monitoring of Behavior for Mood
Self-Monitoring of Behavior for Mood: Individuals will receive daily text messages that include the Self-Monitoring behavior change technique message with the goal of self-monitoring their mood on the prior day.
Action Planning for Mood
Action Planning for Mood: Individuals will receive daily text messages that include the Action Planning behavior change technique with the goal of planning to take action to improve their mood.
Interventions
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Self-Monitoring of Behavior for Physical Activity
Self-Monitoring of Behavior for Physical Activity: Individuals will receive daily text messages that include the Self-Monitoring behavior change technique message with the goal of self-monitoring the number of steps taken on the prior day relative to their baseline average number of steps.
Action Planning for Physical Activity
Action Planning for Physical Activity: Individuals will receive daily text messages that include the Action Planning behavior change technique with the goal of planning to take action to walk an extra 1,000 steps relative to their baseline average step count.
Self-Monitoring of Behavior for Mood
Self-Monitoring of Behavior for Mood: Individuals will receive daily text messages that include the Self-Monitoring behavior change technique message with the goal of self-monitoring their mood on the prior day.
Action Planning for Mood
Action Planning for Mood: Individuals will receive daily text messages that include the Action Planning behavior change technique with the goal of planning to take action to improve their mood.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of type 2 diabetes
* Suboptimal hemoglobin A1C (≥8.0%)
* Positive screen for diabetes distress (Diabetes Distress Scale≥3.0)
* Access to and capable of using a smart cellular phone
* Ambulatory and never informed by clinician that it was not advisable/safe to participate in a low-intensity walking
Exclusion Criteria
* Inability to comply with study protocol during 2-week run-in
* Currently using CGM
* Does not speak English
* Unavailable for follow-up
* Pregnancy
45 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Northwell Health
OTHER
Responsible Party
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Locations
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Northwell Health - Institute of Health System Science
New York, New York, United States
Countries
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Other Identifiers
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22-0900 IRB
Identifier Type: -
Identifier Source: org_study_id
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