Continuous Glucose Monitoring Paired With Remotely Delivered Behavior Change Technique Interventions for Glycemic Management and Diabetes Distress Among Adults With Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwell Health
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Mean Within-Subject Difference in Glucose Time in Range
Study Overview
Brief Summary
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.
Detailed Description
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 aged ≥45 years with type 2 diabetes and diabetes distress. This study will explore the feasibility of using a Personalized Trial (n-of-1) design for widespread use in future research and clinical practice in populations with type 2 diabetes.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
No Masking
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adults aged 45 years or older
- •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
- •Currently on dialysis
- •Inability to comply with study protocol during 2-week run-in
- •Currently using CGM
- •Does not speak English
- •Unavailable for follow-up
- •Pregnancy
Arms & Interventions
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.
Intervention: Self-Monitoring of Behavior for Physical Activity (Behavioral)
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.
Intervention: Self-Monitoring of Behavior for Mood (Behavioral)
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.
Intervention: Action Planning for Mood (Behavioral)
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.
Intervention: Self-Monitoring of Behavior for Physical Activity (Behavioral)
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.
Intervention: Action Planning for Mood (Behavioral)
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.
Intervention: Action Planning for Physical Activity (Behavioral)
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.
Intervention: Action Planning for Physical Activity (Behavioral)
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.
Intervention: Self-Monitoring of Behavior for Mood (Behavioral)
Outcomes
Primary Outcomes
Mean Within-Subject Difference in Glucose Time in Range
Time Frame: Measured continuously during the 10-week study. Averages are computed for baseline/run-in (2 weeks) and intervention (8 weeks; grouped in 4 blocks of 2 weeks) periods. Data are aggregated, averaging 2 blocks for physical activity and 2 blocks for mood.
Time in range will be measured continuously using the Freestyle Libre CGM. Participants will place a CGM sensor every two weeks throughout the 10-week study. Time in range will be aggregated to compute the percent of time (0-100%) that a person spends with their blood glucose levels in the target range of 70-180 mg/dL for each assessment time period (the two-week baseline/run-in and the four two-week intervention blocks). Higher time in range values reflect better blood glucose management. Scores for the two-week intervention blocks will be aggregated. Paired samples t-tests will examine pre-post changes comparing the aggregated post-intervention value to baseline/run-in, with separate analyses for each intervention.
Mean Within-Subject Difference in Diabetes Distress
Time Frame: Assessed at the end of the baseline/run-in period (2 weeks duration) and every 2 weeks during the intervention period (8 weeks duration; grouped in 4 blocks of 2 weeks). Data are aggregated, averaging 2 blocks for physical activity and 2 blocks for mood.
Diabetes distress will be measured using the Diabetes Distress Scale (DSS), a valid and reliable 17-item measure that assesses emotional distress in the setting of diabetes. Item responses range from 1 "not a problem" to 6 "a very serious problem." At each assessment timepoint, a total score will be computed by averaging items. Total scores range from 1 to 6, with higher scores reflecting greater diabetes distress . Scores for the two-week intervention blocks will be aggregated. Paired samples t-tests will examine pre-post changes comparing the aggregated post-intervention value to baseline/run-in, with separate analyses for each intervention.
Secondary Outcomes
- Mean Within-Subject Difference in Steps Per Day(Measured continuously during the 10-week study. Average are computed for baseline/run-in (2 weeks) and intervention (8 weeks; grouped in 4 blocks of 2 weeks) periods. Data are aggregated, averaging 2 blocks for physical activity and 2 blocks for mood.)
- Mean Within-Subject Difference in Diabetes Self-Management Behaviors(Assessed at the end of the baseline/run-in period (2 weeks duration) and every 2 weeks during the intervention period (8 weeks duration; grouped in 4 blocks of 2 weeks). Data are aggregated, averaging 2 blocks for physical activity and 2 blocks for mood.)
- Mean Within-Subject Difference in Depressive Symptom Severity(Assessed at the end of the baseline/run-in period (2 weeks duration) and every 2 weeks during the intervention period (8 weeks duration; grouped in 4 blocks of 2 weeks). Data are aggregated, averaging 2 blocks for physical activity and 2 blocks for mood.)
- Mean Within-Subject Difference in Health-Related Problem-Solving(Assessed at the end of the baseline/run-in period (2 weeks duration) and every 2 weeks during the intervention period (8 weeks duration; grouped in 4 blocks of 2 weeks). Data are aggregated, averaging 2 blocks for physical activity and 2 blocks for mood.)