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

Northwell Health

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Action Planning for Mood; Behavioral: Self-Monitoring of Behavior for Mood; Behavioral: Action Planning for Physical Activity; Behavioral: Self-Monitoring of Behavior for Physical Activity

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05941000

22-0900 IRB

P30AG063786-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

CGM paired with behavior change technique interventions, physical activity intervention first

Experimental group

Description:

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.

Treatment:

Behavioral: Self-Monitoring of Behavior for Physical Activity

Behavioral: Action Planning for Physical Activity

Behavioral: Self-Monitoring of Behavior for Mood

Behavioral: Action Planning for Mood

CGM paired with behavior change technique interventions, mood intervention first

Experimental group

Description:

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.

Treatment:

Behavioral: Self-Monitoring of Behavior for Physical Activity

Behavioral: Action Planning for Physical Activity

Behavioral: Self-Monitoring of Behavior for Mood

Behavioral: Action Planning for Mood