Clinical trial NCT05941000: Continuous Glucose Monitoring and Behavioral Change Intervention for People With Type 2 Diabetes and Diabetes Distress
Official title: Continuous Glucose Monitoring Paired With Remotely Delivered Behavior Change Technique Interventions for Glycemic Management and Diabetes Distress Among Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Diabetes Distress
Behavior Change
Walking
Continuous Glucose Monitoring
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-07-12
Enrollment: 3
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study uses a 2-arm crossover design.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Glucose Time in Range
timeFrame: Time in range will be measured continuously during the 10-week study period. Average time in range will be computed for the baseline/run-in period (2 weeks in duration) and every two weeks during the intervention period (8 weeks in duration).
measure: Change in Diabetes Distress
timeFrame: Diabetes distress will be assessed at the completion of the baseline/run-in period (2 weeks in duration) and every two weeks during the intervention period (8 weeks in duration).
Secondary outcomes:
measure: Change in Steps per Day
timeFrame: Steps per day will be measured continuously during the 10-week study. Average steps per day will be computed for the baseline/run-in period (2 weeks in duration) and every two weeks during the intervention period (8 weeks in duration).
measure: Change in Diabetes Self-Management Behavior
timeFrame: Diabetes self-management behavior will be assessed at the completion of the baseline/run-in period (2 weeks in duration) and every two weeks during the intervention period (8 weeks in duration).
measure: Change in Depressive Symptom Severity
timeFrame: Depressive symptom severity will be assessed at the completion of the baseline/run-in period (2 weeks in duration) and every two weeks during the intervention period (8 weeks in duration).
measure: Change in Health-Related Problem-Solving
timeFrame: Health-related problem-solving will be assessed at the completion of the baseline/run-in period (2 weeks in duration) and every two weeks during the intervention period (8 weeks in duration).
Other outcomes:
Locations:
city: New York
country: United States
facility: Northwell Health - Institute of Health System Science
state: New York
Study officials:
References: