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

NCT05941000 | Completed

• 2 other identifiers: 22-0900 IRBP30AG063786-03
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Diabetes Distress; Behavior Change; Walking; Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (2)

• Change in Glucose Time in Range

  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.

  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).

• Change in Diabetes Distress

  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.

  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 (4)

• Change in Steps per Day

  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).

• Change in Diabetes Self-Management Behavior

  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).

• Change in Depressive Symptom Severity

  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).

• Change in Health-Related Problem-Solving

  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).

Study Arms (2)

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

EXPERIMENTAL

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.

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

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.

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

Interventions

Self-Monitoring of Behavior for Physical Activity BEHAVIORAL

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.

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

Action Planning for Physical Activity BEHAVIORAL

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.

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

Self-Monitoring of Behavior for Mood BEHAVIORAL

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.

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

Action Planning for Mood BEHAVIORAL

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

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Northwell Health - Institute of Health System Science

New York, New York, 10030, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No Masking
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a 2-arm crossover design.

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 12, 2023
• Study Start: September 10, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study protocol, including the statistical analysis plan, will be made available in addition to the informed consent following completion of recruitment but prior to the publication of any data from the current study. De-identified, pooled individual participant data will be made available within a year of final participant data collection. The investigators anticipate this data will be available on the Open Science Framework platform indefinitely.
• Access Criteria: All data and supporting information will be stores on the Open Science Framework, a free web application with no access restrictions.

Locations

US (1)