Type 2 DiabetesNCT05941000
Continuous Glucose Monitoring and Behavioral Change Intervention for People With Type 2 Diabetes and Diabetes Distress
A study testing Self-Monitoring of Behavior for Physical Activity, Action Planning for Physical Activity and Self-Monitoring of Behavior for Mood in people with Type 2 Diabetes, run by Northwell Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Self-Monitoring of Behavior for Physical Activity, Action Planning for Physical Activity and Self-Monitoring of Behavior for Mood
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Northwell Health - Institute of Health System Science
New York, New York, 10030
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Self-Monitoring of Behavior for Physical Activity, Action Planning for Physical Activity, Self-Monitoring of Behavior for Mood, Action Planning for Mood
- Keywords
- Type 2 Diabetes, Diabetes Distress, Behavior Change, Walking, Continuous Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Monitoring of Behavior for Physical ActivityBehavioural
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 ActivityBehavioural
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 MoodBehavioural
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 MoodBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Within-Subject Difference 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.
Measured: 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.
Mean Within-Subject Difference 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.
Measured: 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.
Secondary outcomes (4)
Mean Within-Subject Difference in Steps Per Day
Steps per day will be continuously measured using a Fitbit. Daily steps will be aggregated to generate average steps per day for each assessment time period (the two-week baseline/run-in and the four two-week intervention blocks).
Measured: 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
Diabetes self-management behavior will be assessed using the Summary of Diabetes Self-Care Activities Scale (SDSCA), a valid and reliable 12-item measure that assesses the frequency of engaging in activities for diabetes self-care. The Summary of Diabetes Self-Care Activities Scale is comprised of the following subscales: general diet, specific diet, exercise, blood glucose testing, foot care, and smoking. Item responses range from 0 days to 7 days. At each assessment timepoint, subscale scores will be computed by averaging items to identify the mean number of days engaging in each behavior. Subscale scores range from 0 to 7, with higher scores reflecting more frequent engagement in that behavior.
Measured: 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
Depressive symptom severity will be assessed using the Patient Health Questionnaire-8, a valid and reliable 8-item measure assessing the frequency of experiencing symptoms of depression over the past two weeks. Item responses range from 0 "not at all" to 3 "nearly every day." At each timepoint, a total score will be computed by summing all items. Total scores range from 0 to 24, with higher scores reflecting greater depressive symptom severity.
Measured: 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
Health-related problem-solving will be assessed using two subscales Health Problem-Solving Scale (HPSS). The Health Problem-Solving Scale is a valid and reliable measure of problem-solving orientation and skills in the context of health. Item responses range from 0 "not at all true of me" to 4 "extremely true of me." At each timepoint, subscale scores will be computed for the Avoidant subscale (7 items; range: 0-28) and Impulsive/Careless subscale (8 items, range: 0-32), with higher scores reflecting more of that problem-solving style.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start10 Sep 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study uses a 2-arm crossover design.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941000
- Sponsor's protocol ID
- 22-0900 IRB
- Other IDs
- P30AG063786-03
- Status last verified
- Aug 2026
- First submitted
- 29 Jun 2023
- Last updated
- 22 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05941000
- Acronym / sponsor ID
- 22-0900 IRB
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Diabetes Distress, Behavior Change, Walking, Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Posted 22 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a 2-arm crossover design.
| Arm | Type | Receives |
|---|---|---|
| CGM paired with behavior change technique interventions, physical activity intervention first | Experimental | 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 MoodParticipants 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. |
| CGM paired with behavior change technique interventions, mood intervention first | Experimental | 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 MoodParticipants 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Monitoring of Behavior for Physical ActivitySelf-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. | Behavioural | 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 ActivityAction 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. | Behavioural | 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 MoodSelf-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. | Behavioural | CGM paired with behavior change technique interventions, mood intervention first, CGM paired with behavior change technique interventions, physical activity intervention first |
| Action Planning for MoodAction 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. | Behavioural | CGM paired with behavior change technique interventions, mood intervention first, CGM paired with behavior change technique interventions, physical activity intervention first |
Primary outcome
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.
4 secondary outcomes
Mean Within-Subject Difference in Steps Per Day
Time frame: 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
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.
Mean Within-Subject Difference in Depressive Symptom Severity
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.
Mean Within-Subject Difference in Health-Related Problem-Solving
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All collected IPD will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Monitoring of Behavior for Physical Activity, Action Planning for Physical Activity and Self-Monitoring of Behavior for Mood in people with Type 2 Diabetes, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.