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Behavioural Intervention
CGM + Behavioral Intervention for Type 2 Diabetes
N/A
Waitlist Available
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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).
Awards & highlights
Study Summary
This trial will test if using CGM & text-based behavior changes can improve glycemic regulation & diabetes distress in adults w/type 2 diabetes.
Who is the study for?
This trial is for adults over 45 with type 2 diabetes who are able to walk and use a smartphone. They should have high blood sugar levels (A1C ≥8.0%) and feel stressed about their diabetes. People using dialysis, pregnant women, non-English speakers, or those unable to follow the study plan can't join.Check my eligibility
What is being tested?
The study tests if continuous glucose monitoring combined with text messages encouraging physical activity or improving mood helps control blood sugar and reduces stress in diabetics. Participants wear sensors and get alternating interventions every two weeks for eight weeks after an initial observation period.See study design
What are the potential side effects?
There may be minimal side effects from wearing CGM sensors like skin irritation. The behavioral change texts might not have direct side effects but could influence mood or activity levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Diabetes Distress
Change in Glucose Time in Range
Secondary outcome measures
Change in Depressive Symptom Severity
Change in Diabetes Self-Management Behavior
Change in Health-Related Problem-Solving
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: CGM paired with behavior change technique interventions, physical activity intervention firstExperimental Treatment3 Interventions
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.
Group II: CGM paired with behavior change technique interventions, mood intervention firstExperimental Treatment3 Interventions
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.
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Who is running the clinical trial?
Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,873 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,669 Previous Clinical Trials
28,005,054 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving dialysis.I do not speak English.I am 45 years old or older.I have been diagnosed with type 2 diabetes.I can walk and have never been told by a doctor that it's unsafe for me to do low-intensity walking.You have high levels of stress related to your diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: CGM paired with behavior change technique interventions, mood intervention first
- Group 2: CGM paired with behavior change technique interventions, physical activity intervention first
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide an estimate of the available vacancies for this research endeavor?
"According to the clinicaltrials.gov portal, this study is no longer recruiting patients and has not done so since July 7th 2023. However, there are numerous other ongoing trials that require participants at the present moment - 1459 in total!"
Answered by AI
What is the primary goal of this clinical trial?
"This clinical trial will assess a primary outcome, Diabetes Distress, and three secondary outcomes: the Summary of Diabetes Self-Care Activities Scale (SDSCA), Patient Health Questionnaire-8, and two subscales from the Health Problem-Solving Scale. During the 10 week study period these results will be continuously monitored for an Average Time in Range over both baseline/run-in 2 weeks as well as during 8 weeks of intervention. Responses range on a scale from 0 to 7 days with higher scores indicating more frequent engagement in behavior or greater depressive symptom severity; while responses for HPS Avoidant and Impulsive/Careless Sub"
Answered by AI
Who else is applying?
What site did they apply to?
Northwell Health - Institute of Health System Science
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I want to help improve my health and other get the best treatment as possible.
PatientReceived 1 prior treatment
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