CGM + Behavioral Intervention for Type 2 Diabetes

N/A

Recruiting

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

No Placebo-Only Group

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.

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.

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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Diabetes Distress

Change in Glucose Time in Range

Secondary study objectives

Change in Depressive Symptom Severity

Change in Diabetes Self-Management Behavior

Change in Health-Related Problem-Solving

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: CGM paired with behavior change technique interventions, physical activity intervention firstExperimental Treatment4 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 Treatment4 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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