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Cognitive Behavioral Therapy + CGM for Type 1 Diabetes (ReDUCe Trial)

N/A

Recruiting

Led By Shivani Agarwal, MD

Research Sponsored by Albert Einstein College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English- or Spanish-speaking

T1D duration ≥6 months

Must not have

Comorbid psychiatric condition (e.g. depression, anxiety, or suicidality)

On a non-stable dose of psychiatric medication over the past 2 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month mark

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether adding CBT to standard CGM care can help young adults with type 1 diabetes better manage their condition and reduce diabetes-related distress.

Who is the study for?

This trial is for young adults aged 18-30 with Type 1 Diabetes who experience diabetes distress. They must have been on a stable insulin treatment for at least 3 months, have had diabetes for over half a year, and speak English or Spanish. Not eligible if pregnant, in another study, recently treated for psychological conditions, on unstable psychiatric meds, or have certain disabilities.

What is being tested?

The trial tests whether Cognitive Behavioral Therapy (CBT) aimed at reducing diabetes-related stress works better when combined with Continuous Glucose Monitoring (CGM) than just using CGM alone. It's a virtual study where participants are randomly placed into two groups to compare the effects over six months.

What are the potential side effects?

Since this trial involves therapy and monitoring rather than medication, typical drug side effects aren't expected. However, participants may experience emotional discomfort discussing personal issues during CBT sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I speak English or Spanish.

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I have had Type 1 Diabetes for at least 6 months.

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I am between 18 and 30 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a mental health condition like depression or anxiety.

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My psychiatric medication dose has changed in the last 2 months.

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I have a disability that affects my ability to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month mark

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month mark

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month mark for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Coefficient of Variation (CV) calculated from Continuous Glucose Monitoring (CGM)

Time Above Range (TAR) calculated from Continuous Glucose Monitoring (CGM)

Time Below Range (TBR) calculated from Continuous Glucose Monitoring (CGM)

+1 more

Other study objectives

Diabetes Distress Levels

Hemoglobin A1c

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

Active Control

Group I: Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose MonitoringExperimental Treatment2 Interventions

Participants randomized to this arm will receive Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD), enhanced by review of Continuous Glucose Monitoring (CGM) data. Participants will wear study-supplied CGM for the first 6 months of their participation in the trial.

Group II: Continuous Glucose Monitoring (CGM) OnlyActive Control1 Intervention

Participants randomized to receive Continuous Glucose Monitoring (CGM) will continue to receive their usual care and will also wear CGM throughout the first 6 months of their participation in the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous Glucose Monitoring (CGM)

2009

N/A

~330

0 / 6Eligibility criteria met