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Behavioral Intervention

Telemedicine-Delivered Cognitive Behavioral Therapy + CGM for Type 1 Diabetes & Mental Health (UP-CBT Trial)

N/A

Recruiting

Led By Jeffrey Gonzalez, PhD

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

Type 1 diabetes (T1D) duration ≥ 6 months

Diagnosis of anxiety or depressive mood disorder as per structured diagnostic interview

Must not have

Developmental or sensory disability interfering with participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if using mental health support along with a blood sugar monitoring device helps adults with type 1 diabetes manage their condition better. The study focuses on those who struggle with both mental health and blood sugar control.

Who is the study for?

This trial is for English or Spanish-speaking young adults aged 18-35 with Type 1 diabetes and HbA1c levels between 7.5% and 14%. Participants must have had diabetes for at least six months and be diagnosed with anxiety or depression. It's not open to those with certain disabilities, pregnant women, recent users of psychotropic medications without a stable dose, or individuals who've recently used CBT.

What is being tested?

The study tests telemedicine-delivered UP-CBT combined with continuous glucose monitoring (CGM) to improve mental health symptoms and blood sugar control in young adults with Type 1 diabetes. The therapy aims to help manage anxiety and depression while monitoring glucose levels.

What are the potential side effects?

Since the interventions are non-medical (UP-CBT) and a device (CGM), typical drug side effects aren't expected. However, participants may experience discomfort related to discussing personal issues during therapy sessions or skin irritation from CGM use.

Eligibility Criteria

Inclusion Criteria

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

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

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I have been diagnosed with anxiety or depression.

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I am between 18 and 35 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 disability that affects my ability to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

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

Treatment Details

Study Objectives

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

Secondary study objectives

Time in Range (TIR) calculated from Continuous Glucose Monitoring (CGM)

Other study objectives

Anxiety symptom severity

Depressive symptom severity

Hemoglobin A1c (HbA1c)

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: Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) with Continuous Glucose MonitoringExperimental Treatment2 Interventions

Participants randomized to this arm will receive the Unified Protocol for Cognitive Behavioral Therapy (UP-CBT), 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 / 4Eligibility criteria met