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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
UP-CBT Trial Summary
This trial will evaluate using tech and CGM to help young adults with type 1 diabetes manage anxiety and depression, and improve 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.Check my eligibility
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.See study design
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.
UP-CBT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
UP-CBT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Time in Range (TIR) calculated from Continuous Glucose Monitoring (CGM)
Other outcome measures
Anxiety symptom severity
Depressive symptom severity
Hemoglobin A1c (HbA1c)
UP-CBT 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
Find a Location
Who is running the clinical trial?
Albert Einstein College of MedicineLead Sponsor
287 Previous Clinical Trials
11,856,958 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,634 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
137 Previous Clinical Trials
29,700 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) with Continuous Glucose Monitoring
- Group 2: Continuous Glucose Monitoring (CGM) Only
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are adults over 35 years of age permitted to participate in this research?
"This medical experiment is looking for participants aged 18 to 35. There are 403 studies available for individuals below the age of majority, and 1,849 trials open to those over 65 years old."
Answered by AI
Does my profile meet the criteria for participation in this trial?
"150 participants, aged 18-35 and currently suffering from diabetes, will be admitted to this trial. Additionally, they must have had T1D for at least 6 months; their HbA1c levels need to range between 7.5 - 14%; they should either speak English or Spanish fluently; and finally, a structured diagnostic interview needs confirm an anxiety disorder or depressive mood disorder diagnosis."
Answered by AI
Are new participants being welcomed into this investigation?
"Clinicaltrials.gov displays that this trial, which commenced on May 1st 2023 and was updated last February 16th, is not currently recruiting patients to join the study. However, there are over two thousand alternative clinical trials actively seeking volunteers presently."
Answered by AI
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