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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month mark

Awards & highlights

ReDUCe Trial 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.Check my eligibility

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.See study design

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.

ReDUCe Trial 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.

ReDUCe Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

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 outcome measures

Diabetes Distress Levels

Hemoglobin A1c

ReDUCe 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

Albert Einstein College of MedicineLead Sponsor

287 Previous Clinical Trials

11,856,957 Total Patients Enrolled

Media Library

Type 1 Diabetes Research Study Groups: Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring, 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.

How many participants are actively participating in this clinical trial?

"Affirmative. Data located on clinicaltrials.gov suggests that this medical trial, which was initially made available on June 27th 2022, is still recruiting patients to participate. 150 individuals are wanted between 2 separate facilities."

Answered by AI

Is enrollment available to participants aged 40 and up in this experiment?

"To be eligible for this trial, patients must fall between 18 and 30 years of age. For minors, there are 220 trials available whereas 931 studies accommodate the elderly population."

Answered by AI

Are there any prerequisites for volunteers to join this clinical investigation?

"This investigation requires 150 patients with type 1 diabetes that are between 18 and 30 years of age. To be eligible, they must have had T1D for a minimum duration of 6 months, an HbA1c level within the range 7.5-14%, fluency in either English or Spanish, evidence of distress associated to their condition, and no changes made to their insulin treatment regimen for 3 consecutive months prior to enrolling."

Answered by AI

Is it still feasible to enroll in this experiment?

"The clinical trial is currently recruiting, as evidenced by the information on clinicialtrials.gov. This medical study was initially posted June 27th 2022 and has had its details updated most recently on November 29th 2022."

Answered by AI