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Clinical Trial

Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes

NCT: NCT05000021 · ACTIVE_NOT_RECRUITING

NCT IDNCT05000021
StatusACTIVE_NOT_RECRUITING
Start Date2022-06-27
Completion2027-07
SponsorAlbert Einstein College of Medicine (OTHER)
First posted
Last updated

Brief Summary

This project proposes to use telemedicine-delivered cognitive-behavioral therapy (CBT) enhanced with continuous glucose monitor (CGM) review to target diabetes distress in adults with type 1 diabetes. The efficacy of CBT for diabetes distress (CBT-DD) will be tested in comparison to commercial FDA-approved CGM only in a randomized controlled clinical trial. The investigators' central hypothesis is that the addition of a CBT intervention that targets diabetes distress and self-management directly will yield clinically significant improvements in both diabetes distress and glycemic control relative to CGM alone. The investigators propose to recruit 93 adults (age 18-64) with type 1 diabetes from a national population for an entirely virtual 6-month study over four years, with targeted recruitment of racial/ethnic minorities. In addition to standard measurement of HbA1c for glycemic control and validated patient-reported outcome (PRO) surveys, the investigators plan to innovatively integrate momentary psychological and behavioral data via smartphone-based ecological momentary assessment with CGM data to assess day-to-day changes in diabetes distress, affect, self-management, and glycemia over the course of the trial.

Frequently Asked Questions

What is Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes?

Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes is a clinical trial registered under NCT05000021. Current status: ACTIVE_NOT_RECRUITING.

What is the status of NCT05000021?

The current status of NCT05000021 (Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes) is: ACTIVE_NOT_RECRUITING.

When did Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes start?

Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes started on 2022-06-27.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.