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MinorTrial status changed: Recruiting → Active, Not Recruitingv16Show 4 more changesShow less
Primary completion pushed from Jun 2026 to Oct 2026
Study completion pushed from Jun 2026 to Jul 2027
Enrollment target: estimated 93 to confirmed 96
Site details revised at 2 of 2 sites
MinorPrimary and study completion dates: Aug 2026 to Jun 2026v15Show 4 more changesShow less
Eligibility criteria expanded, about 97 words
Secondary endpoints: 6 to 5
Collaborators: 2 to 3
Publications: 17 to 18
MinorSecondary endpoints: 5 to 6
Site contacts updated at 1 of 2 sites
Eligibility criteria shortened, about 2 words
v14
MinorPrimary and study completion dates: Aug 31, 2026 to Aug 2026
Study description revised
Site contacts updated at 1 of 2 sites
v13
MinorRe-verified, no change to tracked fieldsv12
Show 10 earlier versionsHide 10 earlier versions
NotablePrimary and study completion dates: Mar 2025 to Aug 31, 2026v11
NotableEnrollment target: 150 to 93
Primary and study completion dates: Mar 31, 2025 to Mar 2025
Eligibility criteria expanded, about 11 words
Study description expanded, about 77 words
v10
MinorRe-verified, no change to tracked fieldsv9
MinorEligibility criteria shortened, about 71 wordsv8
NotablePrimary endpoints: 2 to 1v7Show 4 more changesShow less
Interventions: Telemedicine-Delivered Cognitive Behavioral Therapy (Behavioral) to Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring (Behavioral), Continuous Glucose Monitoring…
Secondary endpoints revised (5)
Eligibility criteria expanded, about 3 words
Study description expanded, about 4 words
MinorRe-verified, no change to tracked fieldsv6
NotablePrimary endpoints: 4 to 2
Secondary endpoints: 2 to 5
v5
NotableTrial status: Not Yet Recruiting to Recruitingv4Show 6 more changesShow less
Primary and study completion dates: Aug 2024 to Mar 31, 2025
Start date changed from estimate of May 2022 to Jun 27, 2022
Study description shortened, about 77 words
Site details revised at 2 of 2 sites
Study title expanded, about 6 words
Eligibility criteria shortened, about 5 words
NotableStart date: Nov 2021 to May 2022v3
NotableStart date: Sep 2021 to Nov 2021v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.