Clinical trial NCT05000021: Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes
Official title: Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: diabetes
diabetes distress
young adult
cognitive behavioral therapy
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: DexCom, Inc.
First posted: 2021-08-11
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: The investigators propose a randomized controlled trial (RCT) of CBT-DD, enhanced by CGM feedback. The study period will last for 6 months, with the first 3 months on CGM and consisting of a 2-week run-in period prior to randomization, in which ecological momentary assessment (EMA) data will be collected daily, followed by an 8-week CBT intervention period in which EMA data will be collected weekly surrounding CBT sessions, with a subsequent 2-week period post-intervention in which EMA data will again be collected daily. Both intervention and control groups will be doing the same EMA and CGM procedures to enable matching data for comparison. Follow-up virtual study data collection will occur at 3, 6, 9, and 12 months to assess the primary outcome of HbA1c and durability of intervention effect on diabetes distress and HbA1c. Participants in both arms will be provided a sufficient supply of CGM sensors to track their blood glucose daily, throughout the first 6 months of the study. If participants already have personal CGM, they will replace with study-supplied CGM.

We will also collect qualitative information from people with Type 1 Diabetes (T1D) ages 35-64 to solicit suggestions and inform future study decisions. We will create 2-4 focus groups to ask their impressions about our current study and explore key factors like establishing adult care and attending medical appointments, disease self-management, and adjusting to chronic disease. We will compare interview responses from participant groups who have high vs. low social needs and poor vs. good glycemic control.

Eligibility criteria: Inclusion Criteria:

* 18-64 years old
* HbA1c \>7.5%
* Diabetes Duration \>6 months
* Diabetes Distress level \>40

Exclusion Criteria:

* Comorbid psychiatric condition (e.g. depression, anxiety, or suicidality).
* In treatment for a psychological condition within the last 6 months
* On a non-stable dose of psychiatric medication over the past 2 months
* Developmental or sensory disability interfering with participation
* Current pregnancy, as self-management and glycemic goals differ
* Participations in another behavioral intervention study

Primary outcomes:
measure: Diabetes Distress Levels
timeFrame: 3 month mark (post-intervention)
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: 3 month mark (post-intervention)
measure: Time in Range (TIR) calculated from Continuous Glucose Monitoring (CGM)
timeFrame: 3 month mark (post-intervention)
measure: Time Below Range (TBR) calculated from Continuous Glucose Monitoring (CGM)
timeFrame: 3 month mark (post-intervention)
measure: Time Above Range (TAR) calculated from Continuous Glucose Monitoring (CGM)
timeFrame: 3 month mark (post-intervention)
measure: Coefficient of Variation (CV) calculated from Continuous Glucose Monitoring (CGM)
timeFrame: 3 month mark (post-intervention)
Other outcomes:
measure: Diabetes Distress Levels
timeFrame: 6 month mark
measure: Diabetes Distress Levels
timeFrame: 9 month mark
measure: Diabetes Distress Levels
timeFrame: 12 month mark
measure: Hemoglobin A1c
timeFrame: 6 month month mark
measure: Hemoglobin A1c
timeFrame: 9 month month mark
measure: Hemoglobin A1c
timeFrame: 12 month month mark
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: New York
country: United States
facility: Yeshiva University
state: New York
Study officials:
affiliation: Yeshiva University
name: Jeffrey Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
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