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.
Brief Title
Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes
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.
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
646-592-4376
Central Contact Email
jeffrey.gonzalez@yu.edu
Completion Date
Completion Date Type
Estimated
Conditions
Type 1 Diabetes
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
* 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
Inclusion Criteria
Inclusion Criteria:
* 18-64 years old
* HbA1c \>7.5%
* Diabetes Duration \>6 months
* Diabetes Distress level \>40
* 18-64 years old
* HbA1c \>7.5%
* Diabetes Duration \>6 months
* Diabetes Distress level \>40
Gender
All
Gender Based
false
Keywords
diabetes
diabetes distress
young adult
cognitive behavioral therapy
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
64 Years
Minimum Age
18 Years
NCT Id
NCT05000021
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2021-12789
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes
Primary Outcomes
Outcome Description
The Problem Areas in Diabetes (PAID) scale will be administered
Outcome Measure
Diabetes Distress Levels
Outcome Time Frame
3 month mark (post-intervention)
Secondary Ids
Secondary Id
4-SRA-2021-1071-M-B
Secondary Outcomes
Outcome Description
Hemoglobin A1c (HbA1c) values will be calculated from mailed kits for home collection and analysis by a central laboratory.
Outcome Time Frame
3 month mark (post-intervention)
Outcome Measure
Hemoglobin A1c
Outcome Description
Percent of time with glucose values between 70-180 mg/dl will be calculated from CGM wear in the 3 months after randomization.
Outcome Time Frame
3 month mark (post-intervention)
Outcome Measure
Time in Range (TIR) calculated from Continuous Glucose Monitoring (CGM)
Outcome Description
Percent of time with glucose values below 70 mg/dl will be calculated from CGM wear in the 3 months after randomization.
Outcome Time Frame
3 month mark (post-intervention)
Outcome Measure
Time Below Range (TBR) calculated from Continuous Glucose Monitoring (CGM)
Outcome Description
Percent of time with glucose values above 180 mg/dl will be calculated from CGM wear in the 3 months after randomization.
Outcome Time Frame
3 month mark (post-intervention)
Outcome Measure
Time Above Range (TAR) calculated from Continuous Glucose Monitoring (CGM)
Outcome Description
The CV is the standard deviation of glucose changes divided by the mean glucose value
Outcome Time Frame
3 month mark (post-intervention)
Outcome Measure
Coefficient of Variation (CV) calculated from Continuous Glucose Monitoring (CGM)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
64
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jeffrey Gonzalez
Investigator Email
jeffrey.gonzalez@einsteinmed.edu