Type 1 Diabetes
Conditions
Keywords
diabetes, diabetes distress, young adult, cognitive behavioral therapy
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.
Interventions
DEVICEContinuous Glucose Monitoring (CGM)
Use of commercially available, FDA-approved continuous glucose monitoring (CGM) for 6 months post-randomization. Usual diabetes care will continue and participants can initiate a CGM review from their healthcare providers, as desired. In addition, a nurse practitioner with expertise in CGM will train each participant via video recordings in the proper placement of the device, and technical issues, and provide basic teaching at the beginning of the trial on interpretation of CGM data and self-titration of insulin/self-management. Written materials and online resources for recognizing and managing diabetes distress, along with self-management information and treatment options to discuss with providers will also be provided.
BEHAVIORALCognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring
CBT-DD consists of approximately 10 individual sessions of CBT delivered virtually by trained protocol therapists, conducted over the course of approximately 12 weeks. The CBT-DD consists of 5 core modules targeting negative emotionality and aversive reactions to emotional experiences. These modules are preceded by an introductory session that reviews the patient's presenting symptoms and provides a therapeutic rationale, as well as a module on motivational enhancement. The final module consists of relapse prevention. CBT-DD sessions will integrate a review of Continuous Glucose Monitoring (CGM) data and feedback will be provided by the therapist.
Sponsors
Albert Einstein College of Medicine
Juvenile Diabetes Research Foundation
DexCom, Inc.
Breakthrough T1D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 Diabetes (T1D) duration ≥6 months * English or Spanish speaking * At least moderate Diabetes Distress (DD) (score of ≥2 on T1D-Diabetes Distress Scale) * Stable insulin treatment regimen (insulin prescription, use of pump, etc.) for at least 3 months prior to study enrollment
Exclusion criteria
* Comorbid psychiatric condition, including depression, anxiety, or suicidality, which may be independently associated with the main outcomes of DD or glycemic control. Comorbid psychiatric conditions listed above are being excluded because CBT-DD currently centers on mitigating specifically diabetes distress to improve glycemic outcomes * In treatment for a psychological condition within the last 6 months or on a non-stable dose of psychiatric medication over the last 2 months * Developmental or sensory disability interfering with participation * Current pregnancy, as self-management and glycemic goals differ * Participation in another behavioral intervention study * Use of non-insulin medications or recent medical procedures that would impact glycemic control or use of CGM over the study * Minors * Subjects who do have the capacity to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Distress Levels | Baseline and 3 months post-intervention | Diabetes distress will be assessed using the Problem Areas in Diabetes (PAID) scale. The PAID scale will be administered to each participant via the REDCap database. The PAID scale is a 20 item, self-report questionnaire that describes negative emotions related to diabetes commonly experienced by people with diabetes. For each item, participants are asked to provide a response describing the extent the item is currently a diabetes issue for them using a 5-point Likert scale ranging from 0 ("Not a problem") to 4 ("Serious problem"). Scores are added and multiplied by 1.25, yielding an overall possible score of 0-100. Scores will be summarized by study arm using basic descriptive statistics. Patients scoring \>=40 may be at the level of "emotional burnout" and warrant special attention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 3 months post-intervention | Hemoglobin A1c (HbA1c) values will be calculated using mailed point-of-care (POC) kits for home collection. Samples will be collected, returned, processed, and shipped for analysis by a central laboratory. HbA1c results will be summarized by study arm using basic descriptive statistics. |
| Time in Range (TIR) calculated from Continuous Glucose Monitoring (CGM) | Every 14 days through the first 3 months post-intervention | The percentage of time glucose values were within range (i.e., between 70-180 mg/dL) will be calculated from CGM data during the 3 months after randomization. Results will be summarized by study arm using basic descriptive statistics. |
| Time Below Range (TBR) calculated from CGM | Every 14 days through the first 3 months post-intervention | The percentage of time that glucose values were below range (i.e., ≤ 70 mg/dL and ≤ 55 mg/dL) will be calculated from CGM data during the 3 months after randomization. Percentage of TBR will be calculated for both thresholds. Results will be summarized by study arm using basic descriptive statistics. |
| Time Above Range (TAR) calculated from CGM | Every 14 days through the first 3 months post-intervention | The percentage of time glucose values were above range (≥ 180 mg/dL and ≥ 250 mg/dL) will be calculated from CGM wear data during the 3 months after randomization. Percentage of TAR will be calculated for both thresholds. Results will be summarized by study arm using basic descriptive statistics. |
| Coefficient of Variation (CV) for Glycemic Variability | Every 14 days through the first 3 months post-intervention | The CV for glycemic variability will be calculated based on the values obtained from CGM. CV, which is a measure of variability, is defined as the standard deviation of glucose changes divided by the mean glucose value and will expressed as a percentage. Results will be summarized by study arm. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJeffrey Gonzalez, PhD
Yeshiva University
Outcome results
None listed