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

NCT05000021 | Recruiting DMC FDA Device

• 2 other identifiers: 2021-127894-SRA-2021-1071-M-B
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 1 Diabetes

Keywords

diabetes; diabetes distress; young adult; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Diabetes Distress Levels

  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.

  Baseline and 3 months post-intervention

Secondary Outcomes (5)

• Hemoglobin A1c

  3 months post-intervention

• Time in Range (TIR) calculated from Continuous Glucose Monitoring (CGM)

  Every 14 days through the first 3 months post-intervention

• Time Below Range (TBR) calculated from CGM

  Every 14 days through the first 3 months post-intervention

• Time Above Range (TAR) calculated from CGM

  Every 14 days through the first 3 months post-intervention

• Coefficient of Variation (CV) for Glycemic Variability

  Every 14 days through the first 3 months post-intervention

Other Outcomes (2)

• Diabetes Distress Levels

  Baseline and 6 months, 9 months and 12 months post-intervention

• Hemoglobin A1c

  6 months, 9 months, and 12 months post-intervention

Study Arms (2)

Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring

EXPERIMENTAL

Participants randomized to this arm will receive Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD), enhanced by review of Continuous Glucose Monitoring (CGM) data. Participants will wear study-supplied CGM for the first 6 months of their participation in the trial.

Behavioral: Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring; Device: Continuous Glucose Monitoring (CGM)

Continuous Glucose Monitoring (CGM) Only

ACTIVE COMPARATOR

Participants randomized to receive Continuous Glucose Monitoring (CGM) will continue to receive their usual care and will also wear CGM throughout the first 6 months of their participation in the trial.

Device: Continuous Glucose Monitoring (CGM)

Interventions

Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring BEHAVIORAL

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.

Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring

Continuous Glucose Monitoring (CGM) DEVICE

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.

Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring; Continuous Glucose Monitoring (CGM) Only

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Juvenile Diabetes Research Foundation: collaborator
• DexCom, Inc.: collaborator
• Breakthrough T1D: collaborator

Study Sites (2)

Yeshiva University

New York, New York, 10033, United States

RECRUITING

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

RECRUITING

Related Publications (18)

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  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

Cognitive Behavioral Therapy; Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Jeffrey Gonzalez, PhD

  Yeshiva University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Gonzalez, PhD

CONTACT

646-592-4376; jeffrey.gonzalez@yu.edu

Keyla Ordonez, BS

CONTACT

631-747-9325; keyla.ordonez@einsteinmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 11, 2021
• Study Start: June 27, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)