Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART
ChargeUp
Fusing Rapid-cycle Testing and Adaptive Trial Designs: A Scientific Pipeline to Translate and Individualize Evidence-based Psychosocial and Behavioral Interventions in Routine Type 1 Diabetes Care
2 other identifiers
interventional
200
1 country
1
Brief Summary
This study is designed to compare two behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. At the study baseline, participants will be randomized to take part in one of two virtual, group-based interventions (the "Primary" intervention) utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress. After the initial intervention, participants will complete surveys to assess their response to the material. Participants who are determined to be "non-responders" (i.e., the Primary intervention was not effective) will be re-randomized to one of two "Supplementary" interventions, which will include individualized sessions to learn and/or practice strategies related to either the psychological or problem-solving approach.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2024
CompletedFirst Posted
Study publicly available on registry
May 8, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 15, 2027
October 29, 2025
October 1, 2025
3 years
May 6, 2024
October 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Total Diabetes Distress (T1-DDS Total Score)
Self-reported total diabetes distress will be measured using the 28-item Type 1 Diabetes Distress Scale (T1-DDS Total Score). The scale yields an overall distress score that is the average of all responses rated on a 6-point Likert scale for all 28 items (range 1-6). A score \>= 2.0 is considered clinically significant diabetes distress. The primary efficacy outcomes of this study is the change in the T1D-DDS score and the proportion of individuals with a change in the T1D-DDS score at least as large as one minimally clinically important difference (MCID).
Baseline, Interim (6 weeks), Endpoint (12 weeks)
Secondary Outcomes (12)
Change in Core Diabetes Distress (T1-DDAS Core Score)
Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Sources of Diabetes Distress (T1-DDS Subscale Scores)
Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Perceived Stress
Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Diabetes Quality of Life
Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Perceived Confidence in Diabetes
Baseline, Interim (6 weeks), Endpoint (12 weeks)
- +7 more secondary outcomes
Other Outcomes (10)
Intervention Satisfaction
Interim (6 weeks) and Endpoint (12 weeks)
Perceived Effectiveness of the Intervention
Interim (6 weeks) and Endpoint (12 weeks)
Long-term Change in Total Diabetes Distress (T1-DDS Total Score)
24 and 36 weeks
- +7 more other outcomes
Study Arms (2)
ReCharge
EXPERIMENTALParticipants randomized to ReCharge will participate in an emotions-focused intervention facilitated by a mental health professional.
TakeCharge
EXPERIMENTALParticipants randomized to TakeCharge will participate in a problem-solving focused intervention facilitated by a diabetes care professional.
Interventions
ReCharge is an emotions-focused intervention that utilizes core components of Acceptance and Commitment Therapy (ACT) to address and minimize diabetes distress. This 5-week, group-based, virtual intervention will include a stepwise process to address diabetes distress and provide opportunities to practice new skills. Weekly assignments between the sessions will reinforce class material and give additional practice opportunities. Participants will be expected to interact in each session and will have opportunities to share their experiences and be engaged in discussion with the group and the facilitator.
TakeCharge is a problem-solving focused intervention that empowers participants to identify and make meaningful changes in their blood glucose management and other diabetes-related behaviors. This 5-week, group-based, virtual intervention will include a stepwise process to analyze data and resolve challenging situations surrounding diabetes management and provide opportunities to practice new skills. Weekly assignments between the sessions will reinforce class material and give additional practice opportunities. Participants will be expected to interact in each session and will have opportunities to share their experiences and be engaged in discussion with the group and the facilitator.
Eligibility Criteria
You may qualify if:
- Adults 30 years and older
- Type 1 diabetes OR latent autoimmune diabetes in adults (LADA) clinically managed as type 1 diabetes
- Elevated diabetes distress, defined as a score \>= 2.0 on the T1-DDAS core scale
- English speaking
You may not qualify if:
- Does not receive diabetes care at UNC Endocrinology at Eastowne
- Cannot commit to the pre-scheduled weekly, virtual sessions
- Diagnosis of any major medical or psychiatric condition that would preclude participation
- Diagnosis of dementia or other conditions that affect memory or information retention, such as cognitive impairment
- Visual or auditory impairment that would interfere with participation in a group intervention
- Receiving inpatient psychiatric treatment or history of a suicide attempt within the past 12 months at the time of enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Kahkoska, MD, PhD
University of North Carolina, Chapel Hill
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2024
First Posted
May 8, 2024
Study Start
October 1, 2024
Primary Completion (Estimated)
September 15, 2027
Study Completion (Estimated)
September 15, 2027
Last Updated
October 29, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- beginning 6 and continuing for 18 months following publication
- Access Criteria
- Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Deidentified individual data that supports the results will be shared beginning 6 to 18 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.