Pilot of Pragmatic Delivery of Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes

Not Applicable

Active, not recruiting

• Conditions: Diabetes type1; Diabetes Mellitus, Type 1; Diabetes, Autoimmune; Diabetes Mellitus; Distress, Emotional

• Registration Number: NCT06405386
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-5-6
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Inclusion Criteria:<br><br> - Adults 30 years and older<br><br> - Type 1 diabetes OR latent autoimmune diabetes in adults (LADA) clinically managed as<br> type 1 diabetes<br><br> - Elevated diabetes distress, defined as a score >= 2.0 on the T1-DDAS core scale<br><br> - English speaking<br><br>Exclusion Criteria:<br><br> - Does not receive diabetes care at UNC Endocrinology at Eastowne<br><br> - Cannot commit to the pre-scheduled weekly, virtual sessions<br><br> - Diagnosis of any major medical or psychiatric condition that would preclude<br> participation<br><br> - Diagnosis of dementia or other conditions that affect memory or information<br> retention, such as cognitive impairment<br><br> - Visual or auditory impairment that would interfere with participation in a group<br> intervention<br><br> - Receiving inpatient psychiatric treatment or history of a suicide attempt within the<br> past 12 months at the time of enrollment

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Total Diabetes Distress (T1-DDS Total Score)

Secondary Outcome Measures

Name	Time	Method
Change in Core Diabetes Distress (T1-DDAS Core Score);Change in Sources of Diabetes Distress (T1-DDS Subscale Scores);Change in Perceived Stress;Change in Diabetes Quality of Life;Change in Perceived Confidence in Diabetes;Change in Diabetes Specific Self-Compassion;Change in Hypoglycemic Attitudes and Behaviors;Change in Hemoglobin A1c (HbA1c);Change in Percent of Time in Range (TIR);Change in Percent of Time Below Range (TBR);Change in Percent of Time Above Range (TAR);Glycemic Variability