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Evaluating Affective and Unified Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control
This study is comparing three programs to reduce Diabetes Distress (the worries and concerns that people with diabetes may experience as they struggle to keep blood glucose levels in range) in adults with type 1 diabetes. About a third of participants will take part in the TunedIn program, about a third will take part in the FixIt program, and about a third in the StreamLine program.
Diabetes Distress (DD) is the personal, often hidden side of diabetes: it reflects the unique emotional burdens and strains that individuals with diabetes may experience as they struggle to keep blood glucose levels within range. When high, DD can have a major, negative impact on disease management and glycemic control. High DD is characterized by frustration, feeling overwhelmed, and feeling hopeless and discouraged by the unceasing demands of diabetes. DD is also linked to an individual's beliefs, expectations, current life situation, and personal and social resources. The proposed study is a three-arm, 12-month randomized comparison trial to test the added value of a DD-targeted (TunedIn) intervention vs. a unified DD and management intervention (FixIt), relative to a traditional, educational/behavioral-management intervention (StreamLine). Each of the three programs (arms) will follow a separate, standardized protocol. All participants will receive three months of intervention with nine months of follow-up.
Age
19 - No limit years
Sex
ALL
Healthy Volunteers
No
University of California, San Francisco
San Francisco, California, United States
Start Date
September 15, 2019
Primary Completion Date
February 15, 2023
Completion Date
February 15, 2023
Last Updated
October 28, 2025
296
ACTUAL participants
StreamLine
BEHAVIORAL
TunedIn
BEHAVIORAL
FixIt
BEHAVIORAL
Lead Sponsor
University of California, San Francisco
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07455994