Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control

NACompletedINTERVENTIONAL
Enrollment

296

Participants

Timeline

Start Date

September 15, 2019

Primary Completion Date

February 15, 2023

Study Completion Date

February 15, 2023

Conditions
Type 1 DiabetesDiabetes Distress
Interventions
BEHAVIORAL

StreamLine

"StreamLine is an education/disease management program that focuses on systematic methods to identify and resolve specific blood glucose problems, primarily through changes in carbohydrate consumption, and use of basal and bolus insulin. Participants will attend a brief, four-hour meeting with a Certified Diabetes Educator (CDE) and, using standardized blood glucose data, will learn how to employ a five-point blood glucose management system to identify and resolve blood glucose problems (e.g., excursions, lows) that have the greatest HbA1c or hypoglycemic impacts.~Participants will then meet individually (30 minutes) with their CDE to review their blood glucose data, identify a specific blood glucose problem, and use the five-point program to create a plan to address the problem. Four additional individual meetings (30 minutes) will occur at approximately two to three-week intervals to best support individualized and participant-tailored management-change efforts."

BEHAVIORAL

TunedIn

"TunedIn utilizes emotion regulation-based strategies to help participants observe that how they feel affects what they do regarding diabetes management. Participants will attend two highly interactive group workshops (6 hours followed by 2 hours) facilitated by a psychologist or social worker experienced in diabetes. Each will identify and discuss common emotional responses related to blood glucose management (e.g., over-reacting, avoiding, and lack of mindfulness).~Between the two workshops (two weeks), participants will complete a feeling log to document feelings, situation/context, and resolution around specific management events. Two individual meetings with the interventionist (30 minutes) will allow participants to identify and address a specific diabetes distress-related problem. Four web-based video group meetings (60 minutes, monthly) will continue to support participants over time."

BEHAVIORAL

FixIt

"FixIt combines components of StreamLine and TunedIn to allow participants to explore feelings and expectations alongside the identification of problematic blood glucose patterns. StreamLine will be co-facilitated by a psychologist/social worker experienced in diabetes and a CDE. Participants will attend two group workshops (six hours followed by four hours), separated by two weeks.~Between the two workshops, participants will record their blood glucose data and keep a parallel feeling log to provide context. Four individual meetings with an interventionist (30 minutes) will allow participants to identify and address a specific blood glucose problem and create a plan to address it. Full discussion of diabetes distress-related aspects of the plan will take place to enhance mindfulness and identify typical emotion regulation strategies to ease problem resolution. Three web-based video group meetings (60 minutes, monthly) will continue to support participants over time."

Trial Locations (1)

94143

University of California, San Francisco, San Francisco

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

University of California, San Francisco

OTHER

NCT04016558 - Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control | Biotech Hunter | Biotech Hunter