Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control (EMBARK)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Type 1 Diabetes; Diabetes Distress

Treatments: Behavioral: FixIt; Behavioral: StreamLine; Behavioral: TunedIn

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04016558

133107A

R01DK121241-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 296 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with type 1 diabetes (confirmed by clinical history and/or anti-glutamic acid decarboxylase] antibody testing) on intensive insulin treatment;
• Diagnosis of type 1 diabetes for at least 12 months that occurred at or below age 40;
• Have a recent HbA1c of 7.5% or higher;
• Not have started to use any new (to the participant) diabetes device (such as an insulin pump or continuous glucose monitor) in the past 6 months;
• Internet access through a computer or smart phone;
• Ability to speak/read English.

Exclusion criteria

• No documented psychosis, blindness, dementia, active dialysis, substance abuse, amputations, or severe functional deficits, or recent major surgery or hospitalization in the past year.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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296 participants in 3 patient groups

StreamLine

Experimental group

Description:

Diabetes education, behavioral management

Treatment:

Behavioral: StreamLine

TunedIn

Experimental group

Description:

Diabetes distress reduction, emotion regulation techniques.

Treatment:

Behavioral: TunedIn

FixIt

Experimental group

Description:

Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.

Treatment:

Behavioral: FixIt