Summary

for people ages 19 years and up (full criteria)
at San Francisco, California
study started
estimated completion
Danielle Hessler, Ph.D.

Description

Summary

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.

Official Title

Evaluating Affective and Unified Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control

Details

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.

Keywords

Type 1 Diabetes Diabetes Distress Diabetes Mellitus StreamLine TunedIn FixIt

Eligibility

You can join if…

Open to people ages 19 years and up

  • 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.

You CAN'T join if...

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

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist

  • Danielle Hessler, Ph.D.
    Associate Professor, Family Community Medicine. Authored (or co-authored) 100 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04016558
Study Type
Interventional
Last Updated