Clinical trial NCT04016558: Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control
Official title: Evaluating Affective and Unified Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Diabetes Distress
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-07-11
Enrollment: 276
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diabetes Distress
timeFrame: Change from baseline to 12 months
measure: Hemoglobin A1c (HbA1c)
timeFrame: Change from baseline to 12 months
Secondary outcomes:
measure: Broad quality of life
timeFrame: Change from baseline to 12 months
measure: Hypoglycemic episodes
timeFrame: Change from baseline to 12 months
measure: Depression
timeFrame: Change from baseline to 12 months
measure: Insulin adherence
timeFrame: Change from baseline to 12 months
measure: Nonreactivity to inner experience
timeFrame: Change from baseline to 12 months
measure: Non-judging of experience
timeFrame: Change from baseline to 12 months
measure: Personal Control Over Illness
timeFrame: Change from baseline to 12 months
measure: Interpersonal emotion regulation
timeFrame: Change from baseline to 12 months
measure: Self-compassion - Diabetes (SCS-D)
timeFrame: Change from baseline to 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Danielle Hessler, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fisher L, Hessler D, Polonsky WH, Masharani U, Guzman S, Bowyer V, Strycker L, Ahmann A, Basina M, Blumer I, Chloe C, Kim S, Peters AL, Shumway M, Weihs K, Wu P. T1-REDEEM: A Randomized Controlled Trial to Reduce Diabetes Distress Among Adults With Type 1 Diabetes. Diabetes Care. 2018 Sep;41(9):1862-1869. doi: 10.2337/dc18-0391. Epub 2018 Jul 5.
citation: Fisher L, Hessler D, Polonsky W, Strycker L, Guzman S, Bowyer V, Blumer I, Masharani U. Emotion regulation contributes to the development of diabetes distress among adults with type 1 diabetes. Patient Educ Couns. 2018 Jan;101(1):124-131. doi: 10.1016/j.pec.2017.06.036. Epub 2017 Jul 8.
citation: Hessler DM, Fisher L, Polonsky WH, Masharani U, Strycker LA, Peters AL, Blumer I, Bowyer V. Diabetes distress is linked with worsening diabetes management over time in adults with Type 1 diabetes. Diabet Med. 2017 Sep;34(9):1228-1234. doi: 10.1111/dme.13381. Epub 2017 Jun 18.
citation: Fisher L, Hessler D, Polonsky W, Strycker L, Masharani U, Peters A. Diabetes distress in adults with type 1 diabetes: Prevalence, incidence and change over time. J Diabetes Complications. 2016 Aug;30(6):1123-8. doi: 10.1016/j.jdiacomp.2016.03.032. Epub 2016 Apr 4.
citation: Fisher L, Polonsky WH, Hessler DM, Masharani U, Blumer I, Peters AL, Strycker LA, Bowyer V. Understanding the sources of diabetes distress in adults with type 1 diabetes. J Diabetes Complications. 2015 May-Jun;29(4):572-7. doi: 10.1016/j.jdiacomp.2015.01.012. Epub 2015 Feb 7.