Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control

NCT04016558 | Completed Results DMC

• 2 other identifiers: 133107AR01DK121241-02
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Diabetes Distress

Outcome Measures

Primary Outcomes (2)

• Diabetes Distress at 12 Months

  Self-reported diabetes distress across several domains will be assessed using the Type 1 Diabetes Distress Scale (T1-DDS) a validated measure averaged across items (range 1.0-6.0 with higher scores indicating a higher level of diabetes-related distress).

  12 months

• Hemoglobin A1c (HbA1c) at 12 Months

  Hemoglobin A1c (HbA1c) assay laboratory result

  12 months

Secondary Outcomes (7)

• Hypoglycemic Episodes at 12 Months

  12 months

• Depression Symptoms at 12 Months

  12 months

• Missed Insulin Boluses at 12 Months

  12 months

• Nonreactivity to Inner Experience at 12 Months

  12 months

• Non-judging of Experience at 12 Months

  12 months

Study Arms (3)

StreamLine

EXPERIMENTAL

Diabetes education, behavioral management

Behavioral: StreamLine

TunedIn

EXPERIMENTAL

Diabetes distress reduction, emotion regulation techniques.

Behavioral: TunedIn

FixIt

EXPERIMENTAL

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

Behavioral: FixIt

Interventions

StreamLine BEHAVIORAL

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.

StreamLine

TunedIn BEHAVIORAL

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.

TunedIn

FixIt BEHAVIORAL

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.

FixIt

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (5)

• 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.

  PMID: 29976567 BACKGROUND

• 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.

  PMID: 28739179 BACKGROUND

• 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.

  PMID: 28498610 BACKGROUND

• 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.

  PMID: 27118163 BACKGROUND

• 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.

  PMID: 25765489 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Danielle Hessler
• Organization: University of California, San Francisco

danielle.hessler@ucsf.edu

415-476-6196

Study Officials

• Danielle Hessler, Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 11, 2019
• Study Start: September 15, 2019
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: October 28, 2025
• Results First Posted: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)