Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control

Not Applicable

Completed

• Conditions: Diabetes Distress; Type 1 Diabetes
• Interventions: Behavioral: FixIt; Behavioral: StreamLine; Behavioral: TunedIn

• Registration Number: NCT04016558
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-11
• Study Start: 2019-09-15
• Primary Completion: 2023-02-15
• Study Completion: 2023-02-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FixIt	FixIt	Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.
StreamLine	StreamLine	Diabetes education, behavioral management
TunedIn	TunedIn	Diabetes distress reduction, emotion regulation techniques.

Primary Outcome Measures

Name	Time	Method
Diabetes Distress	Change from baseline to 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).
Hemoglobin A1c (HbA1c)	Change from baseline to 12 months	Assay

Secondary Outcome Measures

Name	Time	Method
Hypoglycemic episodes	Change from baseline to 12 months	Self-reported number and severity of hypoglycemic episodes in the past 6 months, or since the last assessment
Depression	Change from baseline to 12 months	Symptoms of depression will be measured using the self-completion Patient Health Questionnaire (PHQ-8)
Insulin adherence	Change from baseline to 12 months	Self-reported number of missed or skipped insulin boluses in the past week
Broad quality of life	Change from baseline to 12 months	Broad quality if life will be measured using the World Health Organization (Five) Well-Being Index (WHO-5)
Nonreactivity to inner experience	Change from baseline to 12 months	Nonreactivity to inner experience will be assessed by the nonreactivity subscale of the Five Facet Mindfulness Questionnaire
Non-judging of experience	Change from baseline to 12 months	Non-judging of experience will be assessed by the nonjudgmental subscale of the Five Facet Mindfulness Questionnaire
Personal Control Over Illness	Change from baseline to 12 months	The personal control subscale from the Revised Illness Perception Questionnaire will assess participants' perceived control over their illness.
Interpersonal emotion regulation	Change from baseline to 12 months	Interpersonal Emotion Regulation measure (IERQ) will be used to assess openness to using social resources and supports to manage diabetes distress
Self-compassion - Diabetes (SCS-D)	Change from baseline to 12 months	Diabetes-specific self-compassion will be measured using the validate Self-Compassion Scale - Diabetes (SCS-D) in which the average of items is calculated. Items are scored on a scale from 1 to 5 with higher scores indicative of greater self compassion.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States