N/A
N=296
Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control
Type 1 Diabetes · Diabetes Distress
Bottom Line
View on ClinicalTrials.gov: NCT04016558 ↗Enrolled (actual)
296
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Diabetes Distress at 12 Months — 2.34; 2.03; 2.06 score on a scale — p=.007
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- StreamLine (Behavioral); TunedIn (Behavioral); FixIt (Behavioral)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diabetes Distress at 12 Months |
2.34; 2.03; 2.06 | .007 sig |
| PRIMARY Hemoglobin A1c (HbA1c) at 12 Months |
7.52; 7.60; 7.94 | .006 sig |
| SECONDARY Hypoglycemic Episodes at 12 Months |
1.17; 1.32; 1.23 | 0.82 |
| SECONDARY Depression Symptoms at 12 Months |
6.35; 5.94; 7.09 | .01 sig |
| SECONDARY Missed Insulin Boluses at 12 Months |
0.15; 0.17; 0.19 | .40 |
| SECONDARY Nonreactivity to Inner Experience at 12 Months |
23.68; 24.34; 24.22 | — |
| SECONDARY Non-judging of Experience at 12 Months |
31.29; 32.13; 30.48 | .12 |
| SECONDARY Personal Control Over Illness at 12 Months |
24.77; 24.68; 24.99 | .39 |
| SECONDARY Self-compassion - Diabetes (SCS-D) at 12 Months |
3.42; 3.60; 3.44 | <.01 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04016558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.