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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04016558
Other study ID # 133107A
Secondary ID R01DK121241-02
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2019
Est. completion date February 15, 2023

Study information

Verified date December 2023
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Diabetes Distress 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). Change from baseline to 12 months
Primary Hemoglobin A1c (HbA1c) Assay Change from baseline to 12 months
Secondary Broad quality of life Broad quality if life will be measured using the World Health Organization (Five) Well-Being Index (WHO-5) Change from baseline to 12 months
Secondary Hypoglycemic episodes Self-reported number and severity of hypoglycemic episodes in the past 6 months, or since the last assessment Change from baseline to 12 months
Secondary Depression Symptoms of depression will be measured using the self-completion Patient Health Questionnaire (PHQ-8) Change from baseline to 12 months
Secondary Insulin adherence Self-reported number of missed or skipped insulin boluses in the past week Change from baseline to 12 months
Secondary Nonreactivity to inner experience Nonreactivity to inner experience will be assessed by the nonreactivity subscale of the Five Facet Mindfulness Questionnaire Change from baseline to 12 months
Secondary Non-judging of experience Non-judging of experience will be assessed by the nonjudgmental subscale of the Five Facet Mindfulness Questionnaire Change from baseline to 12 months
Secondary Personal Control Over Illness The personal control subscale from the Revised Illness Perception Questionnaire will assess participants' perceived control over their illness. Change from baseline to 12 months
Secondary Interpersonal emotion regulation Interpersonal Emotion Regulation measure (IERQ) will be used to assess openness to using social resources and supports to manage diabetes distress Change from baseline to 12 months
Secondary Self-compassion - Diabetes (SCS-D) 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. Change from baseline to 12 months
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