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FixIt for Diabetes Distress (EMBARK Trial)

N/A

Waitlist Available

Led By Danielle Hessler, Ph.D.

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 12 months

Awards & highlights

EMBARK Trial Summary

This trial is comparing three programs to see which is best at reducing diabetes distress in people with type 1 diabetes.

Eligible Conditions

Diabetes Distress
Type 1 Diabetes

EMBARK Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Diabetes Distress

Hemoglobin A1c (HbA1c)

Secondary outcome measures

Broad quality of life

Depression

Hypoglycemic episodes

+6 more

EMBARK Trial Design

3Treatment groups

Experimental Treatment

Group I: TunedInExperimental Treatment1 Intervention

Diabetes distress reduction, emotion regulation techniques.

Group II: StreamLineExperimental Treatment1 Intervention

Diabetes education, behavioral management

Group III: FixItExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

StreamLine

2019

N/A

~280

FixIt

2019

N/A

~280

TunedIn

2019

N/A

~280

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,315,219 Total Patients Enrolled

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,279 Total Patients Enrolled

Danielle Hessler, Ph.D.Principal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ultimate goal of this investigation?

"The primary aim of this investigation, which will span 12 months in duration and focus on changes from baseline, is to assess the level of Diabetes Distress. Secondary goals include measuring symptoms of Depression with the PHQ-8 self-completion survey, assessing Broad Quality Of Life using WHO-5 Wellbeing Index, as well as verifying Insulin Adherence by asking patients regarding missed or skipped insulin boluses within a 1 week period."

Answered by AI

Does this experiment have any open enrollment opportunities?

"Clinicaltrials.gov states that this clinical trial, first posted on September 15th 2019 and last updated June 17th 2022, is not currently recruiting people for the study. However, 1238 other trials are actively seeking participants at present."

Answered by AI