Reducing Distress And Improving Glycemic Control In Adults With Type 1 Diabetes

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

Diabetes Distress (DD) refers to the emotional and behavioral challenges and burdens that arise through living with and managing diabetes. High DD is characterized by feeling frustrated, overwhelmed and discouraged by the demands of diabetes, and high DD may have a negative impact on disease management and glycemic control; poor glycemic control can also have a negative effect on DD. Few interventions have been assessed that directly target DD or mood in adults with Type 1 diabetes. In this study the investigators will compare two active, evidence-based behavioral interventions to reduce high DD and improve glycemic control and disease management: 1. A Type 1 diabetes education protocol ('KnowIt') that brings together new advances in diabetes education and behavioral management. 2. A DD-reduction protocol ('OnTrack') that helps identify and address the personal stresses and strains of having diabetes. Participants in both arms will attend a single, day-long workshop, four hour-long web group meetings and four personal phone calls with the group facilitator during the intervention period. Assessments will be carried out at baseline and at three and nine months. Hypothesis 1: OnTrack will be superior to KnowIt in the primary and secondary outcomes at follow-up. Hypothesis 2: Changes in self-efficacy and fear of hypoglycemia over time will mediate the difference between the two study arms and primary outcome. Hypothesis 3: The differences between the two study arms and changes in the primary outcomes will be qualified by patient characteristics such as age, length of diagnosis, higher baseline distress or HbA1c.

Key facts

Study ID

NCT02175732

Run by

University of California, San Francisco

People needed

301

Starts

2014-09-01

Expected to finish

2018-12-01

Last updated by the study team

2019-03-25

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 19 or older
• Type 1 diabetes
• Diagnosed at least 12 months
• Intensive insulin use
• Recent HbA1c result of 7.5 or higher
• At least moderate diabetes distress (score 2.0 or higher on T1 Diabetes Distress scale)
• Able to speak/read English fluently

You may not qualify if…

• Severe complications or disorders (e.g. heart attack in past 12 months, psychosis, blindness, end-stage dialysis).

Where it is running

• UC San Francisco, Family and Community Medicine Dept. — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.