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NCT02175732 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of California, San Francisco.

Completed
Registry status
NA
Development phase
301
Enrollment target

NCT02175732: Completed NA study, sponsored by University of California, San Francisco.

NCT02175732 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 301 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02175732, a NA study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
NA
Development phase
301 participants
Enrollment target

Study Summary

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.

Primary Outcome

Distress across several domains will be assessed using the Type 1 Diabetes Distress Scale.

Interventions

  • BEHAVIORAL 'KnowIt'
  • BEHAVIORAL 'OnTrack'

Trial Details

FieldValue
Enrollment Target 301 participants
Start Date 2014-09
Est. Completion 2018-12
Phase NA

What the finished NCT02175732 record still lists

NCT02175732 is an interventional study that assigns participants to a tested intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).

The record links to 0 conditions, and to 2 interventions - of which 'KnowIt' is the first listed.

NCT02175732 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02175732 about?

NCT02175732 is a clinical study titled "Reducing Distress And Improving Glycemic Control In Adults With Type 1 Diabetes". 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 managem...

What is the current status of trial NCT02175732?

This trial is currently completed. It is a NA study. The enrollment target is 301 participants. The study started on 2014-09. Estimated completion is 2018-12.

What interventions are being tested in trial NCT02175732?

The interventions under investigation include: 'KnowIt' (BEHAVIORAL), 'OnTrack' (BEHAVIORAL).

Who is sponsoring clinical trial NCT02175732?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02175732's enrollment target sits among peer trials

301 330th of 2000 higher than 1,671 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02175732, the US trial registry maintained by the National Library of Medicine. NCT02175732 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.