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OpenTrials
Completed

NCT Number: NCT03039933

Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes

The overall objective and Primary Aim of this Limited Competition: Small Grant Program (R03) is to address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by conducting a pilot randomized clinical trial to evaluate the efficacy of Blood Glucose Awareness Training, which has been adapted for, but never evaluated in adolescents with Type 1 Diabetes (T1D) and their parents.

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Key information

Conditions

Type1diabetes Fear of Hypoglycemia

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adolescents aged 10-17 years and their parent(s) or legal guardian;
  • T1D duration >1 year;
  • insulin pump use >6 months;
  • agreement of both parent and adolescent to participate in intervention sessions;
  • elevated scores on the Parent Hypoglycemia Fear Survey - Behavior Subscale.

Exclusion criteria

  • developmental disability or reading disorder that prevents understanding of the intervention materials; and
  • non-English speaking adolescents and parents.

Treatment and study plan

Fear of Hypoglycemia

Behavioral

Participants will receive exposure and response prevention and/or hypoglycemia awareness training.

Treatment as Usual

Other

Treatment As Usual

Other names: Standard of Care

Primary outcomes

  1. Decrease in scores on the Hypoglycemia Fear Survey

    Time frame: Baseline, 3 and 6 months

    To address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by evaluating the efficacy of Blood Glucose Awareness Training as compared to treatment as usual.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • University of Virginia

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 1, 2017
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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