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Trial record 6 of 873 for:    hypoglycemia | "Diabetes Mellitus, Insulin-Dependent"

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

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ClinicalTrials.gov Identifier: NCT03039933
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
University of Virginia
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type1diabetes Fear of Hypoglycemia Behavioral: Fear of Hypoglycemia Other: Treatment As Usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes
Actual Study Start Date : August 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fear of Hypoglycemia Intervention Behavioral: Fear of Hypoglycemia
Participants will receive exposure and response prevention and/or hypoglycemia awareness training.

Treatment As Usual Other: Treatment As Usual
Treatment As Usual
Other Name: Standard of Care




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039933


Contacts
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Contact: Kimberly Driscoll, Ph.D. 909-742-9910 kimberly.driscoll@ucdenver.edu

Locations
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United States, Colorado
University of Colorado, Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Kimberly Driscoll, PhD    303-724-9910    kimberly.driscoll@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
University of Virginia
Investigators
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Principal Investigator: Kimberly Driscoll, Ph.D. University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03039933     History of Changes
Other Study ID Numbers: 16-0645
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases