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

NCT ID: NCT03039933

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type1diabetes Fear of Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fear of Hypoglycemia Intervention

Cognitive behavioral therapy based psychological intervention occurring every other week for 12 weeks.

Group Type ACTIVE_COMPARATOR

Fear of Hypoglycemia

Intervention Type BEHAVIORAL

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

Treatment As Usual

Control group completes questionnaires but does not receive any study intervention. Receives medical care as usual.

Group Type OTHER

Treatment As Usual

Intervention Type OTHER

Treatment As Usual

Interventions

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Fear of Hypoglycemia

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

Intervention Type BEHAVIORAL

Treatment As Usual

Treatment As Usual

Intervention Type OTHER

Other Intervention Names

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Standard of Care

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kimberly Driscoll, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado, Denver

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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16-0645

Identifier Type: -

Identifier Source: org_study_id

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