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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03039933
Enrollment
43
Registered
2017-02-01
Start date
2016-08-31
Completion date
2020-08-31
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type1diabetes, Fear of Hypoglycemia

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.

Interventions

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

OTHERTreatment As Usual

Treatment As Usual

Sponsors

University of Virginia
CollaboratorOTHER
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Decrease in scores on the Hypoglycemia Fear SurveyBaseline, 3 and 6 monthsTo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026