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CompletedNCT03039933Updated Sep 16, 2021

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

An interventional study of Fear of Hypoglycemia and Treatment As Usual in Type1diabetes and Fear of Hypoglycemia, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-09-16.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Aug 2016, registered Dec 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
10 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type1diabetes
  • Fear of Hypoglycemia
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 43 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • developmental disability or reading disorder that prevents understanding of the intervention materials; and
  • non-English speaking adolescents and parents.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Active comparator
    Fear of Hypoglycemia Intervention

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

    Behavioral: Fear of Hypoglycemia

  • Other
    Treatment As Usual

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

    Other: Treatment As Usual

Interventions

  • BehavioralFear of Hypoglycemia

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

  • OtherTreatment As Usual

    Treatment As Usual

    Also known as: Standard of Care

06

What researchers measure

Primary outcomes

  1. Decrease in scores on the Hypoglycemia Fear Survey

    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.

    Time frame: Baseline, 3 and 6 months

07

Study locations

1 site
  • University of Colorado, Denver
    Aurora, Colorado 80045, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03039933
Lead sponsor
University of Colorado, Denver
Collaborators
University of Virginia
Responsible party
Sponsor
First posted
Feb 1, 2017
Start date
Aug 2016
Primary completion
Aug 2020
Completion
Aug 2020
Last update
Sep 16, 2021

Study contacts

Kimberly Driscoll, Ph.D.
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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