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NCT03549104 · ClinicalTrials.gov registry record · NA
A Cognitive Behavioral Therapy (CBT) Intervention to Reduce Fear of Hypoglycemia in Type 1 Diabetes
A NA study of Type 1 Diabetes Mellitus, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- NA
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT03549104: Completed NA study of Type 1 Diabetes Mellitus, sponsored by University of Illinois at Chicago.
NCT03549104 is a NA study of Type 1 Diabetes Mellitus that has completed, run by University of Illinois at Chicago. The registered enrollment target is 51 participants, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03549104, a NA study of Type 1 Diabetes Mellitus, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
All persons with type 1 diabetes are at risk for developing hypoglycemia (low blood sugar). This is a life-threatening condition that leads to profound fear of hypoglycemia and reduced quality of life. Fear of hypoglycemia results in glucose fluctuations (from high to low glucose levels). Young adults are particularly at risk because they report high levels of fear of hypoglycemia and poor glucose control. Currently, no diabetes self-management programs specifically address how to cope with fear of hypoglycemia. The investigators propose to pilot test a fear reduction intervention (Fear Reduction Efficacy Evaluation \[FREE\]) and its effects on fear of hypoglycemia, diabetes self-management, glucose control, and glucose variability.
Primary Outcome
Change in Worry Subscale score. Fear of hypoglycemia is measured with the Worry Subscale of the Hypoglycemia Fear Survey II (HFS-II) which is an 18-item, 5-point Likert-style scale with a possible score range from 0-72. A higher score indicates greater fear of hypoglycemia.
Conditions Studied
Interventions
- BEHAVIORAL Attention Control
- BEHAVIORAL Fear Reduction Intervention
Study Locations (1)
Illinois
- University of Illinois at Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2019-01-14 |
| Est. Completion | 2021-06-30 |
| Phase | NA |
What the finished NCT03549104 record still lists
NCT03549104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Attention Control is the first listed.
NCT03549104 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT03549104 about?
NCT03549104 is a clinical study titled "A Cognitive Behavioral Therapy (CBT) Intervention to Reduce Fear of Hypoglycemia in Type 1 Diabetes". All persons with type 1 diabetes are at risk for developing hypoglycemia (low blood sugar). This is a life-threatening condition that leads to profound fear of hypoglycemia and reduced quality of life. Fear of hypoglycemia results in glucose fluctuations (from high to low glucose levels). Young adul...
What is the current status of trial NCT03549104?
This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2019-01-14. Estimated completion is 2021-06-30.
What conditions does trial NCT03549104 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT03549104?
The interventions under investigation include: Attention Control (BEHAVIORAL), Fear Reduction Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03549104?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03549104 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03549104's enrollment target sits among peer trials
51 51st of 112 higher than 62 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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