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NCT01767831 · ClinicalTrials.gov registry record
Evaluation of a Simulation-Based Educational Tool for Personalized Feedback in Insulin Therapy Management
A clinical trial, sponsored by University of Virginia.
- Terminated
- Registry status
- 15
- Enrollment target
NCT01767831 is a clinical trial that was terminated before completion, run by University of Virginia. The registered enrollment target is 15 participants.
The verdict
NCT01767831 was terminated before completion, sponsored by University of Virginia.
- TERMINATED
- Registry status
- 15 participants
- Enrollment target
Study Summary
This study combines data collection and simulation-based education, and it will enroll up to 36 adults with T1DM who already have experience with insulin pump therapy and some experience with a continuous glucose monitor (CGM). The study will first track participants for of a 3-day CGM-training period. The training period will be followed by a 1-week CGM monitoring and CGM data collection period. Following the 1-week CGM monitoring-only portion of the study, participants will begin the education intervention component of the study, referred to as Insight-Based Online Learning Using Simulation and Education for Diabetes (iBOLUSED). The education intervention component is 4 weeks in length. The intervention will involve daily diary data upload and daily simulation-based feedback based on the collected diary data. During the first week (and for up to 2 weeks) of the intervention, participants will view glycemic outcome data that represents the participant's hypo- and hyperglycemic risk throughout the day, based on the CGM data collected during the CGM monitoring period. In the next 2 weeks of the intervention, participants will have an opportunity to interact with the internet-based system using a simulation-based tool designed to provide insight to the participant regarding the different effects of modifications to insulin therapy. Throughout the educational intervention, participants will record diary data every day through the use of a diary component in the internet-based system. Diary entries include data on meals, physical activity, history of the insulin basal rate and insulin boluses given that day, self-reported stress level, hypo- and hyperglycemic fear levels, and, if applicable, menstrual cycle and any physical illness. Participants will also upload data from the CGM via the Dexcom Data Manager 3 (DM3) software or the Dexcom Studio Software. Two assessments, one prior to the intervention period and one following the intervention, will be administered to gat
Interventions
- BEHAVIORAL iBOLUSED
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2013-03 |
| Est. Completion | 2013-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01767831
The ClinicalTrials.gov registry entry for NCT01767831 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which iBOLUSED is the first listed.
NCT01767831 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01767831 about?
NCT01767831 is a clinical study titled "Evaluation of a Simulation-Based Educational Tool for Personalized Feedback in Insulin Therapy Management". This study combines data collection and simulation-based education, and it will enroll up to 36 adults with T1DM who already have experience with insulin pump therapy and some experience with a continuous glucose monitor (CGM). The study will first track participants for of a 3-day CGM-training peri...
What is the current status of trial NCT01767831?
This trial is currently terminated. The enrollment target is 15 participants. The study started on 2013-03. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01767831?
The interventions under investigation include: iBOLUSED (BEHAVIORAL).
Who is sponsoring clinical trial NCT01767831?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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