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NCT03709108 · ClinicalTrials.gov registry record · NA
Safety and Feasibility of an Insulin Sensitivity-Informed Bolus Calculator in Type 1 Diabetes
A NA study, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT03709108 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 15 participants.
The verdict
NCT03709108, a NA study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a single-center randomized crossover trial. The investigators will target completion of 15 adults (age 18-65 years) with Type 1 Diabetes who use an insulin pump. After completion of the Screening Visit, each subject will participate in a 28-day at home Data Collection Period while using their personal insulin pump, a personal glucometer, a study CGM, and a study activity tracker (i.e., Fitbit). This data collection period may be extended to obtain to gather more days of quality data, if needed per principal investigator judgement. Once the data has been collected and processed, subjects will participate in two 24-hour admissions (Experimental and Control Admission) in a semi-controlled environment (i.e., hotel), performed in the assigned random order. During both admissions, subjects will use the personal insulin pump and glucometer, and a study CGM. The exercise session will consist of three 15-minute bouts of moderate-intensity exercise (i.e., stationary bicycle). Subjects will be provided a controlled dinner; the SI-informed bolus calculator will be used in the Experimental Admission while standard therapy will be used in the Control Admission. Subjects will then be observed overnight and discharged in the following morning.
Interventions
- OTHER SI-Informed Bolus Calculator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-11-19 |
| Est. Completion | 2019-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03709108
The ClinicalTrials.gov registry entry for NCT03709108 describes a study currently listed as completed, categorized as NA. 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 SI-Informed Bolus Calculator is the first listed.
NCT03709108 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03709108 about?
NCT03709108 is a clinical study titled "Safety and Feasibility of an Insulin Sensitivity-Informed Bolus Calculator in Type 1 Diabetes". This is a single-center randomized crossover trial. The investigators will target completion of 15 adults (age 18-65 years) with Type 1 Diabetes who use an insulin pump. After completion of the Screening Visit, each subject will participate in a 28-day at home Data Collection Period while using thei...
What is the current status of trial NCT03709108?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2018-11-19. Estimated completion is 2019-03-31.
What interventions are being tested in trial NCT03709108?
The interventions under investigation include: SI-Informed Bolus Calculator (OTHER).
Who is sponsoring clinical trial NCT03709108?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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