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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: Completed NA study, sponsored by University of Virginia.
NCT03709108 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety and feasibility of the SI-informed bolus calculator as measured by overall and postprandial occurrence of hypoglycemia quantified using the Low Blood Glucose Index (LBGI) computed from CGM data. LBGI is a previously introduced glucose variability measure and strong predictor of severe hypoglycemia, designed to aggregate the frequency and extent of low blood glucose events into a single number. By this definition, a higher LBGI may indicate a large number of mild hypoglycemic events, a sma
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 |
What the finished NCT03709108 record still lists
NCT03709108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which SI-Informed Bolus Calculator is the first listed.
NCT03709108 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03709108's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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