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NCT01714505 · ClinicalTrials.gov registry record · NA
Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy
A NA study, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT01714505: Completed NA study, sponsored by University of Virginia.
NCT01714505 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 20 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
NCT01714505, a NA study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
An unblinded, randomized, cross-over design with each patient participating in two 40-hour outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b) Control using Continuous Glucose Monitor (CGM)- augmented insulin pump treatment outside of a hospital based clinical research center. The principal goal is to validate a smart phone-based control-to-range (CTR) system for ambulatory use and to estimate the effect of CTR vs. sensor-augmented pump therapy, thereby providing justification for further larger home-based trials of CTR.
Primary Outcome
The LBGI reflects the frequency and extent of hypoglycemic episodes and presents the results in "risk space." Thus the LBGI is a weighted average of the number of hypoglycemic readings, with progressively increasing weights as BG levels go down. The increase of the weights follows a risk function; thus the LBGI has been associated with risk for hypoglycemia and prediction of severe hypoglycemic episodes. LBGI \< 2.5 is associated with low risk of hypoglycemia, 2.5 \< LBGI \< 5 is associated wit
Interventions
- DEVICE Diabetes Assistant (DiAs)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-01 |
| Phase | NA |
What the finished NCT01714505 record still lists
NCT01714505 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 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 Diabetes Assistant (DiAs) is the first listed.
NCT01714505 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01714505 about?
NCT01714505 is a clinical study titled "Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy". An unblinded, randomized, cross-over design with each patient participating in two 40-hour outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b) Control using Continuous Glucose Monitor (CGM)- augmented insulin pump treatment outside of a hospital based clinical ...
What is the current status of trial NCT01714505?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2012-10. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01714505?
The interventions under investigation include: Diabetes Assistant (DiAs) (DEVICE).
Who is sponsoring clinical trial NCT01714505?
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 NCT01714505's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 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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