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NCT01469715 · ClinicalTrials.gov registry record · Phase 2
A Clinical Study of the Performance of a Glucose Blinding Protein-Based Continuous Glucose Monitor (GBP CGM)
A Phase 2 study of Type 1 Diabetes Mellitus, sponsored by University of Virginia.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT01469715: Completed Phase 2 study of Type 1 Diabetes Mellitus, sponsored by University of Virginia.
NCT01469715 is a Phase 2 study of Type 1 Diabetes Mellitus that has completed, run by University of Virginia. The registered enrollment target is 16 participants, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01469715, a Phase 2 study of Type 1 Diabetes Mellitus, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the accuracy of the Becton Dickenson (BD) Technologies Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) in patients with Type 1 diabetes during low (goal glucose 55 mg/dL), normal (80-140 mg/dL) and high (\>180mg/dL) glucose levels over a 24 hour period. This will be achieved by monitoring blood sugar levels when a regular dinner meal is given, when a liquid breakfast meal (BOOST Original containing 41 grams Carbohydrates (CHO), 4 grams fat, 10 grams protein) is given, when subcutaneous insulin is dosed to induce hypoglycemia to a goal of 55 mg/dL, and when a regular lunch meal is given. A Continuous Glucose Monitor (CGM) is an electronic device that measures and displays blood sugar (glucose) levels in the body throughout the day and night. The method being used to detect blood sugar in the investigational Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) is different than the method that is currently in use by commercially available models. Some sensors cannot tell the difference between glucose (sugar) and other substances such as Tylenol, aspirin or citric acid etc. Because they cannot tell the difference, they may give false readings. The GBP CGM is made to only recognize glucose in the body rather than other substances (e.g., Tylenol, aspirin, citric acid, etc.). As a result, the investigators expect the new GBP CGM to be more accurate at detecting low blood sugar levels than the current devices.
Primary Outcome
ARD=100\*(G\_sensor-G\_reference)/G\_reference Calculated for when patient's G\_ref was Normal (70-180 mg/dl), Hyperglycemic (\>180 mg/dl) and Hypoglycemic (\<70 mg/dl) The study data includes 208 paired sensor-YSI plasma glucose readings (G\_reference) for each GBP CGM sensor (G\_sensor) inserted for 24 hours during hyperglycemic and hypoglycemic challenge conditions. Data pairs will permit the detailed evaluation of sensor performance parameters, including static accuracy metrics such as med
Conditions Studied
Interventions
- DEVICE GBP CGM
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
What the finished NCT01469715 record still lists
NCT01469715 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which GBP CGM is the first listed.
NCT01469715 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT01469715 about?
NCT01469715 is a clinical study titled "A Clinical Study of the Performance of a Glucose Blinding Protein-Based Continuous Glucose Monitor (GBP CGM)". The purpose of this study is to assess the accuracy of the Becton Dickenson (BD) Technologies Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) in patients with Type 1 diabetes during low (goal glucose 55 mg/dL), normal (80-140 mg/dL) and high (\>180mg/dL) glucose levels over a 24 h...
What is the current status of trial NCT01469715?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2011-11. Estimated completion is 2012-07.
What conditions does trial NCT01469715 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT01469715?
The interventions under investigation include: GBP CGM (DEVICE).
Who is sponsoring clinical trial NCT01469715?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01469715 being conducted?
This trial has 1 study location across Virginia. 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 NCT01469715's enrollment target sits among peer trials
16 97th of 112 higher than 12 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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