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NCT01835964 · ClinicalTrials.gov registry record · NA
Biobehavioral Mechanisms of Glucose Variability
A NA study, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT01835964: Completed NA study, sponsored by University of Virginia.
NCT01835964 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01835964, a NA study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate how blood sugar changes in response to insulin and what the body does to counter-act low blood sugar in people with Type 1 Diabetes Mellitus. Insulin sensitivity is the term used to describe blood sugar changes within the body in response to insulin. Greater understanding of insulin sensitivity, particularly how the body responds to low blood sugar, will help us to better predict how blood sugar levels will change. All subjects will receive a liquid mixed-meal and will have their blood sugar response monitored in order to study insulin sensitivity. All subjects will receive additional insulin injections that are given to cause a low blood sugar in order to understand how the body responds to a low blood sugar. All subjects will be closely monitored during the time the insulin is given, by frequent checks of blood sugar and constant medical and nursing supervision. Details of the visits, tests and procedures are described below. During this study, the study team will ask that subjects to use their own insulin pump and own glucometer. Subjects will need to use the same glucometer for the entire study. Subjects will be provided 1 box of strips. Subjects will be required to use lispro (Humalog) insulin 2-3 days before your inpatient admission which will be provided free of charge.
Primary Outcome
Glucose variability in the days leading to and following the challenge was assessed by computing Low Blood Glucose Index (LBGI) on daily self-monitoring of BG (SMBG) readings. Low LBGI values correspond to lower glucose variability associated with hypoglycemic risk. LBGI values lie between 0 and 100
Interventions
- PROCEDURE Glucose Variability Observation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-02 |
| Phase | NA |
What the finished NCT01835964 record still lists
NCT01835964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Glucose Variability Observation is the first listed.
NCT01835964 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01835964 about?
NCT01835964 is a clinical study titled "Biobehavioral Mechanisms of Glucose Variability". The purpose of this study is to investigate how blood sugar changes in response to insulin and what the body does to counter-act low blood sugar in people with Type 1 Diabetes Mellitus. Insulin sensitivity is the term used to describe blood sugar changes within the body in response to insulin. Great...
What is the current status of trial NCT01835964?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2013-04. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01835964?
The interventions under investigation include: Glucose Variability Observation (PROCEDURE).
Who is sponsoring clinical trial NCT01835964?
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 NCT01835964's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 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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