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NCT01418703 · ClinicalTrials.gov registry record · NA
Feasibility Study of a Modular Control to Range System in Type 1 Diabetes Mellitus
A NA study, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT01418703 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 38 participants.
The verdict
NCT01418703, a NA study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
In this protocol the investigators plan to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). The protocol is designed to challenge the insulin management system with meals and mild exercise, so as to demonstrate its capacity to avoid large glucose excursion with changing metabolic state. This system is designed to both * monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections; * predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection. The investigators plan to enroll 12 adult Type 1 Diabetes Mellitus (T1DM) patients (expected retention 10/12) and compare glucose control performances under two treatments: standard vs. the new insulin management system. The protocol will include a total of 6 admissions per subject (4 out-patients and 2 in-patients): screening, effort test, CGM insertion 1, inpatient 1, CGM insertion 2, and inpatient 2. During the 24h inpatient admissions, the patients will be challenged with 30 minutes of mild exercise and 3 meals, insulin coverage of these events will vary depending on the chosen treatment, each subject will be exposed to both studied treatments (repeated measure design).The order of treatment during the inpatient admissions will be randomized.
Interventions
- DEVICE Closed Loop Control (CLC)
- DEVICE Open Loop
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01418703
The ClinicalTrials.gov registry entry for NCT01418703 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 38 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 2 interventions - of which Closed Loop Control (CLC) is the first listed.
NCT01418703 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01418703 about?
NCT01418703 is a clinical study titled "Feasibility Study of a Modular Control to Range System in Type 1 Diabetes Mellitus". In this protocol the investigators plan to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). The protocol is designed to challenge ...
What is the current status of trial NCT01418703?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2009-10. Estimated completion is 2010-12.
What interventions are being tested in trial NCT01418703?
The interventions under investigation include: Closed Loop Control (CLC) (DEVICE), Open Loop (DEVICE).
Who is sponsoring clinical trial NCT01418703?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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