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NCT01839370 · ClinicalTrials.gov registry record · NA
Phase 2 Study of Adaptive Insulin Meal Supervisor (AIMS) in Adults With Type 1 Diabetes Mellitus
A NA study of Diabetes Mellitus, Type 1, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT01839370: Completed NA study of Diabetes Mellitus, Type 1, sponsored by University of Virginia.
NCT01839370 is a NA study of Diabetes Mellitus, Type 1 that has completed, run by University of Virginia. The registered enrollment target is 9 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01839370, a NA study of Diabetes Mellitus, Type 1, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, a closed-loop Adaptive Insulin Meal Supervisor system (AIMS) utilizing continuous glucose monitoring (CGM), a subcutaneous insulin pump and standard pramlintide therapy will be applied in individuals with type 1 diabetes. Pramlintide, a drug well recognized to help control hyperglycemia with meals, will be evaluated in both closed loop and open loop control. It is expected that the closed loop control condition with pramlintide will improve glycemia, thus combining better control with enhanced safety. In a recent pilot study, the investigators started testing this concept and collected data showing that in order to be successful such strategy must have a controller equipped with the ability to optimize the configuration and timing of meal boluses with concomitant administration of pramlintide. Our preliminary data and review of previously unavailable individual data from a German study indicate a large individual variability in the timing of the appearance of meal insulin needs. Thus, for both adequate safety and efficacy of meal insulin on pramlintide, the investigators have developed a new closed-loop controller that accounts for the variability in the individual responses to a meal and meal delays, the Adaptive Insulin Meal Supervisor system (AIMS). In this study, the performance of a combination between the AIMS system and a standard pramlintide treatment will be tested versus the standard pramlintide treatment alone.
Primary Outcome
Demonstrate that a new Adaptive Insulin Meal Supervisor (AIMS), designed to handle variability in individual responses to a meal, in combination with a Standard pramlintide therapy will result in a more efficacious strategy for controlling glycemia as compared to the standard pramlintide therapy alone in terms of increased percent of glucose measurements between 71 - 180 mg/dL during the day and 71 - 140 mg/dL during the night.
Conditions Studied
Interventions
- DEVICE Closed Loop with Pramlintide
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2013-07 |
| Est. Completion | 2013-11 |
| Phase | NA |
What the finished NCT01839370 record still lists
NCT01839370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 1 intervention - of which Closed Loop with Pramlintide is the first listed.
NCT01839370 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT01839370 about?
NCT01839370 is a clinical study titled "Phase 2 Study of Adaptive Insulin Meal Supervisor (AIMS) in Adults With Type 1 Diabetes Mellitus". In this study, a closed-loop Adaptive Insulin Meal Supervisor system (AIMS) utilizing continuous glucose monitoring (CGM), a subcutaneous insulin pump and standard pramlintide therapy will be applied in individuals with type 1 diabetes. Pramlintide, a drug well recognized to help control hyperglycem...
What is the current status of trial NCT01839370?
This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2013-07. Estimated completion is 2013-11.
What conditions does trial NCT01839370 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT01839370?
The interventions under investigation include: Closed Loop with Pramlintide (DEVICE).
Who is sponsoring clinical trial NCT01839370?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01839370 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
Similar trials for Diabetes Mellitus, Type 1
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 NCT01839370's enrollment target sits among peer trials
9 115th of 118 higher than 3 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 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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