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NCT01261052 · ClinicalTrials.gov registry record · Phase 2
Real-time Adaptation to Changes in Insulin Sensitivity
A Phase 2 study, sponsored by Legacy Health System.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT01261052: Completed Phase 2 study, sponsored by Legacy Health System.
NCT01261052 is a Phase 2 study that has completed, run by Legacy Health System. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01261052, a Phase 2 study, has completed, sponsored by Legacy Health System.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this research study is to test an automated blood glucose control system that includes a new component designed to adapt to stress. The importance of this component is that when Type 1 Diabetics are stressed (for example, from illness or infection), their body is resistant to the effects of insulin. The investigators will be adjusting their blood glucose using insulin and glucagon and making their body less sensitive to insulin with a steroid, hydrocortisone. Insulin is a hormone that lowers blood glucose. Glucagon raises blood glucose when it is low. Both are natural hormones made by people without diabetes. Hydrocortisone is a steroid that will increase their blood glucose temporarily and will be given every 4 hours. All subjects will participate in two 33 hour experiments. One experiment will use the adaptive version of the sensor-based glucose control system. The other study will use the original version of the control system, without the adaptive component, for the first 13 hours. Then, the adaptive component will be added to the glucose control system for the remaining 20 hours of the study. Our primary goal is to assess the effectiveness of the adaptive component to control glucose levels in the presence of steroid-induced insulin resistance in persons with Type 1 Diabetes Mellitus.
Primary Outcome
The effectiveness of the APD and FMPD/APD intervention in adapting to reduced insulin sensitivity was analyzed using mean glucose.
Interventions
- DEVICE The Fading Memory Proportional Derivative/Adaptive Proportional Derivative Algorithm
- DEVICE The Adaptive Proportional Derivative Algorithm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-04 |
| Phase | Phase 2 |
What the finished NCT01261052 record still lists
NCT01261052 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which The Fading Memory Proportional Derivative/Adaptive Proportional Derivative Algorithm is the first listed.
NCT01261052 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01261052 about?
NCT01261052 is a clinical study titled "Real-time Adaptation to Changes in Insulin Sensitivity". The purpose of this research study is to test an automated blood glucose control system that includes a new component designed to adapt to stress. The importance of this component is that when Type 1 Diabetics are stressed (for example, from illness or infection), their body is resistant to the effe...
What is the current status of trial NCT01261052?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2010-11. Estimated completion is 2011-04.
What interventions are being tested in trial NCT01261052?
The interventions under investigation include: The Fading Memory Proportional Derivative/Adaptive Proportional Derivative Algorithm (DEVICE), The Adaptive Proportional Derivative Algorithm (DEVICE).
Who is sponsoring clinical trial NCT01261052?
This trial is sponsored by Legacy Health System, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01261052's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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