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NCT01874392 · ClinicalTrials.gov registry record · NA
Feasibility Study Using Zone-MPC Controller, HMS and Technosphere® Insulin Inhalation System From MannnKind Corp
A NA study of Type 1 Diabetes Mellitus, sponsored by Sansum Diabetes Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT01874392: Completed NA study of Type 1 Diabetes Mellitus, sponsored by Sansum Diabetes Research Institute.
NCT01874392 is a NA study of Type 1 Diabetes Mellitus that has completed, run by Sansum Diabetes Research Institute. The registered enrollment target is 9 participants, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01874392, a NA study of Type 1 Diabetes Mellitus, has completed, sponsored by Sansum Diabetes Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical trial is a feasibility study to assess the performance of an Artificial Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with type 1 diabetes using rapid-acting insulin as well as preprandial inhaled insulin (Technosphere® Insulin Inhalation System by MannKind Corporation). The goal of this proposed study is to explore the feasibility of using multiple insulin delivery routes in order to mimic the physiology of both first- and second-phase insulin secretion. The intent is to exploit the rapid action achieved by inhaled insulin to compensate for part of the meals and utilize the conventional subcutaneous route for management of basal insulin and as second-phase meal-related insulin.
Primary Outcome
This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within Target range 5 hours after meal: \[70-180\] mg/dL.
Conditions Studied
Interventions
- DRUG Investigational inhaled insulin (Technosphere)
- DEVICE Artificial Pancreas (AP) device (APS©)
Study Locations (1)
California
- Sansum Diabetes Research Institute - Santa Barbara
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-06 |
| Phase | NA |
What the finished NCT01874392 record still lists
NCT01874392 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 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Investigational inhaled insulin (Technosphere) is the first listed.
NCT01874392 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01874392 about?
NCT01874392 is a clinical study titled "Feasibility Study Using Zone-MPC Controller, HMS and Technosphere® Insulin Inhalation System From MannnKind Corp". This clinical trial is a feasibility study to assess the performance of an Artificial Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with type 1 diabetes using rapid-acting insulin as well as preprandial inhaled insulin (Technosphere® Insulin Inhalation System...
What is the current status of trial NCT01874392?
This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2012-10. Estimated completion is 2013-06.
What conditions does trial NCT01874392 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT01874392?
The interventions under investigation include: Investigational inhaled insulin (Technosphere) (DRUG), Artificial Pancreas (AP) device (APS©) (DEVICE).
Who is sponsoring clinical trial NCT01874392?
This trial is sponsored by Sansum Diabetes Research Institute, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01874392 being conducted?
This trial has 1 study location across California. 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 NCT01874392's enrollment target sits among peer trials
9 110th of 112 higher than 2 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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