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COMPLETED NA

Medtronic Minimed Overnight Closed-Loop System

NCT01881009 · View on ClinicalTrials.gov ↗

Study Summary

To test the function and safety of the Medtronic Overnight Closed Loop (OCL) System in a closely monitored 12 hour overnight inpatient study. Once the safety of the device has been validated we will move the study to an outpatient diabetes camp setting. The camp setting will allow us to obtain pilot efficacy and safety data in a "real-life" environment. We plan to compare the subject control nights to the subject nights on the OCL system to assess the percent of sensor glucose readings in the target range of 70-150 mg/dl. Based on previous research, we anticipate that the use of the OCL system will contribute to a greater percentage of sensor glucose readings in the target range.

Interventions

  • DEVICE Hybrid Closed-loop System
  • DEVICE Sensor-augmented pump

Study Locations (1)

California

  • Stanford University — Stanford

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2013-06
Est. Completion 2013-08-03
Phase NA

Sponsor

Bruce A. Buckingham

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01881009

The ClinicalTrials.gov registry entry for NCT01881009 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bruce A. Buckingham, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions — of which Hybrid Closed-loop System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01881009 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01881009 about?

NCT01881009 is a clinical study titled "Medtronic Minimed Overnight Closed-Loop System". To test the function and safety of the Medtronic Overnight Closed Loop (OCL) System in a closely monitored 12 hour overnight inpatient study. Once the safety of the device has been validated we will move the study to an outpatient diabetes camp setting. The camp setting will allow us to obtain pilot...

What is the current status of trial NCT01881009?

This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 2013-06. Estimated completion is 2013-08-03.

What conditions does trial NCT01881009 study?

This clinical trial studies the following conditions: Type 1 Diabetes Mellitus, Autoimmune Diabetes, Juvenile-Onset Diabetes, Diabetes, Mellitus, Type 1. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01881009?

The interventions under investigation include: Hybrid Closed-loop System (DEVICE), Sensor-augmented pump (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01881009?

This trial is sponsored by Bruce A. Buckingham, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01881009 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial