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NCT00797823 · ClinicalTrials.gov registry record · Phase 2

Sensor-Augmented Insulin Delivery: Insulin Plus Glucagon Versus Insulin Alone

A Phase 2 study of Type 1 Diabetes, sponsored by Legacy Health System.

Completed
Registry status
Phase 2
Development phase
14
Enrollment target
1
Study location

NCT00797823 is a Phase 2 study of Type 1 Diabetes that has completed, run by Legacy Health System. The registered enrollment target is 14 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00797823, a Phase 2 study of Type 1 Diabetes, has completed, sponsored by Legacy Health System.

COMPLETED
Registry status
Phase 2
Development phase
14 participants
Enrollment target
1
Study location

Study Summary

This study aims to test an insulin and glucagon delivery algorithm designed to be used in conjunction with a continuous glucose monitoring system. This combined glucose sensing/hormone delivery approach is a step on the way to eventual development of an artificial (or automated) pancreas. The insulin and glucagon delivery algorithm is based on the difference between the current blood glucose and the target glucose (proportional error) and the rate of change in blood glucose (derivative error), both adjusted for the recent glucose history. This algorithm is called the Fading Memory Proportional-Derivative (FMPD) Algorithm. The principal investigator of this study has published previous research regarding the use of this algorithm and found it to be well-suited to control blood glucose in type 1 diabetic animals. The addition of glucagon was helpful; better glycemic control with fewer glucose excursions were observed when small intermittent infusions of subcutaneous glucagon were given during times of impending low blood sugar (Ward et al. 2008).

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Glucagon
  • DRUG Insulin, Asp(B28)-

Study Locations (1)

Oregon

  • Legacy Research - Portland

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2008-11
Est. Completion 2009-09
Phase Phase 2

Sponsor

Legacy Health System

21 total trials

What the Registry Record Tells You About NCT00797823

The ClinicalTrials.gov registry entry for NCT00797823 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (98% lower). The listed sponsor is Legacy Health System, which has 21 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00797823 reports 1 study location spanning 1 distinct geographic area - top geographies include Oregon.

Frequently Asked Questions

What is clinical trial NCT00797823 about?

NCT00797823 is a clinical study titled "Sensor-Augmented Insulin Delivery: Insulin Plus Glucagon Versus Insulin Alone". This study aims to test an insulin and glucagon delivery algorithm designed to be used in conjunction with a continuous glucose monitoring system. This combined glucose sensing/hormone delivery approach is a step on the way to eventual development of an artificial (or automated) pancreas. The insuli...

What is the current status of trial NCT00797823?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2008-11. Estimated completion is 2009-09.

What conditions does trial NCT00797823 study?

This clinical trial studies the following conditions: Type 1 Diabetes.

What interventions are being tested in trial NCT00797823?

The interventions under investigation include: Placebo (DRUG), Glucagon (DRUG), Insulin, Asp(B28)- (DRUG).

Who is sponsoring clinical trial NCT00797823?

This trial is sponsored by Legacy Health System, which has 21 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00797823 being conducted?

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

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

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