CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
HIGH error +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02065895
NCT02065895N/ACompleted

Effect of Gain on Closed-Loop Insulin

Joslin Diabetes Center·interventional·Posted Feb 19, 2014·Updated May 17, 2018

In Brief

A clinical study evaluating HIGH error, NO error, and 1 other intervention for Type 1 Diabetes. Completed, enrolled 8 participants across 1 site.

Detailed Summary

The purpose of this study is to test the ability of an advanced external Physiologic Insulin Delivery (ePID) algorithm (a step by step process used to develop a solution to a problem) to get acceptable meal responses over a range of gain. Gain is defined as how much insulin is given in response to a change in a patient's glucose level. This study also examines the effectiveness of the external Physiologic Insulin Delivery (ePID) closed-loop insulin delivery computer software. The investigators would like to assess whether fasting target levels can be achieved as the closed-loop gain increases or decreases, and to evaluate the system's ability to produce an acceptable breakfast meal response.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 19, 2014
Enrollment StartDec 1, 2013
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.4 years ago

Interventions

HIGH errordevice

Overnight and breakfast closed-loop control were performed using a target glucose of 120 mg/dL but with the glucose-value-used-for-control equal to 1.33 times the true glucose value (analogous to higher gain lower target).

NO errordevice

Overnight and breakfast closed-loop control were performed using a target glucose of 120 mg/dL and glucose-value-used-for-control equal to the true glucose value.

LOW errordevice

Overnight and breakfast closed-loop control were performed using a target glucose of 120 mg/dL but with the glucose-value-used-for-control equal to 0.8 times the true glucose value (analogous to lower gain higher target).