At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Comparison of Two Sensor-Augmented Glycemic Control Systems in Persons With Type 1 Diabetes Mellitus: Subcutaneous (SC) Insulin and Glucagon Delivery vs. SC Insulin Only
In Brief
A Phase 2 clinical trial evaluating Insulin, Asp(B28)-, Glucagon, and 1 other intervention for Type 1 Diabetes. Completed, enrolled 14 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
Insulin dosing and frequency calculated by Fading Memory Proportional Derivative algorithm
During incipient hypoglycemia, glucagon was given in an attempt to prevent overt hypoglycemia. Dosing and frequency was calculated by the Fading Memory Proportional Derivative algorithm
Saline solution 0.9%