NCT02379299

DiaCon Dual-Hormone Closed-Loop Glucose Control

Dual-Hormone Closed-Loop Glucose Control in Type 1 Diabetes

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The ultimate T1D treatment tool is a closed-loop glucose control system, i.e. a fully automated system for intensive insulin treatment. Such system will ease the burden of constant treatment decision-making and at the same time it has the potential to safely intensify insulin therapy such that more patients can reach treatment goals. Currently, no off-the-shelf closed-loop system exists but research efforts in this field have been intensified and resulted in great progress in recent years. Most closed-loop systems consist of an insulin pump, a CGM, and a control algorithm residing on a mobile computer that continuously (every 5-15 min) computes the optimal insulin dosage from the CGM values. For daytime blood glucose control, however, we believe that the system needs to be further advanced. Consequently, we have extended our single-hormone closed-loop system such that it now includes a second pump for glucagon delivery and correspondingly we have further developed our control algorithm to compute both insulin and glucagon dosages. We hypothesize that we have developed a safe and effective dual-hormone closed-loop system for patients with type 1 diabetes and that this system is superior to single-hormone closed-loop therapy. The aims of this two-phase project are to 1) demonstrate proof-of-concept and 2) to compare dual-hormone with single-hormone closed-loop glucose control.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	DiaCon dual-hormone closed-loop glucose control algorithm	Dual-hormone closed-loop glucose control
DEVICE	DiaCon single-hormone closed-loop glucose control algorithm	Single-hormone closed-loop glucose control

Timeline

• Primary completion: 2017-07-22
• First posted: 2015-03-04
• Last updated: 2017-08-09

Locations

1 site across 1 country: Denmark