News

Study release CAT trial

Here you will find new information about our first clinical study. We are planning to present our results later this year.

Summary
Rationale First clinical experiments with overnight automated closed-loop control of blood glucose with algorithms developed by research groups in Cambridge and Padua-Pavia showed an increase in time spent in euglycaemia combined with less time spent in hypoglycaemia. Both groups collaborate within the AP@home consortium. The next step is to perform experiments aiming at automated closed-loop control of blood glucose during both night-time and daytime.

Objective
To compare blood glucose control achieved by the two closed-loop algorithms to open loop control during night-time and daytime.

Study design
Randomized three-way cross-over intervention study.

Study population
48 patients, aged 18 or above, with Type 1 diabetes, treated by continuous subcutaneous insulin infusion (CSII) with a rapid-acting insulin analogue for at least 3 months.

Intervention
Patients will receive closed-loop control of their blood glucose for 24 hours, using the Cambridge algorithm on one study day and the Padua-Pavia algorithm on another study day and also 24 hours of open loop control (conventional usage of CSII) on a control day, in a randomised sequence.

Main study parameters/endpoints
Primary outcome measure is the time spent in target range. This is defined as plasma glucose values between 3.9 and 8.0 mmol/L in the basal or late postprandial state and plasma glucose values between 3.9 and 10.0 mmol/L in the early postprandial phase (first 3 hours after the meal).