A Randomised Study to Assess the Efficacy and Safety of Automated Closed-loop Glucose Control in Insulin Treated Type 2 Diabetes (Phase 1), Inpatient Hyperglycaemia Requiring Subcutaneous Insulin Therapy (Phase 2 and Phase 3) and to Evaluate Use of Closed-loop Applying Faster Insulin Aspart Versus Standard Insulin Aspart (Phase 4) (ANGIE02)

NCT01774565 NA COMPLETED

The study assesses the efficacy and safety of closed-loop glucose control in patients with insulin-treated type 2 diabetes. Phase 1 The study objective is to compare conventional insulin therapy with closed-loop glucose control combined with once daily basal insulin injection over 72 hours in hospitalised insulin treated T2D subjects. Phase 2 The study objective is to compare conventional insulin therapy with closed-loop glucose control up to maximum 15 days in hospitalised insulin treated T2D subjects. Phase 3 The study objective is to compare conventional insulin therapy with closed-loop glucose control applying faster insulin aspart up to maximum 15 days in insulin-treated inpatients receiving parenteral and/or enteral nutrition. Phase 4 The study objective is to compare automated closed-loop control using faster acting insulin aspart with closed-loop control using standard insulin aspart.

Details

Lead sponsor	University of Cambridge
Phase	NA
Status	COMPLETED
Enrolment	43
Start date	2016-08
Completion	2018-09-21

Conditions

• Diabetes Mellitus

Interventions

• Fully Automated Closed-Loop Insulin Delivery
• Conventional insulin therapy

Primary outcomes

• Time spent in target glucose range (5.6-10.0mmol/l) — Phase 1 (Pilot study) = 72-hours, Phase 2 (Follow-up study) = Up to 15 days
  Primary outcome will be measured using continuous subcutaneous glucose monitoring (CGM) data (Phase 1-3) and plasma (Phase 4).

Countries

Switzerland, United Kingdom