Closed-loop Insulin Delivery in the General Ward (ANGIE02)
Diabetes Mellitus
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes, Insulin, Closed-Loop, Real-time CGM, Subcutaneous insulin pump, Hospital
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years or older
- Type 2 Diabetes for at least 1 year as defined by WHO (phase 1 and 4)
- Inpatient hyperglycaemia requiring subcutaneous insulin therapy (phase 2 and 3)
- Treatment with subcutaneous insulin alone or in combination with oral glucose-lowering medication(s) (phase 4: basal bolus insulin regime for at least 3 months)
- Receiving parenteral and/or enteral nutrition (phase 3)
- HbA1c<11.0% (phase 4)
Exclusion Criteria:
- Autoimmune type 1 diabetes
- Known or suspected allergy against insulin
- Known proliferative retinopathy
- Current or planned pregnancy or breast feeding
- Unstable or end-stage cardiac and renal disease (phase 1 only)
- Planned surgery during study period (phase 1 only)
- Current in-patient in intensive care unit
- Any physical or psychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by the study clinician
- Likely discharge earlier than 72 hours (phase 1 only)
Sites / Locations
- Inselspital, Bern University Hospital, University of Bern, Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism
- Cambridge University Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Fully Automated Closed-Loop Insulin Delivery (phase 1-4)
Usual care/ fully-automated closed-loop using Iasp
The control algorithm will automatically direct between meals and meal-related subcutaneous insulin delivery utilizing real-time continuous glucose monitoring (RT-CGM) data. The subcutaneous insulin pump will deliver insulin Aspart or similar. In phase 1, a once daily basal insulin analogue will also be given subcutaneously at 20% the patient's usual total daily dose. In phase 3 and 4 faster-acting insulin aspart (Fiasp) is applied.
Phase 1-3: During usual care (conventional therapy), subject's s.c. insulin dose and regimen on admission will be adjusted as necessary by the clinical team according to local centres' usual clinical practice. Subjects will have masked CGM sensors inserted during the study (CGM readings will be masked throughout the study). Phase 4: subjects will receive fully-automated insulin delivery using standard insulin aspart (Iasp)