Brief description of trial (Data source: BASEC)
Im Rahmen akuter Krankheit und durch Stressreaktionen des Körpers kommt es während Spitalaufenthalten oft zu hohen Blutzuckerwerten, die mit Insulin therapiert werden müssen. Durch Änderungen des Krankheitszustandes, Essverhaltens und der Medikation muss die Insulintherapie regelmässig überprüft und angepasst werden. Studien haben gezeigt, dass sich eine ungenügende Blutzuckereinstellung negativ auf den Gesundheitszustand und die Hospitalisationsdauer von Patienten auswirkt.
Fortschritte in der Forschung führten zur Entwicklung von automatisierten Blutzucker-Kontrollsystemen, auch als „Künstliche Bauchspeicheldrüse“ bezeichnet. Die Systeme bestehen aus einem äusserlich getragenen Sensor, der den Blutzucker kontinuierlich misst, einer Insulinpumpe und einer Steuersoftware. Die Software berechnet alle 10-12min, je nach Blutzuckersituation, die erforderliche Insulindosis und steuert eine Insulinpumpe entsprechend an. Je schneller das abgegebene Insulin wird, desto besser kann der Blutzucker eingestellt werden. In einem ersten Schritt wird nach dem Zufallsprinzip entschieden, ob Studienteilnehmende mit dem automatisierten Blutzucker-Kontrollsystem oder der gewöhnlichen Insulintherapie während ihrer Hospitalisation (maximale aber 15 Tage) behandelt werden. in einem zweiten Schritt wird untersucht, ob die Wirksamkeit des automatisierten Blutzucker-Kontrollsystems mit ultra schnellwirkendem Insulin verglichen mi standardmässig verwendetem schnellwirkendem Insulin weiter verbessert werden kann.
Health conditions investigated(Data source: BASEC)
Diabetes bei hospitalisierten Patienten, die mit Insulin behandelt werden müssen
Health conditions
(Data source: WHO)
Diabetes Mellitus
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Automatisiertes Blutzucker-Kontrollsystem
Interventions
(Data source: WHO)
Device: Fully Automated Closed-Loop Insulin Delivery;Device: Conventional insulin therapy
Criteria for participation in trial
(Data source: BASEC)
-mindestens 18-jährig
-Type 2 Diabetes oder Bedarf einer subkutanen Insulintherapie
Exclusion criteria
(Data source: BASEC)
-Autoimmun-Typ 1 Diabetes
-Insulinallergie
-Schwangerschaft oder Stillen
-intensivmedizinische Behandlung
-Spital-Entlassung in weniger als 72h geplant
Inclusion/Exclusion Criteria
(Data source: WHO)
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)
-
Further information on trial
Date trial registered
Jan 18, 2013
Incorporation of the first participant
Aug 1, 2016
Recruitment status
Completed
Academic title
(Data source: WHO)
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)
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Time spent in target glucose range (5.6-10.0mmol/l)
Secundary end point
(Data source: WHO)
Proportion of time with glucose levels below 5.6 mmol/l and above 10.0 mmol/l as recorded by CGM;Average glucose levels, as recorded by CGM;Proportion of time with glucose levels below 3.9 mmol/l as recorded by CGM;Proportion of time with glucose levels below 3.0 mmol/l as recorded by CGM;Proportion of time with glucose levels below 2.8 mmol/l as recorded by CGM;Area under the curve of sensor glucose levels below 3.5 mmol/l as recorded by CGM;Area under the curve of sensor glucose levels below 3.0 mmol/l as recorded by CGM;Standard deviation and coefficient of variation of glucose levels, as recorded by CGM;Proportion of time with glucose levels in significant hyperglycaemic range (>20mmol/l) as recorded by CGM;Total daily insulin dose;Between 24 hour period variability;Number of capillary glucose confirmed hypoglycaemic events <3.5mmol/l;Pre-breakfast, pre-lunch, pre-dinner, and evening capillary glucose values
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Bern
Countries
(Data source: WHO)
Switzerland, United Kingdom
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Lia Bally
+41 31 632 36 77
lia.bally@insel.ch
Contact for general information
(Data source: WHO)
Roman Hovorka, PhD, MSc, BSc
University of Cambridge
Contact for scientific information
(Data source: WHO)
Roman Hovorka, PhD, MSc, BSc
University of Cambridge
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Bern
Date of authorisation by the ethics committee
25.04.2017
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2017-00321
Secondary ID (Data source: WHO)
A092763
ANGIE02
Back to overview
