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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05392452
Other study ID # CLAB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 9, 2022
Est. completion date November 13, 2023

Study information

Verified date January 2024
Source Insel Gruppe AG, University Hospital Bern
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to assess the efficacy, safety and usability of perioperative fully-automated closed-loop insulin delivery versus standard insulin therapy in patients with diabetes other than type 1 diabetes undergoing elective major abdominal surgery.


Description:

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Study Design


Intervention

Device:
CamAPS HX
Fully automated closed-loop subcutaneous insulin delivery system. A model predictive controller modulates insulin delivery every 10-12 minutes based on interstitial glucose measurements.
Drug:
Standard insulin therapy
Standard insulin therapy according to local clinical practice.

Locations

Country Name City State
Switzerland Anaesthesiology, University Hospital Basel Basel
Switzerland Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital Bern

Sponsors (2)

Lead Sponsor Collaborator
Lia Bally University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of severe hypoglycaemia (< 2.2 mmol/L) Based on point-of-care capillary measurements. This is a safety outcome. Assessed from hospital admission until a maximum of 20 days following surgery
Other Number of clinically significant hyperglycaemic events (>20.0 mmol/L) with ketonaemia (beta-hydroxybutyrate >1.0 mmol/L) Based on point-of-care capillary measurements. This is a safety outcome Assessed from hospital admission until a maximum of 20 days following surgery
Primary The proportion of time spent in the target glucose range from 5.6 to 10.0 mmol/L The outcome is based on sensor glucose levels Assessed from hospital admission until a maximum of 20 days following surgery
Secondary Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L) The outcome is based on sensor glucose levels Assessed from hospital admission until a maximum of 20 days following surgery
Secondary Proportion of time spent with sensor glucose <3.0 mmol/L The outcome is based on sensor glucose levels Assessed from hospital admission until a maximum of 20 days following surgery
Secondary Proportion of time spent with sensor glucose < 3.9 mmol/L The outcome is based on sensor glucose levels Assessed from hospital admission until a maximum of 20 days following surgery
Secondary Average of sensor glucose level The outcome is based on sensor glucose levels Assessed from hospital admission or until a maximum of 20 days following surgery
Secondary Proportion of time spent with sensor glucose below target (< 5.6 mmol/L) The outcome is based on sensor glucose levels Assessed from hospital admission until a maximum of 20 days following surgery
Secondary Standard deviation of sensor glucose levels The outcome is based on sensor glucose levels Assessed from hospital admission or until a maximum of 20 days following surgery
Secondary Coefficient of variation of sensor glucose levels The outcome is based on sensor glucose levels Assessed from hospital admission until a maximum of 20 days following surgery
Secondary Total daily insulin dose Insulin dose received by the patients in units/24h Assessed from hospital admission until a maximum of 20 days following surgery
Secondary Post-surgery comorbidity Assessed using the Comprehensive Complication Index (CCI) Assessed at 30 days following surgery
Secondary Length of hospital stay Assessed based on the information in electronic health records Up to 20 days
Secondary Peri- and postoperative costs (perspectives: hospital, statutory health insurance system) Assessed based on the information from device manufacturers, hospital administration system and standard external sources for healthcare utilisation unit costs. Assessed from hospital admission until a maximum of 30 days following surgery
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