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Fully Closed-Loop Insulin Delivery in Abdominal Surgery (CLAB)

NCT05392452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-01-17

No results posted yet for this study

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.

Conditions

  • Perioperative Hyperglycaemia
  • Insulin Therapy
  • Elective Surgery
  • Closed-Loop Glucose Control
  • Artificial Pancreas
  • Liver Diseases
  • Diabetes Mellitus, Type 2
  • Colon Disease
  • Gastric Disease
  • Pancreatic Disease

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    collaborator OTHER

  • Lia Bally

    lead OTHER

Principal Investigators

  • Lia Bally, MD PhD · Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University, Unviersity of Bern

  • Thierry Girard, MD · Anaesthesiology, University Hospital Basel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-09
Primary Completion
2023-10-16
Completion
2023-11-13

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05392452 on ClinicalTrials.gov