Perioperative Closed-loop Glucose Control

NCT04361799 | Completed

• 1 other identifier: POP-LOOP
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of diabetes and hyperglycaemia in surgical patients is rising and associated with grater complication rates, length of stay and mortality rates. Suboptimal glucose management in the perioperative setting remains a major barrier to optimal surgical care. While there are guidelines to manage perioperative diabetes care, implementation is challenging and inconsistent, in part due to a stretched workforce, involvement of several disciplines and clinical teams and shortcomings in clinical training and knowledge. Closed-loop glucose control represents an emerging diabetes treatment modality that autonomously adjusts insulin delivery according to continuously measured glucose levels. The use of fully automated closed-loop insulin delivery may represent an easy-to-adopt approach for safe and effective perioperative diabetes management.

Conditions

Perioperative Hyperglycaemia; Insulin Therapy; Elective Surgery; Closed-Loop Glucose Control; Artificial Pancreas

Outcome Measures

Primary Outcomes (1)

• The proportion of time spent in the target glucose range from 5.6 to 10.0 mmol/L based on sensor glucose levels during the time from hospital admission for elective surgery until discharge.

  Up to 20 days

Secondary Outcomes (7)

• Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L)

  Up to 20 days

• Proportion of time spent with sensor glucose <3.0 mmol/L

  Up to 20 days

• Average of sensor glucose level

  Up to 20 days

• Time spent with sensor glucose below target (5.6 mmol/L)

  Up to 20 days

• Proportion of time spent with sensor glucose levels in significant hyperglycaemia (glucose levels > 20 mmol/L)

  Up to 20 days

Other Outcomes (5)

• Number of severe hypoglycaemic episodes (plasma glucose <2.2 mmol/L)

  Up to 20 days

• Number of clinically significant hyperglycaemic events (>20.0 mmol/L) with ketonaemia (beta-hydroxybutyrate >1.0 mmol/L)

  Up to 20 days

• Post-surgery comorbidity score as assessed using the Clavien Dindo Classification

  Up to 20 days

Study Arms (2)

Closed-loop insulin therapy

EXPERIMENTAL

Device: CamAPS

Standard insulin therapy

ACTIVE COMPARATOR

Drug: Standard insulin therapy

Interventions

CamAPS DEVICE

Fully automated closed-loop subcutaneous insulin delivery system. A model predictive controller modulates insulin delivery every 10-12 minutes based on interstitial glucose measurements.

Closed-loop insulin therapy

Standard insulin therapy DRUG

Standard insulin therapy according to local clinical practice.

Standard insulin therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• The subject is aged 18 years or over
• Diagnosis of type 2 diabetes using standard diagnostic practice (37)
• The subject is planned for an elective abdominal, thoracic or cardiovascular surgery at the University Hospital Bern expected to last ≥2 hours
• The subject requires treatment with subcutaneous insulin as part of the perioperative glucose management
• The subject is literate in German
• The subject is willing to wear study devices 24/7

You may not qualify if:

• Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
• Known or suspected allergy to insulin
• Type 1 diabetes
• Pregnancy, planned pregnancy, or breast feeding
• Medically documented allergy towards the adhesive (glue) of plasters or unable tolerate tape adhesive in the area of sensor placement
• Lack of safe contraception for female participants of childbearing potential for the entire study duration (medically reliable method of contraception are considered oral, injectable, or implantable contraceptives, intrauterine contraceptive devices, or any other methods judged as sufficiently reliable by the investigator in individual cases).
• Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor
• Illicit drug abuse or prescription drug abuse
• Incapacity to give informed consent
• Droplet/airborne isolation precautions
• Participation in another clinical trial that interferes with the interpretation of the study results

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (2)

• Krutkyte G, Roos J, Schuerch D, Czerlau C, Wilinska ME, Wuethrich PY, Herzig D, Hovorka R, Vogt AP, Gloor B, Bally L. Fully Closed-Loop Insulin Delivery in Patients Undergoing Pancreatic Surgery. Diabetes Technol Ther. 2023 Mar;25(3):206-211. doi: 10.1089/dia.2022.0400. Epub 2022 Dec 14.

  PMID: 36449375 DERIVED

• Herzig D, Suhner S, Roos J, Schurch D, Cecchini L, Nakas CT, Weiss S, Kadner A, Kocher GJ, Guensch DP, Wilinska ME, Raabe A, Siebenrock KA, Beldi G, Gloor B, Hovorka R, Vogt AP, Bally L. Perioperative Fully Closed-Loop Insulin Delivery in Patients Undergoing Elective Surgery: An Open-Label, Randomized Controlled Trial. Diabetes Care. 2022 Sep 1;45(9):2076-2083. doi: 10.2337/dc22-0438.

  PMID: 35880252 DERIVED

Study Officials

• Lia Bally, MD PhD

  Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University, Unviersity of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: September 25, 2020
• Primary Completion: September 2, 2021
• Study Completion: September 2, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)