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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed-loop insulin therapy | Experimental |
| |
| Standard insulin therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| Number of severe hypoglycaemic episodes (plasma glucose <2.2 mmol/L) | Safety outcome | Up to 20 days |
| Number of clinically significant hyperglycaemic events (>20.0 mmol/L) with ketonaemia (beta-hydroxybutyrate >1.0 mmol/L) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lia Bally, MD PhD | Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University, Unviersity of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36449375 | Derived | 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. | |
| 35880252 | Derived |
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| Standard insulin therapy | Drug | Standard insulin therapy according to local clinical practice. |
|
| 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 |
| Standard deviation and coefficient of variation of sensor glucose levels | Up to 20 days |
| Total daily insulin requirements | Up to 20 days |
Safety outcome
| Up to 20 days |
| Post-surgery comorbidity score as assessed using the Clavien Dindo Classification | The Clavien Dindo Classification consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The higher the grade, the higher the post-operative comorbidity burden. | Up to 20 days |
| Length of hospital stay | Up to 20 days |
| Proportion when closed-loop was active | Utility outcome (will only be assessed in the closed-loop group) | Up to 20 days |
| 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. |