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| Name | Class |
|---|---|
| University Hospital, Basel, Switzerland | OTHER |
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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.
The prevalence of diabetes and hyperglycaemia in surgical patients is rising and associated not only with greater complication rates, length of stay, morbidity and mortality rates, but also increased hospital costs and readmission rates. Due to the complex interaction of organs involved in glucose homeostasis (e.g. liver, pancreas) and the frequent need for nutrition support, patients undergoing major abdominal surgery are particularly prone to develop dysglycaemia. While there are guidelines for perioperative glucose management, implementation is challenging and inconsistent. Main reasons are lack of resources, clinical inertia based on fear of hypoglycaemia and multiple handovers between teams.
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. In previous work, the investigators demonstrated that fully closed-loop insulin delivery in adults with type 2 diabetes undergoing various elective surgeries (abdominal, vascular, neurologic, orthopaedic, thoracic) improved glycaemic control by increasing time spent in the glycaemic target range, lowering mean sensor glucose and glycaemic variability without increasing the risk of hypoglycaemia.
In this follow-up trial the investigators will focus on patients undergoing major elective abdominal surgery to further explore the potential of the fully automated closed-loop approach to accommodate the complex needs of this population. Involvement of a second study centre and hospital staff for device management will further allow to assess the usability of the fully closed-loop system for larger multi-centre clinical trials as well as readiness to use the approach in usual clinical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed-loop insulin therapy | Experimental | Intervention: Use of a fully-automated closed-loop insulin delivery system from day of admission until hospital discharge (or maximum 20 days). |
|
| Standard insulin therapy | Active Comparator | The control group will receive insulin therapy in accordance with local practice. The insulin regimen during the study period may involve subcutaneous and/or insulin intravenous insulin administration. The modality of insulin treatment, dose adjustment and frequency of glucose monitoring will be at the discretion of the clinical team. No active treatment optimisation will be undertaken by the study team. Participants in the control group will be fitted with the identical study CGM system. The CGM system will be blinded upon hospital admission. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CamAPS HX | 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 | The outcome is based on sensor glucose levels | Assessed from hospital admission until a maximum of 20 days following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Proportion of time spent with sensor glucose <3.0 mmol/L |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Thierry Girard, MD | Anaesthesiology, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaesthesiology, University Hospital Basel | Basel | 4031 | Switzerland | |||
| Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital |
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| Standard insulin therapy | Drug | Standard insulin therapy according to local clinical practice. |
|
The outcome is based on sensor glucose levels |
| Assessed from hospital admission until a maximum of 20 days following surgery |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Post-surgery comorbidity | Assessed using the Comprehensive Complication Index (CCI) | Assessed at 30 days following surgery |
| Length of hospital stay | Assessed based on the information in electronic health records | Up to 20 days |
| 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 |
Based on point-of-care capillary measurements. This is a safety outcome |
| Assessed from hospital admission until a maximum of 20 days following surgery |
| Bern |
| 3010 |
| Switzerland |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D003924 | Diabetes Mellitus, Type 2 |
| D003108 | Colonic Diseases |
| D013272 | Stomach Diseases |
| D010182 | Pancreatic Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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