Diabetes Mellitus, Type 2 Clinical Trial
— CLABOfficial title:
Fully Closed-Loop Insulin Delivery in Abdominal Surgery: a Randomised Controlled Two-centre Trial (CLAB-Study)
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 |
Verified date | January 2024 |
Source | Insel Gruppe AG, University Hospital Bern |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | November 13, 2023 |
Est. primary completion date | October 16, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 years or over - Pre-existing or anticipated (surgery-induced) diabetes other than type 1 diabetes - Expected to require insulin treatment in the perioperative period - Planned for elective major abdominal surgery at the University Hospital Bern or Basel expected to last = 90 minutes, defined as colorectal, pancreatic, gastric (except bariatric surgery) and hepatic (= 2 segments) surgery Exclusion Criteria: - 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 - Likely discharge earlier than 72 hours - Known or suspected allergy to insulin used in this clinical trial - Type 1 diabetes - Pregnancy, planned pregnancy, or breast feeding - 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). - Medically documented allergy towards the adhesive (glue) of plasters or unable tolerate tape adhesive in the area of sensor placement - 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 - Not willingness to wear study devices 24/7 - Not literate in German |
Country | Name | City | State |
---|---|---|---|
Switzerland | Anaesthesiology, University Hospital Basel | Basel | |
Switzerland | Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
Lia Bally | University Hospital, Basel, Switzerland |
Switzerland,
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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