Perioperative Continuous Glucose Monitoring in Patients Undergoing an Abdominal Surgery

NCT03935919 | Completed DMC

• 1 other identifier: GluPop
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study it to assess whether the continuous glucose monitor system Dexcom G6® can be reliably used for perioperative glucose monitoring in 20 prediabetic or diabetic patients undergoing abdominal surgery in terms of data continuity, accuracy and patient tolerability.

Conditions

Diabetes Mellitus; Prediabetes

Keywords

perioperative glucose management; continuous glucose monitoring; diabetes

Outcome Measures

Primary Outcomes (1)

• Sensor accuracy in the perioperative period

  Mean Absolute Relative Difference (MARD) between Dexcom G6 sensor glucose values and capillary blood glucose values measured using the Accu-Check Inform II meter in the perioperative period (%)

  1 day

Secondary Outcomes (38)

• Mean absolute relative difference between sensor glucose and reference glucose in the preoperative period (%)

  1 week

• Mean absolute relative difference between sensor glucose and reference glucose in the postoperative period (%)

  1-2 weeks

• Median absolute relative difference between sensor glucose and reference glucose in the preoperative period (%)

  1 week

• Median absolute relative difference between sensor glucose and reference glucose in the perioperative period (%)

  1 day

• Median absolute relative difference between sensor glucose and reference glucose in the postoperative period (%)

  1-2 weeks

Eligibility Criteria

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

Study Population

The study will involve a total of 20 adults with pre-diabetes, type 1 or type 2 diabetes who will undergo elective abdominal surgery at the University Hospital Bern.

You may qualify if:

• Aged ≥18 years
• Pre-diabetic (HbA1c 5.7-6.5%) or diabetic (regardless of aetiology)
• Scheduled to have elective abdominal surgery at the University Hospital Bern
• Surgery duration \>2 hours

You may not qualify if:

• Planned MRI procedure during hospitalization
• Inability to follow procedures
• Incapacity to give informed consent
• Presence of extensive skin abnormalities at the sensor insertion site (upper arm)
• Known allergic/irritative skin reactions to dressings/adhesives
• Haematocrit values outside the normal range
• Patients with immunosuppression defined as neutrophil count \<0.5x10\^9/L
• Patients on isolation precautions (contact, droplet, airborne)
• Pregnancy or breast-feeding

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

MeSH Terms

Conditions

Diabetes Mellitus; Prediabetic State

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lia Bally, MD PhD

  Inselspital, University Hospital of Bern, University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2019
• First Posted: May 2, 2019
• Study Start: August 13, 2019
• Primary Completion: February 26, 2020
• Study Completion: March 1, 2020
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

CH (1)