Effects of GlucoClear CGM System on the Performance of Insulin Therapy in Critically Ill Patients

NCT03047824 | Completed

• 1 other identifier: P2014/162 / B406201420742
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

After providing written informed consent, the first 20 Subjects meeting Inclusion/Exclusion Criteria will be consecutively enrolled in the Standard of Care cohort. The moderate treatment cohort will then be consecutively enrolled, followed by the tight glycemic control cohort. After sensor insertion, baseline evaluations including APACHE II, SOFA, and laboratory evaluations will be determined. Subjects enrolled in the standard of care cohort will be treated according to the institution's protocol for measuring glucose and managing insulin. These subjects will be monitored on a GlucoClear System but they will not be managed based on the values or trends of the GlucoClear system. Subjects enrolled in the treatment cohorts will be monitored and managed with a special version of the GlucoClear continuous monitoring system. This system contains the GlucoClear Insulin Dosing Algorithm providing insulin dosing recommendations to enable the clinician to manage patient glucose within pre-specified target levels. These recommendations are presented on screen for a clinical professional to approve or override. Subjects in the moderate treatment cohort will have their glucose managed in the range of 120 - 180 mg/dl. Subjects in the tight glycemic control treatment cohort will be managed in the range of 80 - 120 mg/dl. After discharge from the ICU, subjects will followed for adverse events and mortality at 30 days, either by telephone contact or office visit.

Conditions

Metabolic Stress Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Time in target

  Cumulative time in target band (expressed in percentage) will be calculated from the set of BG values recorded by the CGM in both groups.

  72 hours

Secondary Outcomes (6)

• Hypoglycaemic index

  72 hours

• Glycemic variability

  72 hours

• Mortality

  28 days

• Length of stay

  28 days

• SOFA score

  72 hours

Study Arms (2)

Continuous monitoring-guided therapy

OTHER

Healthcare providers were allowed to use the blood glucose values displayed on the intravascular continuous monitoring to adapt insulin therapy

Device: Intravascular continuous monitoring

Standard of care

OTHER

Healthcare providers used the usual intermittent method to adapt insulin therapy; the blood glucose values measured by the intravascular continuous monitoring were not displayed but recorded. Usual care involves the adjustment of insulin infusion based on BG values measured with a blood gas analyser 4-6 times per day.

Other: Standard of care

Interventions

Intravascular continuous monitoring DEVICE

Bedside usual insulin therapy guided by continuous glucose monitoring

Continuous monitoring-guided therapy

Standard of care OTHER

Bedside usual insulin therapy guided by intemittent glucose monitoring

Standard of care

Eligibility Criteria

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

You may qualify if:

• Have an anticipated ICU stay of at least 48 hours;
• Participate or have authorized representative participate in the Informed Consent process and sign/date the approved informed consent form.
• Have an expected ICU stay of ≥ 24 hours up to 72 hours
• Have an APACHE II score of ≥ 10, within the first 24 hours of ICU admission.
• Not be participating in any other investigational interventional study.
• Have hyperglycemia (BG \> 150 mg/dl) up to 6 hours after admission and / or ongoing insulin therapy.
• Access to a large peripheral vein

You may not qualify if:

• End stage pre-existing medical conditions that would preclude the subject from being able to complete up to 72 hours of glucose monitoring and follow up (14 ± 3 days after Sensor removal); Restricted peripheral venous access, inadequate access for reference sampling or any contraindication to the placement of peripheral IV catheters.
• Skin conditions or existing (or planned) medical instrumentation and/or dressings that preclude placing the peripheral IV catheters or dressings (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis, or surgical dressings).
• A known history of heparin-induced thrombocytopenia or any contraindication for anti-coagulation therapy.
• Intolerance to Lactated Ringer's solution ((mEq/liter): Sodium 130; Potassium 4; Calcium 3; Chloride 110; Lactate 28).
• A positive pregnancy test 72 hours prior to Sensor insertion (for subjects of child bearing potential).
• Any condition that, in the opinion of the Investigator, would interfere with their participation in the Study.
• Participated in any other drug, device, or biologic Study within the last 30 days (prior to Sensor insertion) which may clinically interfere with this Study or have not completed the required Protocol follow-up period.

Sponsors & Collaborators

• Erasme University Hospital: lead
• Edwards Lifesciences: collaborator

Related Publications (1)

• Preiser JC, Lheureux O, Thooft A, Brimioulle S, Goldstein J, Vincent JL. Near-Continuous Glucose Monitoring Makes Glycemic Control Safer in ICU Patients. Crit Care Med. 2018 Aug;46(8):1224-1229. doi: 10.1097/CCM.0000000000003157.

  PMID: 29677007 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jean-Louis Vincent, MD PhD

  Erasme University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: February 9, 2017
• Study Start: May 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2015
• Last Updated: March 13, 2017

Record last verified: 2017-02