A Study to Evaluate Continuous Glucose Monitor in Hospitalized, Post-operative Patients With Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

Hospital Use of CGM (Continuous Glucose Monitor) in Post-operative Patients With Diabetes Mellitus at High Risk for Hypo and Hyperglycemia

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04845685
• Other study ID #: 20-010924
• Status: Suspended
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: November 8, 2025

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purposes of this study is to study if CGMs worn in the postoperative ICU or non-ICU hospital setting have adequate accuracy for blood glucose monitoring when compared to point-of-care (POC) capillary glucometers.

Description:

Eligible patients will be approached by research staff either preoperatively or on the first 5 days post-surgery and offered to be enrolled. If agreed to participate, they will be fitted with a blinded CGM monitor (Dexcom G6 PRO) as soon as they are awake and alert after the surgery. They will continue to have their blood glucose check as usual in the ICU and on surgical floors with POC glucometers. On discharge, or at the end of the first CGM sensor life, the sensor will be removed and sensor data will be analyzed. CGM data will be compared with Point-of-Care blood glucose monitoring obtained in the hospital.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: November 8, 2025
• Est. primary completion date: November 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with Type 1 or 2 Diabetes Mellitus.

• Patients 18 years of age or older.

• Admitted for deceased donor renal transplant surgery, pancreas transplant surgery, heart transplant surgery, liver transplant surgery and lung transplant surgery.

• Anticipated minimum of 72h hospital stay.

• Patients on insulin therapy (IV, SQ) post-surgery.

Exclusion Criteria:

• Active COVID-19 infection.

• Pregnant or lactating female.

• Altered Mental Status at the time of sensor placement (sensor will be placed once mental status will improve).

• Inability to provide informed consent.

• Patients taking more than 4 g of acetaminophen in 24 hours or more than 1 gm every 6 hours.

Patients with skin lesions at the application site that may interfere with placement of the sensor.

Patients with known allergy to medical grade adhesive.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Continuous Glucose Monitor (CGM)
A device that measures blood sugar levels every 1-5 minutes

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CGM accuracy	Measured by the mean absolute relative difference (MARD), calculated between matched pairs of POC (point of care) glucose monitors and the closest CGM reading. MARD will be summarized as mean (standard deviation) or median (range) for glucose readings <70g/dl, >180g/dl, >250g/dl respectively.	From date of enrollment and until discharge from the hospital up to 30 days.
Secondary	CGM recorded hypoglycemia episodes	The incidence and duration of hypoglycemic episodes	From date of enrollment and until discharge from the hospital up to 30 days.
Secondary	CGM recorded hyperglycemia episodes	The incidence of hyperglycemic episodes	From date of enrollment and until discharge from the hospital up to 30 days.