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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04845685
Other study ID # 20-010924
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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