Effects of HBO on Glucose in Patients With DM

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Conditions studied: Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1

In brief

The purpose of this Research Study is: 1. To determine the reliability and performance of the Dexcom G6® continuous glucose monitoring (CGM) system in patients with diabetes undergoing hyperbaric oxygen (HBO2) exposure. The study-specific blood glucose meter and CGM system are approved by the FDA (U.S. Food and Drug Administration). 2. To determine whether HBO2 exposure causes blood glucose to drop as a result of the treatment. 3. To determine whether HBO2 causes a change in blood glucagon (a hormone that raises blood glucose). Investigators will be comparing changes in blood glucose and glucagon in volunteers with diabetes who will be exposed to a single hyperbaric oxygen treatment (pressurization to 2.4 atmospheres absolute for 90 minutes) to a control period of 2 hours where volunteers will simulate a hyperbaric treatment while sitting in an examination room breathing room air at sea level pressure. Investigators will be measuring blood glucose with a variety of devices including a continuous glucose monitor, two point-of-care glucometers, and the hospital inpatient laboratory measurement of venous blood.

Key facts

Study ID

NCT04261738

Run by

Legacy Health System

People needed

24

Starts

2022-09-02

Expected to finish

2026-12-01

Last updated by the study team

2024-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Diagnosis of type 1 or type 2 diabetes
• Willing to have 2 subcutaneous glucose monitors for 10 days
• Willing to be NPO after midnight on the day of the study session
• Willing to come to the hyperbaric facility on successive days (one control session and one hyperbaric treatment), spending approximately 3 hours in the facility on each day of testing
• Willing to undergo multiple fingersticks on the days of testing
• Willing to have a peripheral intravenous catheter placed for blood sampling
• Willing to perform four daily fingerstick blood glucose checks throughout the study period

You may not qualify if…

• Contraindication to HBO2 as determined by the study investigator (e.g., pregnancy)
• Previous treatment with HBO2 within 30 days of enrollment
• Current use of CGM is not an exclusion, but participants must use study equipment during the study
• Current use of an insulin pump
• Known allergy to medical-grade adhesives
• Extensive skin changes/disease that preclude wearing the sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis)

Where it is running

• Legacy Emanuel Medical Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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