NCT04261738Terminated
Effects of HBO on Glucose in Patients With DM
Effects of Hyperbaric Oxygen Therapy on Glucose Homeostasis in Patients Living With Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 6 Feb 2020
- Start date
- 2 Sept 2022
- Primary completion date
- 4 Sept 2025
- Lead sponsor
- Legacy Health System
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT04261738
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with HBO2 within 30 days of enrollment
Other illness
- 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)
Other
- Contraindication to HBO2 as determined by the study investigator (e.g., pregnancy)
- Current use of CGM is not an exclusion, but participants must use study equipment during the study
- Current use of an insulin pump
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Legacy Emanuel Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.