MedTrace Logo

Effects of HBO on Glucose in Patients With DM

NCT04261738 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-05-16

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Hyperbaric Oxygen

Volunteers will be given a standard hyperbaric oxygen treatment (2.4 ATA x 90 minutes)

Sponsors & Collaborators

  • DexCom, Inc.

    collaborator INDUSTRY

  • Legacy Health System

    lead OTHER

Principal Investigators

  • Enoch Huang, MD · Legacy Emanuel Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-02
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04261738 on ClinicalTrials.gov