Study Stopped
Facility closure, awaiting relocation
Effects of HBO on Glucose in Patients With DM
Effects of Hyperbaric Oxygen Therapy on Glucose Homeostasis in Patients Living With Diabetes Mellitus
1 other identifier
interventional
24
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Sep 2022
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2020
CompletedFirst Posted
Study publicly available on registry
February 10, 2020
CompletedStudy Start
First participant enrolled
September 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 16, 2024
May 1, 2024
4.2 years
February 6, 2020
May 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
CGM Reading
Estimated glucose value from the continuous glucose monitor
10 days
CGM Reading from Data Logger
Estimated glucose value from the data logger
10 days
Fingerstick point of care glucose
Estimated glucose value from fingersticks during control and HBOT arms
2 days
Fingerstick point of care glucose
Estimated glucose value from fingersticks during the length of the study (4 times/day)
10 days
Hospital laboratory glucose
Estimated glucose value from venous blood during control and HBOT arms
2 days
Hba1c
Baseline Hba1c
One time only on day 3 of study
Secondary Outcomes (1)
Glucagon
2 days
Study Arms (2)
Control
NO INTERVENTIONThe first 2-hour session will be a control where participants will sit quietly (as they would in the hyperbaric chamber) and will not be allowed to consume carbohydrates unless directed to by the hyperbaric department hypoglycemia protocol.
Hyperbaric Oxygen
EXPERIMENTALThe following day for the HBO2 session, subjects will be fitted for an oxygen hood and given a standard HBO2 treatment. In the chamber the pressure will increase to approximately 2-1/2 times normal atmospheric pressure (2.4 atmospheres absolute \[ATA\]). Once they reach the treatment pressure, subjects will breathe oxygen by placing the hood over their head and securing it in place. They will breathe oxygen for a 30-minute period, and then take the hood off for 5 minutes for an "air break." They will have a total of three 30-minute oxygen periods and two 5-minute air breaks. A subject will be in the hyperbaric chamber for approximately 2 hours.
Interventions
Volunteers will be given a standard hyperbaric oxygen treatment (2.4 ATA x 90 minutes)
Eligibility Criteria
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 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Legacy Health Systemlead
- DexCom, Inc.collaborator
Study Sites (1)
Legacy Emanuel Medical Center
Portland, Oregon, 97227, United States
Related Publications (1)
Huang E, Demirel S, Bliss C, Savaser D, Castle JR. Reliability of the Dexcom G6 Continuous Glucose Monitor During Hyperbaric Oxygen Exposure. Diabetes Technol Ther. 2020 May;22(5):360-366. doi: 10.1089/dia.2019.0390. Epub 2020 Feb 6.
PMID: 31916854RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Enoch Huang, MD
Legacy Emanuel Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director, Hyperbaric Medicine and Wound Care Clinic
Study Record Dates
First Submitted
February 6, 2020
First Posted
February 10, 2020
Study Start
September 2, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 16, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share