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Effects of HBO on Glucose in Patients With DM

Primary Purpose

Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperbaric Oxygen
Sponsored by
Legacy Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring hyperbaric oxygen, continuous glucose monitor, hbo, cgm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Legacy Emanuel Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Hyperbaric Oxygen

Arm Description

The 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.

The 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.

Outcomes

Primary Outcome Measures

CGM Reading
Estimated glucose value from the continuous glucose monitor
CGM Reading from Data Logger
Estimated glucose value from the data logger
Fingerstick point of care glucose
Estimated glucose value from fingersticks during control and HBOT arms
Fingerstick point of care glucose
Estimated glucose value from fingersticks during the length of the study (4 times/day)
Hospital laboratory glucose
Estimated glucose value from venous blood during control and HBOT arms
Hba1c
Baseline Hba1c

Secondary Outcome Measures

Glucagon
We will determine whether HBOT has any effect on glucagon levels on control and HBOT arm

Full Information

First Posted
February 6, 2020
Last Updated
March 7, 2023
Sponsor
Legacy Health System
Collaborators
DexCom, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04261738
Brief Title
Effects of HBO on Glucose in Patients With DM
Official Title
Effects of Hyperbaric Oxygen Therapy on Glucose Homeostasis in Patients Living With Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Legacy Health System
Collaborators
DexCom, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this Research Study is: 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). To determine whether HBO2 exposure causes blood glucose to drop as a result of the treatment. 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.
Detailed Description
The purpose of this Research Study is to determine whether the Dexcom G6® continuous glucose monitoring (CGM) system accurately estimates blood glucose in diabetic patients undergoing hyperbaric oxygen (HBO2) exposure. The study-specific CGM system is approved by the FDA (U.S. Food and Drug Administration). Subjects will have the Dexcom CGM inserted underneath the skin of their abdomen. This is done in the office. It is secured to the skin by use of an adhesive patch. The sensor measures glucose levels just underneath the skin. A transmitter is fastened on top of the sensor and sends this information wirelessly to a receiver or compatible smart device. Study participants will also have second sensor inserted in the subcutaneous tissue on the back of the arm as a backup in case of data loss. The subjects will wear the sensors for at least 48 hours and then return to the Hyperbaric Medicine Clinic. At the Hyperbaric Medicine Clinic, study staff will check the CGM system to make sure it has been working properly. The 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. The following day for the HBO2 session, subjects will be fitted for an oxygen hood and given a standard HBO2 treatment. Investigators will obtain concurrent transcutaneous oximetry measurements (TCOM) attached no farther than 3 cm from the commercial CGM on the abdomen to measure tissue oxygenation in the region of the CGM only during HBO2 exposure. The hyperbaric oxygen therapy chamber can accommodate 12 patients at a time. Study subjects could be in the chamber along with regularly scheduled patients. 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. Blood sampling will be identical for both the control and HBO2 exposure days. Subjects will have a peripheral intravenous (IV) catheter placed and a total of 12 samples collected to measure venous blood glucose (12 timepoints), glucagon levels (3 timepoints) and HgA1c, (one time). A RN or MD will be inside the chamber to monitor the subjects and to obtain the IV blood samples. Because CGMs have not been established to be reliable under HBO2 conditions in patients with DM, the protocol will collect Point-of-Care (POC) glucose measurements using the hospital's standard glucometer (Nova Biomedical, Waltham, MA) and the AccuChek Inform II POC glucometer (Roche Diagnostics, Indianapolis, IN) at each testing point. This will be done using a lancet to pierce the skin of the fingertip to get a drop of blood. Subjects in both groups will also be required to perform home glucose monitoring (4 times per day) and record mealtimes and the time of any medications taken throughout the study period. Subjects will return to the clinic on Day 10. The CGM sensor will be removed and the transmitter and display device collected by staff. Removed sensors will be returned to the manufacturer for analysis. That is the end of the subject's study participation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
Keywords
hyperbaric oxygen, continuous glucose monitor, hbo, cgm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Control exposure followed by Hyperbaric Oxygen exposure
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
The 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.
Arm Title
Hyperbaric Oxygen
Arm Type
Experimental
Arm Description
The 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.
Intervention Type
Device
Intervention Name(s)
Hyperbaric Oxygen
Other Intervention Name(s)
HBOT, HBO2
Intervention Description
Volunteers will be given a standard hyperbaric oxygen treatment (2.4 ATA x 90 minutes)
Primary Outcome Measure Information:
Title
CGM Reading
Description
Estimated glucose value from the continuous glucose monitor
Time Frame
10 days
Title
CGM Reading from Data Logger
Description
Estimated glucose value from the data logger
Time Frame
10 days
Title
Fingerstick point of care glucose
Description
Estimated glucose value from fingersticks during control and HBOT arms
Time Frame
2 days
Title
Fingerstick point of care glucose
Description
Estimated glucose value from fingersticks during the length of the study (4 times/day)
Time Frame
10 days
Title
Hospital laboratory glucose
Description
Estimated glucose value from venous blood during control and HBOT arms
Time Frame
2 days
Title
Hba1c
Description
Baseline Hba1c
Time Frame
One time only on day 3 of study
Secondary Outcome Measure Information:
Title
Glucagon
Description
We will determine whether HBOT has any effect on glucagon levels on control and HBOT arm
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enoch Huang, MD
Phone
503-413-1042
Email
enhuang@lhs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Bette Manulik
Phone
503-413-4365
Email
BManulik@LHS.ORG
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enoch Huang, MD
Organizational Affiliation
Legacy Emanuel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Legacy Emanuel Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enoch Huang, MD
Phone
503-413-1042
Email
enhuang@lhs.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31916854
Citation
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.
Results Reference
result

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Effects of HBO on Glucose in Patients With DM

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