Patients will be randomized at a ratio of 2:1, to hyperbaric chamber (100% oxygen at 2 ATA)

Patients will be randomized at a ratio of 2:1, to Sham chamber (21% oxygen at 1 ATA)

T1DM

HBOC group will receive 100% oxygen at 2 ATA for 90 min with 5 min air breaks every 20 min at each session. Intensive management period includes 60 daily sessions, 5 days per week within 12 weeks,

Hyperbaric oxygen chamber (HBOC)

sham Hyperbaric oxygen chamber (HBOC)

Efficacy of Hyperbaric Oxygen Therapy (HBOT) in New-onset Type-1 Diabetes Mellitus

Double Blind, Randomized Controlled Study to Evaluate the Efficacy of Hyperbaric Oxygen Therapy (HBOT) in New-onset Type-1 Diabetes Mellitus

Difference between treatment groups (HBOT/SHBC) in change of β cell function (measured by AUC of stimulated C peptide) from screening to end of study (52 weeks).

Difference between treatment groups (HBOT/SHBC) in change of β cell function (measured by C-max of stimulated C peptide) from screening to end of study (52 weeks).

Difference between groups in achievement of glycemic targets according to ITDD, with a lower ITDD. assessed by: mean and SD of glucose, CV, time spent in range >70%, and time spent at hypoglycemic range < 1% at end of treatment periods, IDD according to weight.

Assaf Harofeh MC

Head Pediatric Endocrinology Unit

A computer with an adaptive model algorithm will guide oxygen weaning.

Oxygen weaning will be done by staff manually.

Hyperoxia

Hypoxia

Oxygen therapy weaning will be guided by a model-based computer algorithm. The computer will detect patients' oxygen saturation and made recommendations for oxygen weaning. A clinical at the bedside will make the adjustments in oxygen therapy if appropriate.

Computer-assisted Oxygen Weaning

Lucile Packard Childrens Hospital

Computer-assisted Oxygen Therapy Weaning in Critically Ill Children

Weaning Oxygen Therapy With Model-based Adaptive Control

Duration of time patients exposed to hyperoxia

Incidence of hypoxia during weaning process

Duration of hypoxia during weaning process

Duration of time oxygen saturation in target range

Incidence high oxygen delivery administration

Duration of time oxygen is delivered at high setting

Azadeh Fayazi

Clinical Assistant Professor

Stanford University

The intervention group will have oxygen therapy adjustment by computer-assistance. The control group will have adjustments by staff.

40 consecutive one hour treatments at 1.5 ATA with 100% O2

hyperoxia/seizures

Efficacy of Hyperbaric Oxygen Therapy (HBOT) in New-onset Type-1 Diabetes Mellitus

Computer-assisted Oxygen Therapy Weaning in Critically Ill Children

The Effect of Hyperbaric Oxygen Therapy on Patients Suffering From Neurologic Deficiency Due Traumatic Brain Injury

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