Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000847415p
Ethics application status
Submitted, not yet approved
Date submitted
3/07/2025
Date registered
6/08/2025
Date last updated
6/08/2025
Date data sharing statement initially provided
6/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study of Quantum Salt-Enhanced (QSE) Phototherapy for Type 1 Diabetes
Scientific title
A Pilot Clinical Study of Quantum Salt-Enhanced (QSE) Phototherapy for Improving Glycaemic Control in Individuals with Type 1 Diabetes Mellitus
Secondary ID [1] 314811 0
None
Universal Trial Number (UTN)
Trial acronym
EndoQSE-T1D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus 338065 0
Condition category
Condition code
Metabolic and Endocrine 334361 334361 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive daily 30-minute sessions of Quantum Salt-Enhanced (QSE) phototherapy for 15 to 21 consecutive days, depending on individual tolerance and scheduling adherence. The intervention uses a non-invasive device (EndoQSE) that emits low-frequency pulsed infrared light in the range of 4.0 to 7.2 Hz, modulated through crystallised mineral salts—lithium chloride (LiCl), magnesium chloride (MgCl2), and zinc chloride (ZnCl2).

Each session comprises three consecutive 10-minute phases with no break between phases, each employing a distinct frequency and mineral salt:

Phase 1 – T-regulatory cell focus (LiCl-modulated frequency: ~4.2 Hz)

Phase 2 – ß-cell inflammatory pathway focus (MgCl2-modulated frequency: ~5.6 Hz)

Phase 3 – Insulin secretion pathway focus (ZnCl2-modulated frequency: ~6.8 Hz)

Sessions are administered at the study clinic by trained research staff. The mineral salts are sealed in ampoules within the device’s optical chamber and are not applied to the participant. The infrared output passes through these crystalline modules, delivering modulated frequency information to the abdominal region (pancreatic zone) via a low-intensity infrared beam (approx. 5 cm in diameter).

The total intervention duration will be a minimum of 15 days, extendable to 21 days if the participant experiences no adverse effects and agrees to continue. Adherence will be monitored via:

Daily attendance logs

Standardised session checklist forms completed by staff

Pre- and post-session feedback questionnaires

No pharmacological substances are introduced into the body; the intervention involves photonic frequency modulation only.
Intervention code [1] 331408 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342048 0
Fasting blood glucose level
Timepoint [1] 342048 0
Assessed daily from Day 1 to Day 21, prior to the commencement of each phototherapy session. Additional reference measurements at Baseline (Day 0) and final assessment (Day 21).
Secondary outcome [1] 449422 0
HbA1c level
Timepoint [1] 449422 0
Evaluated at baseline (Day 0) and Day 21 post-intervention commencement

Eligibility
Key inclusion criteria
Aged 10 to 40 years

Confirmed diagnosis of Type 1 Diabetes Mellitus for at least 3 years (i.e., greater than or equal to 36 months)

On a stable insulin regimen for the past 3 months or longer (either via injection or pump)

Able to attend daily 30-minute clinic visits for the full study period

Able to provide informed consent (or assent with guardian consent for ages 10–15)
Minimum age
10 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of diabetes other than Type 1 Diabetes (e.g., Type 2, MODY, or secondary diabetes)

Use of non-insulin glucose-lowering medications (e.g., GLP-1 agonists, SGLT2 inhibitors) within the last 3 months

History of diabetic ketoacidosis in the last 6 months

Presence of advanced diabetes complications (e.g., proliferative retinopathy, stage 3+ nephropathy, severe neuropathy)

Severe hypoglycaemia unawareness

Major medical illness or condition that could interfere with participation (e.g., cancer, immunodeficiency, epilepsy)

Pregnancy or breastfeeding

Participation in another interventional clinical trial within the past 3 months

Inability to comply with daily clinic visits or give informed consent/assent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study; formal hypothesis testing is not planned. Descriptive statistics will be used to summarise outcomes, including changes in fasting glucose, HbA1c, and patient-reported measures from baseline to end-of-treatment. Where appropriate, paired t-tests or Wilcoxon signed-rank tests may be applied to assess within-subject differences pre- and post-intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2025
Actual
Date of last participant enrolment
Anticipated
15/10/2025
Actual
Date of last data collection
Anticipated
15/11/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 27179 0
New Zealand
State/province [1] 27179 0

Funding & Sponsors
Funding source category [1] 319370 0
Commercial sector/Industry
Name [1] 319370 0
Quantech Group Limited
Country [1] 319370 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Quantech Group Limited
Address
Country
New Zealand
Secondary sponsor category [1] 321855 0
None
Name [1] 321855 0
Address [1] 321855 0
Country [1] 321855 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317944 0
Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 317944 0
Ethics committee country [1] 317944 0
New Zealand
Date submitted for ethics approval [1] 317944 0
10/07/2025
Approval date [1] 317944 0
Ethics approval number [1] 317944 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142642 0
Mr Viktor Volkov
Address 142642 0
Quantech Group Ltd – Clinical Research Division (Proposed study site, pending final site agreement) Health Space Clinic Unit 6, 44 Silverdale Street Silverdale, Auckland 0932 New Zealand
Country 142642 0
New Zealand
Phone 142642 0
+64 2108792360
Fax 142642 0
Email 142642 0
[email protected]
Contact person for public queries
Name 142643 0
Viktor Volkov
Address 142643 0
Quantech Group Ltd – Clinical Research Division (Proposed study site, pending final site agreement) Health Space Clinic Unit 6, 44 Silverdale Street Silverdale, Auckland 0932 New Zealand
Country 142643 0
New Zealand
Phone 142643 0
+64 2108792360
Fax 142643 0
Email 142643 0
[email protected]
Contact person for scientific queries
Name 142644 0
Viktor Volkov
Address 142644 0
Quantech Group Ltd – Clinical Research Division (Proposed study site, pending final site agreement) Health Space Clinic Unit 6, 44 Silverdale Street Silverdale, Auckland 0932 New Zealand
Country 142644 0
New Zealand
Phone 142644 0
+64 2108792360
Fax 142644 0
Email 142644 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor

• Requests must demonstrate alignment with the scientific goals of the study and include a data protection and privacy statement.

What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected] Available on request after primary results publica... [More Details]


Results publications and other study-related documents

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