Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000848404p
Ethics application status
Submitted, not yet approved
Date submitted
4/07/2025
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 2 Diabetes
Scientific title
A Pilot Clinical Study of Quantum Salt-Enhanced (QSE) Phototherapy for Improving Glycaemic Control in Individuals with Type 2 Diabetes Mellitus
Secondary ID [1] 314812 0
None
Universal Trial Number (UTN)
Trial acronym
EndoQSE-T2D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 338066 0
Condition category
Condition code
Metabolic and Endocrine 334362 334362 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 21 consecutive days. The intervention is delivered using a non-invasive device (EndoQSE) that emits low-frequency pulsed infrared light in the range of 3.7 to 8.4 Hz, modulated via sealed crystallised salt ampoules containing potassium chloride (KCl), sodium chloride (NaCl), and chromium(III) chloride (CrCl3).
The infrared beam (diameter ~5 cm) is directed at the abdominal region (pancreatic-liver axis) and passes through the salt ampoules embedded in the optical chamber of the device. No mineral salts are applied directly to the participant’s skin.

Each session consists of three continuous 10-minute phases, without breaks, targeting the following physiological domains:

Phase 1: Insulin sensitivity domain (modulated by KCl; ~3.7–5.2 Hz)

Phase 2: Hepatic glucose activity domain (modulated by NaCl; ~5.4–6.8 Hz)

Phase 3: ß-cell function domain (modulated by CrCl3; ~6.9–8.4 Hz)

The proportion and configuration of salts are pre-determined and standardised in the device’s crystalline modules; no individual tailoring is used in this pilot study. The phototherapy is administered by trained clinical staff at the study site. Participants do not handle the device or the ampoules themselves.

Adherence to the intervention will be assessed through:

Daily attendance logs maintained by study staff

Session checklists confirming treatment duration and phases completed

Participant feedback forms at mid-treatment and end-of-treatment visits

The total duration of the treatment is fixed at 21 days, with no optional extension or early cessation unless adverse events arise.
Intervention code [1] 331409 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342049 0
Fasting blood glucose level
Timepoint [1] 342049 0
Assessed daily from Day 1 to Day 21, with capillary glucose samples taken prior to the commencement of each phototherapy session. Additional reference measurements at Baseline (Day 0) and at the end of treatment (Day 21).
Secondary outcome [1] 449423 0
HbA1c level
Timepoint [1] 449423 0
Assessed daily from Day 1 to Day 21, with capillary glucose samples taken prior to the commencement of each phototherapy session. Additional reference measurements at Baseline (Day 0) and at the end of treatment (Day 21).

Eligibility
Key inclusion criteria
Eligibility
Key inclusion criteria

Age 30 to 65 years

Diagnosed with Type 2 Diabetes Mellitus (per WHO/ADA criteria)

Stable oral hypoglycaemic or non-insulin injectable regimen for at least 3 months

HbA1c between 6.5% and 9.0% within the past 6 weeks

Willing and able to attend daily 30-minute clinic visits for 21 days

Able to provide informed consent
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of insulin therapy

History of diabetic ketoacidosis

Presence of advanced complications (e.g., nephropathy stage 3+, active ulcers, severe retinopathy)

Uncontrolled hypertension (BP >160/100 mmHg)

Severe cardiovascular or neurological disorders

Cancer or immune-related disorders

Pregnancy or breastfeeding

Participation in another interventional clinical trial within 3 months

Inability to attend daily clinic sessions or provide consent

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 pilot study will use descriptive statistics to report pre-post changes in fasting glucose, HbA1c, and subjective outcomes. Where applicable, paired t-tests or Wilcoxon signed-rank tests will be used to explore within-subject changes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/08/2025
Actual
Date of last participant enrolment
Anticipated
20/10/2025
Actual
Date of last data collection
Anticipated
20/11/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 27180 0
New Zealand
State/province [1] 27180 0

Funding & Sponsors
Funding source category [1] 319371 0
Commercial sector/Industry
Name [1] 319371 0
Quantech Group Limited
Country [1] 319371 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Quantech Group Limited
Address
Country
New Zealand
Secondary sponsor category [1] 321856 0
None
Name [1] 321856 0
Address [1] 321856 0
Country [1] 321856 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317946 0
Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 317946 0
Ethics committee country [1] 317946 0
New Zealand
Date submitted for ethics approval [1] 317946 0
10/07/2025
Approval date [1] 317946 0
Ethics approval number [1] 317946 0

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

Contacts
Principal investigator
Name 142646 0
Mr Viktor Volkov
Address 142646 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 142646 0
New Zealand
Phone 142646 0
+64 2108792360
Fax 142646 0
Email 142646 0
[email protected]
Contact person for public queries
Name 142647 0
Viktor Volkov
Address 142647 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 142647 0
New Zealand
Phone 142647 0
+64 2108792360
Fax 142647 0
Email 142647 0
[email protected]
Contact person for scientific queries
Name 142648 0
Viktor Volkov
Address 142648 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 142648 0
New Zealand
Phone 142648 0
+64 2108792360
Fax 142648 0
Email 142648 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)
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?
Yes: Requests must:

Be aligned with the scientific objectives of the study

Include a data protection and privacy plan

Be reviewed by the sponsor or data custodian

Comply with New Zealand data privacy and ethics regulations





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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