None listed
Conditions
Brief summary
This pilot study aims to evaluate the safety and preliminary efficacy of Quantum Salt-Enhanced (QSE) phototherapy using the EndoQSE device in adults with Type 2 Diabetes. The intervention uses low-frequency infrared light modulated by crystallised salts to target glycaemic regulation mechanisms through the abdominal skin over 21 days.
Interventions
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.
Sponsors
Study design
Eligibility
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
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