Type 2 Diabetes Trial, Not Yet Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- The person must be willing and able to give written consent to take part in the study.
- The person must be 22 years of age or older.
- The person must have a body mass index (BMI) between 30 and 50 kg/m².
- The person must have an HbA1c (a blood sugar level measured over time) between 7.5% and 10.5%.
- The person must have Type 2 Diabetes currently managed with a specific type of diabetes medication called a GLP-1 or GLP-1/GIP medication, at the highest dose they can tolerate for at least 6 months, with or without other diabetes tablets, and their doctor must be planning to start them on insulin.
- The person's weight must have been stable (changed by less than 5% of total body weight) in the 3 months before the screening visit.
- The person must meet the medical requirements for a specific weight loss stomach procedure using a device called the OverStitch™ or OverStitch NXT™ system (confirm with trial site).
- The person must have declined or been found unsuitable for metabolic or bariatric (weight loss) surgery.
- The person must agree not to use any weight loss treatments or supplements outside of the study's lifestyle program for one year after the procedure.
- The person must be willing and able to follow the study schedule, including the lifestyle program and all required visits.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People currently using insulin to manage their diabetes (previous short-term insulin use during pregnancy or for up to one month during a serious illness may be acceptable — confirm with trial site).
- People who have not been following their prescribed diabetes medication routine consistently.
- People who have had episodes of reactive or severe low blood sugar within the past year.
- People who have experienced diabetic ketoacidosis or a condition called hyperosmolar nonketotic coma within the past year.
- People with any known conditions that affect weight loss or blood sugar control.
- People taking long-term steroid or immune-suppressing medications at the time of joining, or who are likely to need them during the study.
- People with moderate-to-advanced kidney disease, defined as an eGFR (a measure of kidney function) below 60 mL/min.
- People with ongoing low red blood cell levels (anaemia), specifically a haemoglobin level below 10 g/dL.
- People who drink alcohol at levels considered "heavy drinking" based on guidelines for their sex.
- People who have used prescription or over-the-counter weight loss medications or supplements in the three months before screening, or who plan to use any during the study.
- People whom the trial doctor does not consider suitable for the stomach procedure, based on medical, psychological, or nutritional assessments done in the past 12 months.
- People who are currently pregnant, planning to become pregnant, or breastfeeding within the year following the procedure.
- People considered to be vulnerable subjects (confirm with trial site).
- People who are currently taking part in, or planning to join, another clinical study.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Ildiko Lingvay, MD, UT Southwestern
Phone: 781-305-0506
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Primary endpoints
Serious Adverse Events; Average Change in HbA1c
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.