REGENT-1 Safety and Feasibility of Endoscopic Application of a Novel Therapy for Duodenal Mucosal Regeneration in the Treatment of Type II Diabetes Study)
Aim of Study:
The Regent-1 Study assesses the Endogenex Endoscopic Duodenal Mucosal Regeneration procedure for the treatment of Type 2 Diabetes. The Endogenex device is a novel investigational device that utilises pulsed electric fields to promote regeneration of the duodenal mucosa for improvement in glycemic control in patients with Type 2 Diabetes.
- Aged 18-70 years with Type 2 Diabetes (T2D
- BMI 24–40 kg/M2
Cohort 1: Treated with 1–4 non-insulin glucose lowering medications
- HbA1c 7.5–11.0%
- T2D ≤ 10 yrs
Cohort 2: Treated with basal or premix insulin +/– non-insulin glucose lowering medications
- HbA1c 7.0–9.5%
- On insulin for ≤ 10 yrs
- ≤ 60 IU/day with short/rapid acting components ≤ 30% of daily dose.
What will General Practices and General Practitioners be required to do?
- General Practitioners to review patient lists generated by the patient identification tool TORCHRecruit and refer eligible patients to REGENT-1 Research Team Trial
- $1000 honorarium for the participating general practice to assist with facilitation and coordination of Trial requirements
- General practitioners can apply for self-directed CPD hours
For more information, download the flyer below or visit the website: Endogenex for Type 2 Diabetes (regent1study.com.au)
The ethics code is EC00343
Project ID Number: 78474
St Vincent’s HREC Reference: HREC 187/21