A Feasibility Study to Evaluate the Safety and Effectiveness of a Continuous Blood Glucose Monitor In Adults with Diabetes Mellitus

Glucotrack Australia PTY LTD.0 个研究点目标入组 30 人开始时间: 2025年8月28日最近更新: 2026年7月13日

适应症

试验速览

暂无简介。

•Age 21 to 75 years old inclusive.
•Generally, in good health, as determined by the investigator.
•Clinical diagnosis of type 1 or type 2 diabetes for at least 3 years
•Insulin Therapy – 3 plus injections/day or Continuous Subcutaneous Insulin Infusion (CSII) in Participants with type 1 diabetes, or with basal insulin or multi-dose insulin regimen in Participants with type 2 diabetes.
•HbA1c < 9.0 % as reported on baseline laboratory result.
•BMI in the range 18–32 kg/m2.

•Any biochemical profile, full blood examination or differential result that falls outside the laboratory’s reference range and deemed by the investigator as clinically significant or indicative of a serious chronic illness.
•History of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), or blood clotting disorder that, in the opinion of the Investigator, would compromise the safety of the study Participant.
•Female Participant of childbearing potential who has a positive pregnancy screening test or who is planning to become pregnant or not using adequate method of contraception deemed reliable by Investigator.
•One (1) or more episodes of hypoglycemia or diabetic ketoacidosis (DKA) in the last 6 months requiring an emergency room (ER) visit or hospital admission.
•Known cardiovascular disease that, in the opinion of the Investigator, would compromise the safety of the study Participant.
•End Stage Renal Disease on hemodialysis.
•Current participation in another clinical drug or device study.

发起方

Glucotrack Australia PTY LTD.