Clinical utility of the twiist Automated Insulin Delivery System: first study with twiist

Randomized controlled trials and real-world studies have demonstrated that automated insulin delivery (AID) systems enhance glycemic control and mitigate hypoglycemia risk in individuals with type 1 diabetes. This study evaluated the safety, effectiveness, and usability of the twiist AID System on glycemic outcomes in adults with type 1 diabetes.

This 8-week, prospective, single-center, single-arm study included 20 adults with type 1 diabetes. The primary outcome measures were the percent of time spent in established continuous glucose monitoring (CGM) glycemic target ranges at 8 weeks. The primary efficacy outcome was percent time in range (%TIR; 70-180 mg/dL) at 8 weeks. Secondary outcomes were the change in glucose pre-occlusion detection; the effects of total daily insulin delivery (TDD) on glucose pre- and post-occlusion detection; the effect of Max basal ratio on %TIR; the effect of users' correction range on %TIR; and change in glycated haemoglobin (HbA1c). Changes in TDD and body weight were also assessed.

19 participants completed the study. At 8 weeks, the mean %TIR was 70.3±15.5%. Participants achieved or maintained glycemic targets for all CGM metrics except time above >250 mg/dL. A total of 67 occlusion events occurred in 15 participants. These events were detected within 30 min of rising glucose. Higher max basal ratio settings were associated with higher %TIR. The %TIR for participants with a correction range <100 mg/dL was 79.2±13.4% vs 67.2±15.0% for those with a correction range >100 mg/dL. HbA1c levels decreased (-0.4%±0.5%) in participants with baseline HbA1c >7%. A slight increase in TDD (1.3±16.2 U) and a decrease in body weight (-0.09±2.9 kg) were observed. No serious adverse events were reported.

Eight-week use of twiist enabled participants to achieve or maintain established glycemic targets and suggests the system's ability to detect occlusions before clinically significant glucose rise regardless of TDD. Larger and longer term studies are needed.