TOPLINE

Among adults with insulin-treated type 2 diabetes (T2D), 13 weeks of use of the twiist automated insulin delivery (AID) system, which features a highly customizable algorithm, was associated with a significant reduction in A1c and an increase in time in target glucose range. No severe hypoglycemia occurred with the use of this device.

METHODOLOGY

• AID systems have been shown to be safe and effective in T2D. However, twiist, which is cleared by the FDA and commercially available for type 1 diabetes, had not been tested in T2D.
• Researchers conducted a single-arm pivotal trial to assess the effectiveness and safety of the twiist AID system in 307 adults aged 19-85 years with insulin-treated T2D.
• Participants first wore a continuous glucose monitoring (CGM) sensor to establish baseline glucose levels and then used twiist for 13 weeks.
• Participants were eligible if they had been using one of four insulin regimens for at least 13 weeks before screening: basal-bolus injections, an open-loop pump, premixed insulin, or basal insulin alone. Those already taking noninsulin glucose-lowering medications, such as GLP-1 receptor agonists (GLP-1 RAs) or SGLT2 inhibitors, continued taking them at a stable dose throughout the study.
• The primary outcome was the change in A1c levels, measured at a central laboratory, from baseline to 13 weeks. Secondary outcomes drew on CGM data and included time in range, mean sensor glucose, and percentage of time spent in various glucose ranges.

TAKEAWAY

• At 13 weeks, mean A1c levels reduced from a baseline of 8.1% to 7.4%, a decline of 0.7% (P < .001). Patients with A1c levels ≥ 9% at baseline showed the greatest reduction (from 10.3% to 8.2%).
• The mean time in range (70-180 mg/dL) rose from 57% to 73%, an increase in 16 percentage points (P < .001); the mean glucose levels, percentage of time above 180 mg/dL, and percentage of time above 250 mg/dL decreased significantly (P < .001 for all).
• No events of severe hypoglycemia were reported, and diabetic ketoacidosis was reported in just one patient.
• Patients reported sleeping better and feeling more satisfied with twiist than with the insulin delivery methods they used previously (P < .001 for both).

IN PRACTICE

"[Among] adults with insulin-treated type 2 diabetes, use of the twiist AID system was safe and associated with substantially improved glycemia. Certain unique features of the twiist system may be considered desirable by patients and providers when considering which AID system to use," the authors wrote.

"Benefit was observed in both users and nonusers of GLP-1 RA and SGLT2i [SGLT2 inhibitor] medications, indicating that AID can further improve glycemia beyond the beneficial glycemic effects of these drugs," they added.

SOURCE

This study was led by Carol J. Levy, MD, Icahn School of Medicine at Mount Sinai, New York City. It was published online in Diabetes Care.

LIMITATIONS

This was a single-arm study without a control group. The 13-week follow-up duration was insufficient to assess long-term cardiometabolic outcomes. In addition, the study did not quantify the time needed to train participants to use twiist.

DISCLOSURES

This study received funding from Sequel Med Tech through a grant to the Jaeb Center for Health Research. DEKA Research and Development Corporation provided the study pumps. Two authors declared being employees of Sequel Med Tech. Some authors reported receiving research funding, consulting fees, honoraria, or device support or having other ties with various pharmaceutical and device companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.