Fully Closed-Loop Improves Glycemic Control Compared with Pump with CGM in Adolescents with Type 1 Diabetes and HbA1c...

Area of Science:

• Endocrinology
• Metabolic Diseases
• Pediatric Diabetes Management

Background:

• Adolescents with type 1 diabetes (T1D) often struggle to achieve recommended HbA1c targets.
• The safety and efficacy of fully closed-loop (FCL) insulin delivery systems, which eliminate the need for mealtime boluses, have not been extensively studied in this population.
• This study investigated FCL insulin delivery using faster insulin aspart (Fiasp) in adolescents with T1D and suboptimal glycemic control.

Purpose of the Study:

• To evaluate the efficacy and safety of FCL insulin delivery with CamAPS HX and Fiasp in adolescents with T1D and HbA1c above target.
• To compare glucose control metrics, including time in target range, hyperglycemia, and hypoglycemia, between FCL and standard insulin pump therapy with continuous glucose monitoring (CGM).

Main Methods:

• A two-center, randomized, crossover study involving 24 adolescents (13-19 years) with T1D and above-target HbA1c.
• Participants used either FCL with Fiasp or standard insulin pump therapy with CGM for two 8-week periods in a randomized order.
• Primary endpoint was the percentage of time glucose levels were within the target range (3.9-10.0 mmol/L).

Main Results:

• FCL therapy significantly increased time in target glucose range compared to standard pump therapy (45.2% vs. 32.3%, P < 0.001).
• FCL use resulted in lower time spent in hyperglycemia (>13.9 mmol/L) and lower mean glucose levels.
• The proportion of time spent in hypoglycemia (<3.9 mmol/L) was similar between the two interventions, and no severe hypoglycemia or ketoacidosis events occurred.

Conclusions:

• Fully closed-loop (FCL) insulin delivery with CamAPS HX and Fiasp significantly improved glycemic control in adolescents with T1D and above-target HbA1c.
• The FCL system demonstrated a favorable safety profile, with no increase in severe hypoglycemia.
• FCL technology offers a promising advancement for managing T1D in adolescents who struggle to meet glycemic targets with conventional pump therapy.