2025/09/15 by Irl B. Hirsch, Michael R. Rickels, Dan Raghinaru +94 · 1 voice
Biochemistry, Genetics and Molecular Biology · Medicine · #Diabetes Management and Research #Diabetes and associated disorders #Pancreatic function and diabetes
paper · doi:10.2337/dc25-1125
openalex publication_date 2025/09/15 · openalex created_date 2025/10/10 · openalex updated_date 2026/07/22
OBJECTIVE: The Centers for Medicare & Medicaid Services (CMS) requires a low C-peptide level for insulin pump coverage unless the individual is β-cell autoantibody positive, which precludes coverage of automated insulin delivery (AID) systems for many people with type 2 diabetes. RESEARCH DESIGN AND METHODS: In the Randomized Trial Evaluating the Efficacy and Safety of Control-IQ+ Technology in Adults With Type 2 Diabetes Using Basal-Bolus Insulin Therapy study evaluating the t:slim X2 insulin pump with Control-IQ+ technology, adults with insulin-treated type 2 diabetes were categorized into high C-peptide (n = 195) and low C-peptide (n = 59) groups based on CMS criteria. RESULTS: In the AID group, mean HbA1c decreased from baseline by 0.8%, which was significantly greater than in the control group with both high (P < 0.001) and low (P = 0.02) C-peptide levels. Results were similar in participants ≥65 years old. CONCLUSIONS: The benefit of AID is present with high and low C-peptide levels. Thus, requiring a low C-peptide level as a prerequisite for AID therapy is not warranted.