What question did this study set out to answer?

The central aim is to evaluate how accurately hypoglycemia is represented in administrative claims data for type 1 diabetes and compare it with clinical study rates.

June 7, 2026

2695-LB: Evidence of Hypoglycemia in Claims for People with Type 1 Diabetes

Key Points

The central aim is to evaluate how accurately hypoglycemia is represented in administrative claims data for type 1 diabetes and compare it with clinical study rates.
Analyzed 2021-2023 Medicare, Medicaid, and commercial claims data for people with type 1 diabetes.
Calculated annual rates of hypoglycemia based on diagnosis and treatment codes.
Estimated prevalence of hypoglycemic events using specific diagnosis codes from claims.
10-17% of individuals with type 1 diabetes showed hypoglycemia evidence on claims, lower than the clinical estimate of 38%.
3-7% had severe hypoglycemia recorded on emergency or inpatient claims, compared to clinical reports of up to 20%.
Claims data may not accurately reflect the true occurrence of hypoglycemic events in real-world settings.

Abstract

Introduction and Objective: Clinical trials for cell and gene therapies to treat type 1 diabetes (T1D) often require evidence of hypoglycemia unawareness and severe hypoglycemic events for treatment eligibility. Payers use administrative claims data to understand which people may qualify for new therapies based on trial criteria, which raises the question of how closely hypoglycemia coding in claims reflects clinical estimates of prevalence. Objective: The purpose of this study is to assess evidence of hypoglycemia in administrative claims and compare claims-based prevalence to rates in clinical studies. Methods: We used 2021-2023 Medicare, Medicaid, and commercial enrollment and medical/pharmacy claims data to identify people with T1D and calculate rates of hypoglycemia and severe hypoglycemic events. We identified people with T1D based on T1D ICD-10-CM diagnosis codes and HCPCS and NDC codes for insulin and T1D-related devices on medical and pharmacy claims. We then looked for hypoglycemia diagnosis codes in 2023 to estimate annual hypoglycemia prevalence for people with T1D. Results: We identified 10-17% of people with T1D with evidence of hypoglycemia on any claim annually, substantially lower than prevalences reported in clinical studies of at least 38%. Only 3-7% of people with T1D had evidence of hypoglycemia on an emergency department or acute inpatient claim (i.e., a severe hypoglycemic event). This observed prevalence of severe hypoglycemia is also lower than described in previously published studies - some report prevalence of up to 20%. Conclusion: Hypoglycemic events often occur in real time, outside of a clinical setting. Claims data may not fully reflect the frequency of hypoglycemic events among people with T1D. Relying on claims alone may result in coverage decision making that does not reflect real-world care for people with T1D. Additional research and alternative data sources are needed to fully evaluate the impact of hypoglycemia unawareness and severe hypoglycemic events in this population. Disclosure R.A. Smith: Consultant; Current; Medtronic, JDRF, LabCorp. A. Turner-Phifer: None. S. Pincus: None. J. LeGrand: Employee; Current; JDRF. Y. Omer: Employee; Current; JDRF. C. Cypra: None. H.C. Norris: Consultant; Current; My institution consults to various healthcare industry stakeholders. C. Scott: Consultant; Current; My organization consults to a variety of industry stakeholders. W. Fopalan: Consultant; Current; My institution (Milliman) consults for a variety of healthcare stakeholders.

AI से पूछें

Bookmark