Type 1 diabetes mellitus (T1D) affects 1.5 million people in the United States. With new cell and gene therapies for T1D on the horizon–requiring evidence of severe hypoglycemia and hypoglycemia unawareness–we analyzed current diagnosis patterns for hypoglycemia among people with T1D to better understand potential reporting limitations.

Hypoglycemia is broadly defined as abnormally low blood glucose levels caused by too much insulin in the body, which could expose an individual to potential harm. Hypoglycemia is a common condition experienced by people with T1D because of their impaired glucose regulatory responses and reliance on exogenous insulin for their treatment.

Breakthrough T1D, a research and advocacy organization, commissioned Milliman to analyze 2023 administrative claims data. We found that hypoglycemia, as a whole, may not be accurately reflected: Only 8% to 30% of people with T1D, depending on their insurance coverage, have evidence of hypoglycemia in their claims. Without proper consideration for when and how hypoglycemia is reflected in claims data, payers may underestimate the impact and value of new cell and gene therapies for T1D and therefore may not be able to determine reasonable criteria for access and coverage.

In the report, we discuss:

• Hypoglycemia prevalence: clinical expectations and administrative coding
• Consequences of incomplete hypoglycemia data
• New diagnosis codes for hypoglycemia and their potential impact

Download the full paper (PDF).

This report was commissioned by Breakthrough T1D.