Post-Treatment Monitoring

Currently, the treatment with teplizumab to prevent/slow progression from Stage 2 type 1 diabetes to Stage 3 type 1 diabetes is a one-time therapy. Once the 14-days of treatment have been completed, surveillance and monitoring the patient’s metabolic stability is now required. The median delay from Stage 2 to Stage 3 type 1 diabetes is 32 months and following these patients over time is imperative.

Surveillance will involve periodic evaluation of insulin secretion and glucose stability. This can be performed by OGTT every 6 months, A1C every 3 to 6 months, or using CGM as frequently as the patient desires. The concern with CGM surveillance is the consideration that patients may implement a low CHO diet to reduce glucose spikes and therefore rendering the CGM and A1C less relevant to evaluating progression to Stage 3 as compared to the OGTT. However, the OGTT is a cumbersome test and adherence with having it done at a frequency of every 6 months needs to also be considered.

Patient and caregiver education regarding the signs and symptoms of hyperglycemia and when to seek emergent care is critical to prevent severe and life-threatening hyperglycemia crisis (DKA).

In terms of safety, monitoring for adverse events following the last infusion is recommended, and the period of monitoring depends on the severity of abnormalities at the end of infusion or until the abnormalities are resolved. More specifically, it is recommended to monitor for potential viral reactivation for at least 2 months following the last infusion. Additional post-treatment safety considerations can be found in the references below.