Kimberly Simmons, MD, MPH/MSPH, leads a discussion on long-term monitoring for patients with type 1 diabetes and which providers are most likely to administer and manage teplizumab treatment.
Robert Busch, MD: When the patient gets the 2-week infusion done, they haven’t had the adverse effect, and they go home, who should be monitoring the patient afterward, and what kind of monitoring, Dr Simmons, would you recommend for those patients who’ve had the infusion? Now they have gone home from the infusion site, and they’re happy they will delay their diabetes, so what kind of monitoring would you recommend?
Kimberly Simmons, MD, MPH/MSPH: This is another area where we have limited evidence to know what to do. It’s important to know that some of these patients will develop type 1 diabetes, and so you don’t want them to never be seen again. Having some sort of monitoring to make sure they’re not progressing to clinical diabetes probably every 6 months or so would be important, and then having a tool at home, a way to check blood glucose levels, so if there’s any concern they can seek attention earlier, would be a good way to start.
Robert Busch, MD: Would you send a letter to their pediatrician saying this is what they’re doing? Or do you think the person administering the drug, the site administering would be doing the monitoring? What would you recommend for that to be done?
Kimberly Simmons, MD, MPH/MSPH: To be honest, in talking with many of my general pediatric colleagues, they would feel more comfortable with that follow-up being done in a pediatric endocrinologist’s office. Not that they can’t do it, but their systems are very burdened, and it’s hard to assume additional risk and knowledge about something they don’t already know. I see the follow-up probably being in a pediatric endocrinologist’s office for the time being.
Robert Busch, MD: Dr Goland, since you treat adults and you’ll be heading off type 1 diabetes in the adult with relatives, will you be doing the follow-up in your own practice, or your colleagues? Or will you have the primary care clinician do that?
Robin S. Goland, MD: We follow our antibody-positive TrialNet patients, and many of them ask for a clinical appointment because they’re aware that they are high risk. I would do exactly as Kimberly said, and I agree that our internal medicine colleagues are very overburdened, and there’s no way that they would be able to take this on. So if we order this infusion, they then are antibody-positive patients who have received teplizumab, and they’re ours. I would follow up with them every 6 months. I don’t think I would prescribe a sensor, but a home glucose monitor, which I almost never use, and I would give them instructions about when to use it and when to call us, because you’d hate for somebody in that group to go into DKA [diabetic ketoacidosis].
Robert Busch, MD: I plan the same as you. To me, I’m looking at it as like when we treat prediabetes off-label with medication, we’re the one doing it. The primary care doctor is uncomfortable even with prediabetes if we initiated the treatment.
Robin S. Goland, MD: Yes.
Kimberly Simmons, MD, MPH/MSPH: The other thing that is important is that the pediatrician, primary care physician, or health care provider is aware that there is that risk because it would be helpful. We’re trying to have patients have an emergency card they keep in their wallet, so if they see their primary care provider, an ED [emergency department] physician, or an urgent care physician, they have the card that says they’re at risk for type 1 diabetes, so that makes it onto the differential diagnosis for whatever’s going on.
Robert Busch, MD: Excellent.
Robin S. Goland, MD: People are so overburdened, it’s very hard to communicate.
Robert Busch, MD: Dr Goland, in terms of who’s administering the treatment, I would imagine it would be our colleagues, whether it’s an adult endocrinologist or a pediatric endocrinologist, unless it’s a provider who has type 1 diabetes themselves and is very comfortable managing diabetes. I think this will be our bailiwick, unless any of you think otherwise, that it would be outside of the pediatric endocrinologist or the adult endocrinologist practice?
Kimberly Simmons, MD, MPH/MSPH: No.
Teresa Quattrin, MD: I don’t. It’s incumbent upon us to be good communicators, both with the public and with health care professionals. I personally do not see this happening, and it shouldn’t because that’s all we do, so presumably we’re aware of potential issues that can arise.
Kimberly Simmons, MD, MPH/MSPH: One other thing I did not talk about during the adverse effect profile, because as we mentioned earlier, most people tolerate this medication extremely well, but there still is a risk of cytokine release syndrome. It’s not as high because of how the drug’s been modified and how the dose is ramped up at the beginning, but it is still a potential adverse effect. It must be given in a safe environment, especially to start, so that we have good outcomes as we’re entering into this new phase of administering immunotherapies.
Transcript Edited for Clarity