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So outside of pregnancy there actually is good data and there's actually recommendations that patients can do self titration of their long acting insulin. So for patients with type 2 diabetes, where most of this data comes from, and Obviously for type 1 diabetes, they can actually manage on their own very safely with very low incidence of hypoglycemia. Their basal their long acting insulin requirements like their lantus, okay, Patients can be taught, given the education and then they self titrate. That's a thing. Now they still need periodic visits of course, whether in person or telehealth, but very well established that outside of pregnancy self titration by the patient of their long acting basal insulin is a thing. Here's a question though. What about its use in gdm? Now GDM is going through a mini revolution guys. We've talked about this in previous episodes with CGMs and remember, CGMs don't check venous glucose. They look for the glucose in the interstitial fluid and the time and range. So there's all these things coming out for GDM care that's kind of changed the way we think about this. Well now there's a brand new publication that came out, it's an RCT in the Green Journal on this very issue. And again, this came out April of 2020, the same month that we're recording this. So this has to do with patient self titration of their basal insulin for gdm. Is that a thing? Now I'm going to tell you, as novel as this is and as reassuring as it is, because it had some good points here by some very, very well respected physicians and pillars of MFM like Stephen Gabby. There's still questions that remain. So let me just tell you right now, this is revolutionary, it's visionary, it's nice. But it's not the first to do this because even though this publication here from the US came out in April of 2026, there was a previous publication that came out in 2022, four years ago out of the UK that was not an RCT like this one. It was actually retrospective. But they pretty much did the same thing. All right, so congrats to these authors that published this. And these authors span the gamut of great locations. I'm just, just to let you know, I mean we've got Brown University, of course, we have a Northwestern, very, very well respected places that contributed to this publication. And these authors again are phenomenal and I'm not minimizing what they did at all. But again they're going on the shoulders of a previous study from 2022. So these authors published this from, from several sites in the Green Journal and we're going to talk about this. It does have some limitations here. Now I want to be very clear at the beginning. While this is novel, I don't think it's going to take off as of yet because the old standard, right now the old standard is weekly checks clinician led titration especially to adjust the postprandial devaluate postprandial sugars to fix either their short acting regular insulin or as most people do their lispro which is given before meals. We're going to talk about this as a quick reminder after our intro. So patient self titration of insulin for gdm. Yes, very, very much a thing outside of pregnancy. And now it's kind of making its way into GDM circles. So just as a point of discussion that if a patient asks man, do I have to come back? Can't I just self adjust this thing? Yeah, there's evidence for that, but we don't know what the best way to do it is. So as of right now you may want to follow the general rule. And remember this still has to do with checking, fasting and either one or the more traditional two hours postprandial. And that's one of the things we're going to talk about here. One of the limitations of this study which has to do with the postprandial evaluations, lots of good stuff here. We're going to talk about all this as soon as we come back after this intro, This is Dr. Chapma's obgyn no spin podcast. I can do it myself. So that quote, I can do it myself. I'm not even going to get into, I'm not going to describe the scene. Some of you may get that as it triggers your hippocampus, your memory. That was a silly, silly spoof movie. It was one of the scary movie, you know, spin offs. I'm not gonna get into it, but kind of a gross scene. But anyway, there was a scene where the guy goes, I can do it myself. And we'll just leave it at that. Anyway, patient self titration of their long acting insulin. Remember, we're not talking about them self managing their lispro or their regular insulin. This has to do with their basal. So let's just clear that up right here. It has to do with basal level insulin. And there's some things that are really game changing here. Like boy, that would save us a lot of time if the patients need the proper education to do this and the proper health literacy. And ideally these are done with pre filled pens, right? They just change the number of units so they're not drawing up stuff and make it much more complicated where there's room for error. So having said that, let me just start before we get into this April 2026 publication, a very, very quick, very fast reminder from Amy Valent. Okay? So Amy and I sat in a couple of committees back when I involved with the acog. She is phenomenal and I've talked about her publication from November 2024 back when that came out. Right, November 2024. She had the insulin management for gestational and type 2 diabetes in pregnancy. That's out of the Green Journal. It was a clinical expert series. It was phenomenal and it gave the traditional regimens which was dual agent, which was a long acting together with a more rapid acting like lispro given about 15 or 20 minutes before meals, that standard. However, it is true that in patients who are very insulin naive and maybe aren't don't have obesity or are not living with obesity, I guess that's the PC term. Whatever. It is reasonable once a decision is made to, to give them insulin. Remember insulin's first line, guys, Metformin. I know, I get it. We still use it in times for patients who are dangerous with an insulin pen because of poor health literacy. But metformin has some, some issues. Insulin is first line. It doesn't cross the placenta. It's the best way to go. It is first line. For insulin management of gdm, once you prove that diet and lifestyle changes have not worked. All right, so you, you find a patient who fails her two step process. You say, I'm going to check your sugars for a week, follow this Diet, you walk three times a week at a minimum for 30 to 40 minutes and see how you do and write a little diary and take your sugars in fasting and then two hours postprandial. Remember the goal for fasting is less than and then two hours post pharyngeal less than 120. And if you don't meet those, then everyone's got a different percentage on when you start medication. For me, if you have more than about 40% of your values that are off, definitely 50% of your values that are off, then we start insulin. You should start on insulin. And it's reasonable to start just on a long acting agent. Okay. Now of the all the long acting agents, Lantus not a sponsor, which is Glargine. Okay. Lantusglargine is generally the more preferred agent because it works for up to 24 hours. It doesn't have a peak effect. You can split the dose to twice a day if you need to, especially if you've got higher doses of, of Lantus. You can give one in the morning and one in the afternoon and it's a very nice acting basal insulin. Okay. Again, not a sponsor. However, one of the issues is that if you, as you go up just with a long acting, you really do have to watch and tell the patient to eat throughout the day because you can risk some hypoglycemia because it's still on board. And if they don't have a regular meal, you know, morning, afternoon and night, then they can kind of, they can have little episodes maybe of symptomatic hypoglycemia because it's still in their system. All right, so Lantus works really nicely. Of course, Lantus, given traditionally at nighttime, is going to have its biggest effect. Basal insulins have their biggest effect on fasting blood sugars. So this is what this study is looking at. It's the same thing that the 2022 study looked at. It's patients self adjusting of their long acting to try to fix fasting hyperglycemia. Now, even though they focus on fasting, of course patients still checked their postprandial values either at one or two hours. That was still a thing. Although they really didn't report the specific sugars, what they were, and whether they needed any adjustments in preprandial insulin at that time. We're going to talk about that in the limitations in just a bit. Okay? So I don't want to lose anybody. This is talking about patients who were self instructed, educated to self monitor their basal insulin levels based on cutoffs that they were written down and explained to for fasting values. Okay, now if your question is why do they concentrate on fasting values? Was very easy. That's the main one that nighttime long acting insulin is going to hit. That's how you adjust that. And there is good data, guys, that for gdm, Although postprandial hyperglycemia is an issue, the strongest link to adverse pregnancy outcomes, meaning macrosomia, shoulder dystocia and preeclampsia, that seems to be strongly tied to fasting hyperglycemia. All right, so if somebody ever asks you which sugar do you really want to control, the fasting or the postprandials? The answer is both. But if I have to pick one, then fasting hyperglycemia we've got to get a lid on. Because most of the adverse issues are tied to persistent fasting hyperglycemia. So this is the setting that we're doing the introduction to the lead into the study. Because if we can get fasting hyperglycemia under control quicker than they have to wait to come see us, like you know, every week or so, if they are told at home, hey, if your sugar is above a certain cutoff in the morning and make sure that you're fasting, then you can self adjust and record it and watch for any warning signs. Maybe they can get ahead of the game. Okay, so once again, we're gonna cover this April 2026 Green Journal RCT. It is an RCT, although it's very small numbers that has to do with patient self titration of basal insulin for gdm. The short answer is it worked. It did good things. Although there's questions that remain. Okay, now, and I'll be very clear because I respect Gabby, you know, very, very much, and this is a door opener. But even in this publication they say, look, this is cool. I think it works. There's a place for it. It's not for everybody, but there's a place for it for very motivated patients. However, more study is needed and definitely more studies needed because this was single center and very small number of participants. So single center, small number. Even though it was an rct, we need much more data. Okay. I love the people who did this. I mean, Brown University, Northwestern and the Ohio State University. This Is the empower trial, guys. All right, so Empower 2026 RCT of an N of 5, 6 women 5, 6, 56. Not a lot. Remember, these all had GDM. They all required insulin. And we're comparing two groups here. Those patients who are told, hey, in the morning, if your sugar's whack, you can self titrate. You can adjust your long acting insulin by two units daily and then, you know, follow the instructions or wait for your weekly appointment and let us as clinicians do it. All right, so patient led for daily titration versus clinician led, weekly titration and adjustment. Okay, Right now, weekly clinician adjustment is the standard, right? That's pretty much what we do. So that's what these authors wanted to see. If we tell the patient that they can self change their, their sugar value, their basal insulin value, then will that work? So let me give you this protocol and how this all looked. All right, so here's what the protocol was. They had a starting dose of 10 units of long acting insulin at night. Now, for some, 10 may be a lot. If you have a patient who is very insulin resistant and or is living with obesity, maybe 10 is not enough. So that's one of the issues here. We don't know what number it is good to start. Should it be weight based? Should it be just a universal flat which is going to give everybody 10? That's one of the questions. Okay. But for the simplicity of the protocol, they started everybody at 10. Okay, so 10 units of long acting insulin for those that were going to self titrate. They said check your sugar every morning like you're supposed to anyway. And here are your titration rules. Okay, what did I say that was? Titration rules. My goodness. If their blood sugar was greater than 95, so if it was above the target, that would increase by two units. And give them that to themselves that night and then see what they did the next day. If their sugar was less than 70, fasting, then you decreased. They decreased themselves by two units because that's pretty low. The no change. The sweet spot was between 71 and 94. Everybody good. So if it's above the fasting cutoff of 95, which is the standard cutoff, give yourself two more units. If you woke up and it's like less than 70, brother, that's way too, too low. You need to decrease by 2 units and the sweet spot is to 94. Okay, so and see what you do. So you do it yourself and then come back and we're Going to talk about it. The clinician led titration, had the sugars evaluated on their little log or computer screen or whatever. However, they recorded it by the clinician every week with similar changes based on clinician discretion. All right, so they did whatever they wanted to do. They said, sugars are good, we're going to stay the same, or, oh, we're going to increase by X units, whatever. With the goal of fasting glucose less than 95. Remember, the primary endpoint is fasting hyperglycemia in this protocol. That does not mean that the postprandial Sugar values at 1 and 2 hours are not important. They absolutely are. So that's why I mentioned Amy Valent's publication from November 2024 at the beginning, because I don't want you to walk away that well, all we have to do is give them basal insulin and they can, you know, go up and down from that to keep their fasting values good and everything's gonna be okay. That, that is a very valid point, but it's not in isolation. We still need to monitor their postprandial value. So one value, one hour should be less than 140, two hours should be less than 120. Okay, now it wasn't just the, the, the fasting. They did take a look kind of globally, kind of holistically, the gestalt, if you will, of their postprandial sugars. But here's what they did. Okay, let me read this. Exactly. Secondary glycemic measures collected at the same time as a primary outcome were the postprandial blood glucoses, which were more than 50% at target, meaning it was less than 140 at 1 hour postprandial or less than 120 at 2 hours postprandial within that subsequent week, as well as the mean weekly fasting blood glucose. End quote. So they did take a look, but they kind of did it like a gestalt, like we hit 50% in range. Okay, so they did it kind of in a big bucket view. Now, one of the limitations here, guys, that's similar to the 2022 publication that we're going to talk about in a minute, is that they didn't say if any of those patients in either the clinician or the patient led self titration if they required any more or less of their postprandial insulin needs. They didn't talk about any peri meal. Pre meal is typically this pro about 15 to 20 minutes. If it's regular insulin, remember, you gotta take that about 30 minutes up to 60 minutes before you eat. So my point is they did look at those glucose values postprandial, but they didn't mention if they were received any insulin. That is one of the big limitations here. Okay, now we're going to tell you the results because the results are reassuring. It did what it's supposed to do. The key findings were that mean fasting glucose was actually okay. It was comparable between the self led and the clinician led. It wasn't any better. But the good news is it wasn't any hypoglycemia either. But here's the good news. Oddly enough, the patient LED sample had reduced rates of macrosomia with the relative risk of 0.18. That's pretty good. So it reduced microsomia. The overall absolute number was about 7% in the patient led group and 37% in the clinician group. Meaning. Hey, even though the mean fasting glucoses weren't very different from one group to the other, something seemed to work. So maybe by the patients self adjusting their basal level of insulin throughout the day, they had better control. But that wasn't specifically stated in the conclusions. So did this improve the fasting blood sugars compared to clinician led? No. However, oddly enough, it still reduced microsomia. So it seems to be that if the patient can self adjust their basal level, their lantus quicker than waiting for the clinician to do it in a week, then maybe they're getting better control throughout the day or requiring less perimeal insulin. Although that wasn't specifically stated. Okay, so did this work? Did they have better control of fasting glucose levels? Yes, they did. It was faster time to target, but in the end the mean values weren't any different. Okay, so yes, it worked, but not that impressive. But the good point of that is that it did reduce macrosomia. However. And again, here's, here's a big issue here, guys. One of the big issues is they looked at birth weights and LGA and macrosomia, which is fine, but they didn't look at the worst clinical outcome from that, which is shoulder dystocia. That would have been a great thing to see. Hey, did patient self titration actually reduce shoulder dystocia? We don't know that because that wasn't the data provided. Everybody good? Okay, so it did get a faster time to control fasting hyperglycemia. But in the end it really didn't make a big difference in terms of overall fasting glucose levels. But somehow it still worked in reducing babies Birth weight from LGA and macrosomia because both of those were better. Okay, so it's weird, the big limitations here as we're gonna get ready to wrap this up, I'm talking a little bit about the 2022 retrospective study. But here's the take home message. Fascinating. Patients have the ability, if they're motivated and educated, to self titrate. But in this protocol, Everybody started at 10 units. We don't know if that's the right place to start. And they were told to go up or down by two units. We don't know if that is okay. Should it be three units, should it be four? We don't know. That's just what these authors chose for simplicity. So again, questions remain. Big limitations. Though it's only 56 participants, even the authors say this data supports the need for larger patient centered GDM treatment trials. Okay, so we need more data. It's also single center, so that limits some general ability. It's non blinded. And here's the biggest thing, guys, as we already mentioned, there's no data on whether or not the prandial insulin requirements change. Did this decrease the amount of insulin that was given either as lispro or as regular? We don't know. So we're not really sure how this worked because even though time to target for fasting hyperglycemia was better with patient initiated, the overall mean glucose values towards the entire study period, about seven weeks, weren't vastly different overall, but it still seemed to reduce macrosomia and lga. But we don't know if it reduced shoulder dystocia. Okay, so fascinating if a patient asks, can I self titrate? Yes, along with the basal. Although we're not sure what the best protocol is and we're still missing a lot of information. Now let's leave that for now. And very quickly, before we end this, I just want to touch on, just give you the name of this study from 2022 in the UK. It was not an RCT, but it was pretty much what these authors did, although they used different numbers. This is the McGovern paper, right? This was out of Diabetic Medicine. Diabetic Medicine, that's the journal and the first author is McGovern. The title is very fittingly, patient led Rapid titration of basal insulin in gestational diabetes and its association with improved glycemic control and lower birth weight. Again, they told you the results in the title. Which one of my pet peeves. So yeah, it's right there in the title. Patient Led rapid titration of basal insulin in GDM led to improved glycemic control and lower birth weight. But very similar to the 2026 publication that we just summarized, they looked at birth weights. They didn't look at NICU admissions, cord gases, neonatal hypoglycemia or shoulder dystocia. I would have loved to see that in both of these, but they didn't do that. So this 2022, again, retrospective, they had a before and after study of about 136 women with gestational diabetes. And they did use a little bit different protocol because they went up or down four units at a time. Okay, so we don't know. We don't know. Is it two units? That's okay. Is it four units? We just don't know. And remember, this is also of their basal insulin. But oddly, this McGovern 2022 study did the exact same thing that we just discussed in the April 2026 one, there was no data given on the prandial insulin requirements. In other words, we don't know if they had lower birth weights because they had overall better control and it dropped their lispro or the regular insulin. We don't know that. It just said they're pretty much the same in either camp. We're not going to worry about it. So we do need those specific numbers all to say this Empower trial is opening up the door to patient education and self titration. Remember guys, a basal level. It still requires physician to have a handle on the prandial doses. Either lispro which is given closer to the meal or regular, given a little bit before the meal based on how it works. But it is a good discussion and a good example of how GDM care is evolving. So a couple of take homes and we're going to end this. Number one, insulin is still the first line treatment for GDM in those who you can't trust with insulin for a variety of reasons and I mean that in a bad way. I'm talking about low health literacy, which a lot of my patients, God bless them, the metformin is a far second choice. Not a close second. It's a far second, but you got to do what you got to do do. Insulin is number one. The standard protocols still include basal bolus dosage. Basal bolus. So give a basal amount and then chase the 1 or 2 hours postprandial using Prandial insulin uses either lispro or regular to titrate to the one and two hour cutoff values that We've already discussed number three. It is possible in the motivated patient to self titrate, to say, hey, look, I'm gonna give you some education. If your fasting sugars are kind of jank, and I wouldn't change the sugar every day. See these change their insulin guys every day. That's a lot. That's a lot. Because one day could be a fluke, right? So I would have said give it two days. And on two days, you know, then you can, you know, kind of titrate, but the protocol gets messy. So that's another question. Do that. Should they self manage with values that fall out just on one morning or see what it does the next morning? We don't know. In that 2026, this April 2026 publication, they did it daily titration, right? So if it was above 95, they gave them two extra. If it was under 70, they took away two units. And between 71 and 94 was a sweet spot. We don't really know how to best manage that, but it is possible. So take home. Last message is GDM care is changing. We have covered an RCT of a small number single center called patient self titration of insulin for GDM. Great. Great job, Dr. Gabby et al, in thinking outside the box podcast family, as always, we're thankful for you. We're glad you're part of our podcast community. And now that we've done all that, Michael, let's take it home. This is Dr. Chapma's obgyn no spin podcast. Sam.