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Clinical · Special populations · continued

Type 1 diabetes: off-label use and the evidence gap — what changed since posts 31–60

This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1 · go to the accepted answer.

AF
a.friskTL222 Nov 2024#31

Thank you for taking the time. That was more work than a reply usually is.

11 likes 20mo
PM
p.mbekiTL222 Nov 2024#32
h.koodziej, post #29: Adding a null result on Type 1 diabetes. I looked, carefully, and found nothing, and null results deserve posting precisely because they never are. Go to post

Almost every population discussed here was excluded from the pivotal trials, which means the evidence base is observational at best and absent at worst.

Speaking for myself and not for anyone else who has posted here.

24 likes in reply to #29 20mo
NM
n.moreauTL222 Nov 2024#33

Type 1 diabetes: I would want to see the raw numbers rather than the summary before agreeing. Summaries lose exactly the information that would settle this.

0 likes 20mo
JS
j.steinerTL222 Nov 2024#34

Post #32 describes the usual case. This is about the unusual one.

The reason Type 1 diabetes is hard to answer is that the obvious measurement and the relevant quantity are not the same thing, and substituting one for the other is silent.

3 likes 20mo
AR
a.reyesTL4 Admin22 Nov 2024#35
a.wikstrom, post #27: I had written a reply contradicting post #24 and deleted it. Here is what survived. Type 1 diabetes sits at the boundary between what this community can usefully discuss and what it cannot, and I think it falls on the discussable side, narrowly. Go to post

Adolescent evidence exists for some compounds in this class and is a separate approval decision with its own trials rather than an extension of the adult data.

I am reporting what happened, not recommending it.

7 likes in reply to #27 20mo
MB
m.brobergTL222 Nov 2024 · edited#36
s.ostergaard, post #1: Type 1 diabetes: off-label use and the evidence gap — what changed since — setting out what I have, and where I think it stops being reliable. What changes if the standard account of Type 1 diabetes is wrong? I ask because I have been treating it as settled and I noticed this week that I could not say why. Working through the… Go to post

Post-surgical populations, particularly after procedures affecting the gastrointestinal tract, interact with a delayed-emptying mechanism in ways that need specialist input.

Someone should write this up properly, and it should probably not be me.

17 likes in reply to #1 20mo
SL
s.leclercTL4 Moderator22 Nov 2024#37

The arithmetic in post #34 is right; the assumption feeding it is the part to check.

I would be cautious about generalising from the Type 1 diabetes example above. It is a good example. It is one example.

0 likes 20mo
MI
m.ibarraTL222 Nov 2024#38

Answering the question post #36 raises rather than the one it answers.

A definition problem is doing most of the work in this Type 1 diabetes discussion. Once the term is pinned down I suspect the disagreement mostly goes away and what is left is small.

1 like 20mo
AC
a.cardosoTL222 Nov 2024#39
logbook_erin, post #18: Something worth flagging about Type 1 diabetes: the strongest-sounding claims in this thread are the ones with no source attached, which is the usual pattern and not a coincidence. Go to post

The most useful contribution here is usually a citation to whichever published document comes closest, with a plain statement of how far it is from the question.

I would want the raw data before agreeing with my own summary of it.

23 likes in reply to #18 20mo
BR
buffer_reviewTL3Regular22 Nov 2024 · edited#40

Filing a mild objection to the consensus on Type 1 diabetes. Mild because I might be wrong; an objection because nobody has addressed the case that does not fit.

0 likes 20mo
SI
s.ivaturiTL223 Nov 2024#41
c.ramos, post #21: Answering the question post #19 raises rather than the one it answers. Type 1 diabetes is worth one more sentence than it usually gets, and the sentence is the one about how the number was arrived at. Go to post

Everything in post #37 holds. The case it does not cover is the one I have.

Type 1 diabetes would be much easier to settle if anyone reported the denominator. Almost nobody reports the denominator.

7 likes in reply to #21 20mo
KR
k.redgraveTL223 Nov 2024#42
MN
ma.nascimentoTL223 Nov 2024#43

I think the Type 1 diabetes question is answerable and has not been answered, which is a more optimistic position than most of this thread.

0 likes 20mo
CP
citation_peakTL3Regular23 Nov 2024#44
p.mbeki, post #32: Almost every population discussed here was excluded from the pivotal trials, which means the evidence base is observational at best and absent at worst. Speaking for myself and not for anyone else who has posted here. Go to post

Where the Type 1 diabetes reasoning breaks down for me is the step from the group result to the individual case. That step is almost never argued for.

25 likes in reply to #32 20mo
FH
f.haddadTL223 Nov 2024#45

Dedicated trials in under-studied populations are the only real remedy and several are ongoing, which is worth saying rather than speculating.

Genuinely open to being wrong about this one.

12 likes 20mo
PN
p.novotnyTL2Regular23 Nov 2024#46

An update on my earlier Type 1 diabetes post: the pattern held for another six weeks and then stopped, which I did not predict and cannot explain.

4 likes 20mo
ZS
z.szaboTL223 Nov 2024#47

The strongest argument against my own position on Type 1 diabetes, stated as well as I can state it, since nobody else has yet.

0 likes 20mo
ER
eire_readerTL2Regional · IE23 Nov 2024 · edited#48
buffer_review, post #40: Filing a mild objection to the consensus on Type 1 diabetes. Mild because I might be wrong; an objection because nobody has addressed the case that does not fit. Go to post

Right, and stated more narrowly than I would have dared to state it.

0 likes in reply to #40 20mo
IL
i.lehtinenTL223 Nov 2024#49
QZ
q.zhao_qaTL3Quality assurance23 Nov 2024#50
nl_translator, post #4: Adolescents: a distinct evidence base exists. The compounds are not approved for routine adolescent obesity but are being studied. Adolescent physiology and psychology differ from adults' in ways that matter for this medication class. Go to post

Adding the measurement that post #47 says would settle it.

I would rather this thread reach "we do not know" about Type 1 diabetes than reach a confident answer that nobody can support when asked.

7 likes in reply to #4 20mo
RZ
r.zielinskiTL223 Nov 2024#51
n.moreau, post #33: Type 1 diabetes: I would want to see the raw numbers rather than the summary before agreeing. Summaries lose exactly the information that would settle this. Go to post

I will take the caveat as seriously as the claim, which is the point of putting it there.

13 likes in reply to #33 20mo
LG
lc_gradientTL3Analytical chemist24 Nov 2024#52

Type 1 diabetes is well covered in the tag pages, and the older discussions are better than the recent ones because they were argued out properly. Worth twenty minutes before adding to this one.

27 likes 20mo
CB
c.boatengTL224 Nov 2024#53

Nothing in this subcategory is medical advice and the questions asked here are precisely the ones that need an individual assessment.

0 likes 20mo
RA
r.aldana_pharmdTL4Pharmacist24 Nov 2024#54

Pregnancy and planning: these compounds are not approved for use in pregnancy. Planning windows (how long to wait before attempting pregnancy) are not formally established. Conservative approaches wait several months to allow clearance.

2 likes 20mo
RM
r.mensaTL224 Nov 2024#55
h.koodziej, post #29: Adding a null result on Type 1 diabetes. I looked, carefully, and found nothing, and null results deserve posting precisely because they never are. Go to post

Confirming post #52 from a second method, which matters more than confirming it from a second person.

Genetic and ancestry-related differences in response are asked about regularly and the published evidence is thin enough that the honest answer is short.

I have left out the parts I could not verify.

19 likes in reply to #29 20mo
MD
m.dalgaardTL3Regular24 Nov 2024 · edited#56

I had written a reply contradicting post #54 and deleted it. Here is what survived.

The absence of a reported signal in a population that was barely enrolled is not evidence about that population.

Reading it again, the caveat matters more than the finding.

0 likes 20mo
DV
d.vukovicTL224 Nov 2024#57

The reason Type 1 diabetes keeps being re-asked is that the answer is conditional and people quote it without the condition. It is not that the answer is unknown.

0 likes 20mo
DB
dr_bhattacharyaTL3Physician24 Nov 2024#58
logbook_erin, post #18: Something worth flagging about Type 1 diabetes: the strongest-sounding claims in this thread are the ones with no source attached, which is the usual pattern and not a coincidence. Go to post

Taking Type 1 diabetes seriously for a moment rather than deflecting: the honest position is that the community has observations and no controlled comparison, and those two things support very different sentences.

4 likes in reply to #18 20mo
DB
d.bakkerTL224 Nov 2024#59
chromatogram, post #26: Dedicated trials in under-studied populations are the only real remedy and several are ongoing, which is worth saying rather than speculating. I would be interested in a counterexample if anyone has one. Go to post

Extrapolating a point estimate to somebody well outside the enrolled range should be described as an extrapolation every time it is done.

26 likes in reply to #26 20mo
PM
p.marchettiTL224 Nov 2024#60
a.cardoso, post #39: The most useful contribution here is usually a citation to whichever published document comes closest, with a plain statement of how far it is from the question. I would want the raw data before agreeing with my own summary of it. Go to post

The version of Type 1 diabetes that circulates here is a simplification of a simplification. It is not wrong, but it has lost the conditions under which it holds, and those conditions are where the interesting cases live.

0 likes in reply to #39 20mo