PMID- 37732925
OWN - NLM
STAT- MEDLINE
DCOM- 20230922
LR  - 20230922
IS  - 0038-3317 (Print)
IS  - 0038-3317 (Linking)
VI  - 76
IP  - suppl 6
DP  - 2023 Jun
TI  - Comparison of Visual Methods to Reanalyze Provocative Test Data from Randomized 
      Controlled Clinical Trials in New- or Recent-Onset Type 1 Diabetes.
PG  - s23-s24
AB  - INTRODUCTION: Over the last 13 years, the Immune Tolerance Network (ITN), has 
      conducted trials of agents to abrogate the autoimmunity underlying type 1 
      diabetes. Primary endpoints center on the change of C-peptide production during 
      mixed meal tolerance tests (MMTT), measured as the area under the curve (AUC) or 
      AUC mean over 2-3 years. Studies permit rapid-acting insulin until a few hours 
      before the MMTT, and thus do not exclude overnight hyperglycemia prior to 
      testing. We hypothesize that overnight or fasting hyperglycemia will deplete 
      pre-formed insulin and impact measurements of first-phase insulin secretion and 
      C-peptide AUC. METHODS: Publicly available, deidentified, subject-level data were 
      obtained from ITN TrialShare. We developed several graphical analyses to 
      reexamine results from each MMTT including combined glucose and C-peptide 
      response curves, the centroids of polygons of MMTT timepoints, and ratios 
      comparing extents of excursions of glucose and c-peptide production. RESULTS: We 
      have applied these graphical analyses to 1161 MMTT from 245 subjects in 8 
      studies. Graphical analyses of MMTT results for individuals over the course of 
      the follow-up period reflect the expected loss of c-peptide and higher blood 
      glucose during MMTT; centroids move accordingly, upwards and leftwards. 
      CONCLUSIONS: We were able to analyze MMTT data from ITN studies with several 
      graphical analyses. We are poised to apply these approaches to test our central 
      hypothesis by comparing how deviations from modeled rates of predicted changes 
      for an individual over time correlate with blood glucose levels in the hours 
      before a MMTT. This may lead to refinement of future trial protocols to ensure 
      tighter regulation of glycemic excursions ahead of provocative testing.
CI  - Copyright(c) South Dakota State Medical Association.
FAU - Orozco, Brenda
AU  - Orozco B
AD  - University of South Dakota Sanford School of Medicine.
FAU - Griffin, Kurt J
AU  - Griffin KJ
AD  - University of South Dakota Sanford School of Medicine.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - S D Med
JT  - South Dakota medicine : the journal of the South Dakota State Medical Association
JID - 101265265
RN  - 0 (Blood Glucose)
RN  - 0 (C-Peptide)
RN  - IY9XDZ35W2 (Glucose)
SB  - IM
MH  - Humans
MH  - *Diabetes Mellitus, Type 1/diagnosis/drug therapy
MH  - Blood Glucose
MH  - C-Peptide
MH  - Glucose
MH  - *Hyperglycemia/diagnosis
EDAT- 2023/09/21 12:43
MHDA- 2023/09/22 06:42
CRDT- 2023/09/21 10:13
PHST- 2023/09/22 06:42 [medline]
PHST- 2023/09/21 12:43 [pubmed]
PHST- 2023/09/21 10:13 [entrez]
PST - ppublish
SO  - S D Med. 2023 Jun;76(suppl 6):s23-s24.