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FältnamnIndikatorerMetadata
00005208naa a2200457 4500
001oai:DiVA.org:liu-201566
003SwePub
008240312s2023 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-2015662 URI
0247 a https://doi.org/10.1016/S2213-8587(23)00267-X2 DOI
040 a (SwePub)liu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Taylor, Peter Nu Department of Infection and Immunity, Cardiff University School of Medicine, Cardiff University, Cardiff, UK4 aut
2451 0a C-peptide and metabolic outcomes in trials of disease modifying therapy in new-onset type 1 diabetes: an individual participant meta-analysis
264 1b Elsevier,c 2023
338 a print2 rdacarrier
520 a Background: Metabolic outcomes in type 1 diabetes remain suboptimal. Disease modifying therapy to prevent β-cell loss presents an alternative treatment framework but the effect on metabolic outcomes is unclear. We, therefore, aimed to define the relationship between insulin C-peptide as a marker of β-cell function and metabolic outcomes in new-onset type 1 diabetes.Methods: 21 trials of disease-modifying interventions within 100 days of type 1 diabetes diagnosis comprising 1315 adults (ie, those 18 years and older) and 1396 children (ie, those younger than 18 years) were combined. Endpoints assessed were stimulated area under the curve C-peptide, HbA1c, insulin use, hypoglycaemic events, and composite scores (such as insulin dose adjusted A1c, total daily insulin, U/kg per day, and BETA-2 score). Positive studies were defined as those meeting their primary endpoint. Differences in outcomes between active and control groups were assessed using the Wilcoxon rank test.Findings: 6 months after treatment, a 24·8% greater C-peptide preservation in positive studies was associated with a 0·55% lower HbA1c (p<0·0001), with differences being detectable as early as 3 months. Cross-sectional analysis, combining positive and negative studies, was consistent with this proportionality: a 55% improvement in C-peptide preservation was associated with 0·64% lower HbA1c (p<0·0001). Higher initial C-peptide levels and greater preservation were associated with greater improvement in HbA1c. For HbA1c, IDAAC, and BETA-2 score, sample size predictions indicated that 2-3 times as many participants per group would be required to show a difference at 6 months as compared with C-peptide. Detecting a reduction in hypoglycaemia was affected by reporting methods.Interpretation: Interventions that preserve β-cell function are effective at improving metabolic outcomes in new-onset type 1 diabetes, confirming their potential as adjuncts to insulin. We have shown that improvements in HbA1c are directly proportional to the degree of C-peptide preservation, quantifying this relationship, and supporting the use of C-peptides as a surrogate endpoint in clinical trials.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Endokrinologi och diabetes0 (SwePub)302052 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Endocrinology and Diabetes0 (SwePub)302052 hsv//eng
7001 a Collins, Kimberly Su Critical Path Institute, Tucson, AZ, USA4 aut
7001 a Lam, Annau Alberta Diabetes Institute, University of Alberta, Edmonton, AB, Canada4 aut
7001 a Karpen, Stephen Ru Critical Path Institute, Tucson, AZ, USA4 aut
7001 a Greeno, Briannau Critical Path Institute, Tucson, AZ, USA4 aut
7001 a Walker, Franku Critical Path Institute, Tucson, AZ, USA4 aut
7001 a Lozano, Alejandrou Critical Path Institute, Tucson, AZ, USA4 aut
7001 a Atabakhsh, Elnazu Critical Path Institute, Tucson, AZ, USA4 aut
7001 a Ahmed, Simi Tu The New York Stem Cell Foundation Research Institute, New York, NY, USA4 aut
7001 a Marinac, Marjanau JDRF, New York, NY, USA4 aut
7001 a Latres, Estheru JDRF, New York, NY, USA4 aut
7001 a Senior, Peter Au Alberta Diabetes Institute, University of Alberta, Edmonton, AB, Canada4 aut
7001 a Rigby, Marku Critical Path Institute, Tucson, AZ, USA4 aut
7001 a Gottlieb, Peter Au University of Colorado School of Medicine, Aurora, CO, USA4 aut
7001 a Dayan, Colin Mu Department of Infection and Immunity, Cardiff University School of Medicine, Cardiff University, Cardiff, UK4 aut
7001 a Ludvigsson, Johnny,c Professor,d 1943-u Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus,Trial Outcome Markers Initiative collaboration4 ctb0 (Swepub:liu)johlu29
7102 a Department of Infection and Immunity, Cardiff University School of Medicine, Cardiff University, Cardiff, UKb Critical Path Institute, Tucson, AZ, USA4 org
7730 t The Lancet Diabetes and Endocrinologyd : Elsevierg 11:12, s. 915-925q 11:12<915-925x 2213-8587x 2213-8595
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-201566
8564 8u https://doi.org/10.1016/S2213-8587(23)00267-X

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