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Review
. 2024 Aug 1;47(8):1276-1298.
doi: 10.2337/dci24-0042.

Consensus Guidance for Monitoring Individuals With Islet Autoantibody-Positive Pre-Stage 3 Type 1 Diabetes

Moshe Phillip  1   2 Peter Achenbach  3   4 Ananta Addala  5   6 Anastasia Albanese-O'Neill  7 Tadej Battelino  8   9 Kirstine J Bell  10 Rachel E J Besser  11   12 Ezio Bonifacio  13   14 Helen M Colhoun  15   16 Jennifer J Couper  17   18   19 Maria E Craig  10   20 Thomas Danne  21 Carine de Beaufort  22   23   24 Klemen Dovc  8   9 Kimberly A Driscoll  25   26   27 Sanjoy Dutta  28 Osagie Ebekozien  29 Helena Elding Larsson  30   31 Daniel J Feiten  32 Brigitte I Frohnert  25 Robert A Gabbay  33 Mary P Gallagher  34 Carla J Greenbaum  35 Kurt J Griffin  36   37 William Hagopian  38 Michael J Haller  27   39 Christel Hendrieckx  40   41   42 Emile Hendriks  43 Richard I G Holt  44   45 Lucille Hughes  46 Heba M Ismail  47 Laura M Jacobsen  39 Suzanne B Johnson  48 Leslie E Kolb  49 Olga Kordonouri  21 Karin Lange  50 Robert W Lash  51 Åke Lernmark  30 Ingrid Libman  52 Markus Lundgren  30   53 David M Maahs  5 M Loredana Marcovecchio  54 Chantal Mathieu  55 Kellee M Miller  29 Holly K O'Donnell  25 Tal Oron  1   2 Shivajirao P Patil  56 Rodica Pop-Busui  57 Marian J Rewers  25 Stephen S Rich  58 Desmond A Schatz  59 Rifka Schulman-Rosenbaum  60 Kimber M Simmons  25 Emily K Sims  61 Jay S Skyler  62 Laura B Smith  63 Cate Speake  35 Andrea K Steck  25 Nicholas P B Thomas  64 Ksenia N Tonyushkina  65 Riitta Veijola  66 John M Wentworth  67   68 Diane K Wherrett  69 Jamie R Wood  70 Anette-Gabriele Ziegler  3   4 Linda A DiMeglio  46
Affiliations
Review

Consensus Guidance for Monitoring Individuals With Islet Autoantibody-Positive Pre-Stage 3 Type 1 Diabetes

Moshe Phillip et al. Diabetes Care. .

Erratum in

  • Erratum. Consensus Guidance for Monitoring Individuals With Islet Autoantibody-Positive Pre-Stage 3 Type 1 Diabetes. Diabetes Care 2024;47:1276-1298.
    Phillip M, Achenbach P, Addala A, Albanese-O'Neill A, Battelino T, Bell KJ, Besser REJ, Bonifacio E, Colhoun HM, Couper JJ, Craig ME, Danne T, Beaufort C, Dovc K, Driscoll KA, Dutta S, Ebekozien O, Larsson HE, Feiten DJ, Frohnert BI, Gabbay RA, Gallagher MP, Greenbaum CJ, Griffin KJ, Hagopian W, Haller MJ, Hendrieckx C, Hendriks E, Holt RIG, Hughes L, Ismail HM, Jacobsen LM, Johnson SB, Kolb LE, Kordonouri O, Lange K, Lash RW, Lernmark Å, Libman I, Lundgren M, Maahs DM, Marcovecchio ML, Mathieu C, Miller KM, O'Donnell HK, Oron T, Patil SP, Pop-Busui R, Rewers MJ, Rich SS, Schatz DA, Schulman-Rosenbaum R, Simmons KM, Sims EK, Skyler JS, Smith LB, Speake C, Steck AK, Thomas NPB, Tonyushkina KN, Veijola R, Wentworth JM, Wherrett DK, Wood JR, Ziegler AG, DiMeglio LA. Phillip M, et al. Diabetes Care. 2024 Nov 1;47(11):2033. doi: 10.2337/dc24-er11a. Diabetes Care. 2024. PMID: 39240700 Free PMC article. No abstract available.

Abstract

Given the proven benefits of screening to reduce diabetic ketoacidosis (DKA) likelihood at the time of stage 3 type 1 diabetes diagnosis, and emerging availability of therapy to delay disease progression, type 1 diabetes screening programs are being increasingly emphasized. Once broadly implemented, screening initiatives will identify significant numbers of islet autoantibody-positive (IAb+) children and adults who are at risk for (confirmed single IAb+) or living with (multiple IAb+) early-stage (stage 1 and stage 2) type 1 diabetes. These individuals will need monitoring for disease progression; much of this care will happen in nonspecialized settings. To inform this monitoring, JDRF, in conjunction with international experts and societies, developed consensus guidance. Broad advice from this guidance includes the following: 1) partnerships should be fostered between endocrinologists and primary care providers to care for people who are IAb+; 2) when people who are IAb+ are initially identified, there is a need for confirmation using a second sample; 3) single IAb+ individuals are at lower risk of progression than multiple IAb+ individuals; 4) individuals with early-stage type 1 diabetes should have periodic medical monitoring, including regular assessments of glucose levels, regular education about symptoms of diabetes and DKA, and psychosocial support; 5) interested people with stage 2 type 1 diabetes should be offered trial participation or approved therapies; and 6) all health professionals involved in monitoring and care of individuals with type 1 diabetes have a responsibility to provide education. The guidance also emphasizes significant unmet needs for further research on early-stage type 1 diabetes to increase the rigor of future recommendations and inform clinical care.

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Conflict of interest statement

Duality of Interest. M.P. has received honoraria for participation on advisory boards for AstraZeneca, Eli Lilly, MannKind Corp., Medtronic Diabetes, Pfizer, Sanofi, Dompé, LifeScan, Novo Nordisk, Insulet, Provention Bio, Merck, Ascensia Diabetes Care, Bayer, Embecta, and Tandem Diabetes Care and as a speaker for Eli Lilly, Medtronic Diabetes, Novo Nordisk, Pfizer, Sanofi, and Ascensia Diabetes Care. M.P. owns stocks of DreaMed Diabetes and NG Solutions, and his institution has received research grant support from Eli Lilly, Medtronic Diabetes, Novo Nordisk, Pfizer, Sanofi, DreaMed Diabetes, NG Solutions, Dompé, Lumos, GWave, OPKO, Provention Bio, and AstraZeneca, travel expenses from Medtronic Diabetes and Sanofi, and consulting fees from Qulab Medical and Provention Bio. T.B. served on advisory boards of Novo Nordisk, Sanofi, Eli Lilly, Boehringer Ingelheim, Medtronic, Abbott, and Indigo Diabetes. T.B. received honoraria for participating on the speakers bureau for Eli Lilly, Novo Nordisk, Medtronic, Abbott, Sanofi, Dexcom, Adventis, AstraZeneca, and Roche. T.B.’s institution has received research grant support and travel expenses from Abbott, Medtronic, Novo Nordisk, Sanofi, Novartis, Sandoz, and Zealand Pharma. R.E.J.B. has received consulting fees from Provention Bio. H.M.C. has received research grant support from IQVIA, JDRF, Chief Scientist Office, Diabetes UK, and the UK Medical Research Council (UKRI). H.M.C. has received honorarium from Novo Nordisk and owns shares in Roche Pharmaceuticals and Bayer AG. T.D. has received honoraria and speaker honoraria and consulting fees and his former institution has received research support from Abbott, AstraZeneca, Boehringer Ingelheim, Dexcom, Eli Lilly, Novo Nordisk, Provention Bio, Sanofi, and Vertex Pharmaceuticals. He is a shareholder in DreamMed, Ltd. K.D. has received honorarium for participation on advisory boards for Medtronic and Novo Nordisk and speaker fees from Abbott, Eli Lilly, Novo Nordisk, Medtronic, and Pfizer. O.E. has received research support from MannKind Corp., Medtronic Diabetes, Abbott, Dexcom, Eli Lilly Pharmaceuticals, Janssen Pharmaceuticals, and Vertex Pharmaceuticals. O.E. has also participated on advisory boards for Medtronic and Sanofi. O.E. has received consultation and speaker fees from Medtronic Diabetes, Sanofi, and Vertex. All financial support from industry for O.E. has been through his organization, T1D Exchange. R.A.G. has received honorarium from Lark, Sweetch, StartUp Health, Vida, and Valendo. C.J.G.'s institution received payment from Sanofi as a clinical trial center. K.J.G. has received sponsored travel from JDRF. W.H. received grant/consultancy fees from Sanofi/Provention Bio. M.J.H. has received grants or consultancy fees from Sanofi, MannKind Corp., and SAB Biotherapeutics and is a stock options holder of SAB Biotherapeutics. R.I.G.H. has received honoraria for speaking from EASD, Eli Lilly, ENCORE, Liberum, Novo Nordisk, Rovi, and Boehringer Ingelheim. R.I.G.H. has received conference funding from Novo Nordisk and Eli Lilly. O.K. has received honoraria and lecture fees from Sanofi, Dexcom, and Medtronic. R.W.L. has received a consultancy fee from Cigna Insurance. D.M.M. has received research support from the National Institutes of Health, JDRF, National Science Foundation, and the Leona M. and Harry B. Helmsley Charitable Trust, and his institution has had research support from Medtronic, Dexcom, Insulet, Bigfoot Biomedical, Tandem Diabetes Care, and Roche. C.M. serves or has served on advisory panels for Novo Nordisk, Sanofi, Eli Lilly and Company, Novartis, Boehringer Ingelheim, Roche, Medtronic, Imcyse, Insulet, Biomea Fusion, and Vertex Pharmaceuticals. Financial compensation for these activities has been received by KU Leuven; KU Leuven has received research support for C.M. from Medtronic, Imcyse, Novo Nordisk, Sanofi, and ActoBio Therapeutics. C.M. serves or has served on speakers bureaus for Novo Nordisk, Sanofi, Eli Lilly and Company, Medtronic, and Boehringer Ingelheim. Financial compensation for these activities has been received by KU Leuven. C.M. is president of EASD. All external support of EASD is to be found on www.easd.org. H.K.O.’D. received compensation from Sanofi for attending their advisory board and for speaking at ADA 84th Scientific Sessions. R.P.-B. has received payment or honoraria from Bayer, Lexicon Pharma, Novo Nordisk, Averitas Pharma, Nevro, Roche, and Medtronic. M.J.R. has received honoraria and grants from Sanofi. K.M.S. has received consultancy fees, grants, or honoraria from Provention Bio and Sanofi. E.K.S. has received consulting fees from Sanofi and DRI Healthcare and has received payment for lectures from Health Matters CME, Medscape, Med Learning Group LLC, and the ADA. J.S.S. has been a scientific advisory board member for 4Immune, ActoBiotics, Avotres, and Quell Therapeutics. J.S.S. has been a data safety board member for Imcyse and Provention Bio and is a member of the board of directors for SAB Therapeutics. J.S.S. has been an advisor or consultant for ImmunoMolecular Therapeutics, Novo Nordisk, Remedy Plan, Inc., SAB Therapeutics, and Sanofi. J.S.S. has shares in or is an option holder for 4Immune, Avotres, ImmunoMolecular Therapeutics, Remedy Plan, Inc., and SAB Therapeutics. C.S. has received research funding from Cour Pharmaceuticals and consultancy fees from Sanofi and GentiBio. L.A.D. has received research support to their institution from Dompé, Lilly, MannKind Corp., Medtronic, Provention/Sanofi, and Zealand and consulting fees from Vertex Pharmaceuticals and Abata. L.A.D. has a patent pending for difluoromethylornithine (DFMO). No other potential conflicts of interest relevant to this article were reported.

Figures

None
Graphical abstract
Figure 1
Figure 1
Algorithm for monitoring of people screened positive for one or more islet autoantibodies. *Monitoring frequency and methodology depends on age, length of time since first detection of islet autoantibody, number of islet autoantibodies detected, and presence of symptoms of type 1 diabetes (see Table 1 and Tables 3–5). Ab, antibody; GP, general practitioner; PRN, pro re nata (as needed); Sx, symptoms; T1D, type 1 diabetes.
Figure 2
Figure 2
The continuum of educational needs and competencies: what does one need to know? The image represents the anticipated skills that must be developed within the continuum of stakeholders in monitoring presymptomatic type 1 diabetes. The groups indicated within the pyramid sections should have the competencies described and participate as appropriate. The need is for unified, consistent, globally applicable language at all levels. T1D, type 1 diabetes.

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