Section 3, “Prevention or Delay of Type 2 Diabetes and Associated Comorbidities,” of the Standards of Care in Diabetes—2023 has been updated based on recent U.S. Food and Drug Administration approval of a new drug to delay the incidence of type 1 diabetes.
The online version of the article (https://doi.org/10.2337/dc23-S003) reflects the changes described below.
Jason L. Gaglia, of Joslin Diabetes Center and Harvard Medical School, Boston, MA, has been added as an author due to his expertise in immunology and type 1 diabetes. The author list and disclosures table (p. S281) have been updated accordingly.
A new section, “Pharmacologic Interventions for Type 1 Diabetes,” has been added at the end of the article to include current U.S. Food and Drug Administration guidance on the therapies to delay the occurrence of type 1 diabetes.
The following recommendation has been added as Recommendation 3.14:
“3.14 Teplizumab-mzwv infusion to delay the onset of symptomatic type 1 diabetes should be considered in selected individuals aged ≥8 years with stage 2 type 1 diabetes. Management should be in a specialized setting with appropriately trained personnel. B”
The new section text reads as follows:
“Teplizumab was approved to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older with stage 2 type 1 diabetes based in part upon the efficacy results of a single study in relatives at risk for type 1 diabetes. In this study, 44 individuals were randomized to a 14-day course of teplizumab and 32 to placebo. Based on a Cox proportional hazards model, stratified by age and oral glucose tolerance test status at randomization, median time to stage 3 type 1 diabetes diagnosis was 50 months in the teplizumab group and 25 months in the placebo group, for a difference of 25 months at a median follow-up time of 51 months. In prespecified analyses, the presence of HLA-DR4 and absence of HLA-DR3 were associated with more robust responses to teplizumab (hazard ratio 0.20 [95% CI 0.09–0.45] and 0.18 [95% CI 0.07–0.45], respectively. The most common adverse reactions were lymphopenia (73%) followed by rash (36%).
Numerous clinical studies are being conducted to test methods of preventing or delaying the onset of stage 3 type 1 diabetes in those with evidence of autoimmunity without symptoms, or delaying loss of insulin secretory capacity after onset of stage 3, some with promising results (see ClinicalTrials.gov and trialnet.org).”
To reflect the addition of this information on type 1 diabetes, changes have also been made to the title of the section and the first paragraph.
“Type 2” has been removed from the title of the section. The title now reads as follows:
“3. Prevention or Delay of Diabetes and Associated Comorbidities: Standards of Care in Diabetes—2023.”
The first sentence of the main text (p. S41) referring readers to screening guidelines related has been revised to include type 1 diabetes screening. This sentence now reads as follows:
“For guidelines related to screening for increased risk for type 1 and type 2 diabetes (prediabetes), please refer to Section 2, “Classification and Diagnosis of Diabetes.”