scholarly journals Slowed Metabolic Decline after One Year of Oral Insulin Treatment among Individuals at High Risk for Type 1 Diabetes in the Diabetes Prevention Trial-Type 1 and TrialNet Oral Insulin Prevention Trials

Author(s):  
Ada Admin ◽  
Jay M. Sosenko ◽  
Jay S. Skyler ◽  
Kevan C. Herold ◽  
Desmond A. Schatz ◽  
...  

We assessed whether oral insulin slowed metabolic decline after 1 year of treatment in individuals at high risk for type 1 diabetes.<b> </b>Two oral insulin trials that were negative overall with type 1 diabetes as the primary endpoint were analyzed: the Diabetes Prevention Trial-Type 1 (DPT-1) and TrialNet oral insulin trials. Oral glucose tolerance tests at baseline and after 1 year of treatment were analyzed. Among those at high risk [Diabetes Prevention Trial Risk Score (DPTRS)≥6.75], the AUC C-peptide increased significantly from baseline to 1 year in each oral insulin group, whereas AUC glucose increased significantly in each placebo group. At 1 year, AUC C-peptide/AUC glucose was significantly higher (p<0.05) in the oral insulin group than in the placebo group in each trial (p=0.057 with age adjustment in the TrialNet trial; p<0.01 for trials combined with or without age adjustment). For DPTRS<6.75, oral insulin groups did not differ from placebo groups. <a>The findings suggest that 1 year of treatment with oral insulin slows metabolic deterioration in individuals at high risk for type 1 diabetes.</a> Moreover, the findings further suggest that metabolic endpoints can be useful adjuncts to the diagnostic endpoint in assessments of preventive treatments for the disorder.

2020 ◽  
Author(s):  
Ada Admin ◽  
Jay M. Sosenko ◽  
Jay S. Skyler ◽  
Kevan C. Herold ◽  
Desmond A. Schatz ◽  
...  

We assessed whether oral insulin slowed metabolic decline after 1 year of treatment in individuals at high risk for type 1 diabetes.<b> </b>Two oral insulin trials that were negative overall with type 1 diabetes as the primary endpoint were analyzed: the Diabetes Prevention Trial-Type 1 (DPT-1) and TrialNet oral insulin trials. Oral glucose tolerance tests at baseline and after 1 year of treatment were analyzed. Among those at high risk [Diabetes Prevention Trial Risk Score (DPTRS)≥6.75], the AUC C-peptide increased significantly from baseline to 1 year in each oral insulin group, whereas AUC glucose increased significantly in each placebo group. At 1 year, AUC C-peptide/AUC glucose was significantly higher (p<0.05) in the oral insulin group than in the placebo group in each trial (p=0.057 with age adjustment in the TrialNet trial; p<0.01 for trials combined with or without age adjustment). For DPTRS<6.75, oral insulin groups did not differ from placebo groups. <a>The findings suggest that 1 year of treatment with oral insulin slows metabolic deterioration in individuals at high risk for type 1 diabetes.</a> Moreover, the findings further suggest that metabolic endpoints can be useful adjuncts to the diagnostic endpoint in assessments of preventive treatments for the disorder.


Diabetes ◽  
2020 ◽  
Vol 69 (8) ◽  
pp. 1827-1832 ◽  
Author(s):  
Jay M. Sosenko ◽  
Jay S. Skyler ◽  
Kevan C. Herold ◽  
Desmond A. Schatz ◽  
Michael J. Haller ◽  
...  

Diabetes Care ◽  
2008 ◽  
Vol 31 (11) ◽  
pp. 2188-2192 ◽  
Author(s):  
J. M. Sosenko ◽  
J. P. Palmer ◽  
L. Rafkin-Mervis ◽  
J. P. Krischer ◽  
D. Cuthbertson ◽  
...  

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 1344-P
Author(s):  
EMILY K. SIMS ◽  
HEBA M. ISMAIL ◽  
BRANDON M. NATHAN ◽  
JAY M. SOSENKO

2017 ◽  
Vol 19 (3) ◽  
pp. 403-409 ◽  
Author(s):  
Jay M Sosenko ◽  
Susan Geyer ◽  
Jay S Skyler ◽  
Lisa E Rafkin ◽  
Heba M Ismail ◽  
...  

Diabetes Care ◽  
2009 ◽  
Vol 33 (3) ◽  
pp. 620-625 ◽  
Author(s):  
J. M. Sosenko ◽  
J. P. Palmer ◽  
L. E. Rafkin ◽  
J. P. Krischer ◽  
D. Cuthbertson ◽  
...  

2020 ◽  
Vol 105 (11) ◽  
Author(s):  
Kimber M Simmons ◽  
Jay M Sosenko ◽  
Megan Warnock ◽  
Susan Geyer ◽  
Heba M Ismail ◽  
...  

Abstract Context Once islet autoantibody–positive individuals are identified, predicting which individuals are at highest risk for type 1 diabetes (T1D) is important. A metabolic risk score derived from 2-hour oral glucose tolerance test (OGTT) data, the Diabetes Prevention Trial-Type 1 risk score (DPTRS), can accurately predict T1D. However, 2-hour OGTTs are time-consuming and costly. Objective We aimed to determine whether a risk score derived from 1-hour OGTT data can predict T1D as accurately as the DPTRS. Secondarily, we evaluated whether a 1-hour glucose value can be used for diagnostic surveillance. Methods The DPTRS was modified to derive a 1-hour OGTT risk score (DPTRS60) using fasting C-peptide, 1-hour glucose and C-peptide, age, and body mass index. Areas under receiver operating curves (ROCAUCs) were used to compare prediction accuracies of DPTRS60 with DPTRS in Diabetes Prevention Trial–Type 1 (DPT-1) (n = 654) and TrialNet Pathway to Prevention (TNPTP) (n = 4610) participants. Negative predictive values (NPV) for T1D diagnosis were derived for 1-hour glucose thresholds. Results ROCAUCs for T1D prediction 5 years from baseline were similar between DPTRS60 and DPTRS (DPT-1: 0.805 and 0.794; TNPTP: 0.832 and 0.847, respectively). DPTRS60 predicted T1D significantly better than 2-hour glucose (P &lt; .001 in both cohorts). A 1-hour glucose of less than 180 mg/dL had a similar NPV, positive predictive value, and specificity for T1D development before the next 6-month visit as the standard 2-hour threshold of less than 140 mg/dL (both ≥ 98.5%). Conclusion A 1-hour OGTT can predict T1D as accurately as a 2-hour OGTT with minimal risk of missing a T1D diagnosis before the next visit.


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