Certain changes in blood glucose levels over six months could indicate the onset of type 1 diabetes….
A progression scale for 6 months (PS6M) served as an indicator of short-term glycemic progression toward T1D, and could possibly be a useful tool for evaluating preventive treatments and biomarkers of T1D.
Blood glucose levels are often higher during the last few years before the diagnosis of type 1 diabetes (T1D) in autoantibody-positive patients. By examining the changes in glucose levels during a 6-month period, researchers hoped to identify potential biomarkers and preventive treatments for type 1 diabetes.
Inclusion criteria included individuals with pancreatic autoantibody-positive relatives of patients with T1D. 2-h oral glucose tolerance tests (OGTT) at baseline and within 6 ± 3 months from the baseline OGTT were performed after enrollment of 1,245 participants. Exclusion criteria included individuals diagnosed with T1D at or before the 6-month OGTT. If fasting glucose values OGTTs in asymptomatic patients were ≥126 mg/dL and/or 2-h glucose values were ≥200 mg/dL, OGTTs were repeated to confirm the diagnosis of T1D.
Glucose oxidase method and Toshoh assay were utilized to measure the plasma glucose levels and C-peptide, respectively. Multiple linear regression equations and t-test were usedfor statistical analysis to develop a progression scale for 6 months (PS6M).
After analyzing the results, PS6M was shown to be a strong predictor of developing T1D (p<0.001). The area under the receiver operating characteristic curve was greater for the PS6M compared to the baseline-to-6-month difference (p<0.001). For patients with low PS6M values, the 3-year risk was lower compared to patients with PS6M values ≥100 mg/dL. In addition, PS6M values were greater in patients with two or more autoantibodies at baseline compared to those with one autoantibody (p<0.001). Moreover, PS6M values were also greater in patients with baseline 30-0 min C-peptide values <2.00 ng/mL than with values ≥2.00 ng/mL (p7.00 than with values ≤7.00 (p<0.001).
In conclusion, since the PS6M showed the change in glycemia over a specified period of time, it can be used to evaluate preventive treatments and biomarkers of T1D. In addition, it could reduce numbers and the length of follow-up; therefore, it is feasible to use in early-phase clinical trials.
- PS6M can be used to evaluate preventive treatments and biomarkers of T1D.
- PS6M was shown to be a better predictor of T1D compared to the difference in OGTTs.
- PS6M should only be used in patients with auto-antibody-positive relatives of patients with T1D.
Sosenko JM et al. “The Development and Utility of a Novel Scale That Quantifies the Glycemic Progression Toward Type 1 Diabetes Over 6 Months.” Diabetes Care. 2015 March 10.