Progression of Physiological Parameters Over Time in Type 1 Diabetes Mellitus Patients in France.

Abstract

The objective of this study was to understand the progression over time of physiological parameters, including HbA1c, body mass index (BMI), systolic blood pressure (SBP), total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides, in type 1 diabetes mellitus (T1DM) patients to inform disease modeling. This was a cross-sectional analysis of T1DM patients based on the IMS LifeLink Diabetes Cohort in France, which prospectively collects clinical, biological and treatment information from general practitioners. Patient age, gender, year of diagnosis, BMI, HbA1c, cardiovascular risk factors, renal function and lab test results were collected at baseline and subsequent visits. Data were analyzed using R Studio. T1DM patients who visited their general physician between May 2011 and May 2014 and have received at least one insulin prescription were included in the analysis. A cohort of 605 T1DM patients was included in this analysis. Forty-three percent of patients were male. Average patient age at first visit was 58 years of age. Mean HbA1c was 7.8%, mean SBP was 132 mmHg, and mean BMI was 27.6 kg/m2. Linear regression showed that BMI increased by 0.092 kg/m2 (p<0.001) for each additional year of age. SBP was projected to increase by 0.248 mmHg (p<0.001) per additional year of age, LDL-cholesterol decreased by 0.624 mg/dL for each additional (p=0.017) year of age and triglycerides increased by 1.417 mg/dL for each additional (p=0.041) year of age. Changes in HbA1c, total cholesterol and HDL-cholesterol over time were not significantly correlated with patient age or time since diagnosis. Therefore, health economic modelers may assume that these parameters remain stable over time. Sensitivity analyses were performed to address the potential mislabeling of T2DM as T1DM patients. These results provide relevant inputs for the progression of physiological parameters to model the economic and clinical impacts of T1DM therapies over time.