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Lee Kallenbach, PhD, MPH · Oct 18, 2016

Real World Evidence (RWE) Study on Treatments of Type 2 Diabetes

Results from a Real World Evidence (RWE) Study on Treatments of Type 2 Diabetes at EASD Annual Meeting

The Practice Fusion Medical Team, along with other coauthors, recently presented new findings from a large real-world evidence (RWE) study focused on the treatment of type 2 diabetes (T2D) conducted in multiple ambulatory care settings. The study and results were presented in a research poster at the 52nd annual meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany. In comparing the care given by providers in independent practices to patients in need of intensifying their antidiabetic therapy for managing T2D to the care given by practitioners in different care settings (as reported in other studies), the RWE study showed that providers in independent practices provided similar care for these patients as did providers in large academic centers or other practice settings.

The research poster, entitled “A Cloud-Based Electronic Health Records Study of Treatment Intensification Patterns in Patients with Type 2 Diabetes Uncontrolled on ≥ 2 Oral Antidiabetic Drugs,” provided a summary of this large, multi-ambulatory care center study where researchers performed a retrospective observational analysis of de-identified data from Practice Fusion’s de-identified clinical database, which includes more than 38 million records, representing 6.7% of all practices across the United States.1

Diabetes and treatment intensification

Type 2 diabetes (T2D) is a progressive disease requiring gradual intensification of therapy in order to achieve and maintain glycaemic control. Initial treatment for T2D revolves around lifestyle modification, but most patients who develop T2D will require intensification of treatment, initially with oral antidiabetes drugs (OADs) and eventually with insulin and non-insulin injectable therapies. Timely intensification of antidiabetes treatment in patients with T2D is beneficial in terms of reducing diabetic complications, and is supported by international guidelines.2,3

However, clinical inertia, or the failure to intensify treatment regimens when required, continues to present as a barrier to the effective management of T2D; in the US, fewer than half of patients with T2D receive intensification within 12 months after not meeting their glycaemic targets.4 Although several clinical trials have evaluated the efficacy of treatment intensification in patients with uncontrolled T2D,5,6 there is limited information on clinical practice patterns associated with timely treatment intensification in real-world patients with T2D.

Results of the study

With a cohort of 25,365 de-identified records, the study findings demonstrate that in treating patients in need of intensifying their antidiabetic therapy for managing their T2D:

  • Most providers in independent practices added an additional oral antidiabetic (OAD). However, intensification to injectable forms of therapy, such as a basal insulin or a GLP-1 RA, was infrequent, occurring in less than 10% of patients.
  • Consultation by an independent practice provider with an endocrinologist was a significant predictor for intensification with an injectable therapy (P ≤ 0.001)
  • Treatment of non-intensification affected older patients and those with lower levels of uncontrolled HbA1c (P ≤ 0.001)

This most recent diabetes RWE study demonstrates how the intensification of therapy we observed was largely consistent with those reported in other studies that examined clinical inertia for treating type 2 diabetes in large academic centers or other care settings. As researchers, we can provide clinical insights into what’s happening in real world care settings that are data driven, measurable, and can help demonstrate improved outcomes using retrospective analysis of data.

The results of this study illustrates how EHRs can serve more than a paper substitute: They can provide meaningful insight that helps providers better understand the care of their patients. We’re excited to finalize our analysis of the clinical outcomes and share further results in the near future.

The RWE study abstract can be viewed online by accessing the EASD 52nd annual meeting program from EASD’s website. Read more about the background for this study from an interview with our Principal Investigator, Lee Kallenbach, PhD, MPH ** on

1Physician Office Usage of Electronic Health Records Software. Available from: Accessed July 2016.
2American Diabetes Association. Diabetes Care. 2016;39:S1-112.
3Inzucchi SE, et al. Diabetes Care. 2015;38:140-9.
4Fu AZ, Sheehan J. Diabetes Obes Metab. 2016 May 10 [Epub ahead of print].
5Ismail-Beigi F. Lancet. 2010;376:419-30.
6O’Connor PJ. Ther Adv Endocrinol Metab. 2011;2:17-26.