Sanofi and IBM Watson Health real-world analysis showed that individuals not achieving control on basal insulin within 12 months were unlikely to achieve control during the remainder of the two year study

ABU DHABI, United Arab Emirates, Dec. 5, 2017 /PRNewswire/ -- The likelihood of responding to basal insulin in routine care in the U.S. declined rapidly when blood sugar control was not achieved within the first 12 months after starting treatment. This finding comes from a retrospective observational analysis of a large dataset of U.S. electronic health records by Sanofi and IBM Watson Health and was presented today at the International Diabetes Federation Congress in Abu Dhabi.¹

"Achieving blood glucose targets early has been shown to reduce risks of microvascular complications, but many patients in routine care remain uncontrolled without timely addition of antihyperglycemic agents," said Lawrence Blonde, MD, Director of the Ochsner Diabetes Clinical Research Unit, in the Department of Endocrinology at the Ochsner Medical Center, New Orleans, LA, U.S. "This observational study demonstrated the potential consequences of continuing rather than intensifying diabetes treatment that has not achieved glycemic targets, especially as long as one year after initiating basal insulin treatment."

The retrospective analysis showed that the longer patients maintain basal insulin treatment without achieving glycemic control, the less likely they are to subsequently achieve control. About one-third of patients achieved goal within the first 12 months. For patients who did not reach goal in this time, the likelihood was reduced considerably, to about 3 percent for each subsequent 3 month period up to 2 years.

"While basal insulin plays a central role in treating diabetes, reluctance to intensify treatment may be preventing people from reaching their goals if basal insulin is not sufficient," said Riccardo Perfetti, Senior Medical Officer, Vice President Global Medical Affairs, Diabetes at Sanofi. "We know that patients often stay on insufficient therapies for extended periods. This might be due to the complexity associated with current methods of intensification, which can include higher daily insulin doses, the addition of short-acting insulin and more frequent blood glucose monitoring. Other practical concerns, including referrals and economic factors, may also contribute to this delay."

About the analysis

This observational analysis mapped response rate following the initiation of basal insulin (BI) to treat adults with type 2 diabetes. A cohort of 5,936 patients was retrospectively identified from the IBM Explorys^® set of U.S. electronic health records in November 2017. Patients taking one or more OADs when they received their first BI prescription were included if they had valid HbA_1c data covering at least 180 continuous days of treatment. Patient outcomes were studied only for the period where their data were recorded in Explorys.

Successful blood sugar control was defined as achieving HbA_1c ≤7%. The proportion of patients achieving successful glucose control in each time period after initiating BI is shown in the table below:

"Leveraging real world data and evidence to understand clinical outcomes in day to day diabetes management can provide insights for a disease that is difficult for providers and especially patients to manage," said Kyu Rhee, MD, Chief Health Officer, IBM Watson Health. "This study demonstrates how leaders like Sanofi can apply real world data and machine learning technologies to a clinical question."

As a retrospective observational analysis based on electronic medical record (EMR) data, this study has certain limitations. The current analysis describes the experience of patients within the dataset under specific conditions. The dataset represents an open cohort of mostly insured U.S. patients seeking care, so findings may not be generalizable to the entire U.S. population or international populations. EMR data are not completed for research purposes and vary in completeness of variables of interest. As such, HbA_1c measurements were not consistently performed every 3 months in many patients. Patients were considered uncontrolled until the first recorded HbA1c of ≤7%.

Three additional Sanofi and IBM Watson Health studies presented at IDF showed the value of real-world data, analytics, machine learning and expertise.

References

1. Blonde L, et al. "Real-world observational study to evaluate probability of achieving glycaemic control in patients with type 2 diabetes" Poster presentation P-0489 at International Diabetes Federation Congress, Abu Dhabi, December 4-8 2017. Abstract available via https://conference.idf.org/cmPortal/Searchable/AD2017/config/normal#!abstractdetails/0016079 [Accessed November 2017].

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