The results support policy positions that diabetes self-management education and support should occur at transitions in care.
With the right training, patients starting a new insulin can titrate the dosing and achieve glycemic control better than those relying on physicians, according to study results that Sanofi released Thursday.
The study, called TAKE CONTROL, involved 631 patients with uncontrolled type 2 diabetes (T2D) who had lived with the disease an average of 12 years. All started on Sanofi’s newest insulin, Toujeo, (insulin glargine 300 units/mL), a longer-acting insulin than Sanofi’s Lantus. Of the group, 62% were already using another basal insulin, and 38% were starting insulin for the first time.
Patients were randomized into 2 groups, with 1 group following a titration algorithm managed by the patient and the other following a titration algorithm managed by their physician. If patients were also taking oral medication for their T2D, they remained on those medications.
The goal of the study was to measure noninferiority: in other words, could patients managing their own titration do no worse than a physician? However, the results showed that after 24 weeks, the patient-driven titration group had reduced their glycated hemoglobin (A1C) by an average of 0.13% more than the physician-managed group, which meant they not only achieved non-inferiority (P <.0001) but also measured = .0247 for superiority, meeting a requirement of P = .025.
At least 1 hypoglycemia episode was reported by 36.2% of the patient-driven titration group and 37.0% of the physician-driven titration group. Severe episodes were reported in 0.6% of the patient-driven group and 0.3% of the physician-driven group. A composite score of confirmed or severe hypoglycemia favored the patient-driven titration group.
“The results of the TAKE CONTROL study demonstrate that patients can make a critical contribution to work toward their own effective blood sugar target when they are well-trained and using a basal insulin such as Toujeo,” said Riccardo Perfetti, vice president of medical affairs, Diabetes and Cardiovascular Medical Affairs, Sanofi, in a statement.
The statement said Sanofi is in the midst of a real-world program involving 200,000 patients in the United States and Europe, which will generate data for payers and other research groups.
The findings from TAKE CONTROL would seem to support the position statement of the American Diabetes Association, the American Association of Diabetes Educators, and Academy of Nutrition and Dietetics that diabetes self-management education and support (DSMES) should not be a “one and done” event, but should occur at distinct points in the life of a person with diabetes, one being “at transitions in life and care.” However, reimbursement for DSMES, especially in Medicare, has not tracked the policy position.
Results for TAKE CONTROL were presented at the European Association for the Study of Diabetes, meeting in Lisbon, Portugal.