Device-Supported vs Routine Titration in Type 2 Diabetes
Device-supported titration appears to be safe and efficacious.
This article is part of Endocrinology Advisor's coverage of the American Diabetes Association's 77th Scientific Sessions (ADA 2017), taking place in San Diego, CA. Our staff will report on medical research and technological advances in diabetes and diabetes education, conducted by experts in the field. Check back regularly for more news from ADA 2017.
Compared with routine titration, device-supported titration (MyStar DoseCoach, Sanofi), a combined titration device and blood glucose meter, demonstrated good efficacy and safety in patients with type 2 diabetes, according to data presented at the American Diabetes Association's (ADA) 77th Scientific Sessions, held June 9-13 in San Diego, California.
For the randomized, parallel-group multicenter treat-to-target AUTOMATIX trial (Comparison of MyStar DoseCoach to Routine Titration in Adult Patients With Type 2 Diabetes Mellitus Using Toujeo; ClinicalTrials.gov identifier: NCT02585674), researchers randomly assigned 151 patients with type 2 diabetes 1:1 to device-supported (n=75) or routine glargine 300 U/mL (Gla-300; investigator recommended; n=76) titration regimens.
The rate of patients achieving a fasting self-monitored plasma glucose (FSMPG) target of 90 to 130 mg/dL at week 16 without severe hypoglycemia served as the primary end point measure.
Secondary end points were rate of patients achieving target FSMPG at week 16 without confirmed or severe hypoglycemia, as well as changes in mean FSMPG, hemoglobin A1c, and daily insulin dose from baseline to week 16. The researchers also reported the number of patients who experienced hypoglycemia and adverse events.
Results revealed a nonsignificant increase in the rate of patients who achieved the primary end point in the device-supported group compared with the routine titration group (45.9% vs 36.8%).
The data also indicated a higher rate of patients who achieved a target FSMPG at week 16 without confirmed or severe hypoglycemia in the device-supported group (34.3% vs 14.5%), although superiority was not determined.
In addition, the researchers observed similar rates of patients who experienced hypoglycemia (any event: device supported, 34.7% vs routine, 38.2%), treatment-emergent adverse events (device supported, 45.3% vs routine, 38.2%), and serious adverse events (device supported, 2.7% vs routine, 3.9%).
Likewise, changes in mean FSMPG, hemoglobin A1c, and daily insulin dose from baseline to week 16 were comparable between groups.
"The results show that device-supported titration with Gla-300 has a good efficacy/safety profile and may aid glycemic target achievement," the researchers concluded.
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Edelman S, Bain S, Hasslacher C, et al. Device-supported vs routine titration of insulin glargine 300 U/mL (Gla- 300) in T2DM: efficacy and safety. Late Breaking Poster 131. Presented at: American Diabetes Association's (ADA) 77th Scientific Sessions. June 9-13, 2017; San Diego, CA.