The Effectiveness of Sensor-Augmented Pump Therapy with Automatic Low-Glucose Suspend in Japanese Patients with Type 1 Diabetes

Background and Objective: Sensor-augmented pumps (SAP) that suspend insulin when glucose is low or predicted to go low within the next 30 minutes (The MiniMed™ 640G insulin pump) have been approved in Japan from March 2018. The system, Smart GuardTM technology, would automatically resume insulin delivery when glucose levels recover. The aim of this observational study is to evaluate the effectiveness of Smart GuardTM technology, which may offer the opportunity to reduce hypoglycemia for the patients with type 1 diabetes. The primary outcome is the change of the percentage of time in hypoglycemia (%Time in hypoglycemia <70 mg/dl: %TIHypo) and the secondary outcome is the change of HbA1c (%). Method: In Juntendo University Hospital, among 49 patients with the MiniMed™ 620G (SAP without Smart GuardTM technology), we analyzed the data of 17 patients (male/female: 4/13, age: 51.2±17.6 years old) who changed from 620G to 640G. Results: After 2 months use of 640G, %TIHypo decreased from 2.97[1.15-6.27]% to 1.48[0.06-2.81]%, and HbA1c (%) increased from 7.00[6.45-7.65]% to 7.25[6.73-8.28]%. %TIHyper (%Time in hyperglycemia>180 mg/dl) increased from 26.06[19.74-37.28]% to 31.80[18.65-46.31]%. None of them were statistically significant. Conclusions: In the real-world data, the Smart GuardTM technology of 640G could have decreased the time in hypoglycemia. In many cases, sensor glucose after suspending basal insulin tend to be higher, therefore, patients might have to increase the insulin dose after suspending. We need to study on a larger sample of patients and with a more prolonged follow-up. Disclosure A. Tsunemi: None. J. Sato: Speaker's Bureau; Self; Astellas Pharma Inc., Eli Lilly and Company, Mitsubishi Tanabe Pharma Corporation, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi, Takeda Pharmaceutical Company Limited. M. Kurita: None. Y. Wakabayashi: None. N. Waseda: None. M. Koshibu: None. M. Shinohara: None. A. Ozaki: None. H. Nakamura: None. N. Hirano: None. F. Ikeda: None. H. Watada: Research Support; Self; Astellas Pharma Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo Company, Limited, Kissei Pharmaceutical Co., Ltd., Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Pfizer Inc., Sanofi, Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited, Teijin Pharma Limited. Speaker's Bureau; Self; Astellas Pharma Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo Company, Limited, Eli Lilly and Company, Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Novo Nordisk A/S, Ono Pharmaceutical Co., Ltd., Sanofi, Takeda Pharmaceutical Company Limited, Terumo Medical Corporation. Other Relationship; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Kowa Pharmaceutical Europe Co. Ltd., Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Ono Pharmaceutical Co., Ltd., Sanwa Chemical Industry Co. Ltd., Takeda Pharmaceutical Company Limited.