1050-P: Development and Validation of the Continuous Subcutaneous Insulin Infusion-Related Quality of Life (CSII-QoL) Scale
Authors: TOYODA MASAO , TONE ATSUHITO , KATO KEN , KIMURA MORITSUGU , KAWASHIMA SATOSHI , SAWAKI HIDEAKI , HIROTA YUSHI , OKADA AKIRA , KURODA AKIO , MATSUHISA MUNEHIDE , WATANABE TOMOKAZU , SUGANUMA AKIKO , MURATA TAKASHI , SAKANE NAOKI 
Published: June 2019

Continuous subcutaneous insulin infusion (CSII) is associated with improved glycemic control, reduced incidence of hypoglycemia and improved quality of life (QoL). To date, however, there is no QoL scale specific to CSII. The objective of this study was to develop and validate a scale to measure CSII-QoL for patients with type 1 diabetes (T1D).A total of 50 T1D patients aged ≥15 years who used CSII (28% males; age 47.6±17.0 years, mean±SD; duration of diabetes 14.7±9.7 years; duration of CSII use 6.1±3.3 years; HbA1c 7.4±0.8%) took part in the CSII-QoL study. Twenty-eight potential CSII-QoL items were developed in a combined approach consisting of semi-structured patient interviews, expert input and literature research. The resulting CSII-QoL was tested for factor analysis, validity, reliability and influence factors. The final 25-item questionnaire was found to have a three-domain structure (“convenience,” “social restriction,” and “psychological problems”), high internal consistency (Cronbach’s alpha = 0.851), and substantial test-retest reliability (intraclass correlation coefficient = 0.69). The CSII-QoL score correlated positively with basal insulin ratio, but not with age, sex, HbA1c, or total daily insulin dose. The CSII-QoL score correlated negatively with the Problem Areas in Diabetes (PAID) score. The CSII-QoL is the first CSII-related QoL scale for patients with T1D. This short, validated and reliable instrument can potentially be useful in future clinical studies and in routine clinical patient care. (UMIN-CTR: UMIN000031595).

Disclosure
M. Toyoda: Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo Company, Limited, Eli Lilly and Company, Kyowa Hakko Kirin Co., Ltd., Medtronic Japan Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Novo Nordisk Inc., Sanofi, Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited. A. Tone: Speaker's Bureau; Self; Lilly Diabetes, Medtronic Japan Co., Ltd., Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Sanofi, Sanwa Kagaku Kenkyusho, Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited. K. Kato: None. M. Kimura: None. S. Kawashima: Speaker's Bureau; Self; Novo Nordisk Inc., Sumitomo Dainippon Pharma Co., Ltd. H. Sawaki: None. Y. Hirota: Speaker's Bureau; Self; Abbott, Astellas Pharma Inc., AstraZeneca, Daiichi Sankyo Company, Limited, Eli Lilly and Company, Medtronic Japan Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi, Takeda Pharmaceutical Company Limited, Terumo Medical Corporation. A. Okada: None. A. Kuroda: Speaker's Bureau; Self; Eli Lilly and Company, Novo Nordisk Inc., Sanofi. M. Matsuhisa: Advisory Panel; Self; Eli Lilly and Company. Board Member; Self; Daiichi Sankyo Company, Limited. Research Support; Self; Astellas Pharma Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma Corporation. Speaker's Bureau; Self; Astellas Pharma Inc., Eli Lilly and Company, Mitsubishi Tanabe Pharma Corporation, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Sanofi, Takeda Pharmaceutical Company Limited. T. Watanabe: None. A. Suganuma: None. T. Murata: Research Support; Self; Kowa Company, Ltd. Speaker's Bureau; Self; Kowa Pharmaceutical Co. Ltd., Novo Nordisk Pharma Ltd., Sanofi K.K. N. Sakane: Board Member; Spouse/Partner; Kao Corporation.