Background: Estimating the nutritional content of food is essential for self-management in people with type 2 diabetes mellitus, but it is a difficult skill to learn. The aim of this study was to investigate how diabetes management was impacted by the ability of patients to search for items they ate from a database of 26,300 different foods, and to visualize nutritional intake using the Japanese mobile application (app) "Calomeal."Methods: This was a single-arm, single-center, pilot study. Eighteen outpatients with type 2 diabetes mellitus used the "Calomeal" app for 3 months. The primary endpoint was change in hemoglobin A1c (HbA1c). Secondary endpoints were changes in body weight (BW), lipid parameters, and quality of life scores.
Aims/Introduction In Japan, an insulin pump with predictive low‐glucose management (PLGM) was launched in 2018. It automatically suspends insulin delivery when the sensor detects or predicts low glucose values. The aim of this study was to analyze the safety and efficacy of PLGM in patients treated in a Japanese center. Materials and Methods We carried out a retrospective observational analysis of 16 patients with type 1 diabetes mellitus and one patient after pancreatectomy. They switched from the MiniMed 620G device to the 640G device with PLGM. The primary outcome was the change in the percentage of time in hypoglycemia. The secondary outcome was the change in HbA1c (%) over a period of 3 months. We also explored the presence of “post‐suspend hyperglycemia” with the 640G device. Results After changing to the 640G device, the percentage of time in hypoglycemia (glucose <50 mg/dL) significantly decreased from 0.39% (0–1.51%) to 0% (0–0.44%; P = 0.0407). The percentage of time in hyperglycemia (glucose >180 mg/dL) significantly increased from 25.53% (15.78–44.14%) to 32.9% (24.71–45.49%; P = 0.0373). HbA1c significantly increased from 7.6 ± 1.0% to 7.8 ± 1.1% ( P = 0.0161). From 1.5 to 4.5 h after the resumption of insulin delivery, the percentage of time in hyperglycemia was 32.23% (24.2–53.75%), but it was significantly lower, 2.78% (0–21.6%), when patients manually restarted the pump within 30 min compared with automatic resumption 31.2% (20–61.66%; P = 0.0063). Conclusions Predictive low‐glucose management is an effective tool for reducing hypoglycemia, but possibly elicits “post‐suspend hyperglycemia.” This information is useful for achieving better blood glucose control in the patients treated with PLGM.
Recent randomized controlled studies have revealed that levothyroxine (LT4) treatment improves pregnancy outcomes only in infertile women with subclinical hypothyroidism who have thyroid autoantibodies (TAs), but not for those with high TSH levels within the normal range who have TAs. Here, we retrospectively investigated pregnancy outcomes in infertile Japanese women with 2.5 μIU/mL ≤ TSH < upper reference limit (URL). Between 2012 and 2018, 286 patients diagnosed with infertility were followed for more than 1 year at our institution. Among them, we included 106 patients with 2.5 μIU/mL ≤ TSH < URL. We divided these patients into four groups based on the combination of TA positivity and LT4 treatment status to assess the effects of LT4 treatment considering TA positivity on the incidence of pregnancy or miscarriage. In this study, we did not find any significant differences in the rates of pregnancy or miscarriage among the four groups (p = 0.81 and 0.52, respectively). In addition, logistic regression analysis showed that age and history of miscarriage were associated with the incidence of pregnancy, but presence of TAs and LT4 treatment status were not and that no variables examined were associated with the incidence of miscarriage. In summary, we were not able to demonstrate the benefit of LT4 treatment for pregnancy outcomes in Japanese euthyroid infertile women with 2.5 μIU/mL ≤ TSH < URL regardless of TA status in this study.
Background: The estimation of nutrient content is difficult, but important for self-management of people with type 2 diabetes mellitus (T2DM). In Japan, food-log app has not been penetrated as a treatment tool yet. That could be because Japanese food is diverse and consists of various ingredients. In this study, we investigated the efficacy of app “Calomeal” that enables the patients to search for what they eat among the database of 26300 kinds of foods and to visualize the nutrients using smartphone. Method: We recruited 20 people with T2DM in Juntendo University. They used this app for 3 months on the regular treatment. The blood and urine exams were performed monthly. At the beginning and the end of the study, the estimation of food was also assessed by the dietitian and the questionnaires about QOL (DTSQ/PAID) were performed. Results: 2 were dropped out. 18 participants were 52.3±9.2 y.o., male/female 12/8, BMI 25.8±4.7 kg/m2, and HbA1c 8.1±0.4%. At the end of study, significant reduction was observed in HbA1c and BMI (7.92±0.4 to 7.75±0.5%[p=0.0410], 25.69±5.0 to 25.10±4.8 kg/m2 [p=0.0057]). Reduction of HbA1c and BMI were both correlated to the reduction of carbohydrate (r=0.5018 [p=0.0338], r =0.5542 [p=0.0170]). High correlation was also observed between the reduction of carbohydrate and calorie (r=0.8167 [p<0.0001]). QOL scores showed no-statistically significant improvement. Improvement of PAID score was strongly correlated to how close they could adjust calorie intake to their appropriate amount (r=0.5964 [p=0.0090]). Intriguingly, in some patients, this strong association could be due to not the reduction but the increase of food intake, because the baseline calorie intake of those were lower than the proper amount. Conclusion: Visualizing nutrients via Calomeal improved glycemic control and BMI by reducing over intake. It is of note that in some Japanese people, the adjusting nutrient intake by raising the calorie may contribute to their QOL. Disclosure A. Tsunemi: None. J. Sato: Research Support; Self; Sanofi. Speaker’s Bureau; Self; Daiichi Sankyo, Medtronic, Mitsubishi Tanabe Pharma Corporation, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi, Takeda Pharmaceutical Company Limited, Terumo Medical Corporation. M. Enomoto: None. Y. Iwagaki: None. S. Sugimoto: None. Y. Someya: None. M. Kiya: None. E. Matsuhashi: None. Y. Wakabayashi: None. T. Funayama: None. T. Uchida: None. T. Miyatsuka: None. K. Azuma: None. T. Shimizu: None. H. Satoh: None. A. Kanazawa: Speaker’s Bureau; Self; Novartis Pharma K.K., Sanofi, Takeda Pharmaceutical Company Limited. H. Watada: Advisory Panel; Self; Abbott, Ajinomoto, Astellas Pharma Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Fuji Film, Janssen Pharmaceuticals, Inc., Kowa Company, Ltd., Kyowa Hakko Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi-Aventis, Takeda Pharmaceutical Company Limited, Terumo Medical Corporation. Research Support; Self; Astellas Pharma Inc., Bayer Yakuhin, Ltd., Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo, Eli Lilly Japan K.K., Kissei Pharmaceutical Co., Ltd., Kowa Company, Ltd., Kyowa Hakko Kirin Co., Ltd., Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Novartis Pharma K.K., Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Pfizer Japan Inc., Sanofi-Aventis, Sanwa Kagaku Kenkyusho, Shionogi & Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited, Teijin Pharma Limited, Yakult. Speaker’s Bureau; Self; Astellas Pharma Inc., AstraZeneca, Bayer Yakuhin, Ltd., Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo, Eli Lilly Japan K.K., Kissei Pharmaceutical Co., Ltd., Kowa Company, Ltd., Kyowa Hakko Kirin Co., Ltd., Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi-Aventis, Sanwa Kagaku Kenkyusho, Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited.
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.
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