other:Article Title: Insulin Pump Alarms During Adverse Events: A Qualitative Descriptive Study
Article Snippet: Although two of the four t:slim X2 user guides describe a “CGM error,” none mentioned a “CGM error 42.” For this analysis, we categorized this alarm signal as “unreferenced.” Although AE narratives referred to this as an “alarm,” chapter 13 of the MiniMed 670G and MiniMed 630G user guides entitled “Alarms, alerts, and messages” refers to it as an “alert.” For this analysis, we also categorized this alarm signal as an “alert.” Of the unique alarm signals, 32.5% were not listed in the instructional materials of corresponding pump, and seven of these unreferenced alarms were cited in more than one AE narrative.
Article Title: Cost-effectiveness of advanced hybrid closed loop therapy compared to standard insulin therapy for type 1 diabetes in pregnancy: an economic evaluation of the CRISTAL trial
Article Snippet: Messer LH, Forlenza GP, Sherr JL, et al. Optimizing Hybrid Closed-Loop Therapy in Adolescents and Emerging Adults Using the MiniMed 670G System.
Biomarker Discovery:Article Title: Automated Insulin Delivery in Pregnancies Complicated by Type 1 Diabetes
Article Snippet: .. PICLS study (Pregnancy Intervention With a Closed-Loop System), NCT03774186 45 , MiniMed 670G AID vs SAP without automation therapy with Guardian 3 CGM , USA, 2 centers Mar 2022 , Open-label, pilot RCT 1:1 randomization 14-18 weeks N=23; Eligibility: women GA ≤11 weeks, HbA1c 37-75 mmol/mol (5.5-9%), 18-45 years, T1D diagnosis >1 year, intensive insulin therapy (MDI or CSII); Run-in phase of seven days with study device CGM , Severe hypoglycemic episodes, Time <3.0 mmol/L (54 mg/dL), time <3.5 mmol/L (63 mg/dL), 3.5-7.8 mmol/L (63-140 mg/dL), >7.8 mmol/L (140 mg/dL) and >10 mmol/L (180 mg/dL), fear of hypoglycemia , DKA; skin reactions; duration of hypoglycemic episodes; secondary glycemic outcomes (mean glucose ± standard deviation, J index, high blood glucose index, low blood glucose index, mean amplitude of glycemic excursions [MAGE], continuous overall net glycemic action [CONGA n ]) health status, insulin delivery device satisfaction, glucose monitoring device satisfaction, AID device acceptability, preeclampsia/eclampsia; C-sections; gestational weight gain; miscarriage or stillbirth; LGA; neonatal hypoglycemia , There were no episodes of severe hypoglycemia or DKA after randomization in either group. Mean sensor glucose was lower with SAP compared with AID in the third trimester [7.3 mmol/L vs 6.6 mmol/L (119 [mg/dL vs 132 mg/dL], P < .05), Third trimester TIRp increased with SAP (68.2% vs 60.5% second trimester, P < .05). TIRp was clinically lower in third trimester with AID compared with SAP (61.9% vs 68.2%, P = .1667). TBRp, significantly decreased in AID group (3.5% second trimester and 2.8% third trimester vs 7.9% run-in phase, P < .05 for both).. .. Stewart, 2018 / UK / ISRCTN71510001 and ISRCTN83316328 52 , CGM (FreeStyle Navigator 2; Abbott Diabetes Care, Alameda, CA), insulin delivery was through a DANA-R pump (Diabecare, Sooil, Seoul, South Korea) and the AID systems used were the Florence D2W and Florence D2A (both University of Cambridge, Cambridge, UK). The control algorithm was on a tablet PC for the former and on an Android phone for the latter. , UK, 1 center , Secondary analyses of all women included in the two randomized crossover trials who chose to continue using AID intrapartum and immediate postpartum period [27 (84.4%) of the potential 32 trial participants , TIRp 3.5-7.8 mmol/L (63–140 mg/dL) during pregnancy and TIR 3.9-10 mmol/L (70–180 mg/dL) after delivery , Use of AID was associated with TIRp 82.0% (IQR 49.3, 93.0) during labor and delivery. Postpartum TIR was 83.3% (IQR 75.2, 94.6). There was no difference in maternal intrapartum glucose concentration between mothers of infants with and without neonatal hypoglycemia [6.9 mmol/L or 124 mg/dL and 6.8 mmol/L or 122 mg/dL, P = .84]..
Standard Deviation:Article Title: Automated Insulin Delivery in Pregnancies Complicated by Type 1 Diabetes
Article Snippet: .. PICLS study (Pregnancy Intervention With a Closed-Loop System), NCT03774186 45 , MiniMed 670G AID vs SAP without automation therapy with Guardian 3 CGM , USA, 2 centers Mar 2022 , Open-label, pilot RCT 1:1 randomization 14-18 weeks N=23; Eligibility: women GA ≤11 weeks, HbA1c 37-75 mmol/mol (5.5-9%), 18-45 years, T1D diagnosis >1 year, intensive insulin therapy (MDI or CSII); Run-in phase of seven days with study device CGM , Severe hypoglycemic episodes, Time <3.0 mmol/L (54 mg/dL), time <3.5 mmol/L (63 mg/dL), 3.5-7.8 mmol/L (63-140 mg/dL), >7.8 mmol/L (140 mg/dL) and >10 mmol/L (180 mg/dL), fear of hypoglycemia , DKA; skin reactions; duration of hypoglycemic episodes; secondary glycemic outcomes (mean glucose ± standard deviation, J index, high blood glucose index, low blood glucose index, mean amplitude of glycemic excursions [MAGE], continuous overall net glycemic action [CONGA n ]) health status, insulin delivery device satisfaction, glucose monitoring device satisfaction, AID device acceptability, preeclampsia/eclampsia; C-sections; gestational weight gain; miscarriage or stillbirth; LGA; neonatal hypoglycemia , There were no episodes of severe hypoglycemia or DKA after randomization in either group. Mean sensor glucose was lower with SAP compared with AID in the third trimester [7.3 mmol/L vs 6.6 mmol/L (119 [mg/dL vs 132 mg/dL], P < .05), Third trimester TIRp increased with SAP (68.2% vs 60.5% second trimester, P < .05). TIRp was clinically lower in third trimester with AID compared with SAP (61.9% vs 68.2%, P = .1667). TBRp, significantly decreased in AID group (3.5% second trimester and 2.8% third trimester vs 7.9% run-in phase, P < .05 for both).. .. Stewart, 2018 / UK / ISRCTN71510001 and ISRCTN83316328 52 , CGM (FreeStyle Navigator 2; Abbott Diabetes Care, Alameda, CA), insulin delivery was through a DANA-R pump (Diabecare, Sooil, Seoul, South Korea) and the AID systems used were the Florence D2W and Florence D2A (both University of Cambridge, Cambridge, UK). The control algorithm was on a tablet PC for the former and on an Android phone for the latter. , UK, 1 center , Secondary analyses of all women included in the two randomized crossover trials who chose to continue using AID intrapartum and immediate postpartum period [27 (84.4%) of the potential 32 trial participants , TIRp 3.5-7.8 mmol/L (63–140 mg/dL) during pregnancy and TIR 3.9-10 mmol/L (70–180 mg/dL) after delivery , Use of AID was associated with TIRp 82.0% (IQR 49.3, 93.0) during labor and delivery. Postpartum TIR was 83.3% (IQR 75.2, 94.6). There was no difference in maternal intrapartum glucose concentration between mothers of infants with and without neonatal hypoglycemia [6.9 mmol/L or 124 mg/dL and 6.8 mmol/L or 122 mg/dL, P = .84]..
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