Long-haul travel (flights >6 hours) can be very disruptive for people living with type 1 diabetes (T1D) . As part of a study comparing long-acting basal insulins during long-haul travel (Bevier & ...Castorino, et al) , we evaluated the impact of direction of travel on glucosecontrol (Abbott Freestyle Libre Pro) . Each journey began in Honolulu (HI) with a non-stop flight to New York (NY) lasting hours with a 6-hour time difference. After 72 hours, participants returned non-stop to HI. Each subject completed round trips (using either Glargine or Insulin Degludec as the basal insulin) . Participants traveled in the same direction for either basal insulin. To assess the impact of direction of travel, data using either basal insulin were combined. Overall, 21 participants (13 women, age 34.2±15.2 years, HbA1c 7.5±1.2%) completed both journeys. CGM-derived metrics comparing (a) initial 72 hours at each destination, (b) during each flight and (c) for the total journey are shown below. During sleep, TIR70-180 was 56±26% travelling East to West and 66±26% going from West to East. Although there were no significant differences in CGM-derived metrics irrespective of direction of travel, the data suggest that achieving the recommended time in range between 70-180 mg/dl is elusive for adults with T1D using MDI when travelling across multiple time zones.
Disclosure
W.C.Bevier: Research Support; Abbott Diabetes. H.Liu: Employee; Abbott Diabetes. K.N.Castorino: Consultant; Lilly Diabetes, Research Support; Abbott Diabetes, Dexcom, Inc., Drawbridge Health, Inc., Eyenuk, Inc., Laxmi Therapeutic Devices, Medtronic, National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk, Speaker's Bureau; Dexcom, Inc. D.Kerr: Advisory Panel; Abbott Diabetes, Novo Nordisk A/S, Sanofi, Consultant; Evidation Health, Research Support; Novo Nordisk A/S, Stock/Shareholder; Glooko, Inc., Hi.Health.
Funding
Novo Nordisk Investigator Sponsored Study - ISS-001227
76-LB: Performance of FreeStyle Libre 3 System KARINKA, SHRIDHARA A.; BRAZG, RONALD L.; CASTORINO, KRISTIN N. ...
Diabetes (New York, N.Y.),
06/2022, Letnik:
71, Številka:
Supplement_1
Journal Article
Recenzirano
FreeStyle Libre 3 is the next generation FreeStyle Libre system with the same sensor tail but an on-body component that is about 70% smaller than Libre 2. We evaluated the accuracy of the FreeStyle ...Libre 3 system in people with diabetes ages 4 years or older at 4 U.S sites. This was a non-randomized, multi-center, single-arm study with 100 evaluable subjects (95 subjects aged 6 years or older) on intensive insulin therapy. Subjects 6 years or older participated in up to 3 in-clinic sessions of up to 8 hours each over the 14- day wear period to obtain YSI comparator data. No glycemic challenges were performed during these sessions. For 5 subjects in the 4-5 years age group, capillary fingerstick measurements were performed during one in-clinic session to obtain SMBG comparator data. System performance was evaluated in terms of percent accuracy with respect to venous plasma reference using the YSI2300 Stat glucose analyzer. Accuracy was characterized as the proportion of sensor results that were within ±15%, ± 20%, and ± 40% of their paired YSI values for glucose levels ≥ 70 mg/dL or within ± 15 mg/dL, ± 20 mg/dL, and ± 40 mg/dL of YSI for glucose levels < 70 mg/dL. Other accuracy metrics such as mean bias and mean absolute relative difference (MARD) of the FreeStyle Libre 3 System with respect to YSI were also evaluated and are presented in Table 1. The FreeStyle Libre 3 System showed 93.2 % of values within ±20mg/dL/±20% of the YSI reference with an overall MARD of 7.9% based on the data from the 95 subjects with YSI reference.
Disclosure
S. A. Karinka: Employee; Abbott Diabetes. R. L. Brazg: Research Support; Abbott Diabetes, Lilly Diabetes, Medtronic, Novo Nordisk, Roche Diagnostics, Senseonics. K. N. Castorino: Consultant; Lilly Diabetes, Research Support; Abbott Diabetes, Dexcom, Inc., Drawbridge Health, Inc., Eyenuk, Inc., Laxmi Therapeutic Devices, Medtronic, National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk, Speaker’s Bureau; Dexcom, Inc. D. R. Liljenquist: None. M. Kipnes: None. H. Liu: Employee; Abbott Diabetes.
Funding
Abbott Diabetes Care
Increasing physical activity (PA) in minority populations with type 2 diabetes (T2D) is likely to have important cardiometabolic benefits. The aim of this study is to determine feasibility and ...acceptability of using wearable accelerometers to assess PA, as part of creating a unique, real-world dataset on health determinants, in Hispanic/Latino adults with or at risk for T2D. PA was measured using an ActiGraph wGT3X-BT worn on the right hip 24 hours/day for 7 consecutive days. Insulin resistance (HOMA IR) and Metabolic Syndrome Score (MetS z) were calculated in 157 Hispanic/Latino participants 107 women, (mean ±SD) age 56.7 ± 11.0 years, (median IQR) HbA1c 7.6 6.5, 9.4 %. For those diagnosed with T2D, n=133, duration of diabetes was 13.2±9.0 years. There were significant correlations between Weekday steps and age (-0.31), waist circumference (WC) (-0.30), and BMI (-0.22) (p<0.01). When stratified into 3 groups by Weekday steps (A <4,400, B 4,400 - 7,999, C ≥8,000), group A was significantly different from group C for age (63.8±8.4 vs. 53.3±9.9 years) and WC (111.1±12.9 vs. 96.6±10.7 cm). In conclusion, PA during Weekdays is higher than Weekends for Hispanic/Latino adults with or at risk for T2D. Weekday steps were also associated with a smaller WC and thus lower cardiometabolic risk. In this population, women were significantly more obese and insulin resistant than men.
While physical activity (PA) improves physical health, and wearable accelerometers clarify PA behavior, patterns of PA and cardiometabolic risk have not been well studied in ethnic minorities. In the ...Mil Familias observational cohort study of Hispanic/Latino adults with or at risk for type 2 diabetes (T2D) , PA was measured in 118 women and 59 men (age 56.9±10.6 years, mean±SD, HbA1c 7.1 6.3, 9.2 %, median IQR) ; 150 had T2D (duration 12.2±8.2 years) . An ActiGraph wGT3X-BT was worn on the right hip 24 hours/day for 7 consecutive days (mean 4.5±1.8 days) with ≥hours waking wear time as a valid day. We found that study participants in the low HbA1c (<7.0%) had significantly less waking sedentary minutes (SED) per day than those with high (≥7.0%) HbA1c (see table) . For men, there were significant differences for time standing and sitting, levels of moderate to vigorous physical activity (MVPA) , and LDL cholesterol. In women with diabetes (n=103) , individual fasting HDL (50.7±11.7 mg/dL) was positively correlated with light physical activity minutes (266.0±66.8, r=0.3, p<0.05) . Also, sitting minutes (328±83.2) and standing minutes (352±97.4) correlated with waist circumference (100±12.9 cm) , r=0.2 & r=-0.2, p≤0.respectively. In these Hispanic/Latino adults, PA (from work and/or exercise) and SED time appear to have important cardiometabolic health implications.
Disclosure
W.C.Bevier: Research Support; Abbott Diabetes. S.Lamunion: None. M.Roach: None. N.M.Glantz: Research Support; Abbott. A.Larez: Research Support; Abbott. K.N.Castorino: Consultant; Lilly Diabetes, Research Support; Abbott Diabetes, Dexcom, Inc., Drawbridge Health, Inc., Eyenuk, Inc., Laxmi Therapeutic Devices, Medtronic, National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk, Speaker's Bureau; Dexcom, Inc. K.Y.Chen: None. D.Kerr: Advisory Panel; Abbott Diabetes, Novo Nordisk A/S, Sanofi, Consultant; Evidation Health, Research Support; Novo Nordisk A/S, Stock/Shareholder; Glooko, Inc., Hi.Health.
For people with type 1 diabetes, there are limited evidence-based resources to support self-management when traveling across multiple time zones. Here, we compared glycemic control on insulin ...degludec versus glargine U100 as the basal insulin for adults using multiple daily injections (MDI) while traveling across multiple time zones.
This randomized crossover pilot study compared insulin degludec versus glargine U100 for adults with type 1 diabetes using MDI insulin during long-haul travel to and from Hawaii to New York. Insulin degludec was administered daily at the same time regardless of time zone, and glargine was administered per travel algorithm. Primary end point was the percentage of time in range (TIR) between 70 and 140 mg/dL during the initial 24 h after each direction of travel. Secondary end points included standard continuous glucose monitoring metrics, jet lag, fatigue, and sleep.
The study enrolled 25 participants (56% women, mean ± SD age of 35 ± 14.5 years, HbA1c of 7.4 ± 1.2% 57 ± 13.1 mmol/mol, and diabetes duration of 20.6 ± 15 years). There was no significant difference in glycemic outcomes between the two arms of the study, including TIR, hypoglycemia, or hyperglycemia. Neither group achieved >70% TIR 70-180 mg/dL during travel. Jet lag was greater on glargine U100 in eastward travel but not westward. Fatigue was greater after westward travel on glargine. Sleep was not significantly different between basal insulins.
In adults with type 1 diabetes using MDI of insulin and traveling across multiple time zones, glycemic outcomes were similar comparing insulin degludec and glargine U100.
The Tandem t:slim X2™ insulin pump with Basal-IQ® technology predicts glucose levels 30 minutes ahead based on the last 4 consecutive CGM readings. Insulin delivery is suspended if the predicted ...sensor glucose (SG) is <80 mg/dL or if the observed SG is <70 mg/dL. Insulin delivery resumes as soon as SG begins to rise. The pivotal trial (PROLOG) showed 3 weeks of Basal-IQ® use reduced SG time <70 mg/dL by 31% compared to sensor-augmented pump.
De-identified data voluntarily uploaded to the t:connect® diabetes management application between August 30, 2018, and February 7, 2019, from individuals with diabetes who have used Basal-IQ® technology for 3, 6, and 9 weeks (N=4082, 2370, and 1307 respectively) were retrospectively analyzed. Real-world Basal-IQ® hypoglycemia outcomes were compared to the PROLOG results.
After 3 weeks of real-world use, median time SG <70 mg/dL was 1.0% overall (1.0% daytime and 0.9% nighttime) vs. 2.6% (2.4% daytime and 2.7% nighttime) in PROLOG. Median time with SG <60 was 0.3% and time <50 mg/dL was 0.1%, vs. 0.9% and 0.2% in PROLOG. After 6 and 9 weeks, median time SG <70 mg/dL was 1.1%. Number of insulin suspensions and suspension duration were similar to PROLOG (Table 1).
Basal-IQ® technology was found to be safe and effective in a real-world setting, with similar PLGS activation metrics as observed in PROLOG. Results showed the Basal-IQ® algorithm performs successfully at preventing hypoglycemia.
Disclosure
J.E. Pinsker: Research Support; Self; Ascensia Diabetes Care, Dexcom, Inc., Insulet Corporation, LifeScan, Inc., Roche Diabetes Care, Tandem Diabetes Care. Speaker’s Bureau; Self; Tandem Diabetes Care. K.N. Castorino: Consultant; Self; Abbott. Research Support; Self; Abbott, Dexcom, Inc., Drawbridge, Novo Nordisk Inc., Sanofi US. S.A. Leas: Employee; Self; Tandem Diabetes Care. S. Habif: Employee; Self; Tandem Diabetes Care.
Funding
Tandem Diabetes Care, Inc.
Assessing physical activity (PA) in Hispanics/Latinos with/at risk of type 2 diabetes (T2D) may be challenging due to language, health literacy, and cultural barriers. We compared self-reported PA ...using Spanish-language pictograms (SP) with objectively assessed PA data in Hispanic/Latino adults with low education, with or at risk of T2D. Subjects n=102, 67 women, 88 T2D, age 58.2±10.3 years, BMI 31.3±5.7, HbA1c% 7.9±2.0, (mean±SD), and approximately 50% have less than high school education wore an Actigraph (AG) on the dominant hip to objectively monitor PA (steps) for 7 days stratified by time (6am-12pm, 12pm-6pm, 6pm-12am) and subjectively assessed PA, using SP, (stratified as sleep, sedentary rest and work, housework, manual work, and exercise) and 10-point Likert scale (1 "not active" to 10 "very, very active"). Subjects worked 5 (0-7) median (range) days with 3 also working (sedentary) at weekends. Most participants were asleep 12am - 6am, and 3 worked nights. Subjects self-perceived as very active (7.4±2.1 Likert score) at work. Barring exercise, objectively measured PA increased with SP-reported PA.
Glycemic control varies among different cohorts of pregnant women with diabetes. Most studies examining differences between groups using continuous glucose monitoring (CGM) data were performed with ...older CGM systems worn for 2-7 days. We examined differences in glycemic control and glycemic variability (GV) between pregnant women (n=32) with T1D (n=20), T2D (n=3), or GDM (n=9) in the 2nd and 3rd trimesters using the Dexcom G6 CGM system, worn for 10 days as part of a pregnancy CGM accuracy trial. Pair-wise comparisons were made between groups and group heterogeneity testing was performed. No adjustments were made for multiple comparisons analyses. Most women required insulin therapy (26/32, 81%). The baseline HbA1C levels were similar between groups (Table). The glucose management indicator (GMI) was numerically similar to HbA1C for the T1D and GDM cohorts. Time spent >140 mg/dL (p=0.009) was highest and time in range (63-140 mg/dL) was lowest (p=0.001) in women with T1D compared to the other groups. The coefficient of variation (CV) and mean amplitude of glycemic excursions (MAGE) were highest in the T1D group, lowest in the GDM group, and intermediate in the T2D group (p<0.0001 for each). Glycemic control was better and GV was lower for pregnant women with T2D and GDM compared to women with T1D. CGM use in pregnancy helps elucidate GV.
Disclosure
S. Polsky: None. C.J. Levy: Consultant; Self; Dexcom, Inc. Employee; Spouse/Partner; Allergan plc. Research Support; Self; Abbott, Dexcom, Inc., Insulet Corporation. X. Zhang: Employee; Self; Dexcom, Inc. S. Shah: Employee; Self; Dexcom, Inc. G. Haroush: None. K. Nelson: None. G. O’Malley: Research Support; Self; Abbott, Dexcom, Inc. S.J. Ogyaadu: None. S.J. Brackett: None. C. Levister: None. K.N. Castorino: Research Support; Self; Abbott, Dexcom, Inc., Medtronic, Mylan, Novo Nordisk Inc.
Funding
Dexcom, Inc.
In the U.S., Latinos have the highest proportion of type 2 diabetes (T2D) of any racial/ethnic group. Addressing cultural barriers and limited access to diabetes education may improve diabetes care ...and outcomes in this population. Diabetes Pueblo (DP) is an 11-week, culturally tailored, diabetes self-management education and support (DSMES) program led by Latinos in the community (Promotores). The program has two modules, diabetes fundamentals (DF) and insulin success. A pilot study was conducted to evaluate the feasibility of DP through class attendance and participant satisfaction. Additional endpoints included biometric data, HbA1c, the Diabetes Self-Management Questionnaire (DSMQ), and the Insulin Treatment Appraisal Scale (ITAS). Participants were 25 Latinos with T2D (20 completers) with a mean age of 55.8±10.5 years (64% female, 92% born in Latin America, 39% completed high school). Class attendance averaged 82%. Small nonsignificant improvements were observed in HbA1c, DSMQ, and ITAS positive appraisal at the completion of the program. ITAS negative appraisal scores improved significantly from 43 to 38 (p=0.02). Participant feedback reported improvement in distinguishing between diabetes and prediabetes (p=0.01). Post-class focus groups revealed very high satisfaction with the program, including improved understanding of how behaviors impact health and that insulin initiation does not indicate personal failure. There were no significant changes in biometrics possibly due to the short study duration. These results demonstrate the program’s feasibility through high attendance, program approval, improved diabetes self-management knowledge and acceptance of insulin therapy. This highlights the importance of using a culturally appropriate education program taught by community health workers for higher attendance and engagement. Future research may include larger-scale evaluations of the program with long-term follow-up to detect changes in biometric data.
Disclosure
J. Creason: None. C. Axelrod: None. M.M. Conneely: None. C. Landeros: None. M. Diaz-Rea: None. A.D. Xi: Employee; Self; Eli Lilly and Company. R. Paczkowski: Employee; Spouse/Partner; Amgen. Employee; Self; Eli Lilly and Company. B. Reed: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. F. Gelsey: Employee; Self; Lilly Diabetes. Stock/Shareholder; Self; Lilly Diabetes. K.N. Castorino: Research Support; Self; Abbott, Dexcom, Inc., Medtronic, Mylan, Novo Nordisk Inc.
Funding
Eli Lilly and Company
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