Carmen Quirós, María Teresa Herrera Arranz, Judit Amigó, Ana M Wägner, Pilar I Beato-Vibora, Sharona Azriel-Mira, Elisenda Climent, Berta Soldevila, Beatriz Barquiel, Natalia Colomo, María Durán-Martínez, Rosa Corcoy, Mercedes Codina, Gonzalo Díaz-Soto, Rosa Márquez Pardo, Maria A Martínez-Brocca, Ángel Rebollo Román, Gema López-Gallardo, Martín Cuesta, Javier García Fernández, Maria Goya, Begoña Vega Guedes, Lillian C Mendoza Mathison, Verónica Perea
{"title":"Real-World Evidence of Off-Label Use of Commercially Automated Insulin Delivery Systems Compared to Multiple Daily Insulin Injections in Pregnancies Complicated by Type 1 Diabetes.","authors":"Carmen Quirós, María Teresa Herrera Arranz, Judit Amigó, Ana M Wägner, Pilar I Beato-Vibora, Sharona Azriel-Mira, Elisenda Climent, Berta Soldevila, Beatriz Barquiel, Natalia Colomo, María Durán-Martínez, Rosa Corcoy, Mercedes Codina, Gonzalo Díaz-Soto, Rosa Márquez Pardo, Maria A Martínez-Brocca, Ángel Rebollo Román, Gema López-Gallardo, Martín Cuesta, Javier García Fernández, Maria Goya, Begoña Vega Guedes, Lillian C Mendoza Mathison, Verónica Perea","doi":"10.1089/dia.2023.0594","DOIUrl":"10.1089/dia.2023.0594","url":null,"abstract":"<p><p><b><i>Aims:</i></b> To compare glycemic control and maternal-fetal outcomes of women with type 1 diabetes (T1D) using hybrid closed loop (HCL) versus multiple daily insulin injections (MDI) plus continuous glucose monitoring. <b><i>Methods:</i></b> Multicenter prospective cohort study of pregnant women with T1D in Spain. We evaluated HbA1c and time spent within (TIR), below (TBR), and above (TAR) the pregnancy-specific glucose range of 3.5-7.8 mmol/L. Adjusted models were performed for adverse pregnancy outcomes, including baseline maternal characteristics and center. <b><i>Results:</i></b> One hundred twelve women were included (HCL <i>n</i> = 59). Women in the HCL group had a longer duration of diabetes and higher rates of prepregnancy care. There was no between-group difference in HbA1c in any trimester. However, in the second trimester, MDI users had a greater decrease in HbA1c (-6.12 ± 9.06 vs. -2.16 ± 7.42 mmol/mol, <i>P</i> = 0.031). No difference in TIR (3.5-7.8 mmol/L) and TAR was observed between HCL and MDI users, but with a higher total insulin dose in the second trimester [+0.13 IU/kg·day)]. HCL therapy was associated with increased maternal weight gain during pregnancy (β<sub>adjusted</sub> = 3.20 kg, 95% confidence interval [CI] 0.90-5.50). Regarding neonatal outcomes, newborns of HCL users were more likely to have higher birthweight (β<sub>adjusted</sub> = 279.0 g, 95% CI 39.5-518.5) and macrosomia (OR<sub>adjusted</sub> = 3.18, 95% CI 1.05-9.67) compared to MDI users. These associations disappeared when maternal weight gain or third trimester HbA1c was included in the models. <b><i>Conclusions:</i></b> In a real-world setting, HCL users gained more weight during pregnancy and had larger newborns than MDI users, while achieving similar glycemic control in terms of HbA1c and TIR.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"596-606"},"PeriodicalIF":5.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139989518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Valerie Gao, Janet K Snell-Bergeon, Emily Malecha, Carly A Johnson, Sarit Polsky
{"title":"Clinical Effectiveness of Continuous Glucose Monitoring in Pregnancies Affected by Type 1 Diabetes.","authors":"Valerie Gao, Janet K Snell-Bergeon, Emily Malecha, Carly A Johnson, Sarit Polsky","doi":"10.1089/dia.2023.0548","DOIUrl":"10.1089/dia.2023.0548","url":null,"abstract":"<p><p><b><i>Background:</i></b> Continuous glucose monitoring (CGM) improves neonatal outcomes in type 1 diabetes pregnancies; however, its effectiveness has not been assessed in a real-world setting in the United States. <b><i>Objective:</i></b> The Triple C Study aimed to examine the clinical effectiveness, assessed through maternal glucose control and gestational health outcomes, of CGM use compared with self-monitoring of blood glucose (SMBG) in pregnancies associated with type 1 diabetes in a real-world setting. <b><i>Research Design and Methods:</i></b> We retrospectively identified 160 type 1 diabetes pregnancies at the Barbara Davis Center for Diabetes managed with CGM therapy (<i>n</i> = 109) or SMBG (<i>n</i> = 51) over a 6.5-year period (2014-2020). Obstetric care was provided at multiple practices. CGM use was defined as ≥60% wear in the second and third trimesters of pregnancy. Data were obtained from the electronic medical record system, hospital records, and vital statistics departments (Colorado and Wyoming). We used Student's <i>t</i>-test for continuous variables and chi-square test for categorical variables to compare outcomes between groups. <b><i>Results:</i></b> The CGM group had more participants meeting trimester-specific hemoglobin A1C (HbA1c) goals throughout pregnancy and postpartum (<i>P</i> < 0.01 in each time period). The CGM group had fewer participants never meeting HbA1c goals in any trimester than the SMBG group (<i>P</i> < 0.001). There were no significant differences in neonatal outcomes between groups, other than for macrosomia (12.8% CGM vs. 29.4% SMBG, <i>P</i> = 0.01). Infants of CGM users required a neonatal intensive care unit admission less often (52.9% CGM vs. 68.3% SMBG, <i>P</i> = 0.0989). <b><i>Conclusions:</i></b> CGM use was associated with improved maternal glucose levels in a diverse real-world cohort.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"526-535"},"PeriodicalIF":5.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139930411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gilberte Martine-Edith, Natalie Zaremba, Patrick Divilly, Uffe Søholm, Melanie Broadley, Petra Martina Baumann, Zeinab Mahmoudi, Mikel Gomes, Namam Ali, Evertine J Abbink, Bastiaan de Galan, Julie Brøsen, Ulrik Pedersen-Bjergaard, Allan A Vaag, Rory J McCrimmon, Eric Renard, Simon Heller, Mark Evans, Monika Cigler, Julia K Mader, Stephanie A Amiel, Jane Speight, Frans Pouwer, Pratik Choudhary
{"title":"Associations Between Hypoglycemia Awareness Status and Symptoms of Hypoglycemia Among Adults with Type 1 or Insulin-Treated Type 2 Diabetes Using the Hypo-METRICS Smartphone Application.","authors":"Gilberte Martine-Edith, Natalie Zaremba, Patrick Divilly, Uffe Søholm, Melanie Broadley, Petra Martina Baumann, Zeinab Mahmoudi, Mikel Gomes, Namam Ali, Evertine J Abbink, Bastiaan de Galan, Julie Brøsen, Ulrik Pedersen-Bjergaard, Allan A Vaag, Rory J McCrimmon, Eric Renard, Simon Heller, Mark Evans, Monika Cigler, Julia K Mader, Stephanie A Amiel, Jane Speight, Frans Pouwer, Pratik Choudhary","doi":"10.1089/dia.2023.0596","DOIUrl":"10.1089/dia.2023.0596","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> This study examined associations between hypoglycemia awareness status and hypoglycemia symptoms reported in real-time using the novel Hypoglycaemia-MEasurement, ThResholds and ImpaCtS (Hypo-METRICS) smartphone application (app) among adults with insulin-treated type 1 (T1D) or type 2 diabetes (T2D). <b><i>Methods:</i></b> Adults who experienced at least one hypoglycemic episode in the previous 3 months were recruited to the Hypo-METRICS study. They prospectively reported hypoglycemia episodes using the app for 10 weeks. Any of eight hypoglycemia symptoms were considered present if intensity was rated between \"A little bit\" to \"Very much\" and absent if rated \"Not at all.\" Associations between hypoglycemia awareness (as defined by Gold score) and hypoglycemia symptoms were modeled using mixed-effects binary logistic regression, adjusting for glucose monitoring method and diabetes duration. <b><i>Results:</i></b> Of 531 participants (48% T1D, 52% T2D), 45% were women, 91% white, and 59% used Flash or continuous glucose monitoring. Impaired awareness of hypoglycemia (IAH) was associated with lower odds of reporting autonomic symptoms than normal awareness of hypoglycemia (NAH) (T1D odds ratio [OR] 0.43 [95% confidence interval {CI} 0.25-0.73], <i>P</i> = 0.002); T2D OR 0.51 [95% CI 0.26-0.99], <i>P</i> = 0.048), with no differences in neuroglycopenic symptoms. In T1D, relative to NAH, IAH was associated with higher odds of reporting autonomic symptoms at a glucose concentration <54 than >70 mg/dL (OR 2.18 [95% CI 1.21-3.94], <i>P</i> = 0.010). <b><i>Conclusion:</i></b> The Hypo-METRICS app is sensitive to differences in hypoglycemia symptoms according to hypoglycemia awareness in both diabetes types. Given its high ecological validity and low recall bias, the app may be a useful tool in research and clinical settings. The clinical trial registration number is NCT04304963.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"566-574"},"PeriodicalIF":5.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140184012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Robbe De Groote, Eveline Lefever, Sara Charleer, Phebe Donné, Christophe De Block, Chantal Mathieu, Pieter Gillard
{"title":"Continuous Glucose Monitoring-Derived Glucometrics in Adults with Type 1 Diabetes When Switching Basal Insulins.","authors":"Robbe De Groote, Eveline Lefever, Sara Charleer, Phebe Donné, Christophe De Block, Chantal Mathieu, Pieter Gillard","doi":"10.1089/dia.2023.0616","DOIUrl":"10.1089/dia.2023.0616","url":null,"abstract":"<p><p><b><i>Context:</i></b> Limited evidence is available on the real-world effect of insulin degludec (IDeg) in type 1 diabetes (T1D), using continuous glucose monitoring (CGM)-derived metrics. <b><i>Objective:</i></b> To assess the real-world effect of switching to IDeg from other long-acting insulins on time in ranges (TIRs) measured by CGM, metabolic control, and insulin dose for people with T1D. <b><i>Design:</i></b> This retrospective multicenter study encompassed five time points during a 12-month pre-switch of IDeg and a 12-month follow-up period. For each visit, clinical and CGM data were collected to evaluate temporal trends in glycemic outcomes. <b><i>Participants:</i></b> Of 753 persons with T1D who were assessed for eligibility, 486 persons were included, mostly men (61.5%), 47.4 (16.9) years old and diabetes duration of 23.8 (14.2) years at IDeg-initiation. <b><i>Main Outcome Measure:</i></b> Primary outcome was the evolution of percent TIR (70-180 mg/dL or 3.9-10.0 mmol/L, TIR) before versus after switch to IDeg. <b><i>Results:</i></b> TIR over 24 h increased at 12 months versus baseline (56.7% vs. 52.3%, <i>P</i> < 0.001), mostly during daytime. Time <54 mg/dL (<3.0 mmol/L) over 24 h decreased at 12 months versus baseline (2.02% vs. 2.86%, <i>P</i> < 0.001), mostly during nighttime. Glycated hemoglobin (7.9% vs. 8.1%, <i>P</i> < 0.001) and coefficient of variation (40.0% vs. 41.5%, <i>P</i> < 0.001) improved at 12 months versus baseline. Mean daily basal, bolus and total insulin doses decreased at 12 months (<i>P</i> < 0.001 for all vs. baseline). <b><i>Conclusions:</i></b> This retrospective real-world study reports that switching basal insulin significantly improved time spent in glucometric ranges and glycemic variability in the studied population of people with T1D. Clinical Trial Registration number: NCT05434559.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"587-595"},"PeriodicalIF":5.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140184013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Julie Carstens Søholm, Sidse K Nørgaard, Kirsten Nørgaard, Tine D Clausen, Peter Damm, Elisabeth R Mathiesen, Lene Ringholm
{"title":"Mean Glucose and Gestational Weight Gain as Predictors of Large-for-Gestational-Age Infants in Pregnant Women with Type 1 Diabetes Using Continuous Glucose Monitoring.","authors":"Julie Carstens Søholm, Sidse K Nørgaard, Kirsten Nørgaard, Tine D Clausen, Peter Damm, Elisabeth R Mathiesen, Lene Ringholm","doi":"10.1089/dia.2023.0583","DOIUrl":"10.1089/dia.2023.0583","url":null,"abstract":"<p><p><b><i>Aims/hypothesis:</i></b> To compare glycemic metrics during pregnancy between women with type 1 diabetes (T1D) delivering large-for-gestational-age (LGA) and appropriate-for-gestational-age (AGA) infants, and to identify predictors of LGA infants. <b><i>Materials and Methods:</i></b> A cohort study including 111 women with T1D using intermittently scanned continuous glucose monitoring from conception until delivery. Average sensor-derived metrics: mean glucose, time in range in pregnancy (TIRp), time above range in pregnancy, time below range in pregnancy, and coefficient of variation throughout pregnancy and in pregnancy intervals of 0-10, 11-21, 22-33, and 34-37 weeks were compared between women delivering LGA and AGA infants. Predictors of LGA infants were sought for. Infant growth was followed until 3 months postdelivery. <b><i>Results:</i></b> In total, 53% (<i>n</i> = 59) delivered LGA infants. Mean glucose decreased during pregnancy in both groups, with women delivering LGA infants having a 0.4 mmol/L higher mean glucose from 11-33 weeks (<i>P</i> = 0.01) compared with women delivering AGA infants. Mean TIRp >70% was obtained from 34 weeks in women delivering LGA infants and from 22-33 weeks in women delivering AGA infants. Independent predictors for delivering LGA infants were mean glucose throughout pregnancy and gestational weight gain. At 3 months postdelivery, infant weight was higher in infants born LGA compared with infants born AGA (6360 g ± 784 and 5988 ± 894, <i>P</i> = 0.04). <b><i>Conclusions/interpretations:</i></b> Women with T1D delivering LGA infants achieved glycemic targets later than women delivering AGA infants. Mean glucose and gestational weight gain were independent predictors for delivering LGA infants. Infants born LGA remained larger postdelivery compared with infants born AGA.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"536-546"},"PeriodicalIF":5.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139989576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gregory P Forlenza, Daniel J DeSalvo, Grazia Aleppo, Emma G Wilmot, Cari Berget, Lauren M Huyett, Irene Hadjiyianni, José J Méndez, Lindsey R Conroy, Trang T Ly, Jennifer L Sherr
{"title":"Real-World Evidence of Omnipod<sup>®</sup> 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes.","authors":"Gregory P Forlenza, Daniel J DeSalvo, Grazia Aleppo, Emma G Wilmot, Cari Berget, Lauren M Huyett, Irene Hadjiyianni, José J Méndez, Lindsey R Conroy, Trang T Ly, Jennifer L Sherr","doi":"10.1089/dia.2023.0578","DOIUrl":"10.1089/dia.2023.0578","url":null,"abstract":"<p><p><b><i>Background:</i></b> The Omnipod<sup>®</sup> 5 Automated Insulin Delivery System was associated with favorable glycemic outcomes for people with type 1 diabetes (T1D) in two pivotal clinical trials. Real-world evidence is needed to explore effectiveness in nonstudy conditions. <b><i>Methods:</i></b> A retrospective analysis of the United States Omnipod 5 System users (aged ≥2 years) with T1D and sufficient data (≥90 days of data; ≥75% of days with ≥220 continuous glucose monitor readings/day) available in Insulet Corporation's device and person-reported datasets as of July 2023 was performed. Target glucose setting usage (i.e., 110-150 mg/dL in 10 mg/dL increments) was summarized and glycemic outcomes were examined. Subgroup analyses of those using the lowest average glucose target (110 mg/dL) and stratification by baseline characteristics (e.g., age, prior therapy, health insurance coverage) were conducted. <b><i>Results:</i></b> In total, 69,902 users were included. Multiple and higher glucose targets were more commonly used in younger age groups. Median percentage of time in range (TIR; 70-180 mg/dL) was 68.8%, 61.3%, and 53.6% for users with average glucose targets of 110, 120, and 130-150 mg/dL, respectively, with minimal time <70 mg/dL (all median <1.13%). Among those with an average glucose target of 110 mg/dL (<i>n</i> = 37,640), median TIR was 65.0% in children and adolescents (2-17 years) and 69.9% in adults (≥18 years). Subgroup analyses of users transitioning from Omnipod DASH or multiple daily injections and of Medicaid/Medicare users demonstrated favorable glycemic outcomes among these groups. <b><i>Conclusion:</i></b> These glycemic outcomes from a large and diverse sample of nearly 70,000 children and adults demonstrate effective use of the Omnipod 5 System under real-world conditions.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"514-525"},"PeriodicalIF":5.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139905307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sara Charleer, Steffen Fieuws, Christophe De Block, Nancy Bolsens, Frank Nobels, Kristian Mikkelsen, Chantal Mathieu, Pieter Gillard
{"title":"Evaluation of Glucose Metrics in Adults with Type 1 Diabetes Switching to Insulin Glargine 300 U/mL: A Retrospective, Propensity-Score Matched Study.","authors":"Sara Charleer, Steffen Fieuws, Christophe De Block, Nancy Bolsens, Frank Nobels, Kristian Mikkelsen, Chantal Mathieu, Pieter Gillard","doi":"10.1089/dia.2023.0371","DOIUrl":"10.1089/dia.2023.0371","url":null,"abstract":"<p><p><b><i>Objectives:</i></b> To study real-world effect of switching to Insulin Glargine 300 U/mL (Gla-300) on glucose metrics in people with type 1 diabetes. <b><i>Methods:</i></b> This retrospective secondary-use study compared 151 adults who switched to Gla-300 from first-generation long-acting insulins (Switchers) to 281 propensity-score matched controls (Non-switchers) who continued first-generation long-acting insulins. Primary endpoint was difference in time in range (TIR) evolution. A fictive \"switching\" date was assigned to Non-switchers to facilitate between-group comparisons. <b><i>Results:</i></b> In the period before switching, TIR decreased numerically for people in whom Gla-300 was eventually initiated (-0.05%/month [-0.16 to 0.07]), while it increased for matched controls (0.08%/month [0.02 to 0.015]; between-group difference <i>P</i> = 0.047). After Gla-300-initiation, Switchers had similar TIR increase compared to Non-switchers (<i>P</i> = 0.531). Switchers used higher basal dose than before switch (Δ0.012 U/[kg·d] [0.006 to 0.018]; <i>P</i> < 0.0001). <b><i>Conclusion:</i></b> In real-life, Gla-300 was typically initiated in people where TIR was decreasing, which was reversed after switch using slightly higher basal insulin dose. <b><i>ClinicalTrials:</i></b> ClinicalTrials.gov number NCT05109520.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"488-493"},"PeriodicalIF":5.7,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139930412","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jean-Baptiste Julla, Pauline Jacquemier, Elisabeth Bonnemaison, Guy Fagherazzi, Hélène Hanaire, Pauline Bellicar Schaepelynck, Mihaela Mihaileanu, Eric Renard, Yves Reznik, Jean-Pierre Riveline
{"title":"Assessment of the Impact of Subcutaneous Catheter Change on Glucose Control in Patients with Type 1 Diabetes Treated by Insulin Pump in Open- and Closed-Loop Modes.","authors":"Jean-Baptiste Julla, Pauline Jacquemier, Elisabeth Bonnemaison, Guy Fagherazzi, Hélène Hanaire, Pauline Bellicar Schaepelynck, Mihaela Mihaileanu, Eric Renard, Yves Reznik, Jean-Pierre Riveline","doi":"10.1089/dia.2023.0568","DOIUrl":"10.1089/dia.2023.0568","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> Most continuous subcutaneous insulin infusion (CSII) catheters (KT) are changed every 3 days. This study aims at evaluating whether KT changes impact glucose control while under open-loop (OL) or automated insulin delivery (AID) modes. <b><i>Methods:</i></b> We included patients with type 1 diabetes who used Tandem t:slim x2 insulin pump and Dexcom G6 glucose sensor for 20 days in OL, then as AID. CSII and sensor glucose data in OL and for the past 20 days of 3-month AID were retrospectively analyzed. The percentage of time spent with sensor glucose above 180 mg/dL (%TAR180) was compared between the calendar day of KT change (D0), the next day (D1), and 2 days later (D2). Values were adjusted for age, gender, body mass index (BMI), hemoglobin A1c (HbA1c) at inclusion, and %TAR180 for the 2 h before KT change. <b><i>Results:</i></b> A total of 1636 KT changes were analyzed in 134 patients: 72 women (54%), age: 35.6 ± 15.7 years, BMI: 25.2 ± 4.7 kg/m<sup>2</sup>, and HbA1c: 7.5 ± 0.8%. %TAR180 in the 2 h before the KT change was 51.3 ± 37.0% in OL and 33.2 ± 30.0% in AID mode. In OL, significant absolute increases of %TAR180 at D0 versus D1 (+6.9%; <i>P</i> < 0.0001) or versus D2 (+6.8%; <i>P</i> < 0.0001) were observed. In AID, significant absolute increases of %TA180R at D0 versus D1 (+4.8%; <i>P</i> < 0.0001) or versus D2 (+4.2%; <i>P</i> < 0.0001) were also observed. <b><i>Conclusion:</i></b> This study shows an increase in time spent in hyperglycemia on the day of the KT change both in OL and AID modes. This additional information should be taken into account to improve current AID algorithms. <b><i>ClinicalTrials.gov:</i></b> NCT04939766.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"442-448"},"PeriodicalIF":5.7,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139729235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pablo Rodríguez de Vera Gómez, Carmen Mateo Rodríguez, Beatriz Rodríguez Jiménez, Lucía Hidalgo Sotelo, Mercedes Peinado Ruiz, Eduardo Torrecillas Del Castillo, Desirée Ruiz-Aranda, Isabel Serrano Olmedo, Ángela Candau Martín, María Asunción Martínez-Brocca
{"title":"Impact of Flash Glucose Monitoring on the Fear of Hypoglycemia Phenomenon in Adults with Type 1 Diabetes.","authors":"Pablo Rodríguez de Vera Gómez, Carmen Mateo Rodríguez, Beatriz Rodríguez Jiménez, Lucía Hidalgo Sotelo, Mercedes Peinado Ruiz, Eduardo Torrecillas Del Castillo, Desirée Ruiz-Aranda, Isabel Serrano Olmedo, Ángela Candau Martín, María Asunción Martínez-Brocca","doi":"10.1089/dia.2023.0370","DOIUrl":"10.1089/dia.2023.0370","url":null,"abstract":"<p><p><b><i>Objective:</i></b> To assess the clinical impact of flash glucose monitoring (FGM) systems on fear of hypoglycemia (FoH) and quality of life in adults with type 1 diabetes mellitus (T1DM). <b><i>Methods:</i></b> Prospective quasi-experimental study with a 12-month follow-up. People with T1DM (18-80 years old) and self-monitoring by blood capillary glycemia controls were included. The FH15 questionnaire, a survey validated in Spanish in a comparable study population, was used to diagnose FoH with a cutoff point of 28 points. <b><i>Results:</i></b> A total of 181 participants were included, with a FoH prevalence of 69% (<i>n</i> = 123). A mean reduction in FH15 score of -4 points (95% confidence interval [-5.5 to -3]; <i>P</i> < 0.001) was observed, along with an improvement in quality of life (EsDQOL-test (Diabetes Quality of Life, Spanish version), -7 points [-10; -4], <i>P</i> < 0.001) and satisfaction with treatment (Diabetes Treatment Satisfaction questionnaire, self-reported version [DTSQ-s] test, +4.5 points [4; 5.5], <i>P</i> < 0.001). At the end of the follow-up, 64.2% of the participants saw an improved FoH intensity, compared to 35.8% who scored the same or higher. This improvement in FoH status was associated with a higher time-in-range at the end of the follow-up (<i>P</i> = 0.003), as well as a lower time spent in hyperglycemia (<i>P</i> = 0.005). In addition, it was linked to participants with a high baseline FoH levels (<i>P</i> < 0.001) and those who were university degree holders (<i>P</i> = 0.07). <b><i>Conclusions:</i></b> FGM is associated with an overall reduction of FoH in adults with T1DM and with an increase in their quality of life. Nevertheless, a significant percentage of patients may experience an increase of this phenomenon leading to clinical repercussions and a profound impact on quality of life.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"478-487"},"PeriodicalIF":5.7,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139691384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lukana Preechasuk, Parizad Avari, Nick Oliver, Monika Reddy
{"title":"Switching from Intermittently Scanned Continuous Glucose Monitoring to Real-Time Continuous Glucose Monitoring with a Predictive Urgent Low Soon Alert Reduces Exposure to Hypoglycemia.","authors":"Lukana Preechasuk, Parizad Avari, Nick Oliver, Monika Reddy","doi":"10.1089/dia.2023.0434","DOIUrl":"10.1089/dia.2023.0434","url":null,"abstract":"<p><p>Differences in the effectiveness of real-time continuous glucose monitoring (rtCGM) and intermittently scanned continuous glucose monitoring (isCGM) in type 1 diabetes (T1D) are reported. The impact on percent time in range of switching from an isCGM with glucose threshold-based optional alerts only (FreeStyle Libre 2 [FSL2]) to an rtCGM (Dexcom G7) with an urgent low soon predictive alert was assessed, alongside other secondary outcomes including hemoglobin A1c (HbA1c) and other continuous glucose monitoring metrics. Adults with T1D using FSL2 were switched to Dexcom G7 for 12 weeks. HbA1c and continuous glucose data during FSL2 and Dexcom G7 use were compared. Data from 29 participants (aged 44.8 ± 16.5 years, 12 male and 17 female) were analyzed. After switching to rtCGM, participants spent less time in hypoglycemia below 3.9 mmol/L (70 mg/dL) (3.0% [1.0%, 5.0%] vs. 2.0% [1.0%, 3.0%], <i>P</i> = 0.006) and had higher percentage achievement of time below 3.9 mmol/L (70 mg/dL) of <4% (55.2% vs. 82.8%, <i>P</i> = 0.005). Coefficient of variation was lower (39.3 ± 6.6% vs. 37.2 ± 5.6%, <i>P</i> = 0.008). In conclusion, adults with T1D who switched from isCGM to rtCGM may benefit from reduced exposure to hypoglycemia and glycemic variability.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"498-502"},"PeriodicalIF":5.7,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139691387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}